跳至主要内容
临床试验/NCT04135703
NCT04135703已完成不适用

Prevention of OUD: The HOME (Housing, Opportunities, Motivation and Engagement) Randomized Trial

Ohio State University2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2020年6月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
2
主要终点
Frequency (% Days) of Opioid Use in Prior 3 Months

研究概览

简要总结

Homeless youth have a much higher rate of substance use than non-homeless peers with evidence suggesting that homeless youth have the highest rates of opioid use among youth subgroups in the country (Brands et al., 2005); heroin using homeless youth also appear to have the highest rates of IV drug use and HIV (Rhoades et al., 2014). Given the high rates of opioid use, exposure to violence, mental and physical health challenges, and high rates of mortality in homeless youth, it is surprising that no study to date utilizes a randomized controlled design to test prevention of opioid and other drug use among this vulnerable population. Resolution of youth homelessness through housing and prevention services, often referred to as "Housing First", as proposed in the current study, has great potential to reduce the likelihood for the development of an opioid use disorder as well as other problem behaviors associated with living on the streets. However, only 20-30% of homeless youth samples report ever having stayed at a crisis shelter, 9% report having ever accessed mental health services, and 15% report ever having received substance use treatment (Ray, 2006) indicating a need to reach and engage youth in services that are feasible and acceptable. This study will provide essential information for researchers and providers on the efficacy of housing + opioid and related risk prevention services in an RCT on opioid use, how moderators affect the response, and mechanisms underlying change.

详细描述

The overarching goal of this application is to evaluate a comprehensive intervention for the prevention of opioid use disorder and for increasing other resilient outcomes in this special population of high-risk young adults. Phase I of the study includes a nonrandomized pilot study with a sample of 21 youth to assess initial efficacy, feasibility of recruitment and acceptability of the housing + opioid and related risk prevention services. Upon meeting transition milestones, 240 youth will be randomized into housing + opioid and related risk prevention services versus opioid and related risk prevention services alone for Phase II. In this study, we seek to determine if adding housing to opioid and related risk prevention services yields a significant benefit above and beyond the benefit yielded by opioid and related risk prevention services alone. Phase II follow-up will be conducted at 3, 6, 9 and 12-months post-baseline to assess stability of effects. Sample inclusion criteria, recruitment and screening will be identical for both phases, as described below. The unique components of Phase I and Phase II are then described separately.

Sample Inclusion Criteria.

  1. We will include youth between the ages of 18 to 24 years.
  2. Youth meets the criteria for homelessness as defined by the federal McKinney-Vento Act (2002) as "lacking a fixed, regular, stable, and adequate nighttime residence" and includes "living in a publicly or privately operated shelter designed to provide temporary living accommodations, or a public or private place not designed for, or ordinarily used as, regular sleeping accommodations for human beings."
  3. Youth fails to meet DSM 5 criteria for Opioid Use Disorder as assessed by the SCID (First et al., 2015).
  4. Those who report suicide ideation on the Scale for Suicide Ideation - Worst Point (SSI-W) (Beck, Brown, & Steer, 1997) will also receive suicide prevention.

Participant recruitment and sample availability. Service-connected youth will be recruited from the drop-in and adult shelters, non-service connected youth will be recruited through outreach to local soup kitchens, sandwich lines, the streets, parks and library. Given the high rates of homeless youth in Columbus, we do not anticipate any recruitment problems.

Screening and intake. Project staff will maintain offices within the drop-in center. Youth who are engaged on the streets will be transported to the drop-in center. An RA will engage and screen youth to determine basic eligibility for the study. After the brief screening and stated interest in the project, written consent will be obtained and the Structured Clinical Interview for DSM-5 Disorders (SCID) (First, Williams, Karg, & Spitzer, 2015) section on Opioid Use Disorder, will be administered to determine formal eligibility.

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
Single (Outcomes Assessor)

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

  • ages of 18 to 24 years
  • meets McKinney-Vento definition of homeless
  • fails to meet DSM 5 criteria for Opioid Use Disorder as assessed by the SCID

排除标准

  • 未提供

结局指标

主要结局

Frequency (% Days) of Opioid Use in Prior 3 Months

时间窗: 12 months

frequency (% days in prior 90) of opioid use is measured at baseline, 3, 6, 9 and 12 months post-baseline

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验