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

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcohol Intoxication, Sexual Violence, Helping Behavior

Intervention / Treatment
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* Behavioral: RealConsent1.0
* Behavioral: RealConsent2.0
* Behavioral: Stress Management
* Behavioral: Alcohol intoxication
* Behavioral: No-Alcohol Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RealConsent 1.0 with Alcohol<br>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). | Behavioral: RealConsent1.0<br>* A web-based multi-media sexual violence prevention program that enhances knowledge and skills for effective consent for sex and for prosocial bystander behaviors.<br>Behavioral: Alcohol intoxication<br>* Men assigned to moderate alcohol dose condition (target BrAC .08%) with NIAAA approved alcohol administration procedures<br>|
| Active Comparator: RealConsent 1.0 with Placebo<br>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. | Behavioral: RealConsent1.0<br>* A web-based multi-media sexual violence prevention program that enhances knowledge and skills for effective consent for sex and for prosocial bystander behaviors.<br>Behavioral: No-Alcohol Placebo<br>* Men assigned to an no-alcohol placebo control condition.<br>|
| Experimental: RealConsent2.0 with Alcohol<br>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). | Behavioral: RealConsent2.0<br>* A 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.<br>Behavioral: Alcohol intoxication<br>* Men assigned to moderate alcohol dose condition (target BrAC .08%) with NIAAA approved alcohol administration procedures<br>|
| Experimental: RealConsent2.0 with Placebo<br>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. | Behavioral: RealConsent2.0<br>* A 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.<br>Behavioral: No-Alcohol Placebo<br>* Men assigned to an no-alcohol placebo control condition.<br>|
| Active Comparator: Stress Management with Alcohol<br>Men assigned to complete a web-based stress management program. Men assigned to alcohol intoxication arm (target BrAC=.08). | Behavioral: Stress Management<br>* A 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.<br>Behavioral: Alcohol intoxication<br>* Men assigned to moderate alcohol dose condition (target BrAC .08%) with NIAAA approved alcohol administration procedures<br>|
| Active Comparator: Stress Management with Placebo<br>Men assigned to complete a web-based stress management program. Men assigned to a no-alcohol placebo control arm. | Behavioral: Stress Management<br>* A 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.<br>Behavioral: No-Alcohol Placebo<br>* Men assigned to an no-alcohol placebo control condition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bystander behavior | Bystander behavior will be assessed by a virtual reality (VR) environment titled, Bystanders in Sexual Assault Virtual Environments (B-SAVE). Participants experience a virtual house party and are exposed to 5 situations in which they can either intervene or not. Participants are prompted at two points (with a flashing microphone icon) to verbalize their response in that situation - thus providing 10 opportunities to intervene in sexual risk situations. Verbal responses to each situation are recorded and coded to assess for bystander behavior. | One-month post-intervention | 
| Self-Reported Bystander Behavior | The 44-item Bystander Behavior Scale involves a description of a scenario in which participants are asked if they were exposed to the scenario, did they engage in the behavior (yes/no), if they had been drinking alcohol (yes/no) and if alcohol was present (yes/ no). Response options range from 0 (no) to 1 (yes) for each of the items. A total score for bystander behavior is calculated ranging from 0 (minimum) to 30 (maximum), with higher scores indicating greater bystander behavior in the last three-months. alcohol (yes/no) and if alcohol was present (yes/ no). | Change from Baseline at 6-months | 
| Self-Reported Bystander Behavior | The 44-item Bystander Behavior Scale involves a description of a scenario in which participants are asked if they were exposed to the scenario, did they engage in the behavior (yes/no), if they had been drinking alcohol (yes/no) and if alcohol was present (yes/ no). Response options range from 0 (no) to 1 (yes) for each of the items. A total score for bystander behavior is calculated ranging from 0 (minimum) to 30 (maximum), with higher scores indicating greater bystander behavior in the last three-months. alcohol (yes/no) and if alcohol was present (yes/ no). | Change from Baseline at 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barriers to Sexual Assault Bystander Intervention | The 16-item Barriers to Sexual Assault Bystander Intervention Scale assess barriers to intervention. Mean scores range from 1 (minimum) to 7 (maximum), with higher scores indicate more barriers to intervention. | Change from Baseline at 6-months | 
| Barriers to Sexual Assault Bystander Intervention | The 16-item Barriers to Sexual Assault Bystander Intervention Scale assess barriers to intervention. Mean scores range from 1 (minimum) to 7 (maximum), with higher scores indicate more barriers to intervention. | Change from Baseline at 12-months | 
| Outcome Expectancies for Intervening | The 17-item Outcome Expectancies for Intervening Scale assess outcome expectancies for intervening. Mean scores ranging from 1 (minimum) to 7 (maximum). Higher scores indicate greater positive expectancies for intervening. | Change from Baseline at 6-months | 
| Outcome Expectancies for Intervening | The 17-item Outcome Expectancies for Intervening Scale assess outcome expectancies for intervening. Mean scores ranging from 1 (minimum) to 7 (maximum). Higher scores indicate greater positive expectancies for intervening. | Change from Baseline at 12-months | 
| Bystander Efficacy Scale | 14-item Bystander Efficacy Scale assess bystander confidence to intervene, with response options ranging from 0 % (minimum) to 100% (maximum). A score is created by subtracting the mean of these 14 items from 100 to create a scale of perceived efficacy. Higher scores indicate greater bystander efficacy. | Change from Baseline at 6-months | 
| Bystander Efficacy Scale | 14-item Bystander Efficacy Scale assess bystander confidence to intervene, with response options ranging from 0 % (minimum) to 100% (maximum). A score is created by subtracting the mean of these 14 items from 100 to create a scale of perceived efficacy. Higher scores indicate greater bystander efficacy. | Change from Baseline at 12-months | 
| Bystander Attitude Scale | The 12-item Bystander Attitudes Scale assesses bystander intentions. Response options ranging from 1 (minimum) to 5 (maximum), with greater mean scores indicate higher intentions of intervening. | Change from Baseline at 6-months | 
| Bystander Attitude Scale | The 12-item Bystander Attitudes Scale assesses bystander intentions. Response options ranging from 1 (minimum) to 5 (maximum), with greater mean scores indicate higher intentions of intervening. | Change from Baseline at 12-months | 
| Sexual Violence Perpetration | The 35 items Sexual Experience Survey will be used to assess sexual violence perpetration. Participants indicate the number of times that they did each act ranging from 0 (never) to 3 (3 or more times), with total scores ranging from 0 to 105 with greater scores indicating more perpetration. The mutually exclusive scoring system will be used. The goal is to count people only once according to the most severe act perpetrated. | Change from Baseline at 6-months | 
| Sexual Violence Perpetration | The 35 items Sexual Experience Survey will be used to assess sexual violence perpetration. Participants indicate the number of times that they did each act ranging from 0 (never) to 3 (3 or more times), with total scores ranging from 0 to 105 with greater scores indicating more perpetration. The mutually exclusive scoring system will be used. The goal is to count people only once according to the most severe act perpetrated. | Change from Baseline at 12-months |