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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06365125
Other study ID # 7313E
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 22, 2024
Est. completion date May 1, 2025

Study information

Verified date April 2024
Source Boston University Charles River Campus
Contact Bonnie Rowland, MA
Phone 617-906-6645
Email browland@bu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 129
Est. completion date May 1, 2025
Est. primary completion date May 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Intervention

Behavioral:
eCHECKUP TO GO
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.
Text messaging boosters
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

Locations

Country Name City State
United States Boston University Charles River Campus Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston University Charles River Campus

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Heavy drinking episodes 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
Primary Alcohol-related negative consequences Number of alcohol-related negative consequences experienced in the past month assessed at baseline and 3-month follow-up
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