The Drinking Dashboard Study

Dynamic Personalized Feedback for Young Adults With a History of Blackout

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Drinking
• Intervention / Treatment: Behavioral: Drinking Dashboard

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.

• Study Type: Interventional
• Enrollment (Estimated): 162
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Beth Miller, PhD; Phone Number: 573-882-1813; Email: millmary@health.missouri.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Recruiting
      • University of Missouri-Columbia
      • Contact: Mary Beth Miller, PhD; Phone Number: 573-882-1813; Email: millmary@health.missouri.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drinking Dashboard; Day-level feedback on alcohol use and consequences	Behavioral: Drinking Dashboard; Day-level feedback on alcohol use and consequences
No Intervention: Assessment Only; Daily assessment control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	% of screened participants who (yes/no) complete the baseline assessment (no specific tool)	Baseline
Retention	% of randomized participants who (yes/no) complete 3-month follow-up assessment (no specific tool)	3-month follow-up
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
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Emergency department visits	% of people indicating they visited the emergency department in the past 3 months	Difference in likelihood baseline vs 3 months
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Mary Beth Miller, PhD, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: 2067803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified, individual-level data will be deposited online via the NIAAA Data Archive (NIAAADA). De-identified data, the survey protocol and instrument, and analysis code will also be made available to other qualified investigators upon request.
• IPD Sharing Time Frame: Upon study completion
• IPD Sharing Access Criteria: NOT-AA-19-020
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No