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

摘要 拟议的K99/R 00奖旨在指导申请人独立研究，特别是在移动的健康领域 （mHealth）针对酒精滥用和合并症的新兴成年人的干预措施。新兴的成年人有 与其他年龄组相比，酒精使用障碍、自杀意念和自杀企图的发生率最高。 这些问题是高度共病的，酒精中毒是自杀的危险因素。然而，在这方面， 在这一人群中，利用门诊治疗服务进行酒精或精神健康治疗的比例极低， 在急诊科（艾德）就诊后。新生的成年人可能会对 mHealth干预措施，mHealth非常适合ED。mHealth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治疗之间的差距，并支持那些没有 获得门诊治疗。本研究旨在设计一个循证的互动，化身引导的mHealth 干预，提供持续的教育，技能实践，情绪和行为监测， 反馈，以减少酒精滥用和自杀。这个移动健康平台将根据对以下方面的审查开发： 商业自杀和酒精mHealth应用程序，面对面的综合干预，以及现有的基于头像的 移动健康平台，由共同导师伊斯顿开发。该研究旨在：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的干预化身、内容和特征，消费者（例如，初显期成人 酒精滥用和自杀倾向; n=25），新兴成人酒精和自杀倾向治疗的临床专家 （n=10）和艾德工作人员（n=10）创建干预措施的alpha版本; 2）alpha版本的测试[可用性]， [研究方案的可行性]在一项开放性试点试验中，对（n=20）新兴成年人进行试验，以告知测试版，以及3） 在随机对照[可行性]试验中评估[可接受性和可行性]， 化身引导的移动健康干预+标准艾德护理; n=30）]与活性对照、商业自杀 预防app（MY 3 [+标准艾德护理; n=30）。RCT的次要目的是测试安全性和早期 第6、12和24周时一系列酒精、自杀意念和门诊护理变量的疗效信号 随机化后。]一个探索性的目的是检查同一天酒精滥用和SI的人内变化 通过每日日记和生态瞬时评估，干预组之间的严重程度。培训和 职业发展计划包括课程，讲习班，研讨会，阅读，并在关键领域的实践研究 PI的独立性：跨学科团队内的移动健康干预发展，综合酒精和 针对新兴成年人的自杀干预措施，完全基于技术的干预措施的随机对照试验， 生态数据的滞后序贯分析。R 00项目将提供试点数据，以支持未来的全面- 为化身引导的移动健康干预的[功效试验]提供动力的R 01应用程序。K99/R 00奖项将设立 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.