Alcohol and Violence Prevention for College Students

NCT04089137 | Completed Results DMC

• 1 other identifier: H20066
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 2

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.

Conditions

Alcohol Drinking; Sexual Assault

Outcome Measures

Primary Outcomes (2)

• 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

• Feasibility of Retention

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

  within 3 months of baseline participation

Study Arms (2)

Control

NO INTERVENTION

This is an assessment only control condition.

Positive Change (+Change)

EXPERIMENTAL

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.

Behavioral: Positive Change (+Change)

Interventions

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.

Positive Change (+Change)

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Georgia State University: lead
• Arizona State University: collaborator
• Medical University of South Carolina: collaborator
• Rhode Island Hospital: collaborator

Study Sites (2)

Arizona State University

Tempe, Arizona, 85281, United States

Location

Georgia State University

Atlanta, Georgia, 30303, United States

Location

Related Publications (1)

• Gilmore AK, Leone RM, Oesterle DW, Davis KC, Orchowski LM, Ramakrishnan V, Kaysen D. 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). JMIR Form Res. 2022 Jul 22;6(7):e23823. doi: 10.2196/23823.

  PMID: 35867393 DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Results Point of Contact

• Title: Dr. Amanda Gilmore
• Organization: Georgia State University

agilmore12@gsu.edu

(404) 413-2000

Study Officials

• Amanda K Gilmore, PhD

  Georgia State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Mark Chaffin Center for Healthy Development and Department of Health Policy and Behavioral Sciences, School of Public Health

Model Details: Participants will receive an online intervention targeting alcohol misuse and sexual assault among college students. This will include a personalized normative feedback approach. In the first part of the study, there will be an open pilot (1 arm) and in the second part of the study there will be a control condition (2 arms - intervention + control)

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: September 13, 2019
• Study Start: March 15, 2018
• Primary Completion: September 8, 2021
• Study Completion: September 8, 2021
• Last Updated: February 5, 2025
• Results First Posted: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)