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临床试验/NCT02276534
NCT02276534已完成不适用

SENSE Theatre Research Program

Vanderbilt University2 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2014年8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
136
试验地点
2
主要终点
NEPSY Memory for faces

研究概览

简要总结

The investigator's goal is to address the need for the development of social interventions for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends established behavioral strategies with theatre techniques that emphasize the involvement of peers, play and performance. The resulting synergy extends promising pilot studies in a randomized group experiment.

详细描述

The investigator's goal is to address the need for the development of social interventions for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends established behavioral strategies with theatre techniques that emphasize the involvement of peers, play and performance. The resulting synergy extends promising pilot studies in a randomized group experiment.

Objectives: The purpose of the study is to evaluate and extend the impact of a peer-mediated, theatre-based intervention on children with ASD with an emphasis on social functioning. The 10-session program incorporates theatrical approaches, trained typically developing peers and established behavioral strategies. Previous studies using pre-post designs have reported improvement in several skills, such as face memory, theory of mind and social cognition. A primary objective of this investigation is to utilize a true experimental design while evaluating social ability across multiple levels of analysis including neuropsychological, cognitive, behavioral, and functional outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

  • children diagnosed with autism spectrum disorder with IQ ≥ to 70.

排除标准

  • IQ ≤ 70, children with current aggression toward self or others.

结局指标

主要结局

NEPSY Memory for faces

时间窗: Change from Baseline at Week 10 and Week 16

The measure requires the child to observe 16 faces of children and then remember them immediately and following a 30-minute delay. Raw scores are generated which are converted to standardized scores based on normative data.

Measurement of Salivary Cortisol levels

时间窗: Change from Baseline Cortisol level at 20 minutes, 40 minutes, 60 minutes

Social Responsiveness Scale

时间窗: Change from baseline at Week 10 and Week 16

Adaptive Behavior Assessment System

时间窗: Change from baseline at Week 10 and Week 16

Parent questionnaire of child's adaptive behavior

Parenting Stress Index

时间窗: Change from baseline at Week 10 and Week 16

parent-based questionnaire

Event Related Potentials (ERP) incidental memory task

时间窗: Change from baseline at Week 10 and Week 16

Peer Interaction Playground Paradigm

时间窗: Change from baseline at Week 10 and Week 16

A playground play session conducted with trained typically developing peers.

次要结局

  • Peabody Picture Vocabulary Test(Change from baseline at Week 10 and Week 16)
  • Clinical Evaluation of Fundamentals Recalling Sentences subtest(Change from baseline at Week 10 and Week 16)

研究者

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

Blythe Corbett

Associate Professor

Vanderbilt University

研究点 (2)

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