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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21MH120696 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Cape Town | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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Naturalistic Developmental Behavioral Interventions (NDBIs), an evidence-based early autism spectrum disorder (ASD) intervention approach, target key behaviors that help language development. While efforts to use NDBIs are increasing worldwide, important gaps in our knowledge remain on whether the behaviors targeted by NDBIs are cross-culturally valid. This study in South Africa, a multi-cultural setting, will provide critical information on NDBI treatment targets and a novel digital outcome measure of treatment response.
COVID-19 adaptations: We aim to develop and implement telehealth NDBI coaching and utilize a mixed methods approach to gather implementation and preliminary effectiveness data on the telehealth intervention.
COVID-19 has significantly impacted autism spectrum disorder (ASD) clinical research and disrupted access to intervention services for children and families globally. In this ongoing study in Cape Town South Africa, a caregiver coaching Naturalistic Developmental Behavioral Intervention (NDBI) for young children with ASD has been adapted for implementation by non-specialists and implementation and clinical outcomes are being evaluated. For ongoing clinical trials, the University of Cape Town Institutional Review Board (IRB) has encouraged researchers to switch to a virtual platform, where possible. Telehealth caregiver coaching is cost-effective, increases access to rural and underserved populations, and improves understanding of family home and caregiving routines. We aim to develop and implement telehealth NDBI coaching and utilize a mixed methods approach and a longitudinal pre-post design to gather implementation and preliminary effectiveness data on the telehealth intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caregiver-Child Dyads with ASD (Autism Spectrum Disorder) | Experimental | Participants in this arm will be caregivers of and children with ASD. |
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| Children with typical development | No Intervention | Participants in this arm will be children with typical development. | |
| Children with developmental delay | No Intervention | Participants in this arm will be children with developmental delay. | |
| Caregiver-Child Dyads with ASD (Autism Spectrum Disorder) Telehealth Adaptation | Experimental | Participants in this arm will be caregivers of and children with ASD receiving telehealth intervention (adaptation due to COVID-19 restrictions). |
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| Early Childhood Development (ECD) Practitioners and ECD Practitioner School Supervisors | No Intervention | The ECD worker and/or school supervisor are 1) employed by our participating recruitment partners (Western Cape Education Department Schools) and 2) involved in delivery of the caregiver coaching sessions, either in person or remotely. | |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Start Denver Model (ESDM) | Behavioral | Twelve one hour sessions, skill is introduced by "Help is in your hands" Community ESDM videos. Session skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. "Help is in your hands" Community ESDM materials also provide video examples of other caregivers using the session skill with their child. The early childhood development practitioner then coaches the caregiver in the session skill, in at least two activities. The goal of coaching was to provide enough support for the caregiver to experience success in implementing the new skill with their child. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill across various daily activities, using a daily activities visual aid. |
| Measure | Description | Time Frame |
|---|---|---|
| Supported Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Child engagement states measured by the Joint Engagement Rating Inventory (JERI) ; in the ASD group; the typically developing group; and the developmental delay group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates a very low rating and no time spent in that engagement state, 4 is the midpoint indicating the moderate time and quality of episodes in an engagement state, and 7 indicates a very high rating and high-quality engagement. | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) |
| Coordinated Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Child engagement states measured by the Joint Engagement Rating Inventory (JERI) in the ASD group; the typically developing group; and the developmental delay group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates a very low rating and no time spent in that engagement state, 4 is the midpoint indicating the moderate time and quality of episodes in an engagement state, and 7 indicates a very high rating and high-quality engagement. | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) |
| Symbol-infused Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Child engagement states measured by the Joint Engagement Rating Inventory (JERI) in the ASD group; the typically developing group; and the developmental delay group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates a very low rating and no time spent in that engagement state, 4 is the midpoint indicating the moderate time and quality of episodes in an engagement state, and 7 indicates a very high rating and high-quality engagement. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Telehealth Intervention (as Measured by the Acceptability of Intervention Measure, AIM) | A 5-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scores are indicated on a scale of 1 - 5 with higher scores indicating greater acceptability. | Follow-up (within 2 weeks of ending sessions) |
| Measure | Description | Time Frame |
|---|---|---|
| Postural Sway Measured by the SenseToKnow App | SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name). |
Inclusion Criteria:
For ASD, DD, TD groups
For the ASD group only:
For the developmental delay (DD) group only:
For the typically developing (TD) group only:
-Child screens negative on the Ten Questions and negative for ASD on the ABC
For the Early Childhood Development (ECD) Practitioners and Early Childhood Development Practitioner School Supervisors group:
For the Early Start Denver Model (ESDM) supervisors group:
Exclusion Criteria:
For all groups (ASD, DD, TD)
For the ASD group:
For the developmental delay (DD) group
-Autism diagnosis based on DSM 5 criteria
For typically developing (TD group:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Franz, MB, CHB | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cape Town | Cape Town | West Cape | South Africa |
All individual-level descriptive data will be submitted to the NIH/NIMH (National Institute of Mental Health) data repositories on a quarterly. Submission of all other experimental data will occur after the primary objectives of the R21 have been met. Prior to submission, dedicated research staff will review accuracy and conduct additional manual and automated checks for presence of protected health information (PHI) in the submitted data. Submissions will include protocols, questionnaires, study manuals, variables measured, and any other necessary documentation. All submitted data (both descriptive/raw and analyzed data) will be made available for access by members of the research community according to the provisions defined in the NDAR (National Database for Autism Research) and the NIH/NIMH Data Repositories Data Sharing Policy. All research data will be made accessible to other researchers within four months of submission, allowing sufficient time to complete QA/QC procedures.
