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
About this trial
This is an interventional treatment trial for Depression
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
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
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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