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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05107284
Other study ID # 21-164
Secondary ID K01AA023849
Status Enrolling by invitation
Phase Phase 1/Phase 2
First received
Last updated
Start date April 6, 2022
Est. completion date May 31, 2023

Study information

Verified date April 2023
Source Old Dominion University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 250
Est. completion date May 31, 2023
Est. primary completion date December 8, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Old Dominion University Norfolk Virginia

Sponsors (2)

Lead Sponsor Collaborator
Abby Braitman National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol consumption Participant self-reported number of standard drinks consumed by participant over a typical week for the past 30 days. past 30 days
Secondary 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). past 30 days
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Completed NCT03433794 - Alcohol Health Education Among College Drinkers Phase 1
Completed NCT03440476 - Personalized Booster Feedback After Alcohol Health Education Phase 1/Phase 2
Completed NCT03440463 - Alcohol Health Education With Personalized Feedback Boosters Phase 1/Phase 2