Harm-reduction treatment for homeless adults with alcohol-use disorders (HaRT-A)

描述（由申请人提供）：无家可归和酒精使用障碍（AUD）通常是共同发生的严重公共卫生问题。不幸的是，基于禁欲的治疗方法通常在参与和成功治疗患有AUD的无家可归者方面无效。因此，有人呼吁采取更灵活和以客户为中心的方法，以适应这一群体的需要。为了满足这一需求，我们建议为患有AUD的无家可归者开发和试点评估一种减少伤害的治疗方法（HaRT-A），作为一种创新的，经验丰富的和客户驱动的替代方案，以禁欲为基础的AUD治疗。按照最初的计划，HaRT-A将包括3个阶段的个人行为干预。初步的组成部分包括提供个性化的酒精反馈，引出客户的伤害减少目标，建立改变的动机，并鼓励更安全的饮酒使用非判断，同情的立场，并接受客户无论他们沿着行为改变的频谱。为了最大限度地发挥其功效，HaRT-A正在与社区咨询委员会（CAB）合作设计，该委员会由无家可归者倡导者以及工作人员，管理人员和客户（即，无家可归的人与AUD）在两个，非营利机构的最前沿的危害减少导向的支持服务提供无家可归的人。根据NIH第一阶段治疗开发指南，我们将分四个阶段开发和试点测试HaRT-A。在第一阶段，我们将通过与机构客户和员工的访谈和焦点小组收集定性数据。扎根理论分析将产生一个概念/主题的描述关键酒精主题，从而确定潜在的干预点，以解决在HaRT-A。在第二阶段，我们将使用从具体目标1收集的定性数据开发HaRT-A治疗手册;基于证据的最佳实践方法;以及CAB的指导。第三阶段将在这两个机构开展一项HaRT-A的小型试点RCT（N=160）。受试者将随机接受HaRT-A或机构服务（TAU），并将在基线、测试后（治疗结束后立即）、1个月和3个月随访时进行评估。定量分析将测试HaRT-A与TAU相比的功效。据推测，与TAU参与者相比，HaRT-A参与者将在酒精结果、改变动机和健康相关生活质量（HRQoL）方面表现出更大的改善。次要的探索性分析将初步测试HaRT-A对治疗后6个月的医疗保健和刑事司法利用结果的影响。与NIH治疗保真度建议一致，治疗完整性将在本项目的第四阶段进行测试。在实现这些具体目标的过程中，该项目将为长期研究目标奠定基础，包括更大规模的HaRT-A随机对照试验，并将这种干预措施传播给研究人员、临床医生和社区组织，以改善受影响个人及其社区的结果。

DESCRIPTION (provided by applicant): Homelessness and alcohol-use disorders (AUDs) are commonly co-occurring and serious public health issues. Unfortunately, abstinence-based treatment approaches are generally ineffective in engaging and successfully treating homeless individuals with AUDs. There have therefore been calls for more flexible and client-centered approaches tailored to this population. In response to this need, we are proposing the development and pilot evaluation of a harm-reduction treatment for homeless individuals with AUDs (HaRT-A) as an innovative, empirically informed and client-driven alternative to abstinence-based AUD treatment. As initially planned, the HaRT-A will comprise a 3-session, individual, behavioral intervention. Preliminary components include providing personalized alcohol feedback, eliciting clients' harm-reduction goals, building motivation to change, and encouraging safer drinking using a nonjudgmental, empathetic stance, and acceptance of clients wherever they are along the spectrum of behavior change. To maximize its efficacy, the HaRT-A is being collaboratively designed with a community advisory board (CAB) made up of homeless advocates as well as staff, management and clients (i.e., homeless individuals with AUDs) at two, nonprofit agencies on the forefront of harm reduction oriented supportive service provision for homeless individuals. Consistent with NIH Stage I treatment development guidelines, we will develop and pilot test the HaRT-A in four phases. In Phase I, we will collect qualitative data via interviews and focus groups with agency clients and staff. Grounded theory analyses will yield a conceptual/thematic description of key alcohol themes and will thereby identify potential points for intervention to be addressed in the HaRT-A. In Phase II, we will develop the HaRT-A treatment manual using qualitative data gleaned from Specific Aim 1; evidence-based, best-practice approaches; and guidance of the CAB. Phase III will feature a small, pilot RCT (N=160) of the HaRT-A at the two agencies. Participants will be randomized to receive either the HaRT-A or agency services as usual (TAU), and will be assessed at baseline, posttest (immediately following treatment end), 1-month and 3-month follow-ups. Quantitative analyses will test the efficacy of the HaRT-A compared to TAU. It is hypothesized that HaRT-A participants will show significantly greater improvements on alcohol outcomes, motivation to change, and health-related quality of life (HRQoL) compared to TAU participants. Secondary, exploratory analyses will preliminarily test HaRT-A effects on health-care and criminal justice utilization outcomes up to 6 months posttreatment. Consistent with NIH treatment fidelity recommendations, treatment integrity will be tested in Phase IV of this project. In achieving these specific aims, this project will lay the groundwork for longer-term research objectives, including a larger RCT of the HaRT-A and dissemination of this intervention to researchers, clinicians and community-based organizations to improve outcomes for affected individuals and their communities.