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.
