Feasibility, Acceptability, and Preliminary Effectiveness of Cognitive Behavioral Therapy for Depression in Autistic Youth in Clinical Settings
Starting soon · Not applicable
Conditions studied: Autism Spectrum Disorder, Depressive Disorder, Anxiety Disorders
In brief
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
Key facts
- Study ID
- NCT07755137
- Run by
- Children's Hospital Los Angeles
- People needed
- 140
- Starts
- 2026-12-01
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-08-10
Who can join
Age: 11 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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, or speaking English or Spanish
- Unwilling to participate in study procedures
Where it is running
- Children's Hospital Los Angeles — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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