Effectiveness and Implementation of a Mental Health Intervention for ASD

Study Overview
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Brief Summary
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The purpose of this study is to test the effectiveness of training community mental health therapists to deliver a mental health intervention for ASD (AIM HI) and study the process of implementing AIM HI in community mental health programs.

Detailed Description
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This study is a randomized controlled effectiveness trial of AIM HI (An Individualized Mental Health Intervention for ASD), an intervention designed specifically for implementation in community mental health clinics, to reduce problem behavior among school-age children with autism spectrum disorders (ASD). Although the individual components of AIM HI are well-established evidence-based practice strategies and pilot study data indicate that child behavior problems decrease when their community mental health therapists deliver AIM HI, the effectiveness of the protocol has not been established. Therefore, the primary aims are to test the impact of training community therapists in AIM HI on child and family outcomes and determine how child/ family characteristics and level of therapist fidelity moderate treatment effects. The secondary aim is to collect initial data on implementation outcomes and conduct exploratory analyses to identify barriers and facilitators of AIM HI implementation (e.g., intervention, organization, provider characteristics). This study has the potential to make a significant impact by building local capacity to serve school-age children with ASD in routine service settings, and advancing the science on the effectiveness of packaging evidence-based practices (EBPs) for specific services settings. It will also produce generalizable knowledge about implementation that can be applied for this population/ setting.

Official Title
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Effectiveness and Implementation of a Mental Health Intervention for ASD

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Other: AIM HI Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Therapists Employed as staff or a trainee at participating clinic (publicly-funded mental health program) Employed for at least the next 7 months (i.e., practicum or internship not ending in next 7 months). Has an eligible client on current caseload (see below). Inclusion Criteria for Child/ Parent Participants Child age 5-13 years. Has a current ASD diagnosis on record. Meets criteria for ASD on the Autism Diagnostic Observation Schedule (ADOS) or exhibits other clinical indicators of ASD English or Spanish speaking. Exclusion Criteria for Child/ Parent Participants Child does not present with challenging behaviors. Child does not meet criteria for ASD on the ADOS or exhibit other clinical indicators of ASD

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 13 Years

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: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Community therapist delivers routine care to participant child with no training in AIM HI. | |
| Other: AIM HI Training<br>Therapist enrolls in AIM HI training | Other: AIM HI Training<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change since baseline in child behaviors on the Eyberg Child Behavior Inventory (ECBI) |  | Study Enrollment, 6, 12, 18 months post study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change since baseline in child behaviors on the Social Skills Improvement System (SSIS) Competing Behavior Scale |  | Study Enrollment, 6, 12, 18 months post study enrollment |