As per NDAR requirements
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One participant from the Children with Typical Development group was deemed ineligible post-enrollment.
ASD caregiver-child dyads were recruited from Western Cape Department of Education Autism Schools; children with developmental delay from Neurodevelopmental Clinics at Red Cross Children's Hospital; typically developing children from ECD Centers. ASD caregiver-child dyads could opt to continue with Telehealth intervention when COVID restrictions were implemented. Participants recruited March 2020-March 2021 received telehealth intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Caregiver-Child Dyads With ASD (In-person Intervention ONLY) - Caregivers | Participants in this arm will be caregivers of children with ASD. Early Start Denver Model (ESDM): Twelve one hour sessions, skill is introduced by "Help is in your hands" Community ESDM videos. Session skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. "Help is in your hands" Community ESDM materials also provide video examples of other caregivers using the session skill with their child. The early childhood development practitioner then coaches the caregiver in the session skill, in at least two activities. The goal of coaching was to provide enough support for the caregiver to experience success in implementing the new skill with their child. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill across various daily activities, using a daily activities visual aid. |
| FG001 | Caregiver-Child Dyads With ASD (In-person Intervention ONLY) - Children | Participants in this arm will be children with ASD. Early Start Denver Model (ESDM): Twelve one hour sessions, skill is introduced by "Help is in your hands" Community ESDM videos. Session skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. "Help is in your hands" Community ESDM materials also provide video examples of other caregivers using the session skill with their child. The early childhood development practitioner then coaches the caregiver in the session skill, in at least two activities. The goal of coaching was to provide enough support for the caregiver to experience success in implementing the new skill with their child. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill across various daily activities, using a daily activities visual aid. |
| FG002 | Caregiver-Child Dyads With ASD (In-person, Then Telehealth Intervention) - Caregivers | Participants in this arm will be caregivers of children with ASD who began the intervention in-person and moved to telehealth due to COVID-19 restrictions. In-person: Twelve 1-hour sessions, skill is introduced by "Help is in your hands" Community Early Start Denver Model (C-ESDM) videos. Skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. The ECD practitioner then coaches the caregiver in at least two activities. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill using a daily activities visual aid. Telehealth coaching: The telehealth coaching intervention was informed by the C-ESDM materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached as above (via phone). Prior to the coaching session staff shared session materials with the family via WhatsApp and the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist. |
| FG003 | Caregiver-Child Dyads With ASD (In-person, Then Telehealth Intervention) - Children | Participants in this arm will be children with ASD who began the intervention in-person and moved to telehealth due to COVID-19 restrictions. In-person: Twelve 1-hour sessions, skill is introduced by "Help is in your hands" Community Early Start Denver Model (C-ESDM) videos. Skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. The ECD practitioner then coaches the caregiver in at least two activities. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill using a daily activities visual aid. Telehealth coaching: The telehealth coaching intervention was informed by the C-ESDM materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached as above (via phone). Prior to the coaching session staff shared session materials with the family via WhatsApp and the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist. |
| FG004 | Caregiver-Child Dyads With ASD (Telehealth Intervention ONLY) - Caregivers | Participants in this arm will be caregivers of children with ASD receiving telehealth intervention (adaptation due to COVID-19 restrictions). Telehealth coaching: The telehealth coaching intervention was informed by the Community-Early Start Denver Model (C-ESDM) materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached in strategies to increase child attention to their social world, increase child communication, create and build joint activity routines, and understand and use the ABCs to support the development of new behaviors. The session itself being delivered via phone. Prior to the coaching session staff shared session materials with the family via WhatsApp. Prior to the session the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist. |
| FG005 | Caregiver-Child Dyads With ASD (Telehealth Intervention ONLY) - Children | Participants in this arm will be children with ASD receiving telehealth intervention (adaptation due to COVID-19 restrictions). Telehealth coaching: The telehealth coaching intervention was informed by the Community-Early Start Denver Model (C-ESDM) materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached in strategies to increase child attention to their social world, increase child communication, create and build joint activity routines, and understand and use the ABCs to support the development of new behaviors. The session itself being delivered via phone. Prior to the coaching session staff shared session materials with the family via WhatsApp. Prior to the session the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist. |
| FG006 | Children With Typical Development | Participants in this arm will be children with typical development. No intervention. |
| FG007 | Children With Developmental Delay | Participants in this arm will be children with developmental delay. No intervention. |
| FG008 | Early Childhood Development (ECD) Practitioners and ECD Practitioner School Supervisors | The ECD worker and/or school supervisor are 1) employed by our participating recruitment partners (Western Cape Education Department Schools) and 2) involved in delivery of the caregiver coaching sessions, either in person or remotely. |
