- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04026633
Attitudes & College Experiences (ACE)
August 3, 2022 updated by: Angelo DiBello, Brooklyn College of the City University of New York
Using Counter Attitudinal Advocacy to Change Drinking Behavior & Related Problems
High volume drinking by young adults has proven resistant to long term change, so new approaches are needed.
Given strong associations between alcohol-related attitudes and drinking behavior, the investigators adapt a theory-based attitude change strategy for use in alcohol prevention.
This research tests the impact of a brief counter attitudinal advocacy activity on subsequent drinking and negative consequences.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The persistence of risky drinking among young adults in college calls for continued efforts to prevent harms related to alcohol.
Current prevention interventions have achieved some success, but rely on a single mechanism of change: correcting exaggerated drinking norms.
The investigators propose to test a novel prevention strategy targeting another mechanism of change: creating attitude-behavior dissonance.
To date, changing alcohol-related attitudes and the resulting attitude-behavior discrepancy has been underutilized as a behavior change strategy for alcohol abuse prevention.
Informed by an extensive literature showing strong and consistent associations between alcohol attitudes and drinking behavior, the investigators adapted a brief counter-attitudinal advocacy (CAA) manipulation to the alcohol prevention context.
Study Type
Interventional
Enrollment (Actual)
134
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Brooklyn, New York, United States, 11210
- Brooklyn College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 24 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-24 years of age
- Enrolled in the university's undergraduate four-year degree program
- 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 consequence from drinking in the past month
Exclusion Criteria:
• Status as a graduating senior
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: Enhanced Intervention
Participants assigned to this arm will complete a personal writing task about alcohol use.
|
Participants will write about the use of PBS and alcohol use.
|
Placebo Comparator: Placebo Comparator
Participants assigned to this arm will complete a personal writing task about eating behaviors.
|
Participants will write about eating and exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Alcohol Consumption from Baseline to 1-Month
Time Frame: 1 month after baseline
|
Average of reports from past 30 days on the number of standard drinks consumed by participant over the past 30 days.
|
1 month after baseline
|
Change in Alcohol-related consequences from Baseline to 1- and 3-Months
Time Frame: 1 month and 3 months after baseline
|
The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) (Kahler et al., 2005) is a 24-item self-administered checklist of problems related to drinking; responses are dichotomous (yes/no) and refer to the past month which was collected at baseline and 5-months.
The BYAACQ demonstrates strong psychometric properties and is free of gender bias (Kahler et al., 2005).
|
1 month and 3 months after baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2019
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
April 30, 2022
Study Registration Dates
First Submitted
July 11, 2019
First Submitted That Met QC Criteria
July 17, 2019
First Posted (Actual)
July 19, 2019
Study Record Updates
Last Update Posted (Actual)
August 5, 2022
Last Update Submitted That Met QC Criteria
August 3, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AA025676 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD 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
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Abuse
-
The Morton Center, Inc.National Institute on Alcohol Abuse and Alcoholism (NIAAA)UnknownAlcohol Dependence | Cannabis Dependence | Alcohol Abuse | Cannabis Abuse | Other Substance AbuseUnited States
-
Michael E. DeBakey VA Medical CenterUnknownAlcohol Dependence | Alcohol Abuse | Substance Abuse ProblemUnited States
-
Polaris Health DirectionsUniversity of Massachusetts, WorcesterCompletedAlcohol Abuse, Alcohol DependenceUnited States
-
Kent State UniversityCompletedAlcohol Use Disorder | Alcohol Abuse | Alcohol Abuse, EpisodicUnited States
-
Australian National UniversityUniversity of Peradeniya; Department of Foregin Affairs and Trade, AustraliaCompletedIntimate Partner Violence | Domestic Abuse | Drug and Alcohol AbuseAustralia
-
National Institute on Drug Abuse (NIDA)CompletedDrug/Substance Abuse/Addiction | Alcohol Abuse/AddictionUnited States
-
Queen Mary University of LondonBarts & The London NHS Trust; University of HertfordshireRecruitingAlcohol Use Disorder | Alcohol Abuse or DependenceUnited Kingdom
-
National Institute on Drug Abuse (NIDA)CompletedSubstance Abuse | Drug Abuse | Alcohol AbuseUnited States
-
Baylor College of MedicineCompletedAlcohol Dependence | Substance Abuse | Alcohol AbuseUnited States
-
Fundació Sant Joan de DéuInstituto de Salud Carlos III; European Union; University of Barcelona; Red Salud...UnknownAlcohol Abuse in PregnancySpain
Clinical Trials on CAA
-
Meta RoestenbergCompletedSchistosomiasisNetherlands
-
Mayo ClinicRecruitingEarly Onset Alzheimer DiseaseUnited States
-
Centre de Recherche Médicale de LambarénéUniversität TübingenRecruitingPregnancy | Drug Reaction | Diagnostic | Schistosomiasis HematobiumGabon
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...RecruitingCerebral Amyloid AngiopathyItaly
-
CSD Labs GmbHCompletedSystolic Murmurs | Heart Murmurs | Mitral Valve ProlapseAustria
-
CSD Labs GmbHCompletedSystolic Murmurs | Heart Murmurs | Mitral Valve ProlapseCanada
-
Brown UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); University of HoustonRecruitingAlcohol Drinking | Alcohol AbuseUnited States
-
Institut BergoniéCompletedMedium and Lower Rectal CancerFrance
-
ArQule, Inc. (a wholly owned subsidiary of Merck...Completed
-
ArQule, Inc. (a wholly owned subsidiary of Merck...Completed