跳至主要内容
临床试验/NCT02914951
NCT02914951Enrolling By Invitation不适用

Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents (An Open Pilot Study in Autism Spectrum Disorder)

Yale University2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2016年10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
Enrolling By Invitation
入组人数
6
试验地点
2
主要终点
Aberrant Behavior Checklist - Irritability Scale (ABC-I)

研究概览

简要总结

In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder (ASD) often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, and aggression. The purpose of this study is to investigate cognitive-behavioral therapy (CBT) for disruptive behavior in children with autism spectrum disorders and intellectual disability. This pilot study will include children with ASD and IQ between 55 and 85 in an open study of CBT. CBT is modified in this study to reduce complexity of activities during therapy sessions but retains all key elements and principles of CBT. Assessments of irritability and disruptive behavior will include clinical interviews, parent ratings and child self-report measures. Study participants will be asked to complete functional magnetic resonance imaging (fMRI) to evaluate biomarkers of social perception and emotion regulation before and after CBT.

详细描述

Children with ASD share common symptoms in the core domains of social reciprocity, communication, and repetitive behaviors. In addition to the core symptoms, 50 to 70 percent of children with ASD often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, aggression and self-injury.

In this open pilot study expands clinical research on CBT for irritability to children with autism and mild cognitive impairment. CBT consists of individual weekly sessions dedicated to teaching children to recognize situations that may lead to frustration and to build coping skills for dealing with frustration in socially appropriate ways. Recent research as well as clinical reports suggest that children with mild intellectual disabilities (IQ between 55 and 85) can also benefit from CBT. The intervention is modified to reduce complexity of activities during therapy sessions but retains key elements and principles of CBT. Thus, the modified version of CBT is referred to as "Principles-Based Cognitive Behavior Therapy for Irritability in Autism" or PB-CBT for short. Subjects in this study will receive a comprehensive evaluation of ASD and associated psychopathology. Irritability and related disruptive behaviors will be rated on weekly basis to utilize a single-subject approach to data analysis. Children will be asked to participate in functional magnetic resonance imaging (fMRI) with tasks of social perception and emotion regulation before and after CBT. The purpose of the fMRI portion of the study is to evaluate feasibility of fMRI as an outcome measure in studies of behavioral interventions for children with ASD and intellectual disability.

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
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • DSM-5 diagnosis of Autism Spectrum Disorder
  • Presence of disruptive behaviors such as irritability and anger outbursts
  • IQ between 55 and 85
  • ABC Irritability Scale score greater than or equal to 15
  • Un-medicated or on stable medication regimen
  • Able to complete all study assessment and fMRI procedures

排除标准

  • Medical or psychiatric condition that would require alternative treatment

研究组 & 干预措施

Cognitive-Behavioral Therapy

Experimental

CBT is a behavioral intervention where children are taught various skills for coping with frustration and parents are taught various strategies for managing situations that can be anger-provoking for their child.

干预措施: Cognitive-Behavioral Therapy (Behavioral)

Cognitive-Behavioral Therapy

Experimental

CBT is a behavioral intervention where children are taught various skills for coping with frustration and parents are taught various strategies for managing situations that can be anger-provoking for their child.

干预措施: Functional magnetic resonance imaging (fMRI) (Other)

结局指标

主要结局

Aberrant Behavior Checklist - Irritability Scale (ABC-I)

时间窗: Weekly - up to 20 weeks

The ABC-I is a 15-item parent rating of irritability that has been commonly used in clinical trials in children with ASD.

Modified Overt Aggression Scale (MOAS)

时间窗: Weekly - up to 20 weeks

Modified Overt Aggression Scale (MOAS) is a 16-item scale that reflects the frequency and severity of incidents of aggressive behavior

次要结局

  • Home Situations Questionnaire (HSQ)(endpoint (16 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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