NCT04089137

Alcohol and Violence Prevention for College Students

Completed NA Results posted Last updated 5 February 2025

What this trial tests

NA trial testing Positive Change (+Change) in Alcohol Drinking in 165 participants. Completed in 8 September 2021.

Timeline

15 March 2018

Primary endpoint
8 September 2021

8 September 2021

Quick facts

Lead sponsor	Georgia State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	165
Start date	15 March 2018
Primary completion	8 September 2021
Estimated completion	8 September 2021
Sites	2 locations across United States

Drugs / interventions tested

• Positive Change (+Change)

Conditions studied

• Alcohol Drinking — all drugs for Alcohol Drinking →
• Sexual Assault — all drugs for Sexual Assault →

Sponsor

Georgia State University

Who can join

Adults 18 to 25, any sex, with Alcohol Drinking or Sexual Assault. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility of Enrollment and Recruitment Primary · within 2 year recruitment period

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

Group	Value	95% CI
Control	82
Positive Change (+Change)	83

Feasibility of Retention Primary · within 3 months of baseline participation

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

Group	Value	95% CI
Control	71
Positive Change (+Change)	70

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Web-Based Alcohol and Sexual Assault Prevention Program With Tailored Content Based on Gender and Sexual Orientation: Preliminary Outcomes and Usability Study of Positive Change (+Change).
   Gilmore AK, Leone RM, Oesterle DW, Davis KC, et al · · 2022 · cited 25× · PMID 35867393 · DOI 10.2196/23823
2. Preliminary Efficacy of Positive Change(+Change): A Pilot Randomized Controlled Trial of an Integrated Alcohol and Sexual Assault Prevention Program Tailored by Gender and Sexual Orientation.
   Gilmore AK, Nielsen KE, Salamanca NK, Oesterle DW, et al · · 2025 · cited 4× · PMID 39329408 · DOI 10.1177/08862605241275994