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临床试验/NCT01988623
NCT01988623已完成不适用

Pivotal Response Treatment for Individuals With Intellectual Disabilities

Stanford University2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2012年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks

研究概览

简要总结

The investigators will assess the efficacy of Pivotal Response Treatment (PRT) in the treatment of communication deficits in children with intellectual disabilities. By collecting information about parent and child functioning before and after PRT, The investigators will be able to determine whether the intervention is effective in improving child communication and reducing parent stress.

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
2 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • medically unstable (such as having unstable seizures)
  • primary diagnosis of Autism Spectrum Disorder (ASD) is exclusionary as determined by the investigators

结局指标

主要结局

Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks

时间窗: 6, 12 and 24 weeks

Change from Baseline on the Clinical Global Impression Scale at 6, 12, and 24 weeks

时间窗: 6, 12, and 24 weeks

Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks

时间窗: 6, 12 and 24 weeks

Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks

时间窗: 6, 12 and 24 weeks

次要结局

  • Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 6, 12, and 24 weeks(6, 12 and 24 weeks)
  • Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks(6, 12, and 24 weeks)
  • Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks(6, 12, and 24 weeks)

研究者

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

Antonio Hardan

Professor of Psychiatry and Behavioral Sciences

Stanford University

研究点 (2)

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