Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma

项目摘要/摘要 与聋人拥有的机构国家聋人治疗(NDT)合作，我们提出了有史以来第一个全面的 在聋人社区进行的心理治疗试验。美国聋人社区--50多万人 使用美国手语(ASL)交流的美国人-体验到的比例几乎是 终生饮酒问题与一般人群相比，创伤暴露率是前者的两倍。听证 个人可以获得几种有效的酒精使用障碍(AUD)和创伤治疗； 然而，目前还没有循证治疗方法来治疗聋人客户的任何行为健康问题。 现有的行为健康治疗无法满足聋人患者独特的语言获取需求。聋人的 英语读写水平中位数降至四年级，与健康相关的词汇与非英语词汇相当-- 说的是美国移民。利用广泛的社区参与来解决这些障碍，PI的 聋人和听力研究人员、临床医生、电影制作人、演员、艺术家和患有AUD/PTSD的聋人组成的团队 开发和试点测试的安全标志，一个聋人可访问的工具包，用于寻求安全 治疗方案。安全标志工具包提供了针对特定人群的补充治疗师指南和 客户材料(例如，视觉讲义、拍摄的ASL教学故事)，以满足聋人客户的语言需求。 来自安全单臂飞行员和随机可行性飞行员的初步数据显示， 从基线到随访，酒精使用频率和创伤后应激障碍严重程度。试验性产品的交付 研究治疗师认为干预是可行的，并受到参与者的好评，特别是当 为应对新冠肺炎疫情而转移到虚拟平台--这是不可避免的加速 为了拟议的临床试验，需要开发将安全迹象扩大到国家水平。 利用现有的基础设施和强大的无损检测转介网络，我们将招收144名聋人 过去一个月的创伤后应激障碍和问题饮酒进入一项全国性的、全面的虚拟临床试验，比较(1) 安全性：(2)照常治疗；(3)不治疗对照。术后即刻的主要临床结果 治疗和治疗后随访超过30天的饮酒频率/数量(酒精时间线 和过去30天的创伤后应激障碍严重程度(DSM-5的创伤后应激障碍检查表)。评估将在基线上进行， 治疗中期、治疗后即刻、治疗后三个月随访、治疗后六个月 后续行动。此外，我们将分析潜在的主持人和调解人，导致积极的结果， 包括应对自我效能感、自我同情心、治疗动机和获取健康信息。 我们提出的目标建立在八年的KL2和R34实证工作的基础上，将这一研究计划从 从IB阶段(双臂可行性和试点测试)到II/III阶段(实际效果)。拟议的R01将 有可能验证首次针对聋人的循证治疗，并提供未来的行为 健康研究人员为对聋人进行社区参与的临床试验提供了重要的路线图。

PROJECT SUMMARY/ABSTRACT In partnership with Deaf-owned agency National Deaf Therapy (NDT), we propose the first-ever full-scale psychotherapy trial conducted in the Deaf community. The U.S. Deaf community – more than 500,000 Americans who communicate using American Sign Language (ASL) – experiences nearly triple the rate of lifetime problem drinking compared to the general population and twice the rate of trauma exposure. Hearing individuals have access to several validated treatments for comorbid alcohol use disorder (AUD) and trauma; yet there are no evidence-based treatments to treat any behavioral health condition with Deaf clients. Available behavioral health treatments fail to meet Deaf clients’ unique language access needs. Deaf people’s median English literacy level falls at the fourth grade and health-related vocabulary parallels non-English- speaking U.S. immigrants. Leveraging extensive community engagement to address these barriers, the PI’s team of Deaf and hearing researchers, clinicians, filmmakers, actors, artists, and Deaf people with AUD/PTSD developed and pilot tested Signs of Safety, a Deaf-accessible toolkit to be used with the Seeking Safety treatment protocol. The Signs of Safety toolkit provides a supplemental therapist guide and population-specific client materials (e.g., visual handouts, filmed ASL teaching stories) to meet Deaf clients’ language needs. Preliminary data from the Signs of Safety single-arm pilot and randomized feasibility pilot showed reductions in alcohol use frequency and PTSD severity from baseline to follow-up. The delivery of the experimental intervention was deemed feasible by study therapists and was well-received by participants, especially when moved to a virtual platform in response to the COVID-19 pandemic – an acceleration of the inevitable development needed to scale Signs of Safety to a national level for the proposed clinical trial. Leveraging the existing infrastructure and robust referral network of NDT, we will enroll 144 Deaf adults with past-month PTSD and problem drinking into a national, full-scale, virtual clinical trial comparing (1) Signs of Safety with (2) treatment as usual and (3) a no treatment control. Primary clinical outcomes at immediate post- treatment and post-treatment follow-up are past 30-day alcohol use frequency/quantity (Alcohol Timeline Followback) and past 30-day PTSD severity (PTSD Checklist for DSM-5). Assessment will occur at baseline, mid-treatment, immediate post-treatment, three-month post-treatment follow-up, and six-month post-treatment follow-up. Additionally, we will analyze potential moderators and mediators that lead to positive outcome, including coping self-efficacy, self-compassion, motivation for treatment, and access to health information. Our proposed aims build on eight years of KL2 and R34 empirical work, moving this program of research from Stage IB (two-arm feasibility and pilot testing) to Stage II/III (real world efficacy). The proposed R01 will potentially validate the first-ever evidence-based therapy for Deaf people, as well as provide future behavioral health researchers with a vital roadmap for conducting community-engaged clinical trials with Deaf people.