| FG009 | Early Start Denver Model (ESDM) Supervisors | The local supervisors are 1) trained ESDM therapist, 2) supervise weekly coaching sessions in the schools, and/or 3) supervise remote intervention delivery sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Caregiver-Child Dyads With ASD (In-person Intervention ONLY) - Caregivers | Participants in this arm will be caregivers of children with ASD. Early Start Denver Model (ESDM): Twelve one hour sessions, skill is introduced by "Help is in your hands" Community ESDM videos. Session skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. "Help is in your hands" Community ESDM materials also provide video examples of other caregivers using the session skill with their child. The early childhood development practitioner then coaches the caregiver in the session skill, in at least two activities. The goal of coaching was to provide enough support for the caregiver to experience success in implementing the new skill with their child. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill across various daily activities, using a daily activities visual aid. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Caregivers only. Data not collected on ECD Practitioners and ECD Practitioner School Supervisors or ESDM Supervisors groups. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Supported Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Child engagement states measured by the Joint Engagement Rating Inventory (JERI) ; in the ASD group; the typically developing group; and the developmental delay group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates a very low rating and no time spent in that engagement state, 4 is the midpoint indicating the moderate time and quality of episodes in an engagement state, and 7 indicates a very high rating and high-quality engagement. | Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay. | Posted | Median | Full Range | score on a scale | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) |
Up to 4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caregiver-Child Dyads With ASD (In-person Intervention ONLY) - Caregivers | Participants in this arm will be caregivers of children with ASD. Early Start Denver Model (ESDM): Twelve one hour sessions, skill is introduced by "Help is in your hands" Community ESDM videos. Session skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. "Help is in your hands" Community ESDM materials also provide video examples of other caregivers using the session skill with their child. The early childhood development practitioner then coaches the caregiver in the session skill, in at least two activities. The goal of coaching was to provide enough support for the caregiver to experience success in implementing the new skill with their child. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill across various daily activities, using a daily activities visual aid. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren Franz MBChB, MPH | Duke University | 919-681-0023 | lauren.franz@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2019 | Aug 24, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 9, 2021 | Nov 8, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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Note the autism group will be the only group to receive intervention. The typically developing and developmental delay group will receive one baseline assessment, and no intervention. COVID-19 necessitated a pivot from in-person to telehealth coaching.
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| Early Start Denver Model (ESDM) Supervisors |
| No Intervention |
The local supervisors are 1) trained ESDM therapist, 2) supervise weekly coaching sessions in the schools, and/or 3) supervise remote intervention delivery sessions. |
|
| Telehealth coaching | Behavioral | The telehealth coaching intervention was informed by the Community-Early Start Denver Model (C-ESDM) materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached in strategies to increase child attention to their social world, increase child communication, create and build joint activity routines, and understand and use the ABCs to support the development of new behaviors. The session itself being delivered via phone. Prior to the coaching session staff shared session materials with the family via WhatsApp. Prior to the session the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist. |
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| Baseline and Follow-up (after 12 intervention sessions, up to 3 months) |
| Fluency and Connectedness Measured by the Joint Engagement Rating Inventory (JERI) | Caregiver-child dyadic exchanges measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates no interaction between the dyad, a rating of 7 indicates a balanced dyadic exchange that flows naturally back and forth. | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) |
| Shared Routines and Rituals Measured by the Joint Engagement Rating Inventory (JERI) | Caregiver-child dyadic exchanges measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates no interaction between the dyad, a rating of 7 indicates a balanced dyadic exchange that flows naturally back and forth. | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) |
| Scaffolding Measured by the Joint Engagement Rating Inventory (JERI) | Caregiver strategies measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates that the caregiver rarely uses the caregiver strategy to support the child's activity and language. A rating of 7 indicates that the caregiver frequently uses appropriate strategies to support and expand their child's activity and language. | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) |
| Following in on a Child's Focus Measured by the Joint Engagement Rating Inventory (JERI) | Caregiver strategies measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates that the caregiver rarely uses the caregiver strategy to support the child's activity and language. A rating of 7 indicates that the caregiver frequently uses appropriate strategies to support and expand their child's activity and language. | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) |
| Caregiver Affect Measured by the Joint Engagement Rating Inventory (JERI) | Caregiver strategies measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates that the caregiver rarely uses the caregiver strategy to support the child's activity and language. A rating of 7 indicates that the caregiver frequently uses appropriate strategies to support and expand their child's activity and language. | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) |
| Initiation of Joint Attention (IJA) Measured by the Early Social Communication Scales (ESCS) | Joint attention skills will be measured using the Early Social Communication Scales (ESCS) in the ASD group; the typically developing group; and the developmental delay group. The ESCS assesses nonverbal communication skills, is normed for typically developing children 18 to 30 months of age in addition to children with developmental delay expressive language level is in approximately the same range. Frequency scores for initiation of joint attention (IJA) will be derived from behavioral observations during a series of tasks presented by an examiner blind to child diagnosis. IJA score ranges from 0 to 100 where a higher value indicates greater initiation of joint attention. | Baseline |
