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

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Georgia State University

Status

Completed

Conditions

Sexual Violence
Helping Behavior
Alcohol Intoxication

Treatments

Behavioral: Alcohol intoxication
Behavioral: No-Alcohol Placebo
Behavioral: RealConsent1.0
Behavioral: Stress Management
Behavioral: RealConsent2.0

Study type

Interventional

Funder types

Other

Identifiers

NCT04912492
R01AA027517

Details and patient eligibility

About

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.

Enrollment

667 patients

Sex

All

Ages

21 to 25 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • identify as a man or transgender man, age (21-25)
  • consume weight-based amount of alcohol at least three times during the past year

Exclusion criteria

  • weight over 250 pounds
  • current treatment-seeking for an alcohol use disorder
  • any medical or psychiatric condition, as well as current use of a medication, that would contraindicate alcohol administration.
  • in a relationship over 6 months
  • married/living together
  • Neurological Disorder: diagnosis of a neurological disorder
  • Psychiatric Disorder: past or current diagnosis of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, or any other psychotic disorder
  • Treatment for Alcohol or Drug Use: currently being treated for alcohol, or drug problems; currently interested in seeking treatment for drinking or drug use
  • Physical disability: anh physical disability that would prevent an individual from participating in the virtual reality task (self-report and determined)
  • Significant Hearing Problems: significant hearing problems that would prevent an individual from hearing and responding to the virtual reality task (self-reported and determined)
  • Cardiac Pacemaker
  • Asthma: emergency room visit related to asthma in the past year; use of inhaler more frequently when drinking alcohol; use of oral steroid treatments for asthma in the past year;
  • Legal: any legal restrictions against drinking (e.g., as a condition of probation or parole)
  • Alcohol Abstinence: individuals who consume alcohol monthly or less; individuals who have consumed the amount of alcohol they would be expected to drink during the lab session (determined by their weight) less than 3 times in the last year
  • Head Injury: any past serious head injuries (as indicated by HELPS Brain Injury Screening Tool)
  • Acute Psychiatric Symptomatology: elevated psychological distress as indicated by a score greater than 65 on the Brief Symptom Inventory

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

667 participants in 6 patient groups

RealConsent 1.0 with Alcohol
Active Comparator group
Description:
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:
Behavioral: RealConsent1.0
Behavioral: Alcohol intoxication
RealConsent 1.0 with Placebo
Active Comparator group
Description:
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.
Treatment:
Behavioral: RealConsent1.0
Behavioral: No-Alcohol Placebo
RealConsent2.0 with Alcohol
Experimental group
Description:
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).
Treatment:
Behavioral: RealConsent2.0
Behavioral: Alcohol intoxication
RealConsent2.0 with Placebo
Experimental group
Description:
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.
Treatment:
Behavioral: RealConsent2.0
Behavioral: No-Alcohol Placebo
Stress Management with Alcohol
Active Comparator group
Description:
Men assigned to complete a web-based stress management program. Men assigned to alcohol intoxication arm (target BrAC=.08).
Treatment:
Behavioral: Stress Management
Behavioral: Alcohol intoxication
Stress Management with Placebo
Active Comparator group
Description:
Men assigned to complete a web-based stress management program. Men assigned to a no-alcohol placebo control arm.
Treatment:
Behavioral: Stress Management
Behavioral: No-Alcohol Placebo

Trial contacts and locations

2

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Central trial contact

Laura Salazar, Ph.D.; Dominic Parrott, Ph.D.

Data sourced from clinicaltrials.gov

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