Compensatory Cognitive Training in Clinical High Risk Latino Youth
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Neurocognition (Global Cognitive Index z score)
研究概览
简要总结
This is a randomized study to compare Compensatory Cognitive Training (CCT) versus Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico.
Study hypotheses: Compared to those who receive RT, study participants receiving CCT will show significant improvement in neurocognition, functional capacity, self-rated functioning and clinical measures.
详细描述
This is a 12 week randomized study to compare Compensatory Cognitive Training (CCT) versus Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico.
Study participants will be measured 3 times, at baseline, 12 and 24 weeks on all outcome measures. Study hypothesis: Study participants receiving CCT will show significant improvement at 12 and 24 weeks compared to baseline in 1) Neurocognition using the Global Cognitive Index z score derived from the MATRICS neurocognitive domain scores, 2) Functional Capacity as assessed by the UCSD Performance-based Skills Assessment (UPSA/UPSA-Adolescent), 3) Self-Rated Functioning as measured by the Specific Level of Functioning Scale (SLoF) and 4) Clinical symptom ratings as measured by the Scale of Prodromal Symptoms (SOPS) total score when compared to subjects receiving RT training across study time.
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
- 12 Years 至 30 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet Clinical High Risk criteria
- •Be of Latino descent
- •Speak Spanish as their preferred language
排除标准
- •Concomitant medical or neurological illness
- •Brain injury with loss of consciousness > 30 minutes
- •Current substance abuse (excluding nicotine)
- •High suicidal risk
结局指标
主要结局
Neurocognition (Global Cognitive Index z score)
时间窗: 3 and 6 months post-baseline
The CGI is derived based on Z scores across multiple neurocognitive domains and is a representation of global cognition
次要结局
- Functional capacity (UPSA/UPSA-A)(3 and 6 month post-baseline)
研究者
Kristin Cadenhead, M.D.
Professor
University of California, San Diego