| Response to Joint Attention (RJA) Measured by the Early Social Communication Scales (ESCS) | Joint attention skills will be measured using the Early Social Communication Scales (ESCS) in the ASD group; the typically developing group; and the developmental delay group. The ESCS assesses nonverbal communication skills, is normed for typically developing children 18 to 30 months of age in addition to children with developmental delay expressive language level is in approximately the same range. Frequency scores for response to joint attention (RJA) will be derived from behavioral observations during a series of tasks presented by an examiner blind to child diagnosis. RJA score ranges from 0 to 20 where a higher value indicates greater response to joint attention. | Baseline |
| Language and Communication Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III) | The Griffiths Scales of Child Development, Third Edition (Griffiths III) is a comprehensive, developmental measure for continuous use from birth to 5 years 11 months (71 months). Although not standardized in South Africa (standardization samples are from the United Kingdom and Ireland), this developmental assessment is widely used in South Africa. The Griffiths III provides an overall measure of a child's development, as well as an individual profile of strengths and needs across five areas: Foundations of Learning; Language and Communication; Eye and Hand Coordination; Personal-Social-Emotional; and Gross Motor. Developmental quotients (DQs) were calculated by (Developmental Age/Chronological Age) *100. Griffiths III DQs range from 1 to 100 where higher scores indicate that the child performs at or near expected chronological age as compared with a normative sample of children the same age. | Baseline and Follow up (after 12 intervention sessions, up to 3 months) |
| Personal-Social-Emotional Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III) | The Griffiths Scales of Child Development, Third Edition (Griffiths III) is a comprehensive, developmental measure for continuous use from birth to 5 years 11 months (71 months). Although not standardized in South Africa (standardization samples are from the United Kingdom and Ireland), this developmental assessment is widely used in South Africa. The Griffiths III provides an overall measure of a child's development, as well as an individual profile of strengths and needs across five areas: Foundations of Learning; Language and Communication; Eye and Hand Coordination; Personal-Social-Emotional; and Gross Motor. Developmental quotients (DQs) were calculated by (Developmental Age/Chronological Age) *100. Griffiths III DQs range from 1 to 100 where higher scores indicate that the child performs at or near expected chronological age as compared with a normative sample of children the same age. | Baseline and Follow up (after 12 intervention sessions, up to 3 months) |
| Socialization Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3) | The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) is an individually-administered measure of adaptive behavior that is widely used to assess individuals with intellectual, developmental, and other disabilities. The Vineland-3 contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior. The Caregiver Interview Form uses the Vineland semistructured interview technique to elicit information about the examinee's adaptive functioning from a parent or caregiver. Item responses are collected on a 3-point Likert scale with values representing 0 (never), 1 (sometimes), and 2 (usually or often) to capture frequency of target behavior. Some items require binary responses (yes/no). The VABS-3 Socialization subscale score ranges from 20-140 where a higher score indicates greater frequency of target behavior. | Baseline and Follow up (after 12 intervention sessions, up to 3 months) |
| Communication Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3) | The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) is an individually-administered measure of adaptive behavior that is widely used to assess individuals with intellectual, developmental, and other disabilities. The Vineland-3 contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior. The Caregiver Interview Form uses the Vineland semistructured interview technique to elicit information about the examinee's adaptive functioning from a parent or caregiver. Item responses are collected on a 3-point Likert scale with values representing 0 (never), 1 (sometimes), and 2 (usually or often) to capture frequency of target behavior. Some items require binary responses (yes/no). The VABS-3 Communication subscale score ranges from 20-140 where a higher score indicates greater frequency of target behavior. | Baseline and Follow up (after 12 intervention sessions, up to 3 months) |
| Appropriateness of Telehealth Intervention (as Measured by the Intervention Appropriateness Measure, IAM) | A 5-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scores are indicated on a scale of 1-5 with higher scores indicating greater appropriateness. | Follow-up (within 2 weeks of ending sessions) |
| Feasibility of Intervention (as Measured by the Feasibility of Intervention Measure, FIM) | A 5-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scores are indicated on a scale of 1-5 with higher scores indicating greater feasibility. | Follow-up (within 2 weeks of ending sessions) |
| Fidelity of Intervention Delivery, as Measured by the Caregiver ESDM Fidelity Rating System | ESDM Fidelity Rating System uses a 13 item rating scale that includes ratings of performance on core intervention strategies from 1 to 5 (1 represents a lack of an effective display of the practices specified, and 5 represents the best possible example of this teaching behavior). Fidelity of implementation of Naturalistic Developmental Behavioral Intervention (NDBI) strategies will be manually coded by certified ESDM therapists. Mean fidelity scores (with SD) will be calculated across study participants in order to assess change in NDBI strategies. ESDM Fidelity Rating System scores range from 0 to 100 with a higher score reflecting interactions closer to ESDM principles. | Baseline and Follow-up (up to 4 months) |
| Baseline and Baseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group |
| Gaze Patterns Measured by the SenseToKnow App | SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name). | Baseline and Baseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group |
| Social Referencing Measured by the SenseToKnow App | SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name). | Baseline and Baseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group |
| Affective Response Measured by the SenseToKnow App | SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name). | Baseline and fBaseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group |
| Withdrawal by Subject |
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| Unable to complete intervention due to COVID-19 restrictions |
