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临床试验/NCT00496691
NCT00496691已完成1 期

HIV Prevention for Youth With Severe Mental Illness

Rhode Island Hospital2 个研究点 分布在 1 个国家目标入组 718 人开始时间: 2002年4月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
718
试验地点
2
主要终点
condom use; sexual delay

研究概览

简要总结

This 4-year competing continuation will extend the follow-up for 750 subjects enrolled in a randomized interventions trial, Project STYLE: "HIV Prevention for Youth with Severe Mental Illness" (R01, MH 63008). Extending the follow-up from one year to 36 months will 1) discern the long-term impact of the Project STYLE interventions and 2) permit complex modeling of the predictors and trajectories of sexual health (delay of sex) and risk (incident STIs). Adolescents, particularly those in mental health treatment, are at risk for HIV because of sexual and substance behaviors. Parent-child communication about sexual topics and parental supervision are associated with delays in the onset of sexual activity and more responsible sexual behavior; thus, the parent project, Project STYLE, is a randomized trial that is evaluating the comparative efficacy of three interventions: a) family-based HIV prevention intervention, b) adolescent-only HIV prevention intervention, and c) general health promotion intervention. This multi-site project (Rhode Island Hospital, Emory University, and the University of Illinois at Chicago) is enrolling an ethnically/racially/geographically diverse group of 750 adolescents in outpatient mental health treatment and their parents. Subjects receive a full day group intervention on the day of randomization, return in two weeks for an individual session, participate in a half day booster session three months later, and are assessed six and 12 months after the intervention. This application offers a unique opportunity to assess this already ascertained sample at three additional points (24,30, and 36 months). This is important because few studies have examined the longer-term predictors of the delay of sex and incident STIs over 36 months using a comprehensive array of family functioning, family monitoring/communication, and trauma history. Additionally, this continuation will provide important data concerning the long-term impact of Project STYLE's theoretically based HIV prevention programs which are designed to maintain safe sexual behaviors. The Family-Based program has increased parent/adolescent sexual communication and reduced adolescent unprotected sex after six months and extended assessment will determine whether these benefits are maintained over time.

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
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescent in mental health treatment
  • Living with parent/caregiver past 3 months

排除标准

  • Adolescent is HIV positive
  • Adolescent is pregnant

结局指标

主要结局

condom use; sexual delay

时间窗: 3 years

次要结局

  • parent-adolescent sexual communication(3 years)
  • condom use attitudes(3 years)

研究者

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

Dr. Larry K. Brown

Principal Investigator

Rhode Island Hospital

研究点 (2)

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