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This study will evaluate the feasibility of adapted ESDM-informed caregiver coaching in children with comorbid ASD and ADHD, who are between 36 and <132 months of age. There will be no study provided medication treatment in this study. Children will either be on ADHD medication prescribed by their own personal provider or will not be taking any ADHD medication (this will be documented by the study). The provided behavioral treatment will be eight ~60-minute sessions in ESDM-informed caregiver coaching delivered remotely through telehealth, for 8 consecutive weeks. The behavioral treatment is provided to children through Early Start Denver Model (ESDM)-informed caregiver coaching strategies, implemented within the child's typical daily routine by the caregiver.
The overarching goal of A+ Treatment is to evaluate feasibility and gather pilot data of remotely-delivered ESDM informed caregiver coaching for children with ASD and ADHD which may inform future combination clinical trials (pharmacotherapy and behavioral intervention). Using an implementation science approach, the investigators will characterize the acceptability, appropriateness, feasibility and fidelity of remote behavioral intervention. Approximately 30-35 participants who are between 36 months and <132 months of age with comorbid ASD and ADHD will take part in this study, which includes parent coaching sessions completed remotely. Total participation is expected to require a maximum of 20 weeks, including optional remote follow-up at 16 weeks. The A+ Treatment diagnostic and screening visits will generally occur between 1 and 6 weeks prior to baseline. The provided behavioral treatment will be eight ~60-minute weekly sessions of ESDM-informed caregiver coaching delivered remotely through telehealth, for 8 consecutive weeks. Endpoint assessments will be completed after the final coaching visit. No medication will be provided by the study team. The final assessment will be obtained at 16 weeks after baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A+ Treatment/Feasibility participants | Other | Total participation is expected to require a maximum of 20 weeks (plus optional remote follow-up at 16 week). Diagnostic/screening visits occur between 1 and 6 weeks prior to baseline and start of coaching. ESDM-informed parent coaching (~1 hour sessions) is delivered remotely (through telehealth) with a study clinician for 8 weeks and strategies are implemented within the child's typical daily routines by the caregiver. No medication is provided by the study team. Data is collected weekly and final assessment will be obtained at 16 weeks after baseline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P-ESDM informed caregiver coaching | Behavioral | Caregiver coaching informed by P-ESDM done remotely (via telehealth) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Caregivers and Staff Who Completed Individual Qualitative Interviews to Assess the Acceptability, Appropriateness, and Feasibility of the Intervention | Questions are tailored to stakeholder group and are informed by previous studies that have examined barriers and facilitators during the implementation of a new treatment approach. Interviews will be conducted after completing coaching sessions. Qualitative analysis will use an iterative coding and review process informed by grounded theory. | Week 9/Endpoint |
| Feasibility of Intervention (as Measured by Feasibility of Intervention Measure, FIM) | The FIM is a four-item implementation outcome measure 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. Each item is rated on a 5-point ordinal scale from 1 (completely disagree) to 5 (completely agree). The sum of ratings across all 4 items ranges from 4 to 20, where higher scores indicate greater feasibility, and lower scores indicate lower feasibility. | Week 9/Endpoint |
| Acceptability of Intervention (as Measured by the Acceptability of Intervention Measure, AIM) | The AIM is a four-item implementation outcome measure 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. Each item is rated on a 5-point ordinal scale from 1 (completely disagree) to 5 (completely agree). The sum of ratings across all 4 items ranges from 4 to 20, where higher scores indicate greater acceptability, and lower scores indicate lower acceptability. | Week 9/Endpoint |
| Appropriateness of Intervention (as Measured by the Intervention Appropriateness Measure, IAM) | The IAM is a four-item implementation outcome measure 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. Each item is rated on a 5-point ordinal scale from 1 (completely disagree) to 5 (completely agree). The sum of ratings across all 4 items ranges from 4 to 20, where higher scores indicate greater appropriateness, and lower scores indicate lower appropriateness. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline (Pre-intervention) to 9-weeks (Post-intervention) in Caregiver Sense of Competence Measured by the Parent Sense of Competence Scale. | The parent sense of competence scale is a self-report measure that assesses parenting sense of competence in 3- to 17-year-old children. It is a 16-item 6-point Likert scale questionnaire with ratings ranging from strongly agree (1) to strongly disagree (6). It includes 2 validated factors: satisfaction (9 items) and efficacy (7 items). The scale ranges from 16 to 96, where higher scores indicate greater competence. Change will be measured using the score at each timepoint. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Franz, M.B., CH.B. | Duke University | Principal Investigator |
| Geraldine Dawson, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
Through NDAR (National Database for Autism Research), core assessment and diagnostic data that is de-identified, including Vineland data and autism assessments.
