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

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ClinicalTrials.gov Identifier: NCT02416323
Recruitment Status : Completed
First Posted : April 15, 2015
Last Update Posted : July 9, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Lauren Brookman-Frazee, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Other: AIM HI Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 609 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effectiveness and Implementation of a Mental Health Intervention for ASD
Study Start Date : April 2012
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
No Intervention: Usual Care
Community therapist delivers routine care to participant child with no training in AIM HI.
AIM HI Training
Therapist enrolls in AIM HI training
Other: AIM HI Training



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416323


Locations
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United States, California
Child and Adolescent Services Research Center
San Diego, California, United States, 92123
Sponsors and Collaborators
University of California, San Diego
National Institute of Mental Health (NIMH)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lauren Brookman-Frazee, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02416323    
Other Study ID Numbers: 2011-4131
R01MH094317 ( U.S. NIH Grant/Contract )
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders