Using Counter Attitudinal Advocacy to Change Drinking Behavior

Alcohol Drinking Clinical Trial

Official title:

Using Counter Attitudinal Advocacy to Change Drinking Behavior

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04042909
• Other study ID #: 1809002214
• Secondary ID: R01AA025043
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2021
• Source: Brown University
• Contact: Kate B Carey, PhD
• Phone: 401-863-6558
• Email: kate_carey[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Drinking
• Alcoholism
• Drinking Behavior

Intervention

Behavioral:
• Counter Attitudinal Advocacy
same as Counter Attitudinal Advocacy arm
• Personalized Normative Feedback
same as Personalized Normative Feedback arm

Locations

Country	Name	City	State
United States	University of Houston	Houston	Texas
United States	Brown University	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Brown University	National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	change from baseline to 1-month, 3-month, and 6-month follow ups
Primary	alcohol-related consequences as assessed by the Young Adult Alcohol Consequences Questionnaire	The YAACQ 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	change from baseline to 1-month, 3-month, and 6-month follow ups