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Personalized Feedback After Alcohol Health Education for Members of Greek Life (GREEK Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05107284
Recruitment Status : Enrolling by invitation
First Posted : November 4, 2021
Last Update Posted : May 3, 2023
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Abby Braitman, Old Dominion University

Brief Summary:

Heavy episodic alcohol use within the college student population is widespread, creating problems for student drinkers, their peers, and their institutions. Negative consequences from heavy alcohol use can be mild (e.g., hangovers, missed classes), to severe (e.g., assault, even death). Although online interventions targeting college student drinking reduce alcohol consumption and associated problems, they are not as effective as in-person interventions. Online interventions are cost-effective, offer privacy, reduce stigma, and may reach individuals who would otherwise not receive treatment. In a recently completed randomized, controlled trial, an emailed booster with personalized feedback improved the efficacy of a popular online intervention. A second randomized, controlled trial confirmed efficacy for students of legal drinking age for a longer timeline. Although promising, the booster incorporated in the study needs further empirical refinement.

The current project seeks to build on past progress by further developing and refining the booster. In particular, the current project is an extension of previous work by expanding the investigation into complete social networks (students involved in Greek life). This booster contains feedback about alcohol use tailored to the recipient, and will be emailed 2, 6, 10, and 14 weeks after baseline (experimental condition), or not at all (control condition). This study will be conducted specifically with students who are members of fraternities or sororities at ODU (specifically, those in the organizations that agree to participate). This population engages in heavy alcohol use so is ideal for an alcohol intervention. Members of fraternities and sororities (i.e., "Greek life") engage in more frequent drinking, consume more when drinking, and have higher peak drinking occasions than students not involved in Greek life. We aim to administer the intervention and associated booster among complete networks of Greek organizations to examine how the intervention and booster and progress through social networks.


Condition or disease Intervention/treatment Phase
College Student Drinking Behavioral: e-checkup to go Behavioral: Delayed feedback booster Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: The intervention is an online program, not an individual administering it, so masking is not necessary. Similarly, the same online survey is deployed in all follow-up assessments regardless of condition, and data are not collected by individuals, so masking of investigators is not necessary.
Primary Purpose: Treatment
Official Title: Personalized Feedback After Alcohol Health Education for Members of Greek Life (GREEK Study)
Actual Study Start Date : April 6, 2022
Actual Primary Completion Date : December 8, 2022
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Placebo Comparator: Intervention-only Control
Participants navigate through e-checkup to go, the well-established alcohol intervention. Any follow-up emails sent to them later contain only a reminder to participate in follow-up surveys.
Behavioral: e-checkup to go
The e-checkup to go alcohol program is designed to motivate individuals to reduce their alcohol consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and requires no face-to-face time with an administrator. It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.

Experimental: Intervention plus delayed feedback booster
Participants navigate through e-checkup to go, the well-established alcohol intervention, then receive a series of feedback booster emails. It contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant-reported perceived alcohol norms, actual alcohol norms, their own use, and harm reduction strategies.
Behavioral: e-checkup to go
The e-checkup to go alcohol program is designed to motivate individuals to reduce their alcohol consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and requires no face-to-face time with an administrator. It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.

Behavioral: Delayed feedback booster
Booster emails will contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, their own reported consumption, and reminders of strategies they can use to protect themselves from alcohol-related harm.




Primary Outcome Measures :
  1. Alcohol consumption [ Time Frame: past 30 days ]
    Participant self-reported number of standard drinks consumed by participant over a typical week for the past 30 days.


Secondary Outcome Measures :
  1. Alcohol-Related Consequences [ Time Frame: past 30 days ]
    Participant self-report on the Brief-Young Adult Alcohol Consequences Questionnaire (B-YAACQ; Kahler et al., 2005), which assesses alcohol-related problems experienced by the participant. Total scores are created by summing all individual items, and range from 0 to 24, with higher values representing more problems experienced (i.e., worse outcomes).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must be at least 18 years old so that they can legally consent to participate.
  • Participants must be an undergraduate student at the host institution and a member of a participating fraternitiy or sorority.

Exclusion Criteria:

  • Under 18 years of age
  • Not a member of a participating fraternity or sorority at the host institution.

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): NCT05107284


Locations
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United States, Virginia
Old Dominion University
Norfolk, Virginia, United States, 23529
Sponsors and Collaborators
Abby Braitman
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Abby L Braitman, Ph.D. Old Dominion University
  Study Documents (Full-Text)

Documents provided by Abby Braitman, Old Dominion University:
Study Protocol  [PDF] July 7, 2022
Statistical Analysis Plan  [PDF] July 7, 2022

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abby Braitman, Assistant Professor, Old Dominion University
ClinicalTrials.gov Identifier: NCT05107284    
Other Study ID Numbers: 21-164
K01AA023849 ( U.S. NIH Grant/Contract )
First Posted: November 4, 2021    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcohol Drinking in College
Alcohol Drinking
Drinking Behavior