Recruiting

BA-A

Sponsor:

Stony Brook University

Code:

NCT07812870

Conditions

Autism

Depressed

Depressed Mood

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

BA-A

Study Details

Brief summary:

Autism spectrum disorder is characterized by differences in social communication/interaction and the presence of restricted/repetitive behaviors, with significant heterogeneity in terms of autistic features, language ability, and cognitive characteristics. About 2-3% of individuals in the United States are autistic, and most autistic individuals have co-occurring mental health conditions. Autistic people are 3-4 times more likely to experience depression than non-autistic people. Of the emerging depression treatment research with autistic people, none to date has focused on developing and testing a depression treatment for autistic youth with below average cognitive abilities - a group which comprises over 50% of the autistic community. Therefore, this study seeks to evaluate the feasibility (Aim 1), acceptability (Aim 2), and preliminary treatment effects (Aim 3) of an extension of Behavioral Activation for Depression in Autistic Adolescents (BA-A), adapted to meet the needs of cognitively lower functioning autistic youth.

Conditions

Autism

Depressed

Depressed Mood

Study ID

NCT07812870

Start date

Aug 10, 2026

Status verified date

Sep, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria

  • 12-17 years old
  • Autism diagnosis
  • Symptoms of depression (more specifically, Children's Depression Inventory, Second Edition parent-report and/or self-report T-score ⩾ 65)
  • IQ 60-84
  • Stable on medications for mood, anxiety, and/or behavior for 3 months
  • Participation of same parent(s) in all therapy sessions and assessment visits Exclusion Criteria
  • Participation in another psychotherapy during the study period
  • Imminent risk of harm to self and/or others
  • Bipolar disorder, a personality disorder, and/or schizophrenia or another psychotic disorder

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BA-A

BA-A is an individually delivered manualized 12-session treatment that utilizes established behavioral strategies and incorporates common mental health treatment adaptations for autistic young people.

Interventions

BA-A

BA-A is an individually delivered manualized 12-session treatment that utilizes established behavioral strategies and incorporates common mental health treatment adaptations for autistic young people.

Primary outcome measure

  • Children's Depression Rating Scale, Revised [ Time Frame: Baseline, Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline]), 1-Month Follow-Up (1 month following completion of therapy sessions) ]
  • Children's Depression Inventory, Second Edition [ Time Frame: Baseline, Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline]), 1-Month Follow-Up (1 month following completion of therapy sessions) ]
  • Aberrant Behavior Checklist [ Time Frame: Baseline, Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline]), 1-Month Follow-Up (1 month following completion of therapy sessions) ]
  • Behavioral Activation for Depression Scale-Short Form [ Time Frame: Baseline, Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline]), 1-Month Follow-Up (1 month following completion of therapy sessions) ]
  • Acceptability of Intervention Measure [ Time Frame: Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline]) ]
  • Intervention Appropriateness Measure [ Time Frame: Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline]) ]
  • Feasibility of Intervention Measure [ Time Frame: Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline]) ]

Central Contacts and Locations

Central contacts

Michelle Menezes, PhD

631-638-3819autismandneurodiversitylab@gmail.com

Locations

Stony Brook University

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Michelle Menezes, PhD

631-638-3819autismandneurodiversitylab@gmail.com

More Information

Sponsor

Stony Brook University

Last update posted

Sep 10, 2026

Last verified

Sep, 2026

Keywords

  • Autism
  • Depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Stony Brook University on 2026-09-10.