The Drinking Dashboard Study

Sponsor
University of Missouri-Columbia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05630625
Collaborator
(none)
162
2
25.5

Study Details

Study Description

Brief Summary

The proposed R34 aims to develop and pilot test a dynamic personalized feedback intervention (PFI) that will reduce alcohol use and related consequences among young adults with a history of alcohol-induced blackout.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Drinking Dashboard
N/A

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. The research team developed a dynamic personalized feedback intervention for young adults with a history of blackout. For Aim 1, 15-20 young adults with a history of blackout will provide their perspectives on the proposed content, layout, and language of the intervention. For Aim 2, 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 Design

Study Type:
Interventional
Anticipated Enrollment :
162 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomly assigned to receive the intervention or assessment only.Participants will be randomly assigned to receive the intervention or assessment only.
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Dynamic Personalized Feedback for Young Adults With a History of Blackout
Anticipated Study Start Date :
Mar 15, 2023
Anticipated Primary Completion Date :
Apr 30, 2025
Anticipated Study Completion Date :
Apr 30, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Recruitment [Baseline]

    % of patients who (yes/no) complete the baseline assessment (no specific tool)

  2. Retention [3-month follow-up]

    % of patients who (yes/no) complete 3-month follow-up assessment (no specific tool)

  3. Intervention acceptability [1-month follow-up]

    Measured using the 8-item Client Satisfaction Questionnaire. Scored from 1 to 4, with higher scores indicating greater satisfaction with treatment.

  4. Frequency of high-intensity drinking [Change from baseline to 1-month follow-up]

    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.

  5. Peak BAC [Change from baseline to 1-month follow-up]

    Measured using the Daily Drinking Questionnaire, which asks participants to indicate the maximum number of drinks consumed on one occasion in the past month.

  6. Frequency of blackouts [Change from baseline to 1-month follow-up]

    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.

  7. Alcohol-related consequences [Change from baseline to 1-month follow-up.]

    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

  1. Sexual coercion [Difference in likelihood baseline vs 3 months]

    % of people indicating they (a) were coerced into sexual activity or (b) coerced someone else into sexual activity in the past 3 months

  2. Emergency department visits [Difference in likelihood baseline vs 3mo]

    % of people indicating they visited the emergency department in the past 3 months

  3. Blackout susceptibility [Change from baseline to 1 month]

    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.

  4. Blackout severity [Change from baseline to 1 month]

    If I were to have a blackout, bad things would happen. Scored on a Likert scale, with higher scores indicating more negative attitudes.

  5. Costs/benefits of drinking [Change from baseline to 1 month]

    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).

  6. Blackout self-efficacy [Change from baseline to 1 month]

    % confidence that participants could avoid a blackout, if they wanted to do so

  7. Sleep disturbance [Change from baseline to 1 month]

    Measured using the Insomnia Severity Index. Items scored 0 to 4, with higher scores indicating more severe insomnia.

  8. Mood [Change from baseline to 1 month.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 18-30 years of age

  • Alcohol use in a typical week

  • Any form of alcohol-induced memory impairment in the past month at baseline

Exclusion Criteria:
  • Current treatment for SUD

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Missouri-Columbia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mary E Miller, Clinical Psychologist, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT05630625
Other Study ID Numbers:
  • 2067803
First Posted:
Nov 29, 2022
Last Update Posted:
Nov 29, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 29, 2022