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Behavioral Activation for Treatment of Depression in Adolescents With Autism (BA-A)

Primary Purpose

Depression, Autism

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BA-A
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

  • High suicide risk

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    BA-A

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Children's Depression Inventory, Second Edition, Parent Report
    Children's Depression Inventory, Second Edition, Self Report
    Children's Depression Rating Scale, Revised

    Secondary Outcome Measures

    Spence Children's Anxiety Scale, Self Report
    Spence Children's Anxiety Scale, Parent Report
    Social Skills Improvement System, Parent Report

    Full Information

    First Posted
    August 3, 2021
    Last Updated
    August 18, 2021
    Sponsor
    University of Virginia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05018169
    Brief Title
    Behavioral Activation for Treatment of Depression in Adolescents With Autism
    Acronym
    BA-A
    Official Title
    Behavioral Activation for Treatment of Depression in Adolescents With Autism Spectrum Disorder: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2021 (Anticipated)
    Primary Completion Date
    August 2022 (Anticipated)
    Study Completion Date
    August 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Virginia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression, Autism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    23 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    BA-A
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    BA-A
    Intervention Description
    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 Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    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 Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    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 Pre-specified Outcome Measures:
    Title
    Treatment Fidelity Checklists
    Description
    Treatment Fidelity Checklists will be completed by trained research assistants not involved in the implementation of the intervention.
    Time Frame
    Within 3 months of treatment completion
    Title
    Acceptability/Satisfaction Surveys and Interviews, Self Report
    Time Frame
    Post-treatment (i.e., within one week of finishing 12-week treatment)
    Title
    Acceptability/Satisfaction Surveys and Interviews, Parent Report
    Time Frame
    Post-treatment (i.e., within one week of finishing 12-week treatment)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    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 Exclusion Criteria: High suicide risk
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Micah Mazurek, PhD
    Phone
    (434) 924-5692
    Email
    mm5gt@virginia.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Behavioral Activation for Treatment of Depression in Adolescents With Autism

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