Dynamic Personalized Feedback for Young Adults With a History of Blackout
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
This study aims to develop and pilot test the efficacy of a "Drinking Dashboard" providing participants weekly feedback on the risk factors and consequences of blackout.
详细描述
Approximately 50% of young adults who drink alcohol experience alcohol-induced "blackouts," defined as permanent (en bloc) or temporary (fragmentary) memory loss for events that occurred while they are drinking. This experience of alcohol-induced blackout is associated prospectively with alcohol-related harm, including emergency room visits and sexual coercion, with medical care costs exceeding $469,000 per year. While young adults who have recently experienced a blackout report less favorable evaluations of drinking events and increased motivation to decrease their drinking, they do not actually change their drinking behavior as a result of the blackout alone. Collectively, these data suggest that blackouts may serve as an opportunity for intervention, after which young adults are more likely to respond to alcohol feedback. This R34 aims to develop an intervention tailored to individuals who experience blackouts. In the trial phase, 162 young adults (50% female, ≥50% non-college) who report a history of blackout will be randomly assigned to receive the intervention (n=81) or assessment only (n=81). Outcomes will be assessed immediately post-intervention and at 3-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-30 years of age
- •Binge drinking in a typical week
- •Any form of alcohol-induced memory impairment in the past month at baseline
排除标准
- •Psychiatric disorder requiring immediate clinical attention (e.g., psychosis, suicidal ideation with intent and plan)
研究组 & 干预措施
Drinking Dashboard
Day-level feedback on alcohol use and consequences
干预措施: Drinking Dashboard (Behavioral)
Assessment Only
Daily assessment control group
结局指标
主要结局
Recruitment
时间窗: Baseline
% of eligible screening participants who (yes/no) complete the baseline assessment (no specific tool)
Frequency of High-intensity Drinking
时间窗: Change from baseline to follow-up (1 and 3 months)
Measured using the Daily Drinking Questionnaire, which asks participants to indicate how many standard drinks they consumed on each day of a typical week in the past month.
Change in Peak BAC From Baseline
时间窗: Change from baseline to follow-up (1 and 3 months)
Measured using the Daily Drinking Questionnaire, which asks participants to indicate the maximum number of drinks consumed on one occasion in the past month. Estimated using Widmark's formula (1932).
Frequency of Blackouts
时间窗: Change from baseline to follow-up (1 and 3 months)
Measured using the 8-item Alcohol-Induced Blackout Measure-2 (ABOM-2). Participants indicate how often they have experienced 8 different blackout experiences (e.g., having fuzzy memories of drinking events, being unable to remember hours at a time) in the past month on a scale from 0 (never) to 4 (4 or more times). Item scores are summed to create a total score that ranges from 0 to 32, with higher scores indicating more frequent blackout experiences.
Alcohol-related Consequences
时间窗: Change from baseline to follow-up (1 and 3 months)
Measured using the 24-item Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ). Participants indicate (0=no, 1=yes) if they experienced 24 consequences as a result of drinking in the past month. Items are summed to create a total score, with higher scores indicating a greater number of consequences in the past month.
Retention
时间窗: 3-month follow-up
% of randomized participants who (yes/no) complete 3-month follow-up assessment (no specific tool)
Acceptability
时间窗: 1 month follow-up
Measured using the 8-item Client Satisfaction Questionnaire. Scored from 1 to 4, with higher scores indicating greater satisfaction with treatment.
次要结局
- Mood(Change from baseline to follow-up (1 and 3 months))
- Sexual Coercion(Difference in likelihood baseline vs 3 months)
- Emergency Department Visits(Difference in likelihood baseline vs 3 months)
- Blackout Susceptibility(Change from baseline to follow-up (1 and 3 months))
- Blackout Expectancies (Scale Developed by Investigators for This Study)(Change from baseline to follow-up (1 and 3 months))
- Costs/Benefits of Drinking(Change from baseline to post-treatment (five weeks later))
- Blackout Self-efficacy(Change from baseline to follow-up (1 and 3 months))
- Sleep Disturbance(Change from baseline to follow-up (1 and 3 months))
研究者
Mary E Miller
Clinical Psychologist
University of Missouri-Columbia