NCT06776796

Brief Summary

Individuals will be recruited to participate in a randomized controlled trial to test the efficacy of a prevention program aimed at reducing alcohol use among college students. If randomized to the intervention, participants will view personalized content based on their alcohol use and chosen identity and learn about various topics related to alcohol use, including ways to reduce their use. Control participants will be directed to a website where information regarding mental health and substance use may be found. Baseline mental health, alcohol use, and related constructs will be assessed. Participants will complete a 3-month follow-up survey to assess the efficacy of the tool in symptom reduction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
461

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

August 23, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

January 8, 2025

Last Update Submit

January 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in Alcohol use

    Number of drinks will be assessed using the daily drinking questionnaire. Higher scores indicate higher alcohol use.

    Baseline and 3-months

Study Arms (2)

Online Personalized Normative Feedback Intervention Targeting Alcohol Misuse

EXPERIMENTAL

This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse. It is tailored by the identities chosen by participants including gender, race/ethnicity, and sexual orientation. The intervention is a modified version of an existing evidence-based program, the Brief Alcohol Screening and Intervention for College Students (BASICS) (Dimeff, et. al, 1999).

Behavioral: Online Personalized Normative Feedback Intervention Targeting Alcohol Misuse

Mental Health and Substance Use Resources

PLACEBO COMPARATOR

Participants were directed to a website where information regarding mental health and substance use may be found.

Behavioral: Mental Health and Substance Use Resources

Interventions

This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse. It is tailored by the identities chosen by participants including gender, race/ethnicity, and sexual orientation. The intervention is a modified version of an existing evidence-based program, the Brief Alcohol Screening and Intervention for College Students (BASICS) (Dimeff, et. al, 1999).

Online Personalized Normative Feedback Intervention Targeting Alcohol Misuse

Participants were directed to a website where information regarding mental health and substance use may be found.

Mental Health and Substance Use Resources

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Current student at university of study
  • Valid email address at university of study
  • Identifies as Black, White and LGBTQA+, Latine/a/o or Hispanic,
  • Endorse engaging in heavy episodic drinking at least once in the past month on the screening survey

You may not qualify if:

  • Individuals who identify their sex at birth as intersex or who identify as both heterosexual and gender diverse (Transgender, Genderqueer, Gender non-conforming, Non-binary, Androgynous, and Two-spirit) will be excluded due to the lack of normative data about these groups.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georiga State University

Atlanta, Georgia, 30303, United States

Location

Related Publications (1)

  • Gilmore AK, Leone RM, Reuben K, Garner JB, Flowers N, Chipman T, Patton EE, Capobianco J, Zong ZY, Stappenbeck CA, Ellis JR, Fortson K, Mullican KN, Larimer M. Pilot randomized controlled trial of a tailored personalized normative feedback intervention for college student alcohol use. Drug Alcohol Depend. 2025 Oct 1;275:112824. doi: 10.1016/j.drugalcdep.2025.112824. Epub 2025 Aug 8.

MeSH Terms

Conditions

Alcohol Drinking

Interventions

EthanolMental Health

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsHealthPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be masked to intervention conditions.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and PhD Director, Department of Health Policy & Behavioral Sciences Director, National Center for Sexual Violence Prevention

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 15, 2025

Study Start

August 23, 2023

Primary Completion

January 21, 2024

Study Completion

January 21, 2024

Last Updated

January 15, 2025

Record last verified: 2025-01

Locations