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

NCT07755137 | Not Yet Recruiting DMC

• 2 other identifiers: CHLA-25-002141R34MH140993-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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; Anxiety Disorders; Depressive Disorder

Keywords

depression; autism; youth; anxiety; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• Change in depressive symptom severity

  Change in depressive symptom severity as assessed by the Modified Depression Module of the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS). This is a semi-structured clinical interview evaluating DSM-5 depressive symptoms over the previous 2 weeks. Each symptom is rated on a 6-point scale (1 = not present to 6 = severe). Higher scores indicating greater symptom severity. The outcome will be evaluated as change in total depression severity scores over time and compared between CBT-DAY and TAU groups. The KSADS will be administered four times from baseline to 6 months.

  Baseline to week 24

Secondary Outcomes (6)

• Change in Anxiety Symptoms

  Baseline to week 24

• Change in Suicidal Ideation

  Baseline to week 24

• Change in Life Satisfaction

  Baseline to week 24

• Change in Emotional Reactivity

  Baseline to week 24

• Change in Self-Esteem

  Baseline to week 24

Study Arms (2)

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

EXPERIMENTAL

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.

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

Treatment-as-Usual (TAU)

ACTIVE COMPARATOR

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.

Behavioral: Treatment-as-Usual (TAU)

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.

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

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.

Treatment-as-Usual (TAU)

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Depressive Disorder; Anxiety Disorders; Depression; Autistic Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Mood Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jessica Schwartzman, PhD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Schwartzman, PhD

CONTACT

323-207-5910; trendlab@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Training and Research to Empower NeuroDiversity (TREND) Lab, CHLA

Model Details: Autistic youth will be randomized 1:1 to receive 12 weeks of Cognitive Behavioral Therapy for Depression in Autistic Youth (CBT-DAY) or treatment-as-usual (TAU).

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)