Clinical Trials Directory

Trials / Completed

CompletedNCT04912492

Promoting Prosocial Bystander Behavior in Intoxicated Men: Evaluation of RealConsent2.0

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
667 (actual)
Sponsor
Georgia State University · Academic / Other
Sex
All
Age
21 Years – 25 Years
Healthy volunteers
Accepted

Summary

Sexual violence (SV) is a significant public health problem particularly among 18-24 year old populations. A major risk factor for SV is alcohol use, which via its negative impact on cognitive abilities and decision-making acts as a barrier to intervening in situations at-risk for a SV. This study has two main goals: (1) to determine the effects of proximal alcohol use on young (age 21 to 25) men's prosocial bystander behavior in situations considered at-risk for SV, and (2) to determine the efficacy of an evidence-based, web-based program called RealConsent, which has been augmented to include alcohol-specific content within the context of bystander SV ("RealConsent2.0"), on men's prosocial bystander behavior. The primary study endpoint is prosocial bystander behavior and will be assessed via two modes: (1) a virtual reality (VR) environment ("B-SAVE") and (2) a validated self-report measure of bystander behavior that has been modified to include assessment of proximal alcohol use and presence of alcohol within the context.

Conditions

Interventions

TypeNameDescription
BEHAVIORALRealConsent1.0A web-based multi-media sexual violence prevention program that enhances knowledge and skills for effective consent for sex and for prosocial bystander behaviors.
BEHAVIORALRealConsent2.0A revised and updated web-based multi-media sexual violence prevention program that enhances knowledge and skills for effective consent for sex and for prosocial bystander behaviors, but also integrates new program segments into RealConsent 1.0 specific to how alcohol use can inhibit SV intervention at multiple steps of the decision-making process.
BEHAVIORALStress ManagementA web-based multimedia program designed to help individuals recognize the symptoms and sources of stress and provide them with a wide variety of powerful tools for managing stress.
BEHAVIORALAlcohol intoxicationMen assigned to moderate alcohol dose condition (target BrAC .08%) with NIAAA approved alcohol administration procedures
BEHAVIORALNo-Alcohol PlaceboMen assigned to an no-alcohol placebo control condition.

Timeline

Start date
2022-03-01
Primary completion
2025-07-16
Completion
2025-07-16
First posted
2021-06-03
Last updated
2026-02-04

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT04912492. Inclusion in this directory is not an endorsement.