A+ Treatment/Feasibility of Adapted ESDM-informed Caregiver Coaching Delivered Remotely for Children With ASD and ADHD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sub-study: Feasibility Trial of Adapted ESDM-informed Caregiver Coaching Delivered Remotely for Children With ASD and ADHD

Conditions
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Autism Spectrum Disorder, Adhd

Intervention / Treatment
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* Behavioral: P-ESDM informed caregiver coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of a parent/guardian signed and dated informed consent form. Stated willingness of parent/guardian to comply with all study procedures and availability for the duration of the study. Child is between 36 months and <132 months of age at baseline. Child has a confirmed DSM-5 diagnosis of both ASD and ADHD, informed by results of assessments including: an ASD diagnostic assessment (Brief Observation of Symptoms of Autism [BOSA], Autism Diagnostic Observation Schedule, 2nd Edition [ADOS-2], or TELE-ASD-PEDS, and if applicable the Autism Diagnostic Interview - Revised [ADI-R]) and an ADHD diagnostic (a standardized ADHD Diagnostic Interview and the MINI psychiatric diagnostic interview). Exclusion Criteria: If continuing psychotropic (CNS-active) medications, must not have been changed within 4 weeks prior to baseline. Significant visual, auditory or motor impairments that would preclude participation in ESDM-informed caregiver coaching or completion of key assessments. Inability of the caregiver participating in ESDM-informed caregiver coaching and responding to questionnaires to fluently speak English. Study clinician judgment that it is not in the best interests of the participant and/or the study for the child to participate (including presence of psychiatric conditions or psychiatric symptoms in addition to ASD and ADHD that in the opinion of the PI or based on senior clinical review, would confound assessments and/or affect participation in the study).

Ages Eligible for Study
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Minimum Age: 36 Months
Maximum Age: 131 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A+ Treatment/Feasibility participants<br>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. | Behavioral: P-ESDM informed caregiver coaching<br>* Caregiver coaching informed by P-ESDM done remotely (via telehealth)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative assessment of acceptability, appropriateness, and feasibility of intervention as evaluated through analysis of qualitative individual interviews with stakeholders (Caregivers) | Questions are tailored to stakeholder group (Caregivers) and are informed by previous studies that have examined barriers and facilitators during the implementation of a new treatment approach. Interviews will be conducted with caregivers after they have completed coaching sessions. Qualitative analysis will use an iterative coding and review process informed by grounded theory. | Week 9/Endpoint | 
| Qualitative assessment of acceptability, appropriateness, and feasibility of intervention as evaluated through analysis of qualitative individual interviews with stakeholders (Coaches, Clinicians, and Staff) | Questions are tailored to stakeholder group (Coaches, Clinicians, and Staff) and are informed by previous studies that have examined barriers and facilitators during the implementation of a new treatment approach. Interviews will be conducted with coaches/staff once they delivered the intervention and supported coaching activities for a 6-month period. Qualitative analysis will use an iterative coding and review process informed by grounded theory. | After providing at least 6 months of intervention delivery/support | 
| 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. Responses are averaged to reflect a score for the FIM on a scale ranging from 1 to 5, 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. Responses are averaged to reflect a score for the AIM on a scale ranging from 1 to 5, 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. Responses are averaged to reflect a score for the IAM on a scale ranging from 1 to 5, where higher scores indicate greater appropriateness, and lower scores indicate lower appropriateness. | 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. Observations will be coded by timepoint-naïve certified ESDM therapists from video-recorded caregiver-child interactions. Tabular & graphical summaries of pre and post caregiver implementation fidelity will be generated to assess average change in fidelity of cohort. | Baseline, Week 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in 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 3-17-year-old children. It is a 16-item 6-point Likert scale questionnaire with ratings ranging from strongly agree (1) to strongly disagree. It includes 2 validated factors: satisfaction (9 items) and efficacy (7 items). Higher scores indicate greater competence. Change will be measured using the score at each timepoint. | 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. Higher ratings indicate a greater amount of the aspect 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. These will be measured by 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. | Baseline, Week 9 |