Alcohol Health Education Among College Drinkers

NCT03433794 | Completed Phase 1 Results

• 2 other identifiers: 12-194F32AA021310
• Study Type: interventional
• Target: 537
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

College Student Drinking

Outcome Measures

Primary Outcomes (1)

• Alcohol Consumption

  Participant self-reported number of standard drinks consumed by participant over the past 2 weeks

  Past 2 weeks, reported at Baseline assessment (pre-intervention)

Secondary Outcomes (1)

• Alcohol-related Consequences

  Past 2 weeks, reported at Baseline assessment (pre-intervention)

Study Arms (3)

Control

PLACEBO COMPARATOR

The control group spent 60 minutes on an online education session (Lilly for Better Health) 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. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.

Behavioral: Lilly for Better Health

Intervention Only

ACTIVE COMPARATOR

Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. This is an online intervention, free to institutions and individuals. 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 basic information such as sex, weight, and state of residence so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.

Behavioral: Alcohol 101 Plus (TM)

Intervention-plus-Booster

EXPERIMENTAL

Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. This is an online intervention, free to institutions and individuals. 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 basic information such as sex, weight, and state of residence so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. Importantly, their email 2 weeks later contained a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and reported harm reduction strategies.

Behavioral: Alcohol 101 Plus (TM); Behavioral: Booster

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.

Intervention Only; Intervention-plus-Booster

Booster BEHAVIORAL

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).

Also known as: Personalized Normative Feedback

Intervention-plus-Booster

Lilly for Better Health BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Under age of 18
• Over age of 24
• Not a college student
• Did not drink alcohol in the past 2 weeks

Sponsors & Collaborators

• Abby Braitman: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

MeSH Terms

Conditions

Alcohol Drinking in College

Interventions

Ethanol; Immunization, Secondary

Condition Hierarchy (Ancestors)

Alcohol Drinking; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Results Point of Contact

• Title: Dr. Abby Braitman
• Organization: Old Dominion University

abraitma@odu.edu

757-683-3708

Study Officials

• Abby L Braitman, Ph.D.

  Old Dominion University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The intervention is an online program, not an individual, 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 making is not necessary.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 15, 2018
• Study Start: January 29, 2013
• Primary Completion: September 10, 2014
• Study Completion: September 10, 2014
• Last Updated: December 1, 2020
• Results First Posted: August 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share