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| BG001 | Caregiver-Child Dyads With ASD (In-person Intervention ONLY) - Children | Participants in this arm will be children with ASD. Early Start Denver Model (ESDM): Twelve one hour sessions, skill is introduced by "Help is in your hands" Community ESDM videos. Session skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. "Help is in your hands" Community ESDM materials also provide video examples of other caregivers using the session skill with their child. The early childhood development practitioner then coaches the caregiver in the session skill, in at least two activities. The goal of coaching was to provide enough support for the caregiver to experience success in implementing the new skill with their child. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill across various daily activities, using a daily activities visual aid. |
| BG002 | Caregiver-Child Dyads With ASD (In-person, Then Telehealth Intervention) - Caregivers | Participants in this arm will be caregivers of children with ASD who began the intervention in-person and moved to telehealth due to COVID-19 restrictions. In-person: Twelve 1-hour sessions, skill is introduced by "Help is in your hands" Community Early Start Denver Model (C-ESDM) videos. Skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. The ECD practitioner then coaches the caregiver in at least two activities. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill using a daily activities visual aid. Telehealth coaching: The telehealth coaching intervention was informed by the C-ESDM materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached as above (via phone). Prior to the coaching session staff shared session materials with the family via WhatsApp and the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist. |
| BG003 | Caregiver-Child Dyads With ASD (In-person, Then Telehealth Intervention) - Children | Participants in this arm will be children with ASD who began the intervention in-person and moved to telehealth due to COVID-19 restrictions. In-person: Twelve 1-hour sessions, skill is introduced by "Help is in your hands" Community Early Start Denver Model (C-ESDM) videos. Skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. The ECD practitioner then coaches the caregiver in at least two activities. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill using a daily activities visual aid. Telehealth coaching: The telehealth coaching intervention was informed by the C-ESDM materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached as above (via phone). Prior to the coaching session staff shared session materials with the family via WhatsApp and the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist. |
| BG004 | Caregiver-Child Dyads With ASD (Telehealth Intervention ONLY) - Caregivers | Participants in this arm will be caregivers of children with ASD receiving telehealth intervention (adaptation due to COVID-19 restrictions). Telehealth coaching: The telehealth coaching intervention was informed by the Community-Early Start Denver Model (C-ESDM) materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached in strategies to increase child attention to their social world, increase child communication, create and build joint activity routines, and understand and use the ABCs to support the development of new behaviors. The session itself being delivered via phone. Prior to the coaching session staff shared session materials with the family via WhatsApp. Prior to the session the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist. |
| BG005 | Caregiver-Child Dyads With ASD (Telehealth Intervention ONLY) - Children | Participants in this arm will be children with ASD receiving telehealth intervention (adaptation due to COVID-19 restrictions). Telehealth coaching: The telehealth coaching intervention was informed by the Community-Early Start Denver Model (C-ESDM) materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached in strategies to increase child attention to their social world, increase child communication, create and build joint activity routines, and understand and use the ABCs to support the development of new behaviors. The session itself being delivered via phone. Prior to the coaching session staff shared session materials with the family via WhatsApp. Prior to the session the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist. |
| BG006 | Children With Typical Development | Participants in this arm will be children with typical development. No intervention. |
| BG007 | Children With Developmental Delay | Participants in this arm will be children with developmental delay. No intervention. |
| BG008 | Early Childhood Development (ECD) Practitioners and ECD Practitioner School Supervisors | The ECD worker and/or school supervisor are 1) employed by our participating recruitment partners (Western Cape Education Department Schools) and 2) involved in delivery of the caregiver coaching sessions, either in person or remotely. |
| BG009 | Early Start Denver Model (ESDM) Supervisors | The local supervisors are 1) trained ESDM therapist, 2) supervise weekly coaching sessions in the schools, and/or 3) supervise remote intervention delivery sessions. |
| BG010 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Age, Continuous | Children only. Data not collected on ECD Practitioners and ECD Practitioner School Supervisors or ESDM Supervisors groups. | Mean | Standard Deviation | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| ID | Title | Description |
|---|---|---|
| OG000 | Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Participants in this arm will be caregivers of and children with ASD. Early Start Denver Model (ESDM): Twelve one hour sessions, skill is introduced by "Help is in your hands" Community ESDM videos. Session skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. "Help is in your hands" Community ESDM materials also provide video examples of other caregivers using the session skill with their child. The early childhood development practitioner then coaches the caregiver in the session skill, in at least two activities. The goal of coaching was to provide enough support for the caregiver to experience success in implementing the new skill with their child. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill across various daily activities, using a daily activities visual aid. |
| OG001 | Caregiver-Child Dyads With ASD (Telehealth Intervention) | Participants in this arm will be caregivers of and children with ASD receiving only telehealth intervention (adaptation due to COVID-19 restrictions) or as a continuation of in-person intervention. Telehealth coaching: The telehealth coaching intervention was informed by the Community-Early Start Denver Model (C-ESDM) materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached in strategies to increase child attention to their social world, increase child communication, create and build joint activity routines, and understand and use the ABCs to support the development of new behaviors. The session itself being delivered via phone. Prior to the coaching session staff shared session materials with the family via WhatsApp. Prior to the session the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist. |
| OG002 | Children With Typical Development | Participants in this arm will be children with typical development. No intervention. |
| OG003 | Children With Developmental Delay | Participants in this arm will be children with developmental delay. No intervention. |
