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

Behavioral Activation for Treatment of Depression in Adolescents With Autism Spectrum Disorder: A Pilot 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 autism spectrum disorder or ASD (i.e., Behavioral Activation for Adolescents with ASD, BA-A).

Study Overview

• Status: Completed
• Conditions: Depression; Autism
• Intervention / Treatment: Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: BA-A; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Fidelity Checklists	Treatment Fidelity Checklists will be completed by trained research assistants not involved in the implementation of the intervention.	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)

Collaborators and Investigators

• Sponsor: University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Depression; Depressive Disorder; Autistic Disorder
• Other Study ID Numbers: HSR200385

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No