About this trial
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
Eligibility criteria
Qualifiers
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)
Disqualifiers
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Changes in psychotropic medication regimen during study participation (participants may be withdrawn)
Trial design
Treatments tested in this trial
- CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth)
- Treatment-as-Usual (TAU)
Treatment groups
Sponsors and collaborators
Children's Hospital Los Angeles
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator