Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Location contact
Jessica Schwartzman, PhD
CONTACT
Jessica Schwartzman, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07755137
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
Trial opening soon.
Get Notified11 year–17 year
All sexes
Interventional
Not applicable
Los Angeles, California, 90027, United States
Jessica Schwartzman, PhD
CONTACT
Jessica Schwartzman, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Autistic youth:
Parents/Caregivers:
Exclusion criteria
Autistic youth:
Parents/Caregivers:
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.
Time frame: Baseline to week 24
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 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 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 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 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 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 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.
Contact information is provided by the study sponsor or research team.
Children's Hospital Los Angeles
Other
Acronym: CBT-DAY
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