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临床试验/NCT01233414
NCT01233414已完成不适用

Randomized Trial of Parent Training for Young Children With Autism

Yale University12 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
12
主要终点
Aberrant Behavior Checklist Irritability Subscale

研究概览

简要总结

The purpose of this 24 week study is to determine whether a new Parent Training program is effective in reducing disruptive behaviors in young children with pervasive developmental disorders.

详细描述

Pervasive Developmental Disorders (PDDs) are a group of conditions that includes Autistic Disorder, Asperger's disorder and so called Pervasive Developmental Disorder - Not Otherwise Specified. Children with PDD show delays in speech and language and reduced social interaction. Some children with PDD also have behavior problems, including defiance of rules, aggression, and tantrums. The purpose of this study is to evaluate a new Parent Training program designed to decrease these behavior problems and improve daily living skills.

Following confirmation of eligibility, participants will be randomly assigned to receive either Parent Training or a Psychoeducational Program. The Parent Training program involves specific suggestions about how to deal with behavior problems. The Psychoeducational program covers specific issues related to autism and parenting, including an co-occurring medical conditions and treatment options.

Parents will attend up to 13 one-on-one sessions with a trained therapist over a 24-week period. Participation in the study also involves 2 home visits and 6 monthly assessment visits. The purpose of the assessment visits is to evaluate the child's response to treatment. Evaluations will also be conducted at 3 and 6 months after completion of the study.

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

入选标准

  • Diagnosis of Autistic Disorder, Pervasive Developmental Disorder, Not Otherwise Specified, or Asperger's Disorder
  • Between ages 3 yrs 0 months and 6 yrs 11 months.
  • No planned changes in the intensity of current treatment(s)
  • Medication free or on stable medication

排除标准

  • Diagnosis of Rett's Disorder or Childhood Disintegrative Disorder
  • Participation in a structured parent training program in the past 2 years
  • Developmental age < 18 months (IQ < 35)

结局指标

主要结局

Aberrant Behavior Checklist Irritability Subscale

时间窗: Week 24

Home Situations Questionnaire

时间窗: Week 24

次要结局

  • Vineland Adaptive Behavior Scales(Week 24)
  • Clinical Global Impressions Improvement Scale(Week 24)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Denis Sukhodolsky

Assistant Professor

Yale University

研究点 (12)

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