Randomized Controlled Feasibility Trial of an Avatar Guided Intervention for Young Adults Seen in the Emergency Department With Alcohol Use Problems and Suicidal Thoughts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Acceptability as defined by positive ratings on the WAI-TECH-SF
研究概览
简要总结
The goal of this clinical trial is to learn whether a novel digital avatar (virtual coach) support program can help emerging adults ages 18-29 who present to the emergency department with suicidal thoughts and alcohol misuse (EA-Avatar). The study also aims to learn whether people find the program easy to use and whether daily surveys and the study design are able to be completed by the majority of emerging adult participants.
The main questions this study aims to answer are:
- Do participants use the digital program and find it helpful?
- Is it possible for participants to complete daily surveys for twenty-eight days and follow-up surveys over twelve weeks?
- Are there early signs that the program may help lower alcohol use and suicidal thoughts?
Researchers will compare participants who receive the new digital avatar program plus supportive text messages to participants who receive a freely available suicide safety planning app to see if there are differences in use, engagement, and early signs of benefit.
Participants will:
- Receive standard care from the emergency department
- Be randomly put into one of two groups (EA-Avatar or a free suicide prevention app)
- Depending on their group, use a new avatar-guided digital support program with text message reminders OR use a free suicide safety planning app
- Complete surveys at the start of the study and again at four, eight, and twelve weeks
- Complete short daily surveys for twenty-eight days
详细描述
This study is a randomized controlled feasibility study with emerging adults presenting to the emergency department with alcohol misuse and suicidal ideation, to test the acceptability, feasibility, safety, and initial efficacy of a newly developed digital intervention, as well as the feasibility of research protocols.
Sixty emerging adults aged 18-29 who have received care in the emergency department for alcohol use problems and/or suicidal thoughts will be recruited and asked to complete assessments at baseline, four weeks, eight weeks, and twelve weeks, as well as twenty-eight consecutive days of daily diary surveys. Half of participants will be given access to a newly designed avatar-guided digital intervention and text message intervention for emerging adults(EA-Avatar), while half will receive a freely available suicide safety planning app. Exclusion criteria are conditions that would preclude research participation (e.g., cognitive disabilities, in police custody; under guardianship; at imminent risk of harming oneself in the emergency department).
Participants will complete measures of alcohol use, suicidal ideation, and alcohol-related cognitions and experiences, as well as service utilization. They will also complete a scale of acceptability of the avatar intervention and qualitative interviews of the intervention and research protocols.
Primary aims include participant acceptability of the intervention as rated by satisfaction surveys and feasibility of study procedures and assessments as defined by completion of follow-up assessment and daily surveys for 28 days. Secondary aims include early signals of potential effects on alcohol use severity, binge drinking days, and suicidal ideation severity, as well as safety as defined by adverse and serious adverse events and worsening of alcohol use problems or suicidal ideation severity from baseline to 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) emergency department admission for alcohol- or suicide-related reason since turning 18, OR treated for incidental suicide risk in the emergency department
- •(2) aged 18-29
- •(3) speak, read, and understand English
- •(4) binge drinking in the past month OR alcohol use problems (Alcohol Use Disorders Identification Test score > 5)
- •(5) active suicidal ideation in the past month
- •(6) owning and having access to a personal smartphone
- •(7) willingness to be randomized to an avatar guided intervention for alcohol use problems and suicidal thoughts OR a freely available suicide safety planning app
- •(8) for remote MyChart-based recruitment only, have MyChart activated
排除标准
- •(1) severe cognitive delay, active psychosis, or heavy intoxication that precludes research participation
- •(2) imminent safety risk and have been recently unsafe to themselves or others
- •(3) prisoner or are under arrest
- •(4) not interested or not willing to be randomized to receive the avatar-guided digital intervention or safety plan app
- •(5) under the care of a legal guardian
研究组 & 干预措施
Avatar guided digital health intervention for emerging adults (EA-Avatar)
The avatar-guided digital intervention includes monitoring of alcohol use and triggers of suicidal thoughts, skills to manage alcohol use and suicidal thoughts, resources on how to access outpatient care and crisis hotlines for suicidal thoughts, and achievements for milestones. In addition, text messages with inspirational quotes and reminders to access the avatar platform are used to support engagement and foster hope. They are also given any emergency department care and/or follow-up and referral services they would otherwise receive and can continue any other behavioral health care.
干预措施: EA-Avatar (Behavioral)
Suicide safety plan app
Participants are given information to download a freely available suicide safety planning app. They are also given any emergency department care and/or follow-up and referral services they would otherwise receive and can continue any other behavioral health care.
干预措施: Suicide safety planning app (Behavioral)
结局指标
主要结局
Acceptability as defined by positive ratings on the WAI-TECH-SF
时间窗: 12 weeks
Positive ratings on the Working Alliance Inventory Technology Version, Short Form (WAI-TECH-SF) as measured by an average of 4 out of 7 or higher on the mean score. Minimum = 1, Maximum = 7, higher scores mean better acceptability
Feasibility of research protocols, defined as follow-up retention
时间窗: 12 weeks
Feasibility will be supported by retention of research participants in at least 80% at each of the four assessments
Feasibility of research protocols, defined as adherence to the ecological momentary assessment/daily diary protocol
时间窗: 28 days
Feasibility will be supported by at least 75% of total daily diary surveys across 28 days
次要结局
- Safety, as defined by number of adverse events in each arm(12 weeks)
- Safety, as defined by serious adverse events in each arm(12 weeks)
- Safety as defined by worsening of drinking and suicidal ideation severity(12 weeks)
- Initial efficacy in binge drinking days, defined as days of binge drinking on the Time Line Follow-Back(12 weeks)
- Early efficacy in suicidal ideation severity, as defined by Beck Suicide Scale scores(12 weeks)
研究者
Lourah Kelly
Assistant Professor
University of Massachusetts, Worcester