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

Conditions

• Anxiety Disorders
• Autism Spectrum Disorder
• Depressive Disorder

Eligibility Criteria

Sex

ALL

Age

11 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth) — BEHAVIORAL
  CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth) is a 12-week, autism-adapted cognitive behavioral therapy designed for verbally fluent autistic youth aged 11-17 to reduce depressive symptoms. The intervention targets key mechanisms-emotional reactivity, negative self-esteem, and autism self-knowledge-using developmentally tailored CBT strategies appropriate for autistic individuals.
• Treatment-as-Usual (TAU) — BEHAVIORAL
  Treatment-as-Usual (TAU) consists of standard clinical care delivered by clinicians with limited autism training in the same outpatient setting. It typically involves supportive, talk-based psychotherapy without the structured, autism-adapted components of CBT-DAY.

Study Details

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 Dates

First listed

Aug 10, 2026

Start date

Dec 1, 2026

Status verified

Aug 2026

Primary completion

Mar 31, 2029

Completion

Dec 1, 2029

Study Design

Enrollment

140 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth)
  Participants receive a structured, 12-week Cognitive Behavioral Therapy program adapted for autistic youth, targeting depressive symptoms and underlying mechanisms such as emotional reactivity and self-esteem. Therapy is delivered by trained clinicians with weekly sessions and includes assessments at baseline, mid-treatment, post-treatment, and follow-up.
• Active Comparator: Treatment-as-Usual (TAU)
  Participants receive standard outpatient mental health care, typically consisting of supportive, talk-based therapy provided by clinicians without CBT-DAY training. Participants complete the same assessment schedule as the experimental arm across baseline, treatment, and follow-up timepoints.

Primary Outcome Measure

Change in depressive symptom severity [ Time Frame: Baseline to week 24 ]

Central Contacts

• Jessica Schwartzman, PhD
  323-207-5910
  [email protected]

Locations (1)

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