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| Primary | Coordinated Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Child engagement states measured by the Joint Engagement Rating Inventory (JERI) in the ASD group; the typically developing group; and the developmental delay group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates a very low rating and no time spent in that engagement state, 4 is the midpoint indicating the moderate time and quality of episodes in an engagement state, and 7 indicates a very high rating and high-quality engagement. | Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay. | Posted | Median | Full Range | score on a scale | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) |
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| Primary | Symbol-infused Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Child engagement states measured by the Joint Engagement Rating Inventory (JERI) in the ASD group; the typically developing group; and the developmental delay group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates a very low rating and no time spent in that engagement state, 4 is the midpoint indicating the moderate time and quality of episodes in an engagement state, and 7 indicates a very high rating and high-quality engagement. | Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay. | Posted | Median | Full Range | score on a scale | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) |
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| Primary | Fluency and Connectedness Measured by the Joint Engagement Rating Inventory (JERI) | Caregiver-child dyadic exchanges measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates no interaction between the dyad, a rating of 7 indicates a balanced dyadic exchange that flows naturally back and forth. | Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay. | Posted | Median | Full Range | score on a scale | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) |
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| Primary | Shared Routines and Rituals Measured by the Joint Engagement Rating Inventory (JERI) | Caregiver-child dyadic exchanges measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates no interaction between the dyad, a rating of 7 indicates a balanced dyadic exchange that flows naturally back and forth. | Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay. | Posted | Median | Full Range | score on a scale | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) |
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| Primary | Scaffolding Measured by the Joint Engagement Rating Inventory (JERI) | Caregiver strategies measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates that the caregiver rarely uses the caregiver strategy to support the child's activity and language. A rating of 7 indicates that the caregiver frequently uses appropriate strategies to support and expand their child's activity and language. | Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay. | Posted | Median | Full Range | score on a scale | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) |
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| Primary | Following in on a Child's Focus Measured by the Joint Engagement Rating Inventory (JERI) | Caregiver strategies measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates that the caregiver rarely uses the caregiver strategy to support the child's activity and language. A rating of 7 indicates that the caregiver frequently uses appropriate strategies to support and expand their child's activity and language. | Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay. | Posted | Median | Full Range | score on a scale | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) |
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| Primary | Caregiver Affect Measured by the Joint Engagement Rating Inventory (JERI) | Caregiver strategies measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates that the caregiver rarely uses the caregiver strategy to support the child's activity and language. A rating of 7 indicates that the caregiver frequently uses appropriate strategies to support and expand their child's activity and language. | Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay. | Posted | Median | Full Range | score on a scale | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) |
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| Primary | Initiation of Joint Attention (IJA) Measured by the Early Social Communication Scales (ESCS) | Joint attention skills will be measured using the Early Social Communication Scales (ESCS) in the ASD group; the typically developing group; and the developmental delay group. The ESCS assesses nonverbal communication skills, is normed for typically developing children 18 to 30 months of age in addition to children with developmental delay expressive language level is in approximately the same range. Frequency scores for initiation of joint attention (IJA) will be derived from behavioral observations during a series of tasks presented by an examiner blind to child diagnosis. IJA score ranges from 0 to 100 where a higher value indicates greater initiation of joint attention. | Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. This measure was introduced later in the study and therefore not administered to all participants. Data not collected on the Caregiver-Child Dyads With ASD (Telehealth Intervention) group. | Posted | Mean | Full Range | score on a scale | Baseline |
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| Primary | Response to Joint Attention (RJA) Measured by the Early Social Communication Scales (ESCS) | Joint attention skills will be measured using the Early Social Communication Scales (ESCS) in the ASD group; the typically developing group; and the developmental delay group. The ESCS assesses nonverbal communication skills, is normed for typically developing children 18 to 30 months of age in addition to children with developmental delay expressive language level is in approximately the same range. Frequency scores for response to joint attention (RJA) will be derived from behavioral observations during a series of tasks presented by an examiner blind to child diagnosis. RJA score ranges from 0 to 20 where a higher value indicates greater response to joint attention. | Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. This measure was introduced later in the study and therefore not administered to all participants. Data not collected on the Caregiver-Child Dyads With ASD (Telehealth Intervention) group. | Posted | Mean | Full Range | score on a scale | Baseline |
