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Using Counter Attitudinal Advocacy to Change Drinking Behavior

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ClinicalTrials.gov Identifier: NCT04042909
Recruitment Status : Not yet recruiting
First Posted : August 2, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Houston
Information provided by (Responsible Party):
Kate Carey, Brown University

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.

Condition or disease Intervention/treatment Phase
Alcohol Drinking Alcohol Abuse Behavioral: Counter Attitudinal Advocacy Behavioral: Personalized Normative Feedback Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Using Counter Attitudinal Advocacy to Change Drinking Behavior
Estimated Study Start Date : September 4, 2019
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : June 30, 2022

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.
Behavioral: Counter Attitudinal Advocacy
same as Counter Attitudinal Advocacy arm
Other Name: CAA

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).
Behavioral: Personalized Normative Feedback
same as Personalized Normative Feedback arm
Other Name: PNF

No Intervention: Assessment-only Control
Participants in this arm will not receive any intervention.



Primary Outcome Measures :
  1. drinks per week as assessed by the Daily Drinking Questionnaire [ Time Frame: change from baseline to 1-month, 3-month, and 6-month follow ups ]
    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

  2. alcohol-related consequences as assessed by the Young Adult Alcohol Consequences Questionnaire [ Time Frame: change from baseline to 1-month, 3-month, and 6-month follow ups ]
    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



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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042909


Contacts
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Contact: Kate B Carey, PhD 401-863-6558 kate_carey@brown.edu
Contact: Angelo M. DiBello, PhD 718-951-4814 angelo_dibello@brown.edu

Locations
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United States, Rhode Island
Brown University Not yet recruiting
Providence, Rhode Island, United States, 02912
Contact: Kate B Carey, PhD    401-863-6558    kate_carey@brown.edu   
United States, Texas
University of Houston Not yet recruiting
Houston, Texas, United States, 77204-5022
Contact: Clayton Neighbors, PhD    713-743-2616    cneighbors@uh.edu   
Sponsors and Collaborators
Brown University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Houston
Investigators
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Principal Investigator: Kate B Carey, PhD Brown University

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Responsible Party: Kate Carey, Professor, Brown University
ClinicalTrials.gov Identifier: NCT04042909     History of Changes
Other Study ID Numbers: 1809002214
R01AA025043 ( U.S. NIH Grant/Contract )
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Within one year of study completion
Access Criteria: to be determined

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kate Carey, Brown University:
brief intervention
college students
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders