NCT07812870

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Aug 2026Sep 2027

Study Start

First participant enrolled

August 10, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 31, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

1.1 years

First QC Date

August 31, 2026

Last Update Submit

September 4, 2026

Conditions

Keywords

AutismDepression

Outcome Measures

Primary Outcomes (7)

  • Children's Depression Rating Scale, Revised

    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

    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

    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

    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

    Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline])

  • Intervention Appropriateness Measure

    Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline])

  • Feasibility of Intervention Measure

    Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline])

Study Arms (1)

BA-A

EXPERIMENTAL

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.

Behavioral: BA-A

Interventions

BA-ABEHAVIORAL

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.

BA-A

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Autistic DisorderConsciousness DisordersDepression

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersBehavioral SymptomsBehavior

Study Officials

  • Michelle Menezes, PhD

    Stony Brook University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 31, 2026

First Posted

September 10, 2026

Study Start

August 10, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

September 10, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations