- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06365125
College Student Daily Life and Alcohol Use Study
January 20, 2025 updated by: Boston University Charles River Campus
Enhancing Computer-delivered Approaches to Reduce Heavy/Hazardous Alcohol Use Among College Students
Heavy alcohol use among college students is associated with a range of negative consequences.
However, college students rarely seek resources or treatment to change their alcohol use.
Brief alcohol interventions (BAIs) have been developed as an alternative method to address heavy alcohol use among college students and show promise in reducing hazardous alcohol use in college students.
Despite the established efficacy of BAIs, effects are often small and short-lived, and additional research is needed to investigate how BAIs can become more efficacious and endure for longer periods of time, particularly for computer-delivered interventions to improve accessibility and scalability of these interventions to a wider range of college students.
Boosters or adjunctive components to BAIs have been suggested as a method to enhance the magnitude and duration of intervention effects.
However, there remains a need to identify and test booster approaches that are both appealing and engaging to college students and effective in reducing heavy/hazardous alcohol use above and beyond the magnitude and duration seen by BAIs alone.
The purpose of the study is to develop and test a novel, text-messaging booster as an adjunct to a current, evidence-based brief intervention, eCHECKUP TO GO, aimed at reducing college student heavy/hazardous alcohol use.
Participants will complete baseline measures and will then be randomized to 1 of 3 conditions, stratified by sex at birth: 1) assessment only, 2) BAI only, and 3) Enhanced Intervention (BAI + four weeks of text messaging boosters).
It is hypothesized that those randomized to the enhanced intervention condition will show a greater reduction in heavy/hazardous alcohol use at 3-month follow-up compared to the BAI and assessment only groups.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
129
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Boston University Charles River Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 1) Ages 18-30; 2) report at least 2 heavy drinking episodes in the past month; 3) be enrolled in an undergraduate degree program; 4) own a smartphone with capability to run smartphone application
Exclusion Criteria:
- 1) current or past-year treatment (counseling or medication) for alcohol or drug use, 2) history of delirium tremens and/or seizures as a result of alcohol withdrawal, and 3) a lifetime diagnosis of either bipolar disorder or schizophrenia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Assessment Only
Assessment only condition, no intervention material delivered to this group
|
|
|
Active Comparator: Intervention (BAI) Only
Only the brief alcohol intervention, eCHECKUP TO GO, is administered to this group
|
Single session, web-based intervention for college students aimed at increasing awareness of consequences related to heavy alcohol use and increase motivation to modify one's alcohol use.
Other Names:
|
|
Experimental: Enhanced Intervention
Brief alcohol intervention, eCHECKUP TO GO, + 4 weeks of text messaging boosters (Monday, Thursday-Sunday)
|
Single session, web-based intervention for college students aimed at increasing awareness of consequences related to heavy alcohol use and increase motivation to modify one's alcohol use.
Other Names:
Text messages sent a few times per week following completion of eCHECKUP TO GO to reinforce concepts and assist with goal setting and goal attainment in everyday life
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heavy drinking episodes
Time Frame: assessed at baseline and 3-month follow-up
|
Number of past-month heavy drinking episodes (consuming 4+ drinks for females and 5+ drinks for males in one occasion)
|
assessed at baseline and 3-month follow-up
|
|
Alcohol-related negative consequences
Time Frame: assessed at baseline and 3-month follow-up
|
Number of alcohol-related negative consequences experienced in the past month
|
assessed at baseline and 3-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bonnie Rowland, MA, Boston University Charles River Campus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 22, 2024
Primary Completion (Estimated)
May 1, 2025
Study Completion (Estimated)
May 1, 2025
Study Registration Dates
First Submitted
April 10, 2024
First Submitted That Met QC Criteria
April 10, 2024
First Posted (Actual)
April 15, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 20, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7313E
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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