Clinical trial NCT05630625: The Drinking Dashboard Study
Official title: Dynamic Personalized Feedback for Young Adults With a History of Blackout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to receive the Drinking Dashboard or assessment only.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Recruitment
timeFrame: Baseline
measure: Retention
timeFrame: 3-month follow-up
measure: Acceptability
timeFrame: 1 month follow-up
measure: Frequency of high-intensity drinking
timeFrame: Change from baseline to follow-up (1 and 3 months)
measure: Peak BAC
timeFrame: Change from baseline to follow-up (1 and 3 months)
measure: Frequency of blackouts
timeFrame: Change from baseline to follow-up (1 and 3 months)
measure: Alcohol-related consequences
timeFrame: Change from baseline to follow-up (1 and 3 months)
Secondary outcomes:
measure: Sexual coercion
timeFrame: Difference in likelihood baseline vs 3 months
measure: Emergency department visits
timeFrame: Difference in likelihood baseline vs 3 months
measure: Blackout susceptibility
timeFrame: Change from baseline to follow-up (1 and 3 months)
measure: Blackout severity
timeFrame: Change from baseline to follow-up (1 and 3 months)
measure: Costs/benefits of drinking
timeFrame: Change from baseline to follow-up (1 and 3 months)
measure: Blackout self-efficacy
timeFrame: Change from baseline to follow-up (1 and 3 months)
measure: Sleep disturbance
timeFrame: Change from baseline to follow-up (1 and 3 months)
measure: Mood
timeFrame: Change from baseline to follow-up (1 and 3 months)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Mary Beth Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References: