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

评估安全迹象：针对 AUD 和创伤的聋人无障碍治疗工具包

基本信息

批准号：
10718928
负责人：
Melissa Lee Anderson
金额：
$ 74.52万
依托单位：
UNIV OF MASSACHUSETTS MED SCH WORCESTER
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-01 至 2028-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10718928
关键词：
Acceleration Address Adult Aftercare Alcohol abuse Alcohol consumption Alcohols American American Sign Language Back COVID-19 pandemic Client Clinical Clinical Trials Cognitive Cognitive Therapy Collaborations Communication Communities Compassion Coping Skills Counseling DSM-V Data Development Disparity Education Educational process of instructing Employment Enrollment Evidence based treatment Feasibility Studies Film Foundations Frequencies Future General Population Health Hearing Immigrant Impairment Individual Infrastructure Intervention Language Literature Manuals Mediator Mental Health Mental Health Services Methods Motivation Outcome Participant Persons Population Post-Traumatic Stress Disorders Problem Solving Protocols documentation Provider Psychotherapy Randomized Reporting Research Research Personnel Resources Safety Self Efficacy Services Severities Sexual abuse Sign Language Socialization Testing Text Translations Trauma Treatment Protocols Visual Vocabulary Waiting Lists Work Writing addiction alcohol abuse therapy alcohol comorbidity alcohol use disorder arm artist behavioral health community engagement coping deaf emotional abuse evidence base experience falls feasibility testing follow-up fourth grade functional outcomes indexing literacy physical abuse physical conditioning pilot test programs psychoeducation psychoeducational recruit response timeline trauma exposure treatment as usual treatment research trial comparing verbal virtual virtual clinical trial virtual platform

项目摘要

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.

项目概要/摘要我们与聋人所属机构国家聋人治疗 (NDT) 合作，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——超过 500,000 人。使用美国手语 (ASL) 进行交流的美国人——体验率几乎是使用美国手语 (ASL) 的三倍与普通人群相比，终生饮酒问题和创伤暴露率是普通人群的两倍。个人可以获得多种针对共病酒精使用障碍 (AUD) 和创伤的经过验证的治疗方法；然而，还没有基于证据的治疗方法可以治疗聋人客户的任何行为健康状况。现有的行为健康治疗无法满足聋人客户独特的语言获取需求。四年级英语读写能力中位数下降，与健康相关的词汇与非英语词汇相当 PI 利用广泛的社区参与来解决这些障碍。由聋人和听力研究人员、反叛者、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并试点测试了“安全标志”，这是一个聋人可用的工具包，可与“寻求安全”一起使用安全标志工具包提供了补充治疗师指南和针对特定人群的治疗方案。客户材料（例如视觉讲义、拍摄的美国手语教学故事），以满足聋人客户的语言需求。来自安全迹象单臂试点和随机有效性试点的初步数据显示，从基线到随访的饮酒频率和 PTSD 严重程度。研究治疗师认为干预是可行的，并且受到参与者的好评，特别是当转移到虚拟平台以应对 COVID-19 大流行——不可避免的加速需要开发将安全迹象扩大到国家水平以进行拟议的临床试验。利用现有的基础设施和强大的无损检测转诊网络，我们将招募 144 名聋人成年人过去一个月的 PTSD 和问题饮酒纳入一项全国性全面虚拟临床试验，比较 (1) (2) 照常治疗和 (3) 治疗后立即进行主要临床结果控制的安全性。治疗和治疗后随访是过去 30 天的饮酒频率/数量（酒精时间线跟踪）和过去 30 天的 PTSD 严重程度（DSM-5 的 PTSD 检查表评估）将在基线时进行。治疗中期、治疗后立即、治疗后三个月随访和治疗后六个月此外，我们将分析导致积极结果的潜在调节因素和调解因素，包括应对自我效能、自我同情、治疗动机以及获取健康信息。我们提出的目标建立在八年的 KL2 和 R34 实证工作的基础上，使该研究计划从 IB 阶段（双臂可行性和试点测试）到 II/III 阶段（现实世界功效）拟议的 R01 将。可能验证有史以来第一个针对聋人的循证疗法，并提供未来的行为健康研究人员制定了针对聋人进行社区参与临床试验的重要路线图。