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Completed

NCT Number: NCT05018169

Behavioral Activation for Treatment of Depression in Adolescents With Autism

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).

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Key information

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. Spence Children's Anxiety Scale, 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

  2. Spence Children's Anxiety Scale, 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

  3. Social Skills Improvement System, 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

Other outcomes

  1. Treatment Fidelity Checklists

    Time frame: Within 3 months of treatment completion

    Treatment Fidelity Checklists will be completed by trained research assistants not involved in the implementation of the intervention.

  2. Acceptability/Satisfaction Surveys and Interviews, Self Report

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

  3. Acceptability/Satisfaction Surveys and Interviews, Parent Report

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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

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

Acronym: BA-A

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2021
Registry last updated
Nov 18, 2023

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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