1 year after publication of the results for each of the specific aims or 3 years after the statistical analyses are completed
determined by committee of researchers/administrator at NDAR
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| ID | Title | Description |
|---|---|---|
| FG000 | A+ Treatment Caregiver-Child Dyads - Caregivers | Participants in this arm will be caregivers of children with ASD (Autism Spectrum Disorder) and/or ADHD (Attention Deficit Hyperactivity Disorder). Total participation is expected to require a maximum of 20 weeks (plus optional remote follow-up at 16 week). Diagnostic/screening visits occur between 1 and 6 weeks prior to baseline and start of coaching. Early Start Denver Model (ESDM)-informed parent coaching (~1 hour sessions) is delivered remotely (through telehealth) with a study clinician for 8 weeks and strategies are implemented within the child's typical daily routines by the caregiver. No medication is provided by the study team. Data is collected weekly and final assessment will be obtained at 16 weeks after baseline. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Mar 17, 2022 |
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Feasibility trial
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| Week 9/Endpoint |
| Changes From Baseline (Pre-intervention) to Week 9 (Post-intervention) in Fidelity of Intervention Delivery Using an Adapted Version of the Parent Early Start Denver Model (P-ESDM) Caregiver Fidelity Rating System | The caregiver fidelity rating system measure assesses fidelity of the caregiver in using ESDM principles during a joint activity with their child using ratings of performance on 13 items (1-5 scale). The sum of ratings is used for a total score, ranging from 13 to 65, where higher score is greater fidelity and lower scores indicate lower fidelity. | Baseline, Week 9 |
| Baseline, Week 9 |
| Change From Baseline (Pre-intervention) to 9 Weeks (Post-intervention) in Child Behaviors as Measured by Joint Engagement Rating Inventory (JERI) | Joint Engagement Rating Inventory (JERI) 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. Reported is the change in the sum of 4 items from the JERI (Joint Engagement, Attention to Caregiver, Responsiveness to Partner's Communication Bids, Fluency and Connectedness) coded by a trained, reliable coder who is naïve with respect to whether the observation is from baseline our outcome using video-recorded caregiver-child interactions. The score range is 4 to 28, where a higher score indicates a greater amount of the aspect of joint engagement. | Baseline, Week 9 |
| FG001 | A+ Treatment Caregiver-Child Dyads - Children | Participants in this arm will be children with ASD (Autism Spectrum Disorder) and/or ADHD (Attention Deficit Hyperactivity Disorder). Total participation is expected to require a maximum of 20 weeks (plus optional remote follow-up at 16 week). Diagnostic/screening visits occur between 1 and 6 weeks prior to baseline and start of coaching. Early Start Denver Model (ESDM)-informed parent coaching (~1 hour sessions) is delivered remotely (through telehealth) with a study clinician for 8 weeks and strategies are implemented within the child's typical daily routines by the caregiver. No medication is provided by the study team. Data is collected weekly and final assessment will be obtained at 16 weeks after baseline. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth) |
| FG002 | A+ Treatment Staff | Participants in this arm will be staff who provide A+ Treatment Early Start Denver Model (ESDM)-informed coaching. Total participation is expected to require a maximum of 20 weeks (plus optional remote follow-up at 16 week). Diagnostic/screening visits occur between 1 and 6 weeks prior to baseline and start of coaching. Early Start Denver Model (ESDM)-informed parent coaching (~1 hour sessions) is delivered remotely (through telehealth) with a study clinician for 8 weeks and strategies are implemented within the child's typical daily routines by the caregiver. No medication is provided by the study team. Data is collected weekly and final assessment will be obtained at 16 weeks after baseline. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth) |
| COMPLETED |
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| NOT COMPLETED |
|
Data was not collected on Caregivers of Staff.
