A Remediation Program for Children at High-Risk of Schizophrenia: 22q11.2 Deletion Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- 否
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)
