CClinicalTrials.gg
Status unknownNCT05107284Updated May 3, 2023

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

A Phase 1/2 interventional study of e-checkup to go and Delayed feedback booster in College Student Drinking, sponsored by Abby Braitman. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-03.

Sponsored by Abby Braitman · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • College Student Drinking
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Under 18 years of age
  • Not a member of a participating fraternity or sorority at the host institution.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
250 participants (estimated)

Study arms

  • 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

  • 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 · Behavioral: Delayed feedback booster

Interventions

  • Behaviorale-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.

  • BehavioralDelayed 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.

05

What researchers measure

Primary outcomes

  1. Alcohol consumption

    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 outcomes

  1. 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).

    Time frame: past 30 days

06

Study locations

1 site
  • Old Dominion University
    Norfolk, Virginia 23529, United States
07

References and documents

Publications

  • 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. PubMed 29995326 ↗
  • 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. PubMed 27148633 ↗
  • 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. PubMed 34081487 ↗
  • 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. PubMed 36306162 ↗

Study documents

  • Study protocol · Jul 7, 2022
  • Statistical analysis plan · Jul 7, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT05107284
Lead sponsor
Abby Braitman
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Abby Braitman (Assistant Professor, Old Dominion University) — Sponsor-investigator
First posted
Nov 4, 2021
Start date
Apr 6, 2022
Primary completion
Dec 8, 2022
Completion
May 31, 2023 (estimated)
Last update
May 3, 2023

Study contacts

Abby L Braitman, Ph.D.
principal investigator · Old Dominion University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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