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临床试验/NCT04183400
NCT04183400已完成不适用

Safety Awareness For Empowerment (SAFE): An RCT With Young People Experiencing Homelessness

University of Denver2 个研究点 分布在 1 个国家目标入组 244 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
244
试验地点
2
主要终点
Substance use

研究概览

简要总结

The SAFE study examines the effects of brief mindfulness-based cognitive-behavioral intervention aimed at improving risk-related attention skills (risk detection, problem solving, assertiveness, and help seeking) in order to reduce substance use and victimization among young people (ages 18-21) experiencing homelessness.

详细描述

Youth (ages 18-21) living at a local youth shelter will be recruited and randomly assigned to receive the SAFE intervention (plus usual case management) or to receive usual case management only. Those assigned to SAFE will receive 12 mindfulness-based, cognitive-behavioral modules through a 3-day intensive group intervention provided by an agency intern and a hired project staff member. The intervention uses mindfulness-based cognitive-behavioral approaches to augment youth attention to risk-related processes, including risk detection, problem solving, assertiveness, and help seeking skills. It is hypothesized the intervention will result in reduced substance use and victimization and that these effects will be explained, at least in part, by improved risk-related attention skills (risk detection, problem solving, assertiveness, and help seeking skills). Post baseline interview, participants will be randomly assigned and will participate in a posttest interview (1 week post baseline) and follow up interviews at 6-weeks, 3-months, and 6-months post baseline interview.

研究设计

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

入排标准

年龄范围
18 Years 至 21 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Reside at the partnering community based youth shelter

排除标准

  • As measured by the KSADS (a semi-structured diagnostic interview administered by trained interviewers at baseline):
  • presence of psychotic symptoms;
  • presence of a life-threatening medical/chronic neurological illness that would prevent participation in a 4-day intervention and/or assessments;
  • suicide attempt in last 6 months without current enrollment in therapy or related services to address;
  • chronic self-injurious behavior/cutting without current enrollment in therapy or related services to address
  • hospitalization or residential treatment for psychiatric reasons in last 6 months without current enrollment in therapy or related services to address.

结局指标

主要结局

Substance use

时间窗: Follow up at 6-months post baseline interview

The Substance use domain of the Addiction Severity Index, 5th edition will be used to assess the frequency, type and amount of substance use in the past 30 days. This domain will be adapted to add smoking tobacco to the list of substances.

Victimization

时间窗: Follow up at 6-months post baseline interview

The Juvenile Victimization Questionnaire (JVQ) will be used to asses exposure to a range of types of victimization.

次要结局

  • Substance use symptoms(Follow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baseline)
  • Risk detection(Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline)
  • Help seeking intentions(Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline)
  • Help seeking behaviors(Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline)
  • Assertiveness(Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline)
  • Substance use disorder diagnostic criteria(Follow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baseline)

研究者

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

Kimberly Bender

Professor

University of Denver

研究点 (2)

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