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The Drinking Dashboard Study

Primary Purpose

Alcohol Drinking

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Drinking Dashboard
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Missouri-ColumbiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Drinking Dashboard

Assessment Only

Arm Description

Day-level feedback on alcohol use and consequences

Daily assessment control group

Outcomes

Primary Outcome Measures

Recruitment
% of screened participants who (yes/no) complete the baseline assessment (no specific tool)
Retention
% of randomized participants who (yes/no) complete 3-month follow-up assessment (no specific tool)
Acceptability
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
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.
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.
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.
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.

Secondary Outcome Measures

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
Emergency department visits
% of people indicating they visited the emergency department in the past 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.
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.
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).
Blackout self-efficacy
% confidence that participants could avoid a blackout, if they wanted to do so
Sleep disturbance
Measured using the Insomnia Severity Index. Items scored 0 to 4, with higher scores indicating more severe insomnia.
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.

Full Information

First Posted
November 7, 2022
Last Updated
June 7, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05630625
Brief Title
The Drinking Dashboard Study
Official Title
Dynamic Personalized Feedback for Young Adults With a History of Blackout
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to receive the Drinking Dashboard or assessment only.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drinking Dashboard
Arm Type
Experimental
Arm Description
Day-level feedback on alcohol use and consequences
Arm Title
Assessment Only
Arm Type
No Intervention
Arm Description
Daily assessment control group
Intervention Type
Behavioral
Intervention Name(s)
Drinking Dashboard
Intervention Description
Day-level feedback on alcohol use and consequences
Primary Outcome Measure Information:
Title
Recruitment
Description
% of screened participants who (yes/no) complete the baseline assessment (no specific tool)
Time Frame
Baseline
Title
Retention
Description
% of randomized participants who (yes/no) complete 3-month follow-up assessment (no specific tool)
Time Frame
3-month follow-up
Title
Acceptability
Description
Measured using the 8-item Client Satisfaction Questionnaire. Scored from 1 to 4, with higher scores indicating greater satisfaction with treatment.
Time Frame
1 month follow-up
Title
Frequency of high-intensity drinking
Description
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)
Title
Peak BAC
Description
Measured using the Daily Drinking Questionnaire, which asks participants to indicate the maximum number of drinks consumed on one occasion in the past month.
Time Frame
Change from baseline to follow-up (1 and 3 months)
Title
Frequency of blackouts
Description
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.
Time Frame
Change from baseline to follow-up (1 and 3 months)
Title
Alcohol-related consequences
Description
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.
Time Frame
Change from baseline to follow-up (1 and 3 months)
Secondary Outcome Measure Information:
Title
Sexual coercion
Description
% 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
Title
Emergency department visits
Description
% of people indicating they visited the emergency department in the past 3 months
Time Frame
Difference in likelihood baseline vs 3 months
Title
Blackout susceptibility
Description
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.
Time Frame
Change from baseline to follow-up (1 and 3 months)
Title
Blackout severity
Description
If I were to have a blackout, bad things would happen. Scored on a Likert scale, with higher scores indicating more negative attitudes.
Time Frame
Change from baseline to follow-up (1 and 3 months)
Title
Costs/benefits of drinking
Description
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).
Time Frame
Change from baseline to follow-up (1 and 3 months)
Title
Blackout self-efficacy
Description
% 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)
Title
Sleep disturbance
Description
Measured using the Insomnia Severity Index. Items scored 0 to 4, with higher scores indicating more severe insomnia.
Time Frame
Change from baseline to follow-up (1 and 3 months)
Title
Mood
Description
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.
Time Frame
Change from baseline to follow-up (1 and 3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Beth Miller, PhD
Phone
573-882-1813
Email
millmary@health.missouri.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Beth Miller, PhD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri-Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Beth Miller, PhD
Phone
573-882-1813
Email
millmary@health.missouri.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://grants.nih.gov/grants/guide/notice-files/NOT-AA-19-020.html

Learn more about this trial

The Drinking Dashboard Study

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