Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Clinical Global Impression - Improvement
研究概览
简要总结
This study tests the effectiveness of a transdiagnostic cognitive behavioral therapy for autistic youth with anxiety and/or depression.
详细描述
About 1 in 54 adolescents are estimated to be on the autism spectrum, with over half suffering from anxiety or depressive disorders. These disorders contribute to suicidality, family stress, social impairments, and difficulties transitioning to adulthood among autistic youth. Given the frequency of anxiety and depressive disorders among autistic adolescents and the increased risk of impairment, developing effective treatments for anxiety and depression tailored to this population is a top priority.
Transdiagnostic cognitive behavioral therapy (CBT) for other populations, including typically developing adolescents, may confer broader benefits than disorder-specific CBT and facilitate broader dissemination and implementation. However, there has been little research conducted on transdiagnostic treatments among autistic adolescents. Thus, this study proposes to address this gap by testing transdiagnostic CBT for autistic adolescents with anxiety and depression.
The study involves two phases: 1) a pilot intervention; and 2) a randomized controlled trial.
The pilot intervention will involve 12 adolescent-caregiver dyads to further refine the treatment model and its assessment measures. The randomized trial will involve 100 adolescent-caregiver dyads to further evaluate the clinical efficacy of the treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child is between the ages of 12-17 at consent/assent.
- •The child meets criteria for autism spectrum disorder using evidence-based assessment approaches (e.g., Autism Diagnostic Observation Schedule-Second Edition; Childhood Autism Rating Scale-Second Edition).
- •The child meets criteria for clinically significant anxiety and/or depression symptoms based on elevated scores on the Pediatric Anxiety Rating Scale modified for Autism Spectrum Disorder (>11) and/or the Children's Depression Rating Scale-Revised (>39).
- •Anxiety/depressive disorder is the primary presenting problem as determined by administration of the Mini International Neuropsychiatric Interview
- •One parent/guardian is able and willing to participate.
- •The parent/guardian is 18 years or older.
- •Both parent and child can read and/or understand English.
- •Both parent and child reside in Texas.
排除标准
- •The child has a diagnosis of psychotic disorder and/or conduct disorder.
- •The child has severe suicidal/homicidal ideation and/or self-injury requiring immediate intervention and/or a higher level of care.
- •The child has limited verbal communication abilities.
- •The child is receiving concurrent psychotherapy for anxiety/depression.
- •The child has initiated psychotropic medications within 12 weeks of assessments (or 4 weeks for stimulants/benzodiazepines) or during therapy, and/or has changed dosage of psychotropic medication within 6 weeks of assessment (or 2 weeks for stimulants/benzodiazepines) or during therapy.
结局指标
主要结局
Clinical Global Impression - Improvement
时间窗: 7 days
Clinician-rated child internalizing symptom improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6 = very much improved).
Clinical Global Impression - Severity of Illness
时间窗: 7 days
Clinician-rated child internalizing symptom overall severity. A single item is scored 0-6 (0 = no illness; 6 = extremely severe symptoms).
Revised Children's Anxiety and Depression Scale - Parent-Report
时间窗: 7 days
Parent-rated child anxiety and depression severity. It is a 47-item scale. Each item is scored on a 0 ("never") to 3 ("always") scale (higher scores correspond to greater severity), yielding a total between 0 and 141.
次要结局
- Revised Children's Anxiety and Depression Scale - Self-Report(7 days)
- Pediatric Anxiety Rating Scale modified for Autism(7 days)
- Children's Depression Rating Scale, Revised(7 days)
研究者
Eric A Storch
Professor
Baylor College of Medicine