Feasibility of a Therapist and Parent Guided eHealth Intervention for Obsessive Compulsive Disorder in Youth With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Children's Yale-Brown Obsessive Compulsive Scale
研究概览
简要总结
This study is a feasibility study of Internet-delivered CBT for OCD in children and adolescents (7-17 years) with comorbid Autism Spectrum Disorder.
详细描述
The main objectives of this study is to evaluate the feasibility, acceptability and preliminary efficacy of internet-delivered Cognitive Behavioral Therapy (ICBT) for Obsessive Compulsive Disorder (OCD) in children and adolescents (7-17 years) with Autism Spectrum Disorders (ASD). The study will an open trial with-in group mean comparison design (n=18). The treatment is delivered over 16 weeks. Study participants will be followed up at 3 (primary endpoint), 6 and 12 months after completed treatment. ICBT is expected to decrease OCD-symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of OCD according to DSM-5
- •a diagnosis of autism according to DSM-IV or DSM-5, confirmed with the Autism Diagnostic Interview- Revised or Autism Diagnostic Observation Schedule version 1 or 2 and by medical records
- •a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale
- •age between 7 and 17 years
- •ability to read and write Swedish
- •access to the internet
- •a parent that is able to co-participate in the treatment
- •participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment
排除标准
- •a diagnosis of psychosis, bipolar disorder, severe eating disorder or intellectual disabilities
- •comorbid hoarding disorder or OCD with hoarding as a principal symptom.
- •suicidal ideation
- •subject not able to read or understand the basics of the ICBT material
- •completed CBT for OCD within last 12 months (defined as at least 5 sessions of CBT including exposure and response prevention)
- •ongoing psychological treatment for OCD or any anxiety disorder
- •OCD treatment is not an immediate priority
研究组 & 干预措施
Internet CBT
Participants and their parents receive 16 weeks of internet-delivered cognitive behavior therapy (CBT) with psychologist support.
干预措施: Internet CBT (Behavioral)
结局指标
主要结局
Children's Yale-Brown Obsessive Compulsive Scale
时间窗: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Changein obsessions and compulsions will be measured as the total score on the scale.. Total score ranges from 0 to 40 points, a higher score indicates more severe OCD. The scale is rated by a clinician.
次要结局
- Obsessive-compulsive inventory - child version(Baseline, weekly during treatment, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment)
- Family accommodation scale for obsessive-compulsive disorder(Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment)
- Education, work and social adjustment scale - child and parent version(Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment)
- Mood and Feeling Questionnaire - child and parent version(Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment)
- Mini International Neuropsychiatric Interview for Children and Adolescents(Baseline)
- Children's global assessment scale(Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment)
- Clinical global impression - severity(Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment)
- Children's Assessment Scale for Developmental Disabilities(Baseline)
- Autism spectrum quotient (AQ-10)(Baseline)
- Children's Obsessional Compulsive Inventory Revised - parent rated (ChOCI-R-P)(Baseline, weekly during treatment, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment)
- Completed treatment modules(week 16)
- Clinical global impression - improvement(16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment)
- Client Satisfaction Questionnaire (CSQ-8)(16 weeks)
- Parent strategies(Post-treatment)
- Drop-out rate from treatment(at week 16)
- internet intervention Patient Adherence Scale(8 weeks, 16 weeks)
- Patient EX/RP Adherence Scale(Weekly for 16 weeks (during treatment))
研究者
Fabian Lenhard
PhD, Principal Investigator
Karolinska Institutet