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| Primary | Language and Communication Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III) | The Griffiths Scales of Child Development, Third Edition (Griffiths III) is a comprehensive, developmental measure for continuous use from birth to 5 years 11 months (71 months). Although not standardized in South Africa (standardization samples are from the United Kingdom and Ireland), this developmental assessment is widely used in South Africa. The Griffiths III provides an overall measure of a child's development, as well as an individual profile of strengths and needs across five areas: Foundations of Learning; Language and Communication; Eye and Hand Coordination; Personal-Social-Emotional; and Gross Motor. Developmental quotients (DQs) were calculated by (Developmental Age/Chronological Age) *100. Griffiths III DQs range from 1 to 100 where higher scores indicate that the child performs at or near expected chronological age as compared with a normative sample of children the same age. | Participants who completed the study. Only applicable to child groups. Data not collected on Caregiver-Child Dyads With ASD (Telehealth Intervention) - Children group. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay. | Posted | Median | Full Range | units on a scale | Baseline and Follow up (after 12 intervention sessions, up to 3 months) |
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| Primary | Personal-Social-Emotional Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III) | The Griffiths Scales of Child Development, Third Edition (Griffiths III) is a comprehensive, developmental measure for continuous use from birth to 5 years 11 months (71 months). Although not standardized in South Africa (standardization samples are from the United Kingdom and Ireland), this developmental assessment is widely used in South Africa. The Griffiths III provides an overall measure of a child's development, as well as an individual profile of strengths and needs across five areas: Foundations of Learning; Language and Communication; Eye and Hand Coordination; Personal-Social-Emotional; and Gross Motor. Developmental quotients (DQs) were calculated by (Developmental Age/Chronological Age) *100. Griffiths III DQs range from 1 to 100 where higher scores indicate that the child performs at or near expected chronological age as compared with a normative sample of children the same age. | Participants who completed the study. Only applicable to child groups. Data not collected on Caregiver-Child Dyads With ASD (Telehealth Intervention) - Children group. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay. | Posted | Median | Full Range | units on a scale | Baseline and Follow up (after 12 intervention sessions, up to 3 months) |
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| Primary | Socialization Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3) | The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) is an individually-administered measure of adaptive behavior that is widely used to assess individuals with intellectual, developmental, and other disabilities. The Vineland-3 contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior. The Caregiver Interview Form uses the Vineland semistructured interview technique to elicit information about the examinee's adaptive functioning from a parent or caregiver. Item responses are collected on a 3-point Likert scale with values representing 0 (never), 1 (sometimes), and 2 (usually or often) to capture frequency of target behavior. Some items require binary responses (yes/no). The VABS-3 Socialization subscale score ranges from 20-140 where a higher score indicates greater frequency of target behavior. | Participants who completed the study. Only applicable to the Caregiver-Child Dyads With ASD groups. | Posted | Median | Full Range | score on a scale | Baseline and Follow up (after 12 intervention sessions, up to 3 months) |
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| Primary | Communication Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3) | The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) is an individually-administered measure of adaptive behavior that is widely used to assess individuals with intellectual, developmental, and other disabilities. The Vineland-3 contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior. The Caregiver Interview Form uses the Vineland semistructured interview technique to elicit information about the examinee's adaptive functioning from a parent or caregiver. Item responses are collected on a 3-point Likert scale with values representing 0 (never), 1 (sometimes), and 2 (usually or often) to capture frequency of target behavior. Some items require binary responses (yes/no). The VABS-3 Communication subscale score ranges from 20-140 where a higher score indicates greater frequency of target behavior. | Participants who completed the study. Only applicable to the Caregiver-Child Dyads With ASD groups. | Posted | Median | Full Range | score on a scale | Baseline and Follow up (after 12 intervention sessions, up to 3 months) |
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| Secondary | Acceptability of Telehealth Intervention (as Measured by the Acceptability of Intervention Measure, AIM) | A 5-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scores are indicated on a scale of 1 - 5 with higher scores indicating greater acceptability. | Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD (Telehealth Intervention) - Caregivers, Early Childhood Development (ECD) Practitioners and ECD Practitioner School Supervisors, and Early Start Denver Model (ESDM) Supervisors groups. | Posted | Mean | Standard Deviation | score on a scale | Follow-up (within 2 weeks of ending sessions) |
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| Secondary | Appropriateness of Telehealth Intervention (as Measured by the Intervention Appropriateness Measure, IAM) | A 5-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scores are indicated on a scale of 1-5 with higher scores indicating greater appropriateness. | Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD (Telehealth Intervention) - Caregivers, Early Childhood Development (ECD) Practitioners and ECD Practitioner School Supervisors, and Early Start Denver Model (ESDM) Supervisors groups. | Posted | Mean | Standard Deviation | score on a scale | Follow-up (within 2 weeks of ending sessions) |
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| Secondary | Feasibility of Intervention (as Measured by the Feasibility of Intervention Measure, FIM) | A 5-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scores are indicated on a scale of 1-5 with higher scores indicating greater feasibility. | Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD (Telehealth Intervention) - Caregivers, Early Childhood Development (ECD) Practitioners and ECD Practitioner School Supervisors, and Early Start Denver Model (ESDM) Supervisors groups. | Posted | Mean | Standard Deviation | score on a scale | Follow-up (within 2 weeks of ending sessions) |
