CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 537 enrolled
Drug / intervention
Alcohol 101 Plus (TM) +2 morebehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03433794
NCT03433794Phase 1Completed

Alcohol Health Education

Abby Braitman·interventional·Posted Feb 15, 2018·Updated Dec 1, 2020

In Brief

A Phase 1 clinical trial evaluating Alcohol 101 Plus (TM), Booster, and 1 other intervention for College Student Drinking. Completed, enrolled 537 participants.

Detailed Summary

Alcohol use among college students is both widespread and problematic. There are many negative consequences associated with frequent alcohol use, ranging from mild (e.g., hangovers, missed classes) to severe (e.g., assault, even death). Online interventions targeting alcohol use among college students reduce alcohol consumption and associated problems. These interventions are popular among colleges because they are relatively inexpensive and easily disseminated. However, online interventions are not as efficacious as face-to-face interventions, such as brief motivational interviews. The proposed project employs emailed boosters in a randomized, controlled trial in an effort to improve the efficacy an existing, popular, free online intervention, while at the same time maintaining low cost and easy dissemination. Adding boosters after interventions is a common technique to improve the efficacy of the original intervention. Boosters have been used successfully for alcohol use interventions among those seeking injury treatment in emergency medical settings. However, prior research has not supported booster efficacy for college student alcohol interventions. The current project develops and evaluates the effectiveness of boosters for a widely-used college student alcohol intervention. Specifically, the present project improves boosters by providing easy access via email; providing succinct, personalized feedback; and providing reminders of protective behavioral strategies. To test the effectiveness of adding boosters, participants randomized to alcohol-intervention-plus-boosters receive emails 2 weeks after the intervention with tailored feedback based upon their reported alcohol consumption. Participants are assessed up to nine months. The current research addresses the following specific aims: Aim 1: Improve the efficacy of an easily-disseminated computerized intervention by adding personalized follow-up boosters, where efficacy is evidenced by reduced drinking and negative alcohol-related consequences (i.e., stronger effect sizes in the booster group immediately after receiving the booster). Aim 2: Extend the duration of the reduction in drinking and associated problems through the use of these personalized follow-up boosters (i.e., significant differences between the booster and control groups at later timepoints). Aim 3: Examine protective behavioral strategies highlighted by the booster as mediating behavioral mechanisms of change.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 15, 2018
Enrollment StartJan 29, 2013
Primary CompletionSep 10, 2014
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.4 years ago

Interventions

Alcohol 101 Plus (TM)behavioral

It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide information such as sex, weight, and state so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The program provides updated BACs based upon choices about what to consume and how quickly to consume it. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. It is a non-linear environment, where participants choose which sections of the website to explore.

Boosterbehavioral

Personalized feedback was emailed to participants. Content included sex-specific descriptive normative information (i.e., drinks per week typically consumed by males and females at the same institution), as well as reminders of harm reduction strategies (i.e., techniques the participant reported using in their last survey, versus techniques not used).

Lilly for Better Healthbehavioral

This is an online education session directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. It was not expected to influence alcohol use.