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临床试验/NCT01781923
NCT01781923已完成不适用

A Remediation Program for Children at High-Risk of Schizophrenia: 22q11.2 Deletion Syndrome

Duke University2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2010年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
2
主要终点
Change in sustained attention

研究概览

简要总结

The goal of this study is to collect preliminary data on the efficacy of a cognitive remediation program in improving the neurocognitive deficits in children with chromosome 22q11.2 deletion syndrome (22q11DS). This study involves a two part approaching including a computerized cognitive remediation program (CCRP, Posit Science, CA) in combination with a Social Cognitive Training (SCT) program. The computer-based training program has shown encouraging results in improving learning deficits in individuals with schizophrenia and we now seek to adapt them to children with 22q11DS, who have unique needs due to their lower IQ and high risk of psychosis in late adolescence and adulthood. The SCT is a small-group intervention program based on cognitive enhancement therapy, which has been shown to improve social cognition and functionality in adults with schizophrenia. A preliminary study will be performed using this two-pronged approach, to establish the feasibility and gather preliminary data on neurocognition before and after the intervention in these children; these data would enable a larger randomized controlled study to assess the efficacy of this approach.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
11 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • molecular/cytogenetic confirmation of 22q11DS

排除标准

  • Intelligence Quotient <60
  • diagnosis of psychosis
  • pregnancy
  • home location does not permit participation in small groups

结局指标

主要结局

Change in sustained attention

时间窗: Baseline and 12 weeks

Sustained attention will be assessed using the Continuous Performance Test.

Change in executive function.

时间窗: Baseline and 12 weeks

Change in verbal memory.

时间窗: Baseline and 12 weeks

次要结局

  • Social skills(40 weeks)
  • Change in brain function and white matter structure.(Baseline and 12 weeks)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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