Feasibility, Acceptability, and Preliminary Effectiveness of Cognitive Behavioral Therapy for Dep… (NCT07755137) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Feasibility, Acceptability, and Preliminary Effectiveness of Cognitive Behavioral Therapy for Depression in Autistic Youth in Clinical Settings
United States140 participantsStarted 2026-12-01
Plain-language summary
The goal of this clinical trial is to learn if Cognitive Behavioral Therapy for Depression in Autistic Youth (CBT-DAY) can improve depressive symptoms and related mechanisms in autistic youth aged 11-17 years with depression receiving care in outpatient clinical settings.
The main questions it aims to answer are:
* Does CBT-DAY lead to greater reductions in depressive symptom severity compared to treatment-as-usual (TAU)?
* Does CBT-DAY improve key mechanisms (emotional reactivity, self-esteem, and autism self-knowledge) associated with depression outcomes?
Researchers will compare CBT-DAY versus treatment-as-usual (TAU) to see if CBT-DAY results in greater improvements in depressive symptoms and related outcomes.
Participants will:
* Complete baseline, mid-treatment, post-treatment, and 3-month follow-up assessments (surveys and interviews)
* Be randomly assigned to receive either 12 weeks of CBT-DAY or treatment-as-usual
* Participate in therapy sessions during the 12-week intervention period
* Complete follow-up assessments three months after treatment to evaluate longer-term outcomes
Who can participate
Age range
11 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Autistic youth:
* Age 11 to 17 years
* Prior clinical diagnosis of autism (per record review)
* At least a fifth grade reading level
* An ability to engage in sessions verbally (i.e., full length sentences)
* Elevated symptoms of depression at baseline (RCADS)
* Depression is a current clinical concern and participant is appropriate for intervention (per investigator determination)
* At least one parent/caregiver willing and able to participate
* Eligible to receive services at CHLA
* If taking psychotropic medication, regimen must be stable for at least 8 weeks prior to baseline
Parents/Caregivers:
* Age 18 years or older
* Parent or legal guardian of participating youth
* Able to provide informed consent
* Comfortable reading, writing, or speaking English or Spanish
* Willing to participate in study procedures
Exclusion Criteria:
Autistic youth:
* Lifetime diagnosis of bipolar disorder, psychotic disorder, or intellectual disability
* Severe suicidal or homicidal ideation or self-injury requiring immediate higher-level care
* Currently receiving psychotherapy for depression
* Changes in psychotropic medication regimen during study participation (participants may be withdrawn)
* A reading level below fifth-grade
* An inability to engage in sessions verbally (i.e., nonverbal, minimally verbal)
Parents/Caregivers:
* Not the parent or legal guardian of the participating youth
* Unable to provide informed consent
* Not comfortable reading, writing, o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.