NCT05509218

Brief Summary

The investigators propose to examine mornings after drinking as an optimal time to provide repeated, personalized feedback, with the goal of reducing hazardous drinking. Specifically, the investigators will further develop and pilot test a novel theory-based personalized feedback intervention (PFI) for heavy drinking young adults. Intervention strategies include personalized feedback (e.g., feedback on prior night blood alcohol concentration, consequences) contrasted with both drinking goals set at baseline and corrective normative feedback (e.g., how last night's drinking compares to peers). Up to 170 participants (50% non-college) will be randomized to one of three groups: PFI with monetary incentives for daily surveys, PFI without monetary incentives, or survey assessment only. The investigators will examine recruitment rates, retention rates, confirmation of intervention content delivery/intake, response rates to daily surveys, data quality, and ratings of intervention value. Investigators will test whether these indicators of engagement differ between those who do and do not receive monetary incentives for daily surveys. Further, baseline, post-test, and 3-month follow-up assessments will allow us to examine differences in drinking behavior between PFI and control. The results of the proposed research will result in a novel and scalable intervention for alcohol misuse among young adults, with potential to have an important impact on the public health problem of high-risk drinking.

Trial Health

55
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
2 years until next milestone

Study Start

First participant enrolled

August 26, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 26, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

August 18, 2022

Last Update Submit

August 25, 2025

Conditions

Youth DrinkingAlcohol Drinking

Keywords

young adultspersonalized feedback interventionmobile interventionalcohol use

Outcome Measures

Primary Outcomes (3)

  • drinks per week

    Number of drinks consumed per typical week in the past 30 days

    post-test (end of 4-week intervention) and 3-month follow-up (3 months after end of intervention)

  • heavy drinking frequency

    Number of days drinking 4+ drinks (women) or 5+ drinks (men) in the past 30 days

    post-test (end of 4-week intervention) and 3-month follow-up (3 months after end of intervention)

  • negative alcohol consequences

    Number of consequences reported on the 24-item Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)

    post-test (end of 4-week intervention) and 3-month follow-up (3 months after end of intervention)

Study Arms (3)

Personalized feedback plus incentive

EXPERIMENTAL

Following each daily survey on which a participant indicates prior day drinking, personalized feedback will be provided. Participants in this group will receive $1 per day for submitting their daily survey.

Behavioral: Mobile-delivered personalized feedback

Personalized feedback without incentive

EXPERIMENTAL

Following each daily survey on which a participant indicates prior day drinking, personalized feedback will be provided. Participants in this group will NOT receive $1 per day for submitting their daily survey.

Behavioral: Mobile-delivered personalized feedback

Control

NO INTERVENTION

Participants in this arm will only complete baseline and follow-up surveys.

Interventions

Mobile-delivered personalized feedbackBEHAVIORAL

Following each daily survey on which a participant indicates prior day drinking, personalized feedback will be provided on how their most recent behavior (e.g., drinks last night, drinking days so far this week) compare/contrast with personal goals. Participants will then choose whether to receive additional feedback in any of 7 areas: blood alcohol concentrate on, high risk behaviors, consequences of drinking, caloric intake, spending, how drinking compares to peers, and safe drinking strategies. All participants will receive feedback on drinks consumed, and then be asked to choose at least one additional topic for feedback (following each drinking day). In addition to day-level feedback, an aggregate feedback report on drinking patterns and related behaviors will be delivered twice, once at the end of each 2-week period. Once again, they will have the option to view feedback across the range of topics noted above.

Personalized feedback plus incentivePersonalized feedback without incentive

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-29 years
  • Own a smartphone and use it daily
  • Heavy episodic drinking (4+/5+ drinks for women/men) at least weekly in past month
  • At least one of 10 negative consequences assessed
  • at least somewhat willing to consider drinking even a little less than current

You may not qualify if:

  • current participation in treatment for an alcohol or other substance use disorder
  • participation in an earlier phase of the study
  • enrollment in ongoing alcohol studies at the same university

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Underage DrinkingAlcohol Drinking

Condition Hierarchy (Ancestors)

Adolescent BehaviorBehaviorDrinking Behavior

Study Officials

  • Jennifer E Merrill, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are randomized to one of three conditions: (1) daily surveys plus personalized feedback about yesterday's drinking, with a monetary incentive for survey completion, (2) daily surveys plus personalized feedback about yesterday's drinking, with no monetary incentive, or (3) survey assessment (baseline and follow-up) only
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 22, 2022

Study Start

August 26, 2024

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

August 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

This study will submit and share data with NIAAA Data Archive, a data repository housed within the National Institute of Mental Health Data Archive (NDA). Participants complete a baseline survey of participant characteristics and drinking behavior and related constructs, a post-test survey, and a 3-month follow-up assessment to measure drinking behavior post-intervention. Data from these 3 surveys will be shared.

Time Frame
Data will be shared on or before the NDA submission due dates (April 1 and October 1 each year). It will remain in the archive as per the archive regulations.

Locations

US(1)