Development and evaluation of an avatar-guided mobile health intervention for emerging adults with alcohol misuse and suicidality

摘要 建议的K99/R00奖项旨在引导申请者研究独立性，特别是在移动健康方面 (MHealth)对酗酒和合并疾病的新发成年人进行干预。新兴的成年人有 与其他年龄段相比，酒精使用障碍、自杀意念和自杀企图的发生率最高。 这些问题高度并存，酒精中毒是自杀的风险因素。然而， 在这一人群中，酒精或精神健康门诊治疗服务的利用率极低，甚至 在急诊科(ED)就诊后出现任一问题。新兴的成年人可能会对 MHealth干预措施，而MHealth非常适合ED。移动健康可以通过以下方式解决紧迫的公共卫生需求 弥合出院和获得门诊护理之间的差距，并支持不这样做的新兴成年人 获得门诊服务。本研究旨在设计一种循证互动、以虚拟化身为导向的mHealth 干预措施，提供持续的教育、技能练习、情绪和行为监控以及个性化 减少酒精滥用和自杀的反馈。这个mHealth平台将在审查的基础上开发 商业自杀和酗酒mHealth应用程序、面对面综合干预以及现有的基于化身的 MHealth平台，由共同导师伊斯顿开发。这项研究的目的是：1)征求对拟议的移动健康的反馈 来自国家青年顾问委员会、消费者(例如，新兴成年人)的干预化身、内容和特征 酒精滥用和自杀；n=25)，新兴成人酒精和自杀治疗的临床专家 (n=10)和ED工作人员(n=10)创建干预的阿尔法版本；2)测试阿尔法版本的[可用性]和 [研究方案的可行性]在对(n=20)初露头角的成年人进行的开放试点试验中，告知测试版，以及3) 在一项随机对照[可行性]试验中评估[可接受性和可行性]，比较[ 阿凡达引导的mHealth干预标准ED care；n=30)]主动控制，商业性自杀 预防APP(My3[标准急诊护理；n=30])。随机对照试验的次要目标是测试安全性和及早 酒精、自杀意念和门诊护理变量在6周、12周和24周的疗效信号 随机化后。]一项探索性的目标是检查同一天酗酒和SI的人内变化 通过每日日记和生态瞬时评估进行干预组之间的严重程度。培训和 职业发展计划包括关键领域的课程、研讨会、研讨会、阅读和实践研究 对于PI的独立性：跨学科团队内的移动健康干预发展，整合酒精和 对新兴成人的自杀干预，完全基于技术的干预的随机对照试验， 生态数据的序贯分析滞后。R00项目将提供试点数据，以支持未来全面- 支持R01应用程序，用于虚拟化身引导的mHealth干预的[功效试验]。K99/R00奖将设立 PI的独立研究生涯的基础，专门从事酒精滥用的mHealth干预。

ABSTRACT The proposed K99/R00 award aims to guide the applicant to research independence, specifically in mobile health (mHealth) interventions for emerging adults with alcohol misuse and comorbid conditions. Emerging adults have the highest rates of alcohol use disorders, suicidal ideation, and suicide attempts compared to any other age group. These problems are highly comorbid, with alcohol intoxication serving as a risk factor for suicidality. However, utilization of outpatient treatment services for alcohol or mental health is extremely low in this population, even following emergency department (ED) visits for either problem. Emerging adults are likely to be responsive to mHealth interventions, and mHealth is well-suited to the ED. mHealth can address an urgent public health need by bridging the gap between discharge and access to outpatient care and by supporting emerging adults who do not access outpatient care. This study seeks to design an evidence-informed interactive, avatar-guided mHealth intervention to provide ongoing education, skills practice, mood and behavior monitoring, and personalized feedback to reduce alcohol misuse and suicidality. This mHealth platform will be developed based on a review of commercial suicidality and alcohol mHealth apps, in-person integrated interventions, and an existing avatar-based mHealth platform, developed by co-mentor Easton. The study aims to: 1) seek feedback on the proposed mHealth intervention avatar, content, and features from a national youth advisory board, consumers (e.g., emerging adults with alcohol misuse and suicidality; n=25), clinical experts in emerging adult alcohol and suicidality treatment (n=10) and ED staff (n=10) creating an alpha version of the intervention; 2) test [usability] of the alpha version and [feasibility of research protocols] in an open pilot trial with (n=20) emerging adults, to inform a beta version, and 3) evaluate [acceptability and feasibility] in a randomized controlled [feasibility] trial comparing the beta version [of the avatar-guided mHealth intervention + standard ED care; n=30)] to an active control, a commercial suicide prevention app (MY3 [+ standard ED care; n=30). Secondary aims of the RCT are to test for safety and early signals of efficacy on a range of alcohol, suicidal ideation, and outpatient care variables at 6-, 12-, and 24-weeks post-randomization.] An exploratory aim is to examine within-person changes in same-day alcohol misuse and SI severity between intervention groups via daily diary and ecological momentary assessment. The training and career development plan includes courses, workshops, seminars, reading, and hands-on research in areas critical to the PI’s independence: mHealth intervention development within interdisciplinary teams, integrated alcohol and suicidality interventions for emerging adults, randomized controlled trials with fully-technology-based interventions, and lagged sequential analysis with ecological data. The R00 projects will provide pilot data to support future fully- powered R01 applications for [efficacy trials] of the avatar-guided mHealth intervention. The K99/R00 award will set the foundation of the PI’s independent research career, specializing in mHealth interventions for alcohol misuse.