Feasibility, Acceptability, and Preliminary Effectiveness of Cognitive Behavioral Therapy for Depression in Autistic Youth in Clinical Settings
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change in depressive symptom severity
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in depressive symptom severity
时间窗: 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.
次要结局
- 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)
- Change in Autism Self-Knowledge(Baseline to week 24)
研究者
Jessica Schwartzman
Director, Training and Research to Empower NeuroDiversity (TREND) Lab, CHLA
Children's Hospital Los Angeles