NCT05630625

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2024

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

July 13, 2026

Completed
Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

November 7, 2022

Results QC Date

August 8, 2025

Last Update Submit

July 10, 2026

Conditions

Outcome Measures

Primary Outcomes (7)

  • Recruitment

    % of eligible screening 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)

  • Change in Peak BAC From Baseline

    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).

    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). 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.

    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). 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.

    Change from baseline to follow-up (1 and 3 months)

Secondary Outcomes (8)

  • Sexual Coercion

    Difference in likelihood baseline vs 3 months

  • Emergency Department Visits

    Difference in likelihood baseline vs 3 months

  • Blackout Susceptibility

    Change from baseline to follow-up (1 and 3 months)

  • Blackout Expectancies (Scale Developed by Investigators for This Study)

    Change from baseline to follow-up (1 and 3 months)

  • Costs/Benefits of Drinking

    Change from baseline to post-treatment (five weeks later)

  • +3 more secondary outcomes

Study Arms (2)

Drinking Dashboard

EXPERIMENTAL

Day-level feedback on alcohol use and consequences

Behavioral: Drinking Dashboard

Assessment Only

NO INTERVENTION

Daily assessment control group

Interventions

Day-level feedback on alcohol use and consequences

Drinking Dashboard

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • Binge drinking in a typical week
  • Any form of alcohol-induced memory impairment in the past month at baseline

You may not qualify if:

  • Psychiatric disorder requiring immediate clinical attention (e.g., psychosis, suicidal ideation with intent and plan)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Results Point of Contact

Title
Dr. Mary Beth Miller
Organization
University of Missouri

Study Officials

  • Mary Beth Miller, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to receive the Drinking Dashboard or assessment only.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 29, 2022

Study Start

May 30, 2023

Primary Completion

April 9, 2024

Study Completion

April 9, 2024

Last Updated

July 13, 2026

Results First Posted

July 13, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Upon study completion
Access Criteria
NOT-AA-19-020
More information

Locations