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| ID | Type | Description | Link |
|---|---|---|---|
| K12TR004416-01 | U.S. NIH Grant/Contract | View source |
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Study was prematurely terminated by funder.
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The goal of this clinical trial is to assess whether telehealth-based Family Navigation (FN) expedites enrollment (e.g., reduces time in days) in community-based autism intervention for Black toddlers under the age of 4 after their initial diagnosis of autism.
The main questions it aims to answer are:
Does Family Navigation decrease the time to initiation of intervention for Black toddlers with autism?
Does Family Navigation improve developmental outcomes at 18 months post-diagnosis of autism?
Does Family Navigation improve caregiver well-being?
Caregivers in the Family Navigation condition will receive 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom.
Researchers will compare participants who receive family navigation to participants who receive the standard of care (educational materials) to see if family navigation outperforms the standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family Navigation | Experimental | Participants randomized to the Family Navigation condition will receive up to 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom. |
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| Educational Materials | Active Comparator | The comparison condition ("Educational Materials") consists of providing the participant's caregivers information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations. Families in this condition will receive this information throughout 4 timepoints in the first 3 months after enrolling. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Family Navigation | Behavioral | Participants randomized to the Family Navigation condition will receive up to 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Initiation of Autism Specific Intervention | The date of initiation (date 2) of autism-specific intervention will be the date that families report the first session with a therapist following the diagnosis (date 1). Time will be calculated as the number of days elapsed between these two dates (date 2 - date 1). | From enrollment up to 6 months post |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Well-Being Score | Scores on the General Well-Being Schedule will be used to measure caregiver well-being. Total scores range from 0-110. Higher scores are indicative of more positive well-being. There are 3 proposed scoring cut-points: 0-60 reflects "severe distress", 61-72 reflects "moderate distress", and 73-110 reflects "positive well-being). | 6 months post enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly Caravella, PhD | UNC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolina Institute for Developmental Disabilities | Carrboro | North Carolina | 27510 | United States |
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina.
9 to 36 months following publication.
Investigator must have approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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Of the 33 participants (16 Family Units [FU]) who met initial eligibility and signed informed consent, 31 participants (15 FUs) completed Baseline and remained eligible for randomization. Of those eligible, 6 participants (3 FUs) did not continue following randomization and did not receive any exposure to a study intervention. Data are reported below for the 25 participants (12 FUs) exposed to a study intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Family Navigation | Family Units randomized to the Family Navigation condition will receive up to 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom. Virtual Family Navigation: Family Unit Caregivers randomized to the Family Navigation condition will receive up to 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom. |
| FG001 | Educational Materials | The comparison condition ("Educational Materials") consists of providing the Family Unit Caregiver information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations. Family Units in this condition will receive this information throughout 4 timepoints in the first 3 months after randomization. Educational Materials: The comparison condition ("Educational Materials") consists of providing the Family Unit Caregivers information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations). Families in this condition will receive this information throughout 4 timepoints in the first 3 months after enrolling. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Family Navigation | Family Units randomized to the Family Navigation condition will receive up to 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom. Virtual Family Navigation: Family Unit Caregivers randomized to the Family Navigation condition will receive up to 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Data are reported separately for Caregivers and Children. |
| 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 | Time to Initiation of Autism Specific Intervention | The date of initiation (date 2) of autism-specific intervention will be the date that families report the first session with a therapist following the diagnosis (date 1). Time will be calculated as the number of days elapsed between these two dates (date 2 - date 1). | Data are reported for 3 children in Family Navigation and 2 children in Educational Materials who had initiated community-based services at the time the study was terminated. Therefore, these data are right-censored at 180 days. | Posted | Mean | Full Range | days | From enrollment up to 6 months post |
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The study planned to collect adverse events from the time of signing informed consent until 18 months later. However, due to early study termination the longest adverse event collection period was only 7.5 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 | Family Navigation Caregivers | Caregivers randomized to the Family Navigation condition will receive up to 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Caravella, PhD | University of North Carolina at Chapel Hill | 919-891-2613 | kelly_caravella@med.unc.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 | Apr 15, 2026 | Apr 21, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 19, 2025 | Jun 12, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Educational Materials | Behavioral | The comparison condition ("Educational Materials") consists of providing the participant's caregivers information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations. Families in this condition will receive this information throughout 4 timepoints in the first 3 months after enrolling. |
|
| Child's Developmental Functioning Score | The Early Learning Composite from the Mullen Scales of Early Learning (MSEL) will be used to measure developmental functioning. The Early Learning Composite (ELC) is a standardized composite score derived from the 5 subtests measured on the MSEL. It has a mean of 100 and a standard deviation of 15. Higher scores indicate stronger performance. | 18 months post enrollment |
| Child's Adaptive Functioning Score | The Adaptive Behavior Assessment Scale, Third Edition (ABAS-3) will be used to measure adaptive functioning. The ABAS-3 assesses 3 domains of adaptive behavior, including Conceptual, Social, and Practical. The General Adaptive Composite (GAC) is a composite score derived from the 4 domains. It has a mean of 100 and a standard deviation of 15. Higher scores indicate stronger adaptive behavior skills. | 18 months post enrollment |
| Appropriateness of Intervention Score | The Intervention Appropriateness Measure (IAM) is a 4 question survey that assesses a participant's experience with or thoughts about the intervention's appropriateness. A scaled score can be created by averaging the item-level responses. Scaled score values range from 1 to 5. Cut-off scores or norms for interpretation are not yet available; however, higher scores indicate greater appropriateness. | 6 months after enrollment |
