Behavioral Activation for Treatment of Depression in Adolescents With Autism

NCT05018169 | Completed

• 1 other identifier: HSR200385
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression; Autism

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

• 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

Other Outcomes (3)

• Treatment Fidelity Checklists

  Within 3 months of treatment completion

• Acceptability/Satisfaction Surveys and Interviews, Self Report

  Post-treatment (i.e., within one week of finishing 12-week treatment)

• Acceptability/Satisfaction Surveys and Interviews, Parent Report

  Post-treatment (i.e., within one week of finishing 12-week treatment)

Study Arms (1)

BA-A

EXPERIMENTAL

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.

Behavioral: BA-A

Interventions

BA-A BEHAVIORAL

Session 1 focuses on the treatment rationale, structure, and expectations, and includes psychoeducation on depression. Session 2 focuses on working with parent(s) to help them support their teen through treatment. Session 3 focuses on the (situation)/behavior/feeling cycle and how teens individuals can get trapped in a cycle of depression and inactivity. Session 4 focuses on the assessment of values and choosing preferred activities to target. Session 5 focuses on teaching skills for in-person and electronic communication. Session 6 focuses on identifying barriers to treatment success. Session 7 focuses on teaching teens to handle disagreements. Session 8 focuses on the utilization of adaptive coping skills. Sessions 9-11 are meant to be used flexibly and should include review of any challenging concepts. Session 12 is the termination session and focuses on maintaining treatment gains. Between every session, teens will track their activity for homework.

BA-A

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Depression; Autistic Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Novartis U.S. Foundation Professor of Education

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 24, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)