Behavioral Activation for Treatment of Depression in Adolescents With Autism

Not Applicable

Completed

• Conditions: Depression; Autism
• Interventions: Behavioral: BA-A

• Registration Number: NCT05018169
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-24
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BA-A	BA-A	Teens will participate in BA-A. BA-A is a 12-session manualized treatment that utilizes established BA strategies and incorporates common mental health treatment adaptations for young people with ASD.

Primary Outcome Measures

Name	Time	Method
Children's Depression Inventory, Second Edition, Parent Report	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	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	Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States