- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04042909
Using Counter Attitudinal Advocacy to Change Drinking Behavior
May 6, 2025 updated by: Kate Carey, Brown University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The persistence of risky drinking among young adults in college calls for continued efforts to prevent harms related to alcohol.
Many prevention interventions rely on a primary mechanism of change: correcting exaggerated drinking norms.
We propose to test a novel prevention strategy targeting another mechanism of change: creating attitude-behavior dissonance.
To date, attitude change activities have not been harnessed as a behavior change strategy for alcohol abuse prevention, so this study adapts counter-attitudinal advocacy (CAA) to the alcohol prevention context.
The goals of the proposed research are to demonstrate (a) the utility of CAA to change high volume drinking and related consequences, (b) that attitude change and attitude-behavior dissonance mediates the CAA manipulation effect, and (c) that CAA-induced risk reduction is not inferior to an established intervention based on Personalized Normative Feedback (PNF).
A pair of studies will be implemented across two sites.
First surveys to document peer behaviors and normative perceptions (N = 500 at each site) will be conducted, in order to deliver accurate, campus-specific PNF.
The next study consists of a randomized controlled trial (RCT) with 2 experimental conditions (CAA and PNF) and a 3rd assessment only control condition to determine the impact of CAA on alcohol outcomes.
For the RCT, a total of 600 heavy drinking students who have endorsed alcohol-related negative consequences will be recruited.
Alcohol outcomes will be assessed at 1-, 3-, and 6-month follow-ups to test hypotheses that, relative to assessment only control, the CAA manipulation will decrease alcohol consumption and consequences.
We will also test the hypothesis that CAA condition will be no less efficacious than (i.e., not inferior to) the PNF condition.
The RCT also allows tests of hypotheses about effect moderators and mediators.
This study will demonstrate the generalizability of CAA activities to the alcohol prevention context, as well as their generalizability across demographically different settings.
Implications for the public health include establishing the efficacy of a new approach for reducing high volume drinking and related consequences among young adults.
Study Type
Interventional
Enrollment (Actual)
591
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02912
- Brown University
-
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Texas
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Houston, Texas, United States, 77204-5022
- University of Houston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 26 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- status as a second semester Senior
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Counter Attitudinal Advocacy
Participants in this arm will articulate ways to avoid alcohol-related consequences using self-generated protective strategies and publicly state those strategies.
|
same as Counter Attitudinal Advocacy arm
Other Names:
|
|
Active Comparator: Personalized Normative Feedback
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).
|
same as Personalized Normative Feedback arm
Other Names:
|
|
No Intervention: Assessment-only Control
Participants in this arm will not receive any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Drinks Per Week as Assessed by the Daily Drinking Questionnaire
Time Frame: 6-month follow up
|
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
Time Frame: 6-month follow up
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kate B Carey, PhD, Brown University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 12, 2019
Primary Completion (Actual)
January 30, 2023
Study Completion (Actual)
January 30, 2023
Study Registration Dates
First Submitted
July 31, 2019
First Submitted That Met QC Criteria
July 31, 2019
First Posted (Actual)
August 2, 2019
Study Record Updates
Last Update Posted (Actual)
May 16, 2025
Last Update Submitted That Met QC Criteria
May 6, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1809002214
- R01AA025043 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
Within one year of study completion
IPD Sharing Access Criteria
to be determined
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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