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临床试验/NCT03123146
NCT03123146已完成不适用

Functional Behavior-based Cognitive-Behavioral Therapy for Obsessive Compulsive Behavior in Children With Autism Spectrum Disorder: A Randomized Controlled Trial

Tricia Vause1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2010年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
1
主要终点
Change in Repetitive Behavior Scale (RBS_SCR)

研究概览

简要总结

Individuals with high functioning autism spectrum disorder (ASD) frequently experience obsessions and/or compulsions that are similar to those specified in Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5) criteria for obsessive compulsive disorder (OCD). However, little research exists on effective interventions for OCD symptoms (referred to as OCBs) in ASD. In a randomized controlled trial, a manualized functional behavior-based cognitive-behavior therapy (Fb-CBT) consisting of traditional CBT components (psychoeducation and mapping, cognitive-behavioral skills training, exposure, and response prevention) as well as function-based behavioral assessment will be evaluated. Participants will be assigned randomly to Fb-CBT or treatment as usual (TAU). Primary and secondary outcome measures will be used to evaluate the efficacy of the treatment, and will be administered at pre and post-intervention as well as six month follow-up.

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
7 Years 至 13 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Previous diagnosis of ASD
  • •Presence of OCBs as defined by Sameness, Ritualistic and Compulsive subscales on the RBS-R
  • •a Full Scale IQ (WISC-IV; Wechsler, 2004) ≥ 70
  • •parent indicated no planned change in child medication during the study (unless the physician deemed the change medically necessary)

排除标准

  • •participation in treatment for anxiety
  • •participation in treatment for repetitive behaviour
  • •participation in treatment for intensive behavioural intervention

研究组 & 干预措施

Fb-Cognitive Behavioral Therapy

Experimental

Functional Behavior-Based Cognitive Behavioral Therapy: Group activities, individual work in parent-child dyads, group parent training, and social skills exercises.

干预措施: Functional Behavior-Based Cognitive Behavioral Therapy (Behavioral)

Treatment as Usual (TAU)

No Intervention

Children assigned to this condition received "usual care," meaning that they could continue with any services. This group acted as a control group whereby access to intervention was patient-directed.

结局指标

主要结局

Change in Repetitive Behavior Scale (RBS_SCR)

时间窗: Assessment occurred at baseline and 2 weeks following end of treatment, as well as at follow-up (6 months following the cessation of treatment)

The RBS is a 43-item parent rating measure of repetitive behavior. It is comprised of a four-point Likert scale ranging from (0) behavior does not occur, to (3) behavior occurs and is a severe problem . The RBS\_SCR scale specifically focusses on the assessment of sameness, compulsive, and ritualistic behaviors

Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)

时间窗: Assessment occurred at baseline and 2 weeks following end of treatment

A 10-item, semi-structured interview used to assess symptom severity for children ages 6 through 17 years. Each item is rated on a 5-point ordinal scale from 0 (none) to 4 (extreme)' For the purpose of this study, only the 5-item Compulsion score was used pre and post-treatment.

次要结局

  • Change in The child Obsessive-Compulsive Impact Scale-Revised (COIS-R)(Assessment occurred at baseline and 2-weeks following the end of treatment, as well as at follow-up (6 months following the cessation of treatment))
  • Parent OCB Rating Scale.(Scale was completed by parents at baseline, each day throughout the 9-week treatment period, and at follow-up (6 months following the cessation of treatment))
  • Change in Repetitive Behavior Scale 100 (RBS_100)(Assessment occurred at baseline and 2 weeks following the end of treatment, as well as at follow-up (6 months following the cessation of treatment))

研究者

发起方
Tricia Vause
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tricia Vause

Associate Professor

Brock University

研究点 (1)

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