AutismNCT07812870
Behavioral Activation for Treatment of Depression in Autistic Adolescents With Below Average Intelligence
A study testing BA-A in people with Autism and Depressed, run by Stony Brook University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Autism, Depressed, Depressed Mood
- What is being tested?
- BA-A
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University
Stony Brook, New York, 11794
Michelle Menezes, PhD, 631-638-3819, autismandneurodiversitylab@gmail.com
About this study
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
- Being tested
- BA-A
- Keywords
- Autism, Depression
- Medical subject headings
- Autistic Disorder, Consciousness Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BA-ABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: BA-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Depression Rating Scale, Revised
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline])
Intervention Appropriateness Measure
Measured: Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline])
Feasibility of Intervention Measure
Measured: Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start10 Aug 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Menezes, Stony Brook University
- Investigators
- Michelle Menezes, PhD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812870
- Sponsor's protocol ID
- IRB2026-00072
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Activation for Treatment of Depression in Autistic Adolescents With Below Average Intelligence
- ClinicalTrials.gov ID
- NCT07812870
- Acronym / sponsor ID
- IRB2026-00072
- Conditions
- Autism, Depressed, Depressed Mood
- Keywords
- Autism, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BA-A | Experimental | Behavioral: BA-ABA-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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BA-ABA-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. | Behavioural | BA-A |
Primary outcome
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])
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Menezes, PhD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BA-A in people with Autism and Depressed, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Menezes, PhD (631-638-3819, autismandneurodiversitylab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.