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RealConsent2.0 for Preventing Sexual Violence

N/A
Recruiting
Led By Laura Salazar, Ph.D.
Research Sponsored by Georgia State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Identify as a man or transgender man, age 21-25
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 12-months
Awards & highlights

Study Summary

This trial is testing the effects of alcohol on young men's ability to intervene in situations that could lead to sexual violence, as well as testing a web-based program designed to teach bystanders how to intervene when they see potential sexual violence.

Who is the study for?
This trial is for men aged 21-25 who have consumed alcohol in the past year. It's not suitable for those in a long-term relationship, with certain psychiatric or neurological disorders, significant hearing problems, severe asthma, legal restrictions against drinking, infrequent alcohol consumption, serious head injuries, over 250 pounds weight or seeking treatment for substance use.Check my eligibility
What is being tested?
The study tests how alcohol affects young men's willingness to help prevent sexual violence and evaluates RealConsent2.0—a web-based program designed to promote helpful intervention by bystanders at risk situations when alcohol is involved—using VR scenarios and self-reports.See study design
What are the potential side effects?
Since this trial involves interventions like stress management programs and virtual reality experiences rather than medical treatments or drugs, traditional side effects are not applicable. However, participants may experience discomfort from VR usage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man or transgender man aged between 21 and 25.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 12-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 12-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bystander behavior
Self-Reported Bystander Behavior
Secondary outcome measures
Barriers to Sexual Assault Bystander Intervention
Bystander Attitude Scale
Bystander Efficacy Scale
+2 more

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: RealConsent2.0 with PlaceboExperimental Treatment2 Interventions
Men assigned to complete a revised web-based multi-media sexual violence and bystander intervention prevention program. Men assigned to a no-alcohol placebo control arm.
Group II: RealConsent2.0 with AlcoholExperimental Treatment2 Interventions
Men assigned to complete a revised web-based multi-media sexual violence and bystander intervention prevention program. Men assigned to alcohol intoxication arm (target BrAC=.08).
Group III: Stress Management with AlcoholActive Control2 Interventions
Men assigned to complete a web-based stress management program. Men assigned to alcohol intoxication arm (target BrAC=.08).
Group IV: Stress Management with PlaceboActive Control2 Interventions
Men assigned to complete a web-based stress management program. Men assigned to a no-alcohol placebo control arm.
Group V: RealConsent 1.0 with PlaceboActive Control2 Interventions
Men assigned to complete a web-based multi-media sexual violence and bystander intervention prevention program. Men assigned to a no-alcohol placebo control arm.
Group VI: RealConsent 1.0 with AlcoholActive Control2 Interventions
Men assigned to complete a web-based multi-media sexual violence and bystander intervention prevention program. Men assigned to alcohol intoxication arm (target breath alcohol concentration (BrAC=.08).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alcohol intoxication
2019
N/A
~360

Find a Location

Who is running the clinical trial?

Georgia State UniversityLead Sponsor
58 Previous Clinical Trials
24,864 Total Patients Enrolled
University of Nebraska LincolnOTHER
34 Previous Clinical Trials
9,311 Total Patients Enrolled
Laura Salazar, Ph.D.Principal InvestigatorGeorgia State University

Media Library

Alcohol intoxication Clinical Trial Eligibility Overview. Trial Name: NCT04912492 — N/A
Alcohol Intoxication Research Study Groups: Stress Management with Alcohol, Stress Management with Placebo, RealConsent2.0 with Alcohol, RealConsent 1.0 with Placebo, RealConsent2.0 with Placebo, RealConsent 1.0 with Alcohol
Alcohol Intoxication Clinical Trial 2023: Alcohol intoxication Highlights & Side Effects. Trial Name: NCT04912492 — N/A
Alcohol intoxication 2023 Treatment Timeline for Medical Study. Trial Name: NCT04912492 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being welcomed into this research initiative?

"Clinicaltrials.gov confirms that this clinical trial is actively seeking applicants, with its initial posting on March 1st 2022 and last update two weeks later on the 14th of the same month."

Answered by AI

What is the aggregate number of people in this experiment?

"Yes, the information found on clinicaltrials.gov demonstrates that this research is actively enrolling participants. It was originally posted on March 1st 2022 and has recently been updated on March 14th of the same year. The trial requires 840 patients from two different sites to be recruited."

Answered by AI

Is this investigation into treatments open to those aged 18 and older?

"This trial requires that applicants fall within the 21-25 age bracket. Meanwhile, 6 other trials are available for those beneath 18 and 5 additional studies exist to accommodate elderly patients above 65 years old."

Answered by AI

Who qualifies for enrollment in this research project?

"The recruitment phase of this trial requires that potential participants are between 21 and 25 years old, show altruistic tendencies, and total 840 people."

Answered by AI

What is the purpose of this clinical investigation?

"The primary goal of the clinical trial, which will be evaluated a month after the intervention is administered, pertains to Self-Reported Bystander Behavior. Secondary outcomes include Self-Efficacy to Intervene (as measured by an 18 question scale), Barriers to Sexual Assault Bystander Intervention (11 questions) and Outcome Expectancies for Intervening 17 items). Responses range from 1 -7 with higher scores reflecting greater confidence/positive expectancies."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
Georgia State University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Promoting Prosocial Bystander Behavior in Intoxicated Men: Evaluation of RealConsent2.0
Laura F Salazar 2022. "Promoting Prosocial Bystander Behavior in Intoxicated Men: Evaluation of RealConsent2.0". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04912492.
~221 spots leftby Aug 2025
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