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

Sponsor
Georgia State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04912492
Collaborator
University of Nebraska Lincoln (Other)
840
2
6
30
420
14

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: RealConsent1.0
  • Behavioral: RealConsent2.0
  • Behavioral: Stress Management
  • Behavioral: Alcohol intoxication
  • Behavioral: No-Alcohol Placebo
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
840 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Promoting Prosocial Bystander Behavior in Intoxicated Men: Evaluation of RealConsent2.0
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: RealConsent 1.0 with Alcohol

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
A web-based multi-media sexual violence prevention program that enhances knowledge and skills for effective consent for sex and for prosocial bystander behaviors.

Behavioral: Alcohol intoxication
Men assigned to moderate alcohol dose condition (target BrAC .08%) with NIAAA approved alcohol administration procedures

Active Comparator: RealConsent 1.0 with Placebo

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
A web-based multi-media sexual violence prevention program that enhances knowledge and skills for effective consent for sex and for prosocial bystander behaviors.

Behavioral: No-Alcohol Placebo
Men assigned to an no-alcohol placebo control condition.

Experimental: RealConsent2.0 with Alcohol

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
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.

Behavioral: Alcohol intoxication
Men assigned to moderate alcohol dose condition (target BrAC .08%) with NIAAA approved alcohol administration procedures

Experimental: RealConsent2.0 with Placebo

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
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.

Behavioral: No-Alcohol Placebo
Men assigned to an no-alcohol placebo control condition.

Active Comparator: Stress Management with Alcohol

Men assigned to complete a web-based stress management program. Men assigned to alcohol intoxication arm (target BrAC=.08).

Behavioral: Stress Management
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.

Behavioral: Alcohol intoxication
Men assigned to moderate alcohol dose condition (target BrAC .08%) with NIAAA approved alcohol administration procedures

Active Comparator: Stress Management with Placebo

Men assigned to complete a web-based stress management program. Men assigned to a no-alcohol placebo control arm.

Behavioral: Stress Management
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.

Behavioral: No-Alcohol Placebo
Men assigned to an no-alcohol placebo control condition.

Outcome Measures

Primary Outcome Measures

  1. Bystander behavior [One-month post-intervention]

    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 10 situations in which they can either intervene or not. Verbal responses to each situation are recorded and coded to assess for bystander behavior.

  2. Self-Reported Bystander Behavior [Change from Baseline at 6-months]

    The 30-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).

  3. Self-Reported Bystander Behavior [Change from Baseline at 12-months]

    The 30-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).

Secondary Outcome Measures

  1. Barriers to Sexual Assault Bystander Intervention [Change from Baseline at 6-months]

    The 11-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.

  2. Barriers to Sexual Assault Bystander Intervention [Change from Baseline at 12-months]

    The 11-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.

  3. Outcome Expectancies for Intervening [Change from Baseline at 6-months]

    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.

  4. Outcome Expectancies for Intervening [Change from Baseline at 12-months]

    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.

  5. Bystander Efficacy Scale [Change from Baseline at 6-months]

    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.

  6. Bystander Efficacy Scale [Change from Baseline at 12-months]

    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.

  7. Bystander Attitude Scale [Change from Baseline at 6-months]

    The 11-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.

  8. Bystander Attitude Scale [Change from Baseline at 12-months]

    The 11-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.

  9. Sexual Violence Perpetration [Change from Baseline at 6-months]

    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.

  10. Sexual Violence Perpetration [Change from Baseline at 12-months]

    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.

  11. Comfort with Intervening [Change from Baseline at 6-months]

    The 8-item subscale of the Reactions to Offensive Language & Behavior Scale will be used to assess men's comfort with intervening. Mean scores range from 1 (Not at all comfortable) to 7 (Extremely comfortable), with greater scores indicate greater comfort with intervening.

  12. Comfort with Intervening [Change from Baseline at 12-months]

    The 8-item subscale of the Reactions to Offensive Language & Behavior Scale will be used to assess men's comfort with intervening. Mean scores range from 1 (Not at all comfortable) to 7 (Extremely comfortable), with greater scores indicate greater comfort with intervening.

  13. Self-Efficacy to Intervene [Change from Baseline at 6-months]

    This 18-item scale assesses men's confidence with intervening. Response options ranging from 1 (Not at all confident) to 7 (Extremely confident), with greater mean scores indicating greater confidence with intervening.

  14. Self-Efficacy to Intervene [Change from Baseline at 12-months]

    This 18-item scale assesses men's confidence with intervening. Response options ranging from 1 (Not at all confident) to 7 (Extremely confident), with greater mean scores indicating greater confidence with intervening.

  15. Intervention Social Norms [Change from Baseline at 6-months]

    This 7-item subscale of the Reactions to Offensive Language & Behavior Scale assesses perceived social norms related to intervening. Response options ranging from 1 (Never) to 7 (Always), with greater mean scores indicating greater perceptions of other men's intervention likelihood.

  16. Intervention Social Norms [Change from Baseline at 12-months]

    This 7-item subscale of the Reactions to Offensive Language & Behavior Scale assesses perceived social norms related to intervening. Response options ranging from 1 (Never) to 7 (Always), with greater mean scores indicating greater perceptions of other men's intervention likelihood.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • being male, age (21-25)

  • consuming alcohol during the past year

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Georgia State University Atlanta Georgia United States 30303
2 University of Nebraska-Lincoln Lincoln Nebraska United States 68588

Sponsors and Collaborators

  • Georgia State University
  • University of Nebraska Lincoln

Investigators

  • Principal Investigator: Laura Salazar, Ph.D., Georgia State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Laura F Salazar, Multiple Principal Investigator, Georgia State University
ClinicalTrials.gov Identifier:
NCT04912492
Other Study ID Numbers:
  • R01AA027517
First Posted:
Jun 3, 2021
Last Update Posted:
Mar 15, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2022