Alcohol Drinking Clinical Trial
Official title:
Alcohol and Violence Prevention for College Students
NCT number | NCT04089137 |
Other study ID # | H20066 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 15, 2018 |
Est. completion date | September 8, 2021 |
Verified date | November 2021 |
Source | Georgia State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Heavy episodic drinking and sexual assault (SA) are problematic on college campuses. This project will adapt already developed interventions targeting alcohol use and SA to a mHealth format and involve content that incorporates federal guidelines and CDC recommendations to integrate both bystander intervention and risk reduction content with new innovative personalized content for each risk group (cis-gender heterosexual men, cis-gender heterosexual women, and sexual/gender minorities). Alpha testing with key stakeholders, an open pilot trial, and a randomized pilot trial will be conducted to establish acceptability and to estimate sample size for a larger randomized controlled trial.
Status | Completed |
Enrollment | 165 |
Est. completion date | September 8, 2021 |
Est. primary completion date | September 8, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 25 Years |
Eligibility | Inclusion Criteria: - 18-25 years old - Current student at university of study - Valid email address at university of study - Endorse engaging in heavy episodic drinking at least once in the past month on the screening survey Exclusion Criteria: - There are no exclusion criteria other than not meeting inclusion criteria |
Country | Name | City | State |
---|---|---|---|
United States | Georgia State University | Atlanta | Georgia |
United States | Arizona State University | Tempe | Arizona |
Lead Sponsor | Collaborator |
---|---|
Georgia State University | Arizona State University, Medical University of South Carolina, Rhode Island Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of enrollment and recruitment | Feasibility of enrollment recruitment was assessed by the number of anticipated participants enrolled in the study | within 2 year recruitment period | |
Primary | Feasibility of retention | Feasibility of retention was assessed by the number of participants retained in the study | within 3 months of baseline participation |
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