NCT04042909

Brief Summary

High volume drinking by young adults has proven resistant to change, so new approaches are needed. We adapt a theory-based attitude change strategy for use in alcohol prevention. This research tests the impact of brief writing and advocacy activities on subsequent drinking and negative consequences.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
591

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

July 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

November 12, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

May 16, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

3.2 years

First QC Date

July 31, 2019

Results QC Date

April 1, 2025

Last Update Submit

May 6, 2025

Conditions

Alcohol DrinkingAlcohol Abuse

Keywords

brief interventioncollege students

Outcome Measures

Primary Outcomes (2)

  • Drinks Per Week as Assessed by the Daily Drinking Questionnaire

    Number of standard drinks consumed in a typical week over the past 30 days; scores can range from zero but have no upper limit as they are counts of drinks

    6-month follow up

  • Alcohol-related Consequences as Assessed by the Young Adult Alcohol Consequences Questionnaire

    The Young Adult Alcohol Consequences Questionnaire is a checklist of 48 different consequences that could be experienced over the past 30 days; the total score ranges from 0-48; higher scores indicate more problems experienced in the past 30 days

    6-month follow up

Study Arms (3)

Counter Attitudinal Advocacy

EXPERIMENTAL

Participants in this arm will articulate ways to avoid alcohol-related consequences using self-generated protective strategies and publicly state those strategies.

Behavioral: Counter Attitudinal Advocacy

Personalized Normative Feedback

ACTIVE COMPARATOR

Participants in this arm will view personalized normative feedback regarding their 1) own drinking quantity and frequency of drinking, 2) perceptions of typical drinking by same-sex students' on campus (i.e., perceived descriptive norms), and 3) actual drinking rates by same-sex students' on campus (i.e., actual descriptive norms).

Behavioral: Personalized Normative Feedback

Assessment-only Control

NO INTERVENTION

Participants in this arm will not receive any intervention.

Interventions

Counter Attitudinal AdvocacyBEHAVIORAL

same as Counter Attitudinal Advocacy arm

Also known as: CAA
Counter Attitudinal Advocacy
Personalized Normative FeedbackBEHAVIORAL

same as Personalized Normative Feedback arm

Also known as: PNF
Personalized Normative Feedback

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-26
  • Male or female student at Brown University or University of Houston
  • Past month heavy episodic drinking (for men, \>5 drinks in one day, for women \>4 drinks in one day)
  • At least two self-reported negative consequences from drinking in the past month

You may not qualify if:

  • status as a second semester Senior

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brown University

Providence, Rhode Island, 02912, United States

Location

University of Houston

Houston, Texas, 77204-5022, United States

Location

Related Publications (1)

  • Carey KB, DiBello AM, Hatch MR, Weinstein AP, Neighbors C. Efficacy of counter-attitudinal advocacy and personalized feedback for heavy-drinking college students. J Consult Clin Psychol. 2025 May;93(5):357-368. doi: 10.1037/ccp0000949. Epub 2025 Mar 13.

    PMID: 40080603DERIVED

MeSH Terms

Conditions

Alcohol DrinkingAlcoholism

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Kate B. Carey
Organization
Brown University
kate_carey@brown.edu
4018636558

Study Officials

  • Kate B Carey, PhD

    Brown University

    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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 2, 2019

Study Start

November 12, 2019

Primary Completion

January 30, 2023

Study Completion

January 30, 2023

Last Updated

May 16, 2025

Results First Posted

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

After all data have been collected and the results of the study have been published, de-identified data will be made available to other qualified investigators upon request. The request will be evaluated by the investigators to ensure that it meets reasonable demands of scientific integrity.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Within one year of study completion
Access Criteria
to be determined

Locations

US(2)