NCT07036198

Brief Summary

The project will develop brief interventions that allow participants to customize which groups they receive feedback for in relation to things such as drinking norms for younger or older students, student athletes, etc. The goal is to provide content that is meaningful and engaging to all users.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress7%
Apr 2026Sep 2027

First Submitted

Initial submission to the registry

April 8, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

April 8, 2025

Last Update Submit

March 10, 2026

Conditions

Keywords

young adultsalcohol-related harmRCTnormative feedback

Outcome Measures

Primary Outcomes (6)

  • Alcohol use - drinks per month

    Daily Drinking Questionnaire will assess drinks on average over the past month by recording the number of drinks consumed on each day of a typical week. Response options range from 0 drinks to 25+ drinks. Lower score is a better outcome, higher score is a worse outcome.

    Screening, Baseline, Follow-ups, an average of 3 months

  • Alcohol use - Quantity per occasion

    Quantity/Frequency/Peak Alcohol Use Index will assess amount of alcohol consumed over the past month with how many days alcohol was consumed, average consumption, and peak consumption. Response options range from 0 to 30 days for frequency, and 1 to 12+ drinks for quantity and peak. Lower score is a better outcome, higher score is a worse outcome.

    Screening, Baseline, Follow-ups, an average of 3 months

  • Alcohol use - Heavy episodic drinking

    Heavy Episodic Drinking measure will assess how many times over the past month heavy drinking episodes occurred, defined as 4 or more drinks (females) or 5 or more drinks (males) on a single occasion. Response options range from 0 to 7 days. Lower score is a better outcome, higher score is a worse outcome.

    Screening, Baseline, Follow-ups, an average of 3 months

  • Alcohol use - Peak drinks & peak BAC

    Electronic Blood Alcohol content will be assessed and calculated using peak drinks over x amount of time. A lower BAC is a better outcome, a higher BAC is a worse outcome.

    Screening, Baseline, Follow-ups, an average of 3 months

  • Alcohol use - Alcohol Use Disorders Identification Test

    The AUDIT is a 10-item self-report screening tool assessing hazardous and harmful alcohol use over the past year. Items are rated on varying 5-point Likert-type scales assessing frequency, quantity, and consequences of alcohol use. Lower score is a better outcome, higher score is a worse outcome.

    Baseline, Follow-ups, an average of 3 months

  • Alcohol use - Brief Young Adult Alcohol Consequences Questionnaire

    The Brief YAACQ is a 24-item assessment of alcohol-related consequences in young adults. Response options for the items are yes or no. Higher score (i.e. more 'yes' responses) is a worse outcome, lower score (i.e. more 'no' responses) is a better outcome.

    Baseline, Follow-ups, an average of 3 months

Secondary Outcomes (2)

  • Perceived descriptive norms for each normative referent group

    Baseline, Follow-ups, an average of 3 months

  • Perceived injunctive drinking norms for typical students at UW

    Baseline, Follow-ups, an average of 3 months

Study Arms (3)

CPNF

ACTIVE COMPARATOR

Customizable personalized normative feedback (CPNF) intervention whereby individuals can explore normative feedback for a wider variety of referent groups so that PNF is a truly personalized and engaging experience.

Behavioral: Customizable personalized normative feedback (CPNF)

standard PNF

ACTIVE COMPARATOR

Standard personalized normative feedback.

Behavioral: Personalized normative feedback (PNF)

Attention-Matched Control (AMC)

ACTIVE COMPARATOR

Attention-matched control.

Behavioral: Attention-Matched Control (AMC)

Interventions

The CPNF intervention allows individuals to explore normative feedback for a wider variety of referent groups so that PNF is a truly personalized and engaging experience.

CPNF

Correcting misperceptions about peers' alcohol use behaviors and contrasting one's own use to the actual norms of their peers.

standard PNF

Participants in the AMC condition will complete all measures at the same time as participants in the CPNF condition but will not receive any information on drinking norms. Instead, participants in the AMC will receive normative feedback on sleep health, video game use, and gambling behaviors, and will similarly be able to choose the normative referent groups they wish to view feedback on for these behaviors. The AMC will thus serve as a non-treatment comparison that controls for assessment reactivity and effects of history and maturation.

Attention-Matched Control (AMC)

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Enrolled at the University of Washington either part- or full-time
  • Report 3 or more past-month drinking occasions
  • Report 3 or more drinks per occasion in the past month, on average
  • Report 4 or more drinks during the peak drinking occasion in the past month
  • Pass attention-check items

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Mary Larimer, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Larimer, Ph.D.

CONTACT

Ty Tristao, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 8, 2025

First Posted

June 25, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

All scientific data (qualitative interview transcriptions, survey response data) will be both preserved and shared. Data will be made publicly available to the research community. This will include but may not be limited to (a) semi-structured interview questions, (b) survey items and corresponding response options (including missingness coding), (c) a codebook for scoring survey items and composite scales, (d) a detailed description of internally computed variables (e.g., time spent viewing intervention content), and (e) documentation of intervention components that participants were exposed to (both treatment and control conditions). Public use and restricted access study data and associated documentation will be made available to the research community free of charge through the NIAAA Data Archive.

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
Data will be shared with the general research community at the time of an associated publication, or the end of the award/support period, whichever comes first.
Access Criteria
The data will be made available for sharing with the general research community via the NDA website. Investigators at institutions with a Federal Wide Assurance (FWA) will be able to gain access to NDA data by submitting a data access request in accordance with applicable NDA policies.

Locations