Clinical trial NCT05018169: Behavioral Activation for Treatment of Depression in Adolescents With Autism
Official title: Behavioral Activation for Treatment of Depression in Adolescents With Autism Spectrum Disorder: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Autism
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 18
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Children's Depression Inventory, Second Edition, Parent Report
timeFrame: Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment
measure: Children's Depression Inventory, Second Edition, Self Report
timeFrame: Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment
measure: Children's Depression Rating Scale, Revised
timeFrame: Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment
Secondary outcomes:
measure: Spence Children's Anxiety Scale, Self Report
timeFrame: Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment
measure: Spence Children's Anxiety Scale, Parent Report
timeFrame: Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment
measure: Social Skills Improvement System, Parent Report
timeFrame: Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment
Other outcomes:
measure: Treatment Fidelity Checklists
timeFrame: Within 3 months of treatment completion
measure: Acceptability/Satisfaction Surveys and Interviews, Self Report
timeFrame: Post-treatment (i.e., within one week of finishing 12-week treatment)
measure: Acceptability/Satisfaction Surveys and Interviews, Parent Report
timeFrame: Post-treatment (i.e., within one week of finishing 12-week treatment)
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: