Skip to main content
Clinical Trials/NCT04089137
NCT04089137
Completed
Not Applicable

Alcohol and Violence Prevention for College Students

Georgia State University2 sites in 1 country165 target enrollmentMarch 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alcohol Drinking
Sponsor
Georgia State University
Enrollment
165
Locations
2
Primary Endpoint
Feasibility of Enrollment and Recruitment
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

Specific aims are as follows: Aim 1 (Stage IA): Modify Alcohol and Sexual Assault Prevention (ASAP) content to an eHealth format to include personalized content for each risk group (1. cisgender heterosexual men; 2. cisgender heterosexual women; and 3. sexual and gender minorities). Aim 1a: Assess normative behaviors (n = 500) regarding alcohol use and SA for feedback. Aim 1b: Adapt and assess initial acceptability of a workbook version of the intervention content among key stakeholders (college administrators and students from each risk group \[n=5 from each group\]). Aim 2 (Stage IB): Open Pilot Trial. Obtain usability of ASAP among 30 students who engage in HED (10 from each risk group) in an open pilot trial. Aim 3 (Stage IB): A pilot to assess effect size and variability for planning a randomized trial in the future. Randomize students who engage in HED to ASAP or control condition to observe preliminary effect sizes and estimate the variability using a 3-month follow-up. Sample size was determined to estimate the variability within a reasonable margin of error. This calculation also accounted the low base rates of SA and 20% attrition. This led to a sample size of 162 students (n=54 from each risk group).

Registry
clinicaltrials.gov
Start Date
March 15, 2018
End Date
September 8, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amanda Gilmore

Assistant Professor, Mark Chaffin Center for Healthy Development and Department of Health Policy and Behavioral Sciences, School of Public Health

Georgia State University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Feasibility of Enrollment and Recruitment

Time Frame: within 2 year recruitment period

Feasibility of enrollment recruitment was assessed by the number of anticipated participants enrolled in the study

Feasibility of Retention

Time Frame: within 3 months of baseline participation

Feasibility of retention was assessed by the number of participants retained in the study

Study Sites (2)

Loading locations...

Similar Trials