NCT07755137Not yet recruiting
Feasibility, Acceptability, and Preliminary Effectiveness of Cognitive Behavioral Therapy for Depression in Autistic Youth in Clinical Settings
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 5 Aug 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- Children's Hospital Los Angeles
- Diseases
- Autism
- NCT number
- NCT07755137
What you commit to
- Study type: Interventional
- Planned participants: 140
- From 1 Dec 2026 to the primary completion date, 31 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving psychotherapy for depression
- Changes in psychotropic medication regimen during study participation (participants may be withdrawn)
Other illness
- Lifetime diagnosis of bipolar disorder, psychotic disorder, or intellectual disability
Other
- Autistic youth:
- Severe suicidal or homicidal ideation or self-injury requiring immediate higher-level care
- 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, or speaking English or Spanish
- Unwilling to participate in study procedures
Who the study is looking for
- 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
Age in the registry: 11 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.