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RealConsent2.0 for Preventing Sexual Violence

N/A

Waitlist Available

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

Must not have

Any medical or psychiatric condition, as well as current use of a medication, that would contraindicate alcohol administration

Physical disability: any physical disability that would prevent an individual from participating in the virtual reality task (self-report and determined)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at 12-months

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.

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.

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

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I am a man or transgender man aged between 21 and 25.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have any health conditions or take medications that make it unsafe for me to consume alcohol.

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I do not have a physical disability that stops me from using virtual reality.

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I have been diagnosed with a neurological disorder.

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I weigh more than 250 pounds.

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I am experiencing significant psychological distress.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at 6-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline at 6-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 6-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bystander behavior

Self-Reported Bystander Behavior

Secondary study objectives

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

0 / 6Eligibility criteria met