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OpenTrials
Completed

NCT Number: NCT02416323

Effectiveness and Implementation of a Mental Health Intervention for ASD

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.

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Key information

Age range

5 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child and Adolescent Services Research Center

San Diego, California, 92123, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AIM HI Training

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: AIM HI

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Apr 15, 2015
Registry last updated
Jul 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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