Anxiety Disorders, Autism Spectrum Disorder, Depressive Disorder
Conditions
Keywords
depression, autism, youth, anxiety, cognitive behavioral therapy
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
Interventions
BEHAVIORALCBT-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.
BEHAVIORALTreatment-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
Children's Hospital Los Angeles
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in depressive symptom severity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety Symptoms | 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. |
| Change in Suicidal Ideation | 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. |
| Change in Life Satisfaction | 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. |
| Change in Emotional Reactivity | 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. |
| Change in Self-Esteem | 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. |
| Change in Autism Self-Knowledge | 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. |
Countries
United States
Contacts
CONTACTJessica Schwartzman, PhD
PRINCIPAL_INVESTIGATORJessica Schwartzman, PhD
Children's Hospital Los Angeles
Outcome results
None listed