| Feasibility of Intervention Score | The Feasibility of Intervention Measure (FIM) is a 4 question survey that assesses a participant's experience with or thoughts about the intervention's feasibility. A scaled score can be created by averaging the item-level responses. Scaled score values range from 1 to 5. Cut-off scores or norms for interpretation are not yet available; however, higher scores indicate greater appropriateness. | 6 months after enrollment |
| Acceptability of Intervention Score | The Acceptability of Intervention Measure (AIM) is a 4 question survey that assesses a participant's experience with or thoughts about the intervention's acceptability. A scaled score can be created by averaging the item-level responses. Scaled score values range from 1 to 5. Cut-off scores or norms for interpretation are not yet available; however, higher scores indicate greater appropriateness. | 6 months after enrollment |
| BG001 | Educational Materials | The comparison condition ("Educational Materials") consists of providing the Family Unit Caregiver information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations. Family Units in this condition will receive this information throughout 4 timepoints in the first 3 months after randomization. Educational Materials: The comparison condition ("Educational Materials") consists of providing the Family Unit Caregivers information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations). Families in this condition will receive this information throughout 4 timepoints in the first 3 months after enrolling. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Data are reported separately for Caregivers and Children. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Data are reported separately for Caregivers and Children. | Count of Participants | Participants |
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| Race (NIH/OMB) | Data are reported separately for Caregivers and Children. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Educational Materials | Family Units randomized to the Educational Materials condition will receive up to 4 information packets throughout 4 timepoints in the first 3 months after randomization. This packets include information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations. |
|
|
| Secondary | Caregiver Well-Being Score | Scores on the General Well-Being Schedule will be used to measure caregiver well-being. Total scores range from 0-110. Higher scores are indicative of more positive well-being. There are 3 proposed scoring cut-points: 0-60 reflects "severe distress", 61-72 reflects "moderate distress", and 73-110 reflects "positive well-being). | Data are reported for the 2 caregivers in each condition who provided data by the time the study was terminated. | Posted | Mean | Full Range | score on a scale | 6 months post enrollment |
|
|
|
| Secondary | Child's Developmental Functioning Score | The Early Learning Composite from the Mullen Scales of Early Learning (MSEL) will be used to measure developmental functioning. The Early Learning Composite (ELC) is a standardized composite score derived from the 5 subtests measured on the MSEL. It has a mean of 100 and a standard deviation of 15. Higher scores indicate stronger performance. | No participants made it to this timepoint in the study, due to premature study termination. | Posted | 18 months post enrollment |
|
|
| Secondary | Child's Adaptive Functioning Score | The Adaptive Behavior Assessment Scale, Third Edition (ABAS-3) will be used to measure adaptive functioning. The ABAS-3 assesses 3 domains of adaptive behavior, including Conceptual, Social, and Practical. The General Adaptive Composite (GAC) is a composite score derived from the 4 domains. It has a mean of 100 and a standard deviation of 15. Higher scores indicate stronger adaptive behavior skills. | No participants made it to this timepoint in the study, due to premature study termination. | Posted | 18 months post enrollment |
|
|
| Secondary | Appropriateness of Intervention Score | The Intervention Appropriateness Measure (IAM) is a 4 question survey that assesses a participant's experience with or thoughts about the intervention's appropriateness. A scaled score can be created by averaging the item-level responses. Scaled score values range from 1 to 5. Cut-off scores or norms for interpretation are not yet available; however, higher scores indicate greater appropriateness. | This outcome was intended to be collected once at approximately 6 months post enrollment during facilitated live interviews with research staff. Unlike other Month 6 outcomes collected via emailed surveys, this assessment required a live interview visit. Study termination occurred before the interview protocol was finalized and any scheduled live interview visits were cancelled. As a result, no participants completed this assessment and no data were collected. | Posted | 6 months after enrollment |
|
|
| Secondary | Feasibility of Intervention Score | The Feasibility of Intervention Measure (FIM) is a 4 question survey that assesses a participant's experience with or thoughts about the intervention's feasibility. A scaled score can be created by averaging the item-level responses. Scaled score values range from 1 to 5. Cut-off scores or norms for interpretation are not yet available; however, higher scores indicate greater appropriateness. | This outcome was intended to be collected once at approximately 6 months post enrollment during facilitated live interviews with research staff. Unlike other Month 6 outcomes collected via emailed surveys, this assessment required a live interview visit. Study termination occurred before the interview protocol was finalized and any scheduled live interview visits were cancelled. As a result, no participants completed this assessment and no data were collected. | Posted | 6 months after enrollment |
|
|
| Secondary | Acceptability of Intervention Score | The Acceptability of Intervention Measure (AIM) is a 4 question survey that assesses a participant's experience with or thoughts about the intervention's acceptability. A scaled score can be created by averaging the item-level responses. Scaled score values range from 1 to 5. Cut-off scores or norms for interpretation are not yet available; however, higher scores indicate greater appropriateness. | This outcome was intended to be collected once at approximately 6 months post enrollment during facilitated live interviews with research staff. Unlike other Month 6 outcomes collected via emailed surveys, this assessment required a live interview visit. Study termination occurred before the interview protocol was finalized and any scheduled live interview visits were cancelled. As a result, no participants completed this assessment and no data were collected. | Posted | 6 months after enrollment |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Family Navigation Children | Children of caregivers randomized to the Family Navigation condition will receive up to 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Educational Materials Caregivers | The comparison condition ("Educational Materials") consists of providing the Family Unit Caregiver information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations. Family Units in this condition will receive this information throughout 4 timepoints in the first 3 months after randomization. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | Educational Materials Children | The comparison condition ("Educational Materials") consists of providing the Family Unit Caregiver information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations. Family Units in this condition will receive this information throughout 4 timepoints in the first 3 months after randomization. | 0 | 6 | 0 | 6 | 0 | 6 |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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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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| 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 |
|