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| Secondary | Fidelity of Intervention Delivery, as Measured by the Caregiver ESDM Fidelity Rating System | ESDM Fidelity Rating System uses a 13 item rating scale that includes ratings of performance on core intervention strategies from 1 to 5 (1 represents a lack of an effective display of the practices specified, and 5 represents the best possible example of this teaching behavior). Fidelity of implementation of Naturalistic Developmental Behavioral Intervention (NDBI) strategies will be manually coded by certified ESDM therapists. Mean fidelity scores (with SD) will be calculated across study participants in order to assess change in NDBI strategies. ESDM Fidelity Rating System scores range from 0 to 100 with a higher score reflecting interactions closer to ESDM principles. | Participants who completed the study. Only applicable to the Caregiver-Child Dyads With ASD Caregiver groups. | Posted | Median | Full Range | score on a scale | Baseline and Follow-up (up to 4 months) |
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| Other Pre-specified | Postural Sway Measured by the SenseToKnow App | SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name). | Not Posted | Baseline and Baseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group | Participants |
| Other Pre-specified | Gaze Patterns Measured by the SenseToKnow App | SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name). | Not Posted | Baseline and Baseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group | Participants |
| Other Pre-specified | Social Referencing Measured by the SenseToKnow App | SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name). | Not Posted | Baseline and Baseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group | Participants |
| Other Pre-specified | Affective Response Measured by the SenseToKnow App | SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name). | Not Posted | Baseline and fBaseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group | Participants |
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Caregiver-Child Dyads With ASD (In-person Intervention ONLY) - Children | Participants in this arm will be children with ASD. Early Start Denver Model (ESDM): Twelve one hour sessions, skill is introduced by "Help is in your hands" Community ESDM videos. Session skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. "Help is in your hands" Community ESDM materials also provide video examples of other caregivers using the session skill with their child. The early childhood development practitioner then coaches the caregiver in the session skill, in at least two activities. The goal of coaching was to provide enough support for the caregiver to experience success in implementing the new skill with their child. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill across various daily activities, using a daily activities visual aid. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | Caregiver-Child Dyads With ASD (In-person, Then Telehealth Intervention) - Caregivers | Participants in this arm will be caregivers of children with ASD who began the intervention in-person and moved to telehealth due to COVID-19 restrictions. In-person: Twelve 1-hour sessions, skill is introduced by "Help is in your hands" Community Early Start Denver Model (C-ESDM) videos. Skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. The ECD practitioner then coaches the caregiver in at least two activities. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill using a daily activities visual aid. Telehealth coaching: The telehealth coaching intervention was informed by the C-ESDM materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached as above (via phone). Prior to the coaching session staff shared session materials with the family via WhatsApp and the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | Caregiver-Child Dyads With ASD (In-person, Then Telehealth Intervention) - Children | Participants in this arm will be children with ASD who began the intervention in-person and moved to telehealth due to COVID-19 restrictions. In-person: Twelve 1-hour sessions, skill is introduced by "Help is in your hands" Community Early Start Denver Model (C-ESDM) videos. Skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. The ECD practitioner then coaches the caregiver in at least two activities. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill using a daily activities visual aid. Telehealth coaching: The telehealth coaching intervention was informed by the C-ESDM materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached as above (via phone). Prior to the coaching session staff shared session materials with the family via WhatsApp and the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG004 | Caregiver-Child Dyads With ASD (Telehealth Intervention ONLY) - Caregivers | Participants in this arm will be caregivers of children with ASD receiving telehealth intervention (adaptation due to COVID-19 restrictions). Telehealth coaching: The telehealth coaching intervention was informed by the Community-Early Start Denver Model (C-ESDM) materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached in strategies to increase child attention to their social world, increase child communication, create and build joint activity routines, and understand and use the ABCs to support the development of new behaviors. The session itself being delivered via phone. Prior to the coaching session staff shared session materials with the family via WhatsApp. Prior to the session the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG005 | Caregiver-Child Dyads With ASD (Telehealth Intervention ONLY) - Children | Participants in this arm will be children with ASD receiving telehealth intervention (adaptation due to COVID-19 restrictions). Telehealth coaching: The telehealth coaching intervention was informed by the Community-Early Start Denver Model (C-ESDM) materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached in strategies to increase child attention to their social world, increase child communication, create and build joint activity routines, and understand and use the ABCs to support the development of new behaviors. The session itself being delivered via phone. Prior to the coaching session staff shared session materials with the family via WhatsApp. Prior to the session the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG006 | Children With Typical Development | Participants in this arm will be children with typical development. No intervention. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG007 | Children With Developmental Delay | Participants in this arm will be children with developmental delay. No intervention. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG008 | Early Childhood Development (ECD) Practitioners and ECD Practitioner School Supervisors | The ECD worker and/or school supervisor are 1) employed by our participating recruitment partners (Western Cape Education Department Schools) and 2) involved in delivery of the caregiver coaching sessions, either in person or remotely. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG009 | Early Start Denver Model (ESDM) Supervisors | The local supervisors are 1) trained ESDM therapist, 2) supervise weekly coaching sessions in the schools, and/or 3) supervise remote intervention delivery sessions. | 0 | 3 | 0 | 3 | 0 | 3 |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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