Alcohol Drinking
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALDrinking Dashboard
Day-level feedback on alcohol use and consequences
Sponsors
University of Missouri-Columbia
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Participants will be randomly assigned to receive the Drinking Dashboard or assessment only.
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-30 years of age * Binge drinking in a typical week * Any form of alcohol-induced memory impairment in the past month at baseline
Exclusion criteria
* Psychiatric disorder requiring immediate clinical attention (e.g., psychosis, suicidal ideation with intent and plan)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | Baseline | % of eligible screening participants who (yes/no) complete the baseline assessment (no specific tool) |
| Retention | 3-month follow-up | % of randomized participants who (yes/no) complete 3-month follow-up assessment (no specific tool) |
| Acceptability | 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. |
| Frequency of High-intensity Drinking | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual Coercion | 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 |
| Emergency Department Visits | Difference in likelihood baseline vs 3 months | % of people indicating they visited the emergency department in the past 3 months |
| Blackout Susceptibility | 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. |
| Blackout Expectancies (Scale Developed by Investigators for This Study) | 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. |
| Costs/Benefits of Drinking | 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. |
| Blackout Self-efficacy | Change from baseline to follow-up (1 and 3 months) | % confidence that participants could avoid a blackout, if they wanted to do so |
| Sleep Disturbance | 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. |
| Mood | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMary Beth Miller, PhD
University of Missouri-Columbia
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 22.09 years STANDARD_DEVIATION 2.72 |
| En bloc blackout | 56 Participants |
| Race/Ethnicity, Customized Asian only | 6 Participants |
| Race/Ethnicity, Customized Black only | 3 Participants |
| Race/Ethnicity, Customized Hispanic or Latine only | 9 Participants |
| Race/Ethnicity, Customized Multiracial or Multiethnic | 15 Participants |
| Race/Ethnicity, Customized Other race | 1 Participants |
| Race/Ethnicity, Customized White only | 97 Participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 82 |
| other Total, other adverse events | 0 / 74 | 0 / 82 |
| serious Total, serious adverse events | 0 / 74 | 0 / 82 |
Outcome results
None listed