MedPath

Alcohol and Violence Prevention for College Students

Not Applicable
Completed
Conditions
Alcohol Drinking
Sexual Assault
Interventions
Behavioral: Positive Change (+Change)
Registration Number
NCT04089137
Lead Sponsor
Georgia State University
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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
165
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Positive Change (+Change)Positive Change (+Change)This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. This intervention targets alcohol use, sexual assault victimization risk, sexual assault perpetration, and bystander intervention and is tailored by gender and sexual orientation.
Primary Outcome Measures
NameTimeMethod
Feasibility of Enrollment and Recruitmentwithin 2 year recruitment period

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

Feasibility of Retentionwithin 3 months of baseline participation

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Arizona State University

🇺🇸

Tempe, Arizona, United States

Georgia State University

🇺🇸

Atlanta, Georgia, United States

© Copyright 2025. All Rights Reserved by MedPath