Feasibility, Acceptability, and Preliminary Effectiveness of Cognitive Behavioral Therapy for Depression in Autistic Youth in Clinical Settings

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-17
SponsorChildren's Hospital Los Angeles

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Changes in psychotropic medication regimen during study participation (participants may be withdrawn)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

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Children's Hospital Los Angeles

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator