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临床试验/NCT02188797
NCT02188797已完成不适用

Brief AOD Use and Sexual Risk Reduction Group MI Intervention for Homeless

RAND3 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
RAND
入组人数
200
试验地点
3
主要终点
Change in use of drinking protective strategies

研究概览

简要总结

The goal of this study is to evaluate a group-based motivational interviewing (MI)-delivered risk reduction program for homeless young adults. It is hypothesized that youth who participate in the program will show greater reductions in substance use intentions, behavior and consequences, as well as sexual activity intentions and risk behavior, over a 3-month period compared to a usual care control sample of youth who do not participate in the program.

详细描述

This study addresses an important gap in prevention services for homeless youth by conducting a pilot test of an innovative 4-session integrated substance use and sexual risk reduction program for this population that is feasible to deliver in settings where these youth seek services. The study has 2 specific aims:

Aim 1: Investigate whether homeless youth who participate in the program show reductions in substance use and intentions, behavior and consequences, as well as sexual activity intentions and risk behavior, over a 3-month period compared to a usual care control sample of youth who do not receive the program.

Aim 2: Gain a better understanding of intervention effects by exploring whether improvements in self-efficacy, readiness to change, outcome expectancies, and exposure to peer substance use and offers serve as explanatory mechanisms for reductions in substance use- and sexual activity- related intentions and risk behaviors among youth who participate in the program.

The program will be evaluated using a form of group-randomized design, although with crossover of conditions and groups to avoid the problems of power reduction associated with conventional group randomization. The unit of analysis will be the individual, but individuals will be assigned to groups based on the agency where they are seeking services. Youth at two drop-in centers serving homeless youth will either be in the intervention condition or a "usual care" control condition. The field period will be divided into four phases. The two agencies will alternate across phases in serving as the "intervention site" or "control site," with each agency having a total of two intervention phases and two control phases.

Intervention Condition: This condition involves a four-session voluntary intervention that is delivered within a drop-in center setting and is based on the investigator's previous intervention work with adolescents and young adults. Each session lasts approximately 1 hour. The intervention focuses on both sexual risk behavior and substance use. Although some sessions focus more heavily on sexual risk and others on substance use, each session includes content that emphasizes the interrelated nature of these two risk behaviors. In all sessions, participants will receive a personalized feedback sheet that specifically addresses a topic being discussed during that particular session. An motivational interviewing approach will be used to present material during the group sessions.

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 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • between 18-24 years, receiving services at one of the participating drop-in centers, planning to be in the study area for the next month

排除标准

  • obvious cognitive impairment observed during screening process; non-English speaking

结局指标

主要结局

Change in use of drinking protective strategies

时间窗: baseline, 3 months

Change in number of different sex partners

时间窗: baseline, 3 months

Change in substance use before or during sex

时间窗: baseline, 3 months

Change in condom use

时间窗: baseline, 3 months

Change in HIV knowledge

时间窗: baseline, 3 months

Change in sexual intentions

时间窗: baseline, 3 months

Separate items for intentions for buying/getting condoms, carrying condoms, talking to partner about condoms, using condoms, using condoms when drinking or using drugs, getting tested

Change in substance use

时间窗: baseline, 3 months

past month quantity-frequency of alcohol and marijuana; past 3 months frequency of alcohol, binge drinking, marijuana, crack, cocaine, heroin, methamphetamine, ecstasy, hallucinogens, inhalants, prescription drug misuse

Change in negative consequences from drinking

时间窗: baseline, 3 months

Change in sex-related protective strategies

时间窗: baseline, 3 months

Change in substance use intentions

时间窗: baseline, 3 months

Intentions to use the following in the next 3 months: alcohol; marijuana; other drugs

Change in HIV testing

时间窗: baseline, 3 months

Self-report of being tested in lifetime, past 3 months

次要结局

未报告次要终点

研究者

发起方
RAND
申办方类型
Other
责任方
Sponsor

研究点 (3)

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