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临床试验/NCT03368001
NCT03368001已完成不适用

Investigating Social Competence in Youth With Autism: A Multisite Randomized Control Trial

Vanderbilt University Medical Center6 个研究点 分布在 1 个国家目标入组 318 人开始时间: 2017年11月22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
318
试验地点
6
主要终点
Developmental Neuropsychological Assessment (NEPSY) Memory for Faces Delayed

研究概览

简要总结

Our treatment, SENSE Theatre, combines several well-documented, effective behavioral strategies and theatre techniques. The proposed project will extend previous findings showing improving improvement in memory for faces. The multisite randomized control trial will include a large sample of 240 children with autism spectrum disorder (ASD) randomly assigned to the experimental (SENSE Theatre) or an active control condition (Tackling Teenage Together).

详细描述

Recent findings from a randomized control trial (RCT) show immediate between-group effects and evidence of target engagement on the hypothesized mechanism of action, memory for faces, which was evaluated by neuropsychological and event-related potential (ERP) measures. Moreover, the RCT demonstrated treatment effects on social communication skills that generalized to home and community settings. Finally, maintained treatment effects were observed on communication symptoms. The proposed project will extend these findings and provide a stronger test of efficacy using a multisite RCT of SENSE Theatre with a large sample of participants with ASD (8 to 16 years) randomized to an experimental and an active control group. The RCT will assess target engagement of memory for faces and functional change in social interaction with peers. Thus, the overarching aim of the study is to determine whether detected changes in face memory and social interaction are due to the SENSE Theatre treatment and the extent to which these changes generalize and maintain. If predicted results occur, it will provide strong empirical support for a community-based treatment that has generalized effects on a set of core deficits that otherwise have life-long consequences for children and adolescents with ASD.

8/18/2021: Record was updated to delete the outcome measure "Computer memory for faces" as it was not included as a primary outcome variable in the Institutional Review Board (IRB) approved protocol dated 9/13/2017.

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

入选标准

  • Children with high-functioning ASD (IQ > or = to 70).

排除标准

  • Children who evidence aggression toward other people.

结局指标

主要结局

Developmental Neuropsychological Assessment (NEPSY) Memory for Faces Delayed

时间窗: Change from baseline to end of treatment (10 weeks).

A measure of face memory following a delay. Possible score ranges from a scaled score of 1-19 with high scores reflecting better face memory.

Incidental Face Memory (IFM) Event-Related Potential (ERP) Task

时间窗: Change from baseline to end of treatment (10 weeks) and at two-month follow-up.

The IFM involves passive viewing of novel faces one of which repeats. The dependent measure is the difference in ERP amplitude of 250-500 ms time window between the repeated and single face presentation. Positive values indicate better face memory.

次要结局

  • Social Responsiveness Scale (SRS) Communication(Baseline, post-treatment (10 weeks), and two-month follow-up.)
  • Adaptive Behavior Scales for Children (ABAS)(Baseline, post-treatment (10 weeks), and two-month follow-up.)
  • Contextual Assessment of Social Skills (CASS) Interested(Baseline, post-treatment (10 weeks), and two-month follow-up.)
  • Child Behavior Checklist (CBCL)(Baseline, post-treatment (10 weeks), and two-month follow-up.)

研究者

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

Blythe Corbett

Professor

Vanderbilt University Medical Center

研究点 (6)

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