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

N/ANot Yet RecruitingNCT07755137

Children's Hospital Los Angeles140 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Autism Spectrum Disorder Depressive Disorder

Eligibility

Sex: ALLMin age: 11 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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 * Willing to participate in study procedures Exclusion Criteria: 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

Outcomes

Primary Outcomes

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.