An interventional study of CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth) and Treatment-as-Usual (TAU) in Autism Spectrum Disorder, Depressive Disorder and Anxiety Disorders, sponsored by Children's Hospital Los Angeles. Not yet recruiting at 1 site in United States. Open to participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Treatment
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:
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:
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 140 is above the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Children's Hospital Los Angeles is the lead sponsor of 152 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Compared within Autistic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Autism Spectrum Disorder. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Autistic youth:
Parents/Caregivers:
Exclusion Criteria:
Autistic youth:
Parents/Caregivers:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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) 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.
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.
Time frame: Baseline to week 24
Change in Anxiety Symptoms
Change in anxiety symptom severity as assessed by the Pediatric Anxiety Rating Scale adapted for Autism Spectrum Disorder (PARS-ASD). This is a semi-structured clinical interview assessing type and severity of anxiety symptoms. Each symptom is rated on a 6 point scale (0 = never to 5 = always). Higher scores indicate greater severity of anxiety symptoms. The outcome will be evaluated as change in anxiety scores over time and compared between CBT DAY and TAU groups. The PARS-ASD will be administered four times from baseline to 6 months.
Time frame: Baseline to week 24
Change in Suicidal Ideation
Change in severity of suicidal ideation measured by the Suicidal Ideation Questionnaire-Junior (SIQ-Jr). This is a youth-report survey evaluating dfrequency of suicidal thoughts over the previous 2 weeks. Items are rated on a 7-point scale (0 = never to 6 = almost every day), with higher total scores indicating more severe suicidal ideation. The outcome will be evaluated as change in suicidal ideation scores over time and compared between CBT DAY and TAU groups. The SIQ-Jr will be administered four times from baseline to 6 months.
Time frame: Baseline to week 24
Change in Life Satisfaction
Change in youth-reported life satisfaction measured using the PROMIS Pediatric Short Form - Life Satisfaction. This is a youth-report survey evaluating satisfaction with life over the past month. Items are rated on a 5-point scale, with higher scores indicating greater life satisfaction. The outcome will be evaluated as change in life satisfaction over time and compared between CBT DAY and TAU groups. The PROMIS will be administered four times from baseline to 6 months.
Time frame: Baseline to week 24
Change in Emotional Reactivity
Change in emotional reactivity as assessed by the Emotion Dysregulation Inventory (EDI). This is a youth- and parent-report survey evaluating emotion dysregulation in youth. Each symptom is rated on a 5-point scale (0 = not at all to 4 = very severe). Higher scores indicate greater emotion dysregulation. The outcome will be evaluated as change in emotional dysregulation over time and compared between CBT DAY and TAU groups. The EDI will be administered four times from baseline to 6 months.
Time frame: Baseline to week 24
Change in Self-Esteem
Change in self-esteem as assessed by the Rosenberg Self-Esteem Scale (RSES). This is a youth-report survey evaluating self-esteem. Each item is rated on a 4-point scale (1 = strongly disagree to 4 = strongly agree). Higher scores indicate higher self-esteem. The outcome will be evaluated as change in self-esteem scores over time and compared between CBT DAY and TAU groups. The RSES will be administered four times from baseline to 6 months.
Time frame: Baseline to week 24
Change in Autism Self-Knowledge
Change in autism self-knowledge as assessed by the Autism Personal and Community Identity (APCI) scale. This is a youth-report survey evaluating autism self-knowledge. Each item is rated on a 6-point scale (1 = strong disagree to 6 = strongly agree). Higher scores indicate higher autism self-knowledge. The outcome will be evaluated as change in autism self-knowledge over time and compared between CBT DAY and TAU groups. The APCI will be administered four times from baseline to 6 months.
Time frame: Baseline to week 24
Plan to share: No
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