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

Summary

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

Conditions

• Autism Spectrum Disorder
• Depressive Disorder
• Anxiety Disorders

Interventions

BEHAVIORAL

CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth)

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.

BEHAVIORAL

Treatment-as-Usual (TAU)

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Children's Hospital Los Angeles

  lead OTHER

Principal Investigators

• Jessica Schwartzman, PhD · Children's Hospital Los Angeles

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

11 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-12-01

Primary Completion

2029-03-31

Completion

2029-12-01

Countries

• United States

Study Locations