Alcohol and Violence Prevention for College Students

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.

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Key information

Conditions

Alcohol Drinking Behavior Drinking Behavior Sexual Assault

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University, Tempe, Arizona, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive Change (+Change)

Behavioral

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 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

Sponsors and collaborators

Lead sponsor

Georgia State University

Other

Collaborators

Arizona State University
Medical University of South Carolina
Rhode Island Hospital

Registry information

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Sep 13, 2019
Registry last updated: Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed