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临床试验/NCT02960451
NCT02960451已完成不适用

Randomized Trial of Usual Care vs. Specialized, Phase-specific Care for Youth at Risk for Psychosis

Yale University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Global Assessment of Functioning

研究概览

简要总结

The purpose of this study is to determine whether specialty care is superior to usual care in the treatment of patients at clinical high risk for psychosis.

详细描述

This study is a randomized clinical effectiveness trial for patients at clinical high risk for psychosis that compares two treatments: 1) specialty care delivered in a specialized clinical for patients at clinical high risk for psychosis versus 2) treatment as usual in the community.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

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

  • Subjects must meet all of the following:
  • Male or female between 12 and 30 years old.
  • Understand and sign an informed consent (or assent for minors) document in English.
  • Meet diagnostic criteria for prodromal syndrome as per COPS criteria.

排除标准

  • Subjects must not meet any of the following:
  • Diagnosis of current or lifetime Axis I psychotic disorder, including mood disorder with psychotic symptoms.
  • Impaired intellectual functioning (full-scale IQ<70). However, those with an IQ in the 65-69 range will not be excluded if they score >75 on the WRAT Reading.
  • Past or current history of a clinically significant central nervous system disorder that may contribute to prodromal symptoms or confound their assessment.
  • Alcohol or substance dependence in the past 6 months.

研究组 & 干预措施

PRIME care

Experimental

Specialized care in the PRIME clinic

干预措施: PRIME care (Other)

Usual care

Active Comparator

Usual care in the community

干预措施: Usual care (Other)

结局指标

主要结局

Global Assessment of Functioning

时间窗: 24 months

次要结局

  • Service utilization(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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