Behavioral Activation for Treatment of Depression in Adolescents With Autism

Depression Clinical Trial

— BA-A  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05018169
• Other study ID #: HSR200385
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: November 2023
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autistic Disorder
• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Acceptability/Satisfaction Surveys and Interviews, Self Report		Post-treatment (i.e., within one week of finishing 12-week treatment)
Other	Acceptability/Satisfaction Surveys and Interviews, Parent Report		Post-treatment (i.e., within one week of finishing 12-week treatment)
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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