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| ID | Title | Description |
|---|---|---|
| BG000 | A+ Treatment Caregiver-Child Dyads - Caregivers | Participants in this arm will be caregivers of children with ASD and/or ADHD. Total participation is expected to require a maximum of 20 weeks (plus optional remote follow-up at 16 week). Diagnostic/screening visits occur between 1 and 6 weeks prior to baseline and start of coaching. Early Start Denver Model (ESDM)-informed parent coaching (~1 hour sessions) is delivered remotely (through telehealth) with a study clinician for 8 weeks and strategies are implemented within the child's typical daily routines by the caregiver. No medication is provided by the study team. Data is collected weekly and final assessment will be obtained at 16 weeks after baseline. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth) |
| BG001 | A+ Treatment Caregiver-Child Dyads - Children | Participants in this arm will be children with ASD and/or ADHD. Total participation is expected to require a maximum of 20 weeks (plus optional remote follow-up at 16 week). Diagnostic/screening visits occur between 1 and 6 weeks prior to baseline and start of coaching. Early Start Denver Model (ESDM)-informed parent coaching (~1 hour sessions) is delivered remotely (through telehealth) with a study clinician for 8 weeks and strategies are implemented within the child's typical daily routines by the caregiver. No medication is provided by the study team. Data is collected weekly and final assessment will be obtained at 16 weeks after baseline. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth) |
| BG002 | A+ Treatment Staff | Participants in this arm will be staff who provide A+ Treatment Early Start Denver Model (ESDM)-informed coaching. Total participation is expected to require a maximum of 20 weeks (plus optional remote follow-up at 16 week). Diagnostic/screening visits occur between 1 and 6 weeks prior to baseline and start of coaching. Early Start Denver Model (ESDM)-informed parent coaching (~1 hour sessions) is delivered remotely (through telehealth) with a study clinician for 8 weeks and strategies are implemented within the child's typical daily routines by the caregiver. No medication is provided by the study team. Data is collected weekly and final assessment will be obtained at 16 weeks after baseline. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | months |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Number of Caregivers and Staff Who Completed Individual Qualitative Interviews to Assess the Acceptability, Appropriateness, and Feasibility of the Intervention | Questions are tailored to stakeholder group and are informed by previous studies that have examined barriers and facilitators during the implementation of a new treatment approach. Interviews will be conducted after completing coaching sessions. Qualitative analysis will use an iterative coding and review process informed by grounded theory. | Caregivers and staff who completed the individual qualitative interviews. Caregivers responded to the questions for both themselves and their child. | Posted | Count of Participants | Participants | Week 9/Endpoint |
|
|
| |||||||||||||||||||||||||||||
| Primary | Feasibility of Intervention (as Measured by Feasibility of Intervention Measure, FIM) | The FIM is a four-item implementation outcome measure 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. Each item is rated on a 5-point ordinal scale from 1 (completely disagree) to 5 (completely agree). The sum of ratings across all 4 items ranges from 4 to 20, where higher scores indicate greater feasibility, and lower scores indicate lower feasibility. | Caregivers who completed the FIM. Caregivers responded to the questions for both themselves and their child. Data not collected on staff. | Posted | Mean | Standard Deviation | score on a scale | Week 9/Endpoint |
| ||||||||||||||||||||||||||||||
| Primary | Acceptability of Intervention (as Measured by the Acceptability of Intervention Measure, AIM) | The AIM is a four-item implementation outcome measure 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. Each item is rated on a 5-point ordinal scale from 1 (completely disagree) to 5 (completely agree). The sum of ratings across all 4 items ranges from 4 to 20, where higher scores indicate greater acceptability, and lower scores indicate lower acceptability. | Caregivers who completed the AIM. Caregivers responded to the questions for both themselves and their child. Data not collected on staff. | Posted | Mean | Standard Deviation | score on a scale | Week 9/Endpoint |
| ||||||||||||||||||||||||||||||
| Primary | Appropriateness of Intervention (as Measured by the Intervention Appropriateness Measure, IAM) | The IAM is a four-item implementation outcome measure 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. Each item is rated on a 5-point ordinal scale from 1 (completely disagree) to 5 (completely agree). The sum of ratings across all 4 items ranges from 4 to 20, where higher scores indicate greater appropriateness, and lower scores indicate lower appropriateness. | Caregivers who completed the IAM. Caregivers responded to the questions for both themselves and their child. Data not collected on staff. | Posted | Mean | Standard Deviation | score on a scale | Week 9/Endpoint |
| ||||||||||||||||||||||||||||||
| Primary | Changes From Baseline (Pre-intervention) to Week 9 (Post-intervention) in Fidelity of Intervention Delivery Using an Adapted Version of the Parent Early Start Denver Model (P-ESDM) Caregiver Fidelity Rating System | The caregiver fidelity rating system measure assesses fidelity of the caregiver in using ESDM principles during a joint activity with their child using ratings of performance on 13 items (1-5 scale). The sum of ratings is used for a total score, ranging from 13 to 65, where higher score is greater fidelity and lower scores indicate lower fidelity. | Caregiver-child dyads who completed the study. Caregivers responded to the questions for both themselves and their child. Data not collected on staff. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 9 |
| ||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline (Pre-intervention) to 9-weeks (Post-intervention) in Caregiver Sense of Competence Measured by the Parent Sense of Competence Scale. | The parent sense of competence scale is a self-report measure that assesses parenting sense of competence in 3- to 17-year-old children. It is a 16-item 6-point Likert scale questionnaire with ratings ranging from strongly agree (1) to strongly disagree (6). It includes 2 validated factors: satisfaction (9 items) and efficacy (7 items). The scale ranges from 16 to 96, where higher scores indicate greater competence. Change will be measured using the score at each timepoint. | Caregivers who completed the Parent Sense of Competence Scale. Data not collected on children or staff. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 9 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline (Pre-intervention) to 9 Weeks (Post-intervention) in Child Behaviors as Measured by Joint Engagement Rating Inventory (JERI) | Joint Engagement Rating Inventory (JERI) 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. Reported is the change in the sum of 4 items from the JERI (Joint Engagement, Attention to Caregiver, Responsiveness to Partner's Communication Bids, Fluency and Connectedness) coded by a trained, reliable coder who is naïve with respect to whether the observation is from baseline our outcome using video-recorded caregiver-child interactions. The score range is 4 to 28, where a higher score indicates a greater amount of the aspect of joint engagement. | Caregiver-child dyads who completed the study. Caregivers responded to the questions for both themselves and their child. Data not collected on staff. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 9 |
|
Up to 9 weeks
Adverse Event information was not collected on caregivers or staff.
