Clinical trial NCT04912492: Promoting Prosocial Bystander Behavior in Intoxicated Men: Evaluation of RealConsent2.0
Official title: Promoting Prosocial Bystander Behavior in Intoxicated Men: Evaluation of RealConsent2.0
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Intoxication
Sexual Violence
Helping Behavior
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: University of Nebraska Lincoln
First posted: 2021-06-03
Enrollment: 667
Sex: ALL
Minimum age (years): 21
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Bystander behavior
timeFrame: One-month post-intervention
measure: Self-Reported Bystander Behavior
timeFrame: Change from Baseline at 6-months
measure: Self-Reported Bystander Behavior
timeFrame: Change from Baseline at 12-months
Secondary outcomes:
measure: Barriers to Sexual Assault Bystander Intervention
timeFrame: Change from Baseline at 6-months
measure: Barriers to Sexual Assault Bystander Intervention
timeFrame: Change from Baseline at 12-months
measure: Outcome Expectancies for Intervening
timeFrame: Change from Baseline at 6-months
measure: Outcome Expectancies for Intervening
timeFrame: Change from Baseline at 12-months
measure: Bystander Efficacy Scale
timeFrame: Change from Baseline at 6-months
measure: Bystander Efficacy Scale
timeFrame: Change from Baseline at 12-months
measure: Bystander Attitude Scale
timeFrame: Change from Baseline at 6-months
measure: Bystander Attitude Scale
timeFrame: Change from Baseline at 12-months
measure: Sexual Violence Perpetration
timeFrame: Change from Baseline at 6-months
measure: Sexual Violence Perpetration
timeFrame: Change from Baseline at 12-months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
city: Lincoln
country: United States
facility: University of Nebraska-Lincoln
state: Nebraska
Study officials:
affiliation: Georgia State University
name: Laura Salazar, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: