NCT02416323

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
609

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

July 9, 2018

Status Verified

July 1, 2018

Enrollment Period

5.8 years

First QC Date

April 7, 2015

Last Update Submit

July 5, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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

    Study Enrollment, 6, 12, 18 months post study enrollment

Study Arms (2)

Usual Care

NO INTERVENTION

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

AIM HI Training

OTHER

Therapist enrolls in AIM HI training

Other: AIM HI Training

Interventions

AIM HI Training

Eligibility Criteria

Age5 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child and Adolescent Services Research Center

San Diego, California, 92123, United States

Location

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 15, 2015

Study Start

April 1, 2012

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

July 9, 2018

Record last verified: 2018-07

Locations