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Clinical Trials/NCT05018169
NCT05018169
Completed
Not Applicable

Behavioral Activation for Treatment of Depression in Adolescents With Autism Spectrum Disorder: A Pilot Study

University of Virginia1 site in 1 country18 target enrollmentAugust 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
University of Virginia
Enrollment
18
Locations
1
Primary Endpoint
Children's Depression Inventory, Second Edition, Parent Report
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

In this study, the investigators will examine the feasibility, acceptability, and preliminary efficacy of a novel, behavior-based approach for treatment of depression symptoms in adolescents with autism spectrum disorder or ASD (i.e., Behavioral Activation for Adolescents with ASD, BA-A).

Detailed Description

In this study, the investigators will examine the feasibility, acceptability, and preliminary efficacy of a novel, behavior-based approach for treatment of depression symptoms in adolescents with ASD (i.e., Behavioral Activation for Adolescents with ASD, BA-A). BA-A is a 12-session manualized treatment that utilizes established behavioral activation strategies and incorporates common mental health treatment adaptations for young people with ASD. For this project, the investigators will pilot BA-A with 23 adolescents (12-17 years of age) with ASD and clinically significant depression symptoms. To investigate BA-A feasibility, the investigators will examine treatment session attendance and therapist treatment fidelity. To investigate BA-A acceptability, the investigators will utilize a mixed methods approach, inclusive of surveys and qualitative interviews, to inform BA-A protocol refinement. To investigate BA-A preliminary efficacy, the investigators will examine depression symptoms, as well as secondary outcome measures, at pre-treatment, post-treatment, and one-month follow-up.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
August 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Micah Mazurek

Novartis U.S. Foundation Professor of Education

University of Virginia

Eligibility Criteria

Inclusion Criteria

  • Previous diagnosis of ASD by a qualified health care provider
  • Children's Depression Inventory, Second Edition (CDI2) parent-report and/or self-report T- score ≥ 65
  • Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II) Full Scale IQ, Two-Subtest Form (FSIQ-2) ≥ 85
  • Participation of a parent or legal guardian living in the same home who can read and write in English at or above the fifth grade level
  • Teens must have been on a stable dose of medications for mood, anxiety, or behavior for at least three months prior to enrollment and have no planned medication changes during study period
  • Not actively participating in another psychotherapy during study period

Exclusion Criteria

  • High suicide risk
  • Physical aggression
  • Psychotic and/or manic symptoms

Outcomes

Primary Outcomes

Children's Depression Inventory, Second Edition, Parent Report

Time Frame: Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment

Children's Depression Inventory, Second Edition, Self Report

Time Frame: Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment

Children's Depression Rating Scale, Revised

Time Frame: Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment

Secondary Outcomes

  • Social Skills Improvement System, Parent Report(Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment)
  • Spence Children's Anxiety Scale, Self Report(Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment)
  • Spence Children's Anxiety Scale, Parent Report(Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment)

Study Sites (1)

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