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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 | A+ Treatment Caregiver-Child Dyads - Caregivers | Participants in this arm will be caregivers of children with ASD and/or ADHD. Total participation is expected to require a maximum of 20 weeks (plus optional remote follow-up at 16 week). Diagnostic/screening visits occur between 1 and 6 weeks prior to baseline and start of coaching. Early Start Denver Model (ESDM)-informed parent coaching (~1 hour sessions) is delivered remotely (through telehealth) with a study clinician for 8 weeks and strategies are implemented within the child's typical daily routines by the caregiver. No medication is provided by the study team. Data is collected weekly and final assessment will be obtained at 16 weeks after baseline. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth) | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | A+ Treatment Caregiver-Child Dyads - Children | Participants in this arm will be children with ASD and/or ADHD. Total participation is expected to require a maximum of 20 weeks (plus optional remote follow-up at 16 week). Diagnostic/screening visits occur between 1 and 6 weeks prior to baseline and start of coaching. Early Start Denver Model (ESDM)-informed parent coaching (~1 hour sessions) is delivered remotely (through telehealth) with a study clinician for 8 weeks and strategies are implemented within the child's typical daily routines by the caregiver. No medication is provided by the study team. Data is collected weekly and final assessment will be obtained at 16 weeks after baseline. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth) | 0 | 26 | 0 | 26 | 14 | 26 |
| EG002 | A+ Treatment Staff | Participants in this arm will be staff who provide A+ Treatment Early Start Denver Model (ESDM)-informed coaching. Total participation is expected to require a maximum of 20 weeks (plus optional remote follow-up at 16 week). Diagnostic/screening visits occur between 1 and 6 weeks prior to baseline and start of coaching. Early Start Denver Model (ESDM)-informed parent coaching (~1 hour sessions) is delivered remotely (through telehealth) with a study clinician for 8 weeks and strategies are implemented within the child's typical daily routines by the caregiver. No medication is provided by the study team. Data is collected weekly and final assessment will be obtained at 16 weeks after baseline. P-ESDM informed caregiver coaching: Caregiver coaching informed by P-ESDM done remotely (via telehealth) | 0 | 0 | 0 | 0 | 0 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abrasions of extremities | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Aggression | Psychiatric disorders | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | Non-systematic Assessment |
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| Allergic hypersensitivity | Immune system disorders | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Depressed mood | Psychiatric disorders | Non-systematic Assessment |
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| Disturbance in attention | Psychiatric disorders | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Encopresis | Gastrointestinal disorders | Non-systematic Assessment |
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| Enuresis | Renal and urinary disorders | Non-systematic Assessment |
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| Frustration | Psychiatric disorders | Non-systematic Assessment |
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| Gastrointestinal upset | Gastrointestinal disorders | Non-systematic Assessment |
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| Gastrointestinal virus | Gastrointestinal disorders | Non-systematic Assessment |
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| Insomnia | Nervous system disorders | Non-systematic Assessment |
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| Joint sprain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Learning disability | Nervous system disorders | Non-systematic Assessment |
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| Mood alterations with depression symptoms | Psychiatric disorders | Non-systematic Assessment |
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| Motor tic | Nervous system disorders | Non-systematic Assessment |
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| Nasal discharge | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Obsessive rumination | Psychiatric disorders | Non-systematic Assessment |
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| Pica | Psychiatric disorders | Non-systematic Assessment |
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| Seizure | Nervous system disorders | Non-systematic Assessment |
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| Tooth disorder | Gastrointestinal disorders | Non-systematic Assessment |
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| Upper respiratory infection | Infections and infestations | Non-systematic Assessment |
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| Xerosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren Franz MBChB, MPH | Duke University | 919-681-0023 | lauren.franz@duke.edu |
| Apr 4, 2023 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2021 | Jun 15, 2022 | ICF_000.pdf |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
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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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