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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04453007
Other study ID # 20-044
Secondary ID K01AA023849
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date November 30, 2020
Est. completion date September 12, 2022

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 (Braitman & Henson, 2016). A second randomized, controlled trial confirmed efficacy for students of legal drinking age for a longer timeline (Braitman & Lau-Barraco, 2018). 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, to identify the most efficacious timing for sending the feedback. The content will be similar across conditions, but will be disseminated at different times to identify the most impactful timeline. There will be 6 study conditions: those who receive the emailed feedback 2, 6, 10, or 14 weeks after baseline, or at all of those times, or not at all (control). Thus, the aim of the current study is to identify optimal timing for sending the tailored booster feedback via booster email.


Recruitment information / eligibility

Status Completed
Enrollment 195
Est. completion date September 12, 2022
Est. primary completion date September 12, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 24 Years
Eligibility Inclusion Criteria: - Current college students at the sponsor institution at the time of enrollment - Between the ages of 18 and 24 - Consumed at least standard drink of alcohol in the past 2 weeks Exclusion Criteria: - Under age of 18 - Over age of 24 - Not a college student - Did not drink alcohol in the past 2 weeks

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.
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 (2)

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

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 Young Adult Alcohol Consequences Questionnaire (YAACQ; Read, Kahler, Strong, & Colder, 2006), which assesses alcohol-related problems experienced by the participant. Total scores are created by summing all individual items, and range from 0 to 48, with higher values representing more problems experienced (i.e., worse outcomes). past 30 days
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