An interventional study of Counter Attitudinal Advocacy and Personalized Normative Feedback in Alcohol Drinking and Alcohol Abuse, sponsored by Brown University. Completed at 2 sites in United States. Open to participants aged 18 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Brown University · Not applicable, Interventional, and Prevention
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.
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.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's enrollment of 591 is above the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →Brown University is the lead sponsor of 290 studies on the registry; 40 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 19 (73%) have results posted.
Compared within Alcohol Drinking, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
Participants in this arm will not receive any intervention.
same as Counter Attitudinal Advocacy arm
Also known as: CAA
same as Personalized Normative Feedback arm
Also known as: PNF
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
Time frame: 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
Time frame: 6-month follow up
| Milestone | Counter Attitudinal Advocacy | Personalized Normative Feedback | Assessment-only Control |
|---|---|---|---|
| Started | 194 | 197 | 200 |
| Completed | 191 | 196 | 200 |
| Not completed | 3 | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Withdrew: Duplicate cases | 2 | 0 | 0 |
| Withdrew: Technical problem | 0 | 1 | 0 |
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
| drinks per week | Counter Attitudinal Advocacy | Personalized Normative Feedback | Assessment-only Control |
|---|---|---|---|
| Drinks Per Week as Assessed by the Daily Drinking Questionnaire | 6.8 ± 7.6 | 6.0 ± 5.2 | 7.1 ± 6.8 |
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
| problems | Counter Attitudinal Advocacy | Personalized Normative Feedback | Assessment-only Control |
|---|---|---|---|
| Alcohol-related Consequences as Assessed by the Young Adult Alcohol Consequences Questionnaire | 6.4 ± 7.0 | 7.2 ± 7.4 | 8.3 ± 8.6 |
Collected over through study completion, an average of 12 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Counter Attitudinal Advocacy | 0/191 (0%) | 0/191 (0%) | 0/191 (0%) |
| Personalized Normative Feedback | 0/196 (0%) | 0/196 (0%) | 0/196 (0%) |
| Assessment-only Control | 0/200 (0%) | 0/200 (0%) | 0/200 (0%) |
| Age, Continuous(years) | Counter Attitudinal Advocacy | Personalized Normative Feedback | Assessment-only Control | Total |
|---|---|---|---|---|
| Mean | 19.7 ± 1.4 | 19.9 ± 1.7 | 20.0 ± 1.7 | 19.9 ± 1.6 |
| Sex: Female, Male(Participants) | Counter Attitudinal Advocacy | Personalized Normative Feedback | Assessment-only Control | Total |
|---|---|---|---|---|
| Female | 119 | 124 | 126 | 369 |
| Male | 72 | 72 | 74 | 218 |
| Ethnicity (NIH/OMB)(Participants) | Counter Attitudinal Advocacy | Personalized Normative Feedback | Assessment-only Control | Total |
|---|---|---|---|---|
| Hispanic or Latino | 46 | 43 | 47 | 136 |
| Not Hispanic or Latino | 145 | 153 | 153 | 451 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Counter Attitudinal Advocacy | Personalized Normative Feedback | Assessment-only Control | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 3 | 1 | 3 | 7 |
| Asian | 46 | 47 | 44 | 137 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 16 | 20 | 13 | 49 |
| White | 80 | 95 | 93 | 268 |
| More than one race | 24 | 16 | 27 | 67 |
| Unknown or Not Reported | 22 | 17 | 20 | 59 |
| Region of Enrollment(participants) | Counter Attitudinal Advocacy | Personalized Normative Feedback | Assessment-only Control | Total |
|---|---|---|---|---|
| United States | 191 | 196 | 200 | 587 |
| Drinks per week(drinks per week) | Counter Attitudinal Advocacy | Personalized Normative Feedback | Assessment-only Control | Total |
|---|---|---|---|---|
| Mean | 9.9 ± 6.2 | 9.8 ± 5.9 | 10.0 ± 7.8 | 9.9 ± 6.7 |
| Alcohol problems(problems) | Counter Attitudinal Advocacy | Personalized Normative Feedback | Assessment-only Control | Total |
|---|---|---|---|---|
| Mean | 11.1 ± 7.0 | 12.0 ± 7.6 | 11.5 ± 7.2 | 11.5 ± 7.3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol, Informed consent form
Time frame: Within one year of study completion
Access criteria: to be determined
Ran from Nov 2019 to primary completion in Jan 2023, 38 months.
Results were first posted in May 2025, 2 years 3 months after primary completion.
Of 328 non-industry interventional studies with no phase under Alcohol Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 38 months is above that.
Counting every sponsor, half of 336 studies reached it within 24 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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