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NCT Number: NCT07812870

Behavioral Activation for Treatment of Depression in Autistic Adolescents With Below Average Intelligence

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Behavior Behavioral Symptoms Child Development Disorders, Pervasive Consciousness Disorders Depressed Depressed Mood Depression Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stony Brook University

Stony Brook, New York, 11794, United States

Location status: Recruiting

Location contact

Michelle Menezes, PhD

CONTACT

[email protected]

631-638-3819

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BA-A

Behavioral

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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. Acceptability of Intervention Measure

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

  6. Intervention Appropriateness Measure

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

  7. Feasibility of Intervention Measure

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

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Menezes, PhD

CONTACT

[email protected]

631-638-3819

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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