NCT07812870 · Stony Brook University
Behavioral Activation for Treatment of Depression in Autistic Adolescents With Below Average Intelligence
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
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])
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
- 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
Where
- Stony Brook, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 10, 2026 · Source of record for eligibility and locations