The Drinking Dashboard Study

Alcohol Drinking Clinical Trial

Official title:

Dynamic Personalized Feedback for Young Adults With a History of Blackout

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05630625
• Other study ID #: 2067803
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2023
• Source: University of Missouri-Columbia
• Contact: Mary Beth Miller, PhD
• Phone: 573-882-1813
• Email: millmary[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: April 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Behavioral:
• Drinking Dashboard
Day-level feedback on alcohol use and consequences

Locations

Country	Name	City	State
United States	University of Missouri-Columbia	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	% of screened participants who (yes/no) complete the baseline assessment (no specific tool)	Baseline
Primary	Retention	% of randomized participants who (yes/no) complete 3-month follow-up assessment (no specific tool)	3-month follow-up
Primary	Acceptability	Measured using the 8-item Client Satisfaction Questionnaire. Scored from 1 to 4, with higher scores indicating greater satisfaction with treatment.	1 month follow-up
Primary	Frequency of high-intensity drinking	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 from baseline to follow-up (1 and 3 months)
Primary	Peak BAC	Measured using the Daily Drinking Questionnaire, which asks participants to indicate the maximum number of drinks consumed on one occasion in the past month.	Change from baseline to follow-up (1 and 3 months)
Primary	Frequency of blackouts	Measured using the 8-item Alcohol-Induced Blackout Measure-2 (ABOM-2). Items are scored from 0 to 4, with higher scores indicating more frequent blackout experiences.	Change from baseline to follow-up (1 and 3 months)
Primary	Alcohol-related consequences	Measured using the 24-item Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ). Items scores yes/no, with higher scores indicating a greater number of consequences in the past month.	Change from baseline to follow-up (1 and 3 months)
Secondary	Sexual coercion	% of people indicating they (a) were coerced into sexual activity or (b) coerced someone else into sexual activity in the past 3 months	Difference in likelihood baseline vs 3 months
Secondary	Emergency department visits	% of people indicating they visited the emergency department in the past 3 months	Difference in likelihood baseline vs 3 months
Secondary	Blackout susceptibility	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 a Likert scale, with higher scores indicating more susceptibility.	Change from baseline to follow-up (1 and 3 months)
Secondary	Blackout severity	If I were to have a blackout, bad things would happen. Scored on a Likert scale, with higher scores indicating more negative attitudes.	Change from baseline to follow-up (1 and 3 months)
Secondary	Costs/benefits of drinking	Measured using the Cunningham et al. (1997) scale of 16 benefits and 16 costs of decreasing alcohol use. Responses range 1 (not important) to 5 (extremely important).	Change from baseline to follow-up (1 and 3 months)
Secondary	Blackout self-efficacy	% confidence that participants could avoid a blackout, if they wanted to do so	Change from baseline to follow-up (1 and 3 months)
Secondary	Sleep disturbance	Measured using the Insomnia Severity Index. Items scored 0 to 4, with higher scores indicating more severe insomnia.	Change from baseline to follow-up (1 and 3 months)
Secondary	Mood	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 positive/negative mood.	Change from baseline to follow-up (1 and 3 months)