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Using Counter Attitudinal Advocacy to Change Drinking Behavior

Primary Purpose

Alcohol Drinking, Alcohol Abuse

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counter Attitudinal Advocacy
Personalized Normative Feedback
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking focused on measuring brief intervention, college students

Eligibility Criteria

18 Years - 26 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brown UniversityRecruiting
  • University of HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Counter Attitudinal Advocacy

Personalized Normative Feedback

Assessment-only Control

Arm Description

Participants in this arm will articulate ways to avoid alcohol-related consequences using self-generated protective strategies and publicly state those strategies.

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).

Participants in this arm will not receive any intervention.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
July 31, 2019
Last Updated
May 13, 2021
Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Houston
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1. Study Identification

Unique Protocol Identification Number
NCT04042909
Brief Title
Using Counter Attitudinal Advocacy to Change Drinking Behavior
Official Title
Using Counter Attitudinal Advocacy to Change Drinking Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Alcohol Abuse
Keywords
brief intervention, college students

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Counter Attitudinal Advocacy
Arm Type
Experimental
Arm Description
Participants in this arm will articulate ways to avoid alcohol-related consequences using self-generated protective strategies and publicly state those strategies.
Arm Title
Personalized Normative Feedback
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Assessment-only Control
Arm Type
No Intervention
Arm Description
Participants in this arm will not receive any intervention.
Intervention Type
Behavioral
Intervention Name(s)
Counter Attitudinal Advocacy
Other Intervention Name(s)
CAA
Intervention Description
same as Counter Attitudinal Advocacy arm
Intervention Type
Behavioral
Intervention Name(s)
Personalized Normative Feedback
Other Intervention Name(s)
PNF
Intervention Description
same as Personalized Normative Feedback arm
Primary Outcome Measure Information:
Title
drinks per week as assessed by the Daily Drinking Questionnaire
Description
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
change from baseline to 1-month, 3-month, and 6-month follow ups
Title
alcohol-related consequences as assessed by the Young Adult Alcohol Consequences Questionnaire
Description
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
Time Frame
change from baseline to 1-month, 3-month, and 6-month follow ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kate B Carey, PhD
Phone
401-863-6558
Email
kate_carey@brown.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Angelo M. DiBello, PhD
Phone
718-951-4814
Email
angelo_dibello@brown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate B Carey, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate B Carey, PhD
Phone
401-863-6558
Email
kate_carey@brown.edu
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204-5022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clayton Neighbors, PhD
Phone
713-743-2616
Email
cneighbors@uh.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Using Counter Attitudinal Advocacy to Change Drinking Behavior

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