University of Missouri-Columbia
Columbia, Missouri, 65212, United States
NCT Number: NCT05630625
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.
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Notify Me18 year–30 year
All sexes
Interventional
Not applicable
Columbia, Missouri, 65212, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Day-level feedback on alcohol use and consequences
Time frame: Baseline
% of eligible screening participants who (yes/no) complete the baseline assessment (no specific tool)
Time frame: 3-month follow-up
% of randomized participants who (yes/no) complete 3-month follow-up assessment (no specific tool)
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Difference in likelihood baseline vs 3 months
% of people indicating they (a) were coerced into sexual activity or (b) coerced someone else into sexual activity in the past 3 months
Time frame: Difference in likelihood baseline vs 3 months
% of people indicating they visited the emergency department in the past 3 months
Time frame: Change from baseline to follow-up (1 and 3 months)
How likely is it that you will lose memory of drinking events as a result of alcohol use in the next 30 days? Scored on 0-100 scale, with higher scores indicating more susceptibility.
Time frame: Change from baseline to follow-up (1 and 3 months)
Participants responded to 6 items indicating the extent to which they believed that blackouts would be (1) enjoyable, (2) good, (3) beneficial, (4) wise, (5) pleasant, and (6) safe. Responses were strongly disagree =1, disagree = 2, neutral = 3, agree = 4, strongly agree = 5. Scores from each of the six items were averaged, with higher scores indicating more positive expectancies for blackout.
Time frame: Change from baseline to post-treatment (five weeks later)
Measured using the Alcohol and Drug Consequences Questionnaire scale. Participants indicated the extent to which they agreed with 16 statements regarding the benefits of decreased alcohol use (e.g., I would feel better physically). Responses range 0 (not important / wouldn't happen) to 4 (extremely important). Responses are summed, with higher scores indicating greater perceived benefits of decreasing alcohol use.
Time frame: Change from baseline to follow-up (1 and 3 months)
% confidence that participants could avoid a blackout, if they wanted to do so
Time frame: Change from baseline to follow-up (1 and 3 months)
Measured using the Insomnia Severity Index. Participants rate the extent to which they have struggled with sleep in the past two weeks (e.g., difficulty falling asleep, difficulty staying asleep, worry/distress about sleep). Responses range from 0 (e.g., none) to 4 (e.g., very severe). Items are summed and range 0-28, with higher scores indicating more severe insomnia.
Time frame: Change from baseline to follow-up (1 and 3 months)
Measured using the Positive and Negative Affect Schedule. Scores range 1 (very slightly or not at all) to 5 (extremely), with higher scores indicating more negative mood.
University of Missouri-Columbia
Other
Dynamic Personalized Feedback for Young Adults With a History of Blackout
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