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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03433794
Other study ID # 12-194
Secondary ID F32AA021310
Status Completed
Phase Phase 1
First received
Last updated
Start date January 29, 2013
Est. completion date September 10, 2014

Study information

Verified date November 2020
Source Old Dominion University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Alcohol use within the college student population 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). College student alcohol use is a significant problem, and reducing consumption and associated problems is a priority among researchers, educators, and mental health professionals who work with this population. 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 current project employs emailed boosters in a randomized, controlled trial in an effort to improve the efficacy an existing, popular, free online intervention, Alcohol 101 Plus (TM), 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 improved the efficacy or effect duration for interventions targeting smoking cessation, mammograms, dating violence, caregiver skills, binge eating, and many other behaviors. Boosters have been used successfully for alcohol use interventions among those seeking injury treatment in emergency medical settings. Despite these successes, 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 by improving on the design of boosters. Specifically, the present project improves boosters by providing easy access via email to minimize burden; providing succinct, personalized feedback; and providing reminders of protective behavioral strategies. To test the effectiveness of adding boosters, participants randomized to the alcohol-intervention-plus-boosters condition receive emails 2 weeks after the intervention with tailored feedback based upon their reported alcohol consumption. Participants are initially assessed biweekly, then every three months 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 after the significant differences between the intervention-only and control groups erode). Aim 3: Examine protective behavioral strategies highlighted by the booster as mediating behavioral mechanisms of change. 3A: Determine if increased exposure to protective strategies through an emailed booster results in increased use of these strategies. 3B: Determine if those who increase their use of protective behavioral strategies decrease their alcohol consumption and related problems they experience. 3C: Assess the combination of these two effects (i.e., the indirect effect). The proposed study will be a critical first step to adapt existing online interventions. The findings from this study will be used to identify implications for modifying the protocol or booster.


Recruitment information / eligibility

Status Completed
Enrollment 537
Est. completion date September 10, 2014
Est. primary completion date September 10, 2014
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:
Alcohol 101 Plus (TM)
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.
Booster
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 Health
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.

Locations

Country Name City State
n/a

Sponsors (2)

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 2 weeks, reported at Baseline assessment (pre-intervention)
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