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临床试验/NCT02245607
NCT02245607Unknown不适用

Compensatory Cognitive Training in Clinical High Risk Latino Youth

University of California, San Diego3 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2014年10月最近更新:
适应症

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

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

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

Kristin Cadenhead, M.D.

Professor

University of California, San Diego

研究点 (3)

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