Clinical trial NCT04042909: Using Counter Attitudinal Advocacy to Change Drinking Behavior
Official title: Using Counter Attitudinal Advocacy to Change Drinking Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Alcohol Abuse
Keywords: brief intervention
college students
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: University of Houston
First posted: 2019-08-02
Enrollment: 591
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Drinks Per Week as Assessed by the Daily Drinking Questionnaire
timeFrame: 6-month follow up
measure: Alcohol-related Consequences as Assessed by the Young Adult Alcohol Consequences Questionnaire
timeFrame: 6-month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
affiliation: Brown University
name: Kate B Carey, PhD
role: PRINCIPAL_INVESTIGATOR
References: