Personalized Feedback After Alcohol Health Education for Members of Greek Life (GREEK Study)
Primary Purpose
College Student Drinking
Status
Enrolling by invitation
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
e-checkup to go
Delayed feedback booster
Sponsored by
About this trial
This is an interventional treatment trial for College Student Drinking
Eligibility 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.
Sites / Locations
- Old Dominion University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Intervention-only Control
Intervention plus delayed feedback booster
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Alcohol consumption
Participant self-reported number of standard drinks consumed by participant over a typical week for the past 30 days.
Secondary Outcome Measures
Alcohol-Related Consequences
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).
Full Information
NCT ID
NCT05107284
First Posted
October 25, 2021
Last Updated
April 28, 2023
Sponsor
Abby Braitman
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT05107284
Brief Title
Personalized Feedback After Alcohol Health Education for Members of Greek Life (GREEK Study)
Official Title
Personalized Feedback After Alcohol Health Education for Members of Greek Life (GREEK Study)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
December 8, 2022 (Actual)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Abby Braitman
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
College Student Drinking
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention-only Control
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Intervention plus delayed feedback booster
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
e-checkup to go
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Delayed feedback booster
Intervention Description
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 Measure Information:
Title
Alcohol consumption
Description
Participant self-reported number of standard drinks consumed by participant over a typical week for the past 30 days.
Time Frame
past 30 days
Secondary Outcome Measure Information:
Title
Alcohol-Related Consequences
Description
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).
Time Frame
past 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abby L Braitman, Ph.D.
Organizational Affiliation
Old Dominion University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Old Dominion University
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23529
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29995326
Citation
Braitman AL, Lau-Barraco C. Personalized Boosters After a Computerized Intervention Targeting College Drinking: A Randomized Controlled Trial. Alcohol Clin Exp Res. 2018 Sep;42(9):1735-1747. doi: 10.1111/acer.13815. Epub 2018 Jul 11.
Results Reference
background
PubMed Identifier
27148633
Citation
Braitman AL, Henson JM. Personalized boosters for a computerized intervention targeting college drinking: The influence of protective behavioral strategies. J Am Coll Health. 2016 Oct;64(7):509-19. doi: 10.1080/07448481.2016.1185725. Epub 2016 May 5.
Results Reference
background
PubMed Identifier
34081487
Citation
Braitman AL, Strowger M, Lau-Barraco C, Shipley JL, Kelley ML, Carey KB. Examining the added value of harm reduction strategies to emailed boosters to extend the effects of online interventions for college drinkers. Psychol Addict Behav. 2022 Sep;36(6):635-647. doi: 10.1037/adb0000755. Epub 2021 Jun 3.
Results Reference
background
PubMed Identifier
36306162
Citation
Braitman AL, Shipley JL, Strowger M, Ayala Guzman R, Whiteside A, Bravo AJ, Carey KB. Examining Emailed Feedback as Boosters After a College Drinking Intervention Among Fraternities and Sororities: Rationale and Protocol for a Remote Controlled Trial (Project Greek). JMIR Res Protoc. 2022 Oct 28;11(10):e42535. doi: 10.2196/42535.
Results Reference
derived
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Personalized Feedback After Alcohol Health Education for Members of Greek Life (GREEK Study)
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