Effectiveness and Implementation of a Mental Health Intervention for ASD

NCT ID: NCT02416323

Last Updated: 2018-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

609 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2018-02-28

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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

AIM HI Training

Therapist enrolls in AIM HI training

Group Type OTHER

AIM HI Training

Intervention Type OTHER

Interventions

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AIM HI Training

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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).


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

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
Minimum Eligible Age

5 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Lauren Brookman-Frazee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Child and Adolescent Services Research Center

San Diego, California, United States

Site Status

Countries

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United States

References

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Caplan B, Chlebowski C, Lind T, Rangel E, Brookman-Frazee L. Therapist-Reported Adaptations to an Autism Intervention: Family-Level Predictors and Associations with Fidelity. J Autism Dev Disord. 2024 Oct 28. doi: 10.1007/s10803-024-06603-z. Online ahead of print.

Reference Type DERIVED
PMID: 39466584 (View on PubMed)

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. 2024 Sep-Oct;53(5):783-795. doi: 10.1080/15374416.2022.2096046. Epub 2022 Jul 26.

Reference Type DERIVED
PMID: 35881774 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32755632 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30840040 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27407039 (View on PubMed)

Other Identifiers

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R01MH094317

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2011-4131

Identifier Type: -

Identifier Source: org_study_id

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