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Effectiveness and Implementation of a Mental Health Intervention for ASD (AIM HI)

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AIM HI Training
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Autism Spectrum Disorder

Eligibility Criteria

5 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria for Therapists

  1. Employed as staff or a trainee at participating clinic (publicly-funded mental health program)
  2. Employed for at least the next 7 months (i.e., practicum or internship not ending in next 7 months).
  3. Has an eligible client on current caseload (see below).

Inclusion Criteria for Child/ Parent Participants

  1. Child age 5-13 years.
  2. Has a current ASD diagnosis on record.
  3. Meets criteria for ASD on the Autism Diagnostic Observation Schedule (ADOS) or exhibits other clinical indicators of ASD
  4. English or Spanish speaking.

Exclusion Criteria for Child/ Parent Participants

  1. Child does not present with challenging behaviors.
  2. Child does not meet criteria for ASD on the ADOS or exhibit other clinical indicators of ASD

Sites / Locations

  • Child and Adolescent Services Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Usual Care

AIM HI Training

Arm Description

Community therapist delivers routine care to participant child with no training in AIM HI.

Therapist enrolls in AIM HI training

Outcomes

Primary Outcome Measures

Change since baseline in child behaviors on the Eyberg Child Behavior Inventory (ECBI)

Secondary Outcome Measures

Change since baseline in child behaviors on the Social Skills Improvement System (SSIS) Competing Behavior Scale

Full Information

First Posted
April 7, 2015
Last Updated
July 5, 2018
Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02416323
Brief Title
Effectiveness and Implementation of a Mental Health Intervention for ASD
Acronym
AIM HI
Official Title
Effectiveness and Implementation of a Mental Health Intervention for ASD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
609 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Community therapist delivers routine care to participant child with no training in AIM HI.
Arm Title
AIM HI Training
Arm Type
Other
Arm Description
Therapist enrolls in AIM HI training
Intervention Type
Other
Intervention Name(s)
AIM HI Training
Primary Outcome Measure Information:
Title
Change since baseline in child behaviors on the Eyberg Child Behavior Inventory (ECBI)
Time Frame
Study Enrollment, 6, 12, 18 months post study enrollment
Secondary Outcome Measure Information:
Title
Change since baseline in child behaviors on the Social Skills Improvement System (SSIS) Competing Behavior Scale
Time Frame
Study Enrollment, 6, 12, 18 months post study enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Child and Adolescent Services Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35881774
Citation
Caplan B, Lind T, Chlebowski C, Martinez K, May GC, Gomez Alvarado CJ, Brookman-Frazee L. Training Community Therapists in AIM HI: Individual Family and Neighborhood Factors and Child/Caregiver Outcomes. J Clin Child Adolesc Psychol. 2022 Jul 26:1-13. doi: 10.1080/15374416.2022.2096046. Online ahead of print.
Results Reference
derived
PubMed Identifier
32755632
Citation
Brookman-Frazee L, Chlebowski C, Villodas M, Roesch S, Martinez K. Training Community Therapists to Deliver an Individualized Mental Health Intervention for Autism Spectrum Disorder: Changes in Caregiver Outcomes and Mediating Role on Child Outcomes. J Am Acad Child Adolesc Psychiatry. 2021 Mar;60(3):355-366. doi: 10.1016/j.jaac.2020.07.896. Epub 2020 Aug 2.
Results Reference
derived
PubMed Identifier
30840040
Citation
Brookman-Frazee L, Roesch S, Chlebowski C, Baker-Ericzen M, Ganger W. Effectiveness of Training Therapists to Deliver An Individualized Mental Health Intervention for Children With ASD in Publicly Funded Mental Health Services: A Cluster Randomized Clinical Trial. JAMA Psychiatry. 2019 Jun 1;76(6):574-583. doi: 10.1001/jamapsychiatry.2019.0011.
Results Reference
derived
PubMed Identifier
27407039
Citation
Stadnick N, Chlebowski C, Baker-Ericzen M, Dyson M, Garland A, Brookman-Frazee L. Psychiatric comorbidity in autism spectrum disorder: Correspondence between mental health clinician report and structured parent interview. Autism. 2017 Oct;21(7):841-851. doi: 10.1177/1362361316654083. Epub 2016 Jul 11.
Results Reference
derived

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Effectiveness and Implementation of a Mental Health Intervention for ASD

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