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

Primary Purpose

Alcohol Intoxication, Sexual Violence, Helping Behavior

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RealConsent1.0
RealConsent2.0
Stress Management
Alcohol intoxication
No-Alcohol Placebo
Sponsored by
Georgia State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Intoxication

Eligibility Criteria

21 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Georgia State UniversityRecruiting
  • University of Nebraska-LincolnRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

RealConsent 1.0 with Alcohol

RealConsent 1.0 with Placebo

RealConsent2.0 with Alcohol

RealConsent2.0 with Placebo

Stress Management with Alcohol

Stress Management with Placebo

Arm 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).

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.

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).

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.

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

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

Outcomes

Primary Outcome Measures

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.
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).
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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 5, 2021
Last Updated
August 28, 2023
Sponsor
Georgia State University
Collaborators
University of Nebraska Lincoln
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1. Study Identification

Unique Protocol Identification Number
NCT04912492
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgia State University
Collaborators
University of Nebraska Lincoln

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Intoxication, Sexual Violence, Helping Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
605 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RealConsent 1.0 with Alcohol
Arm Type
Active Comparator
Arm 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).
Arm Title
RealConsent 1.0 with Placebo
Arm Type
Active Comparator
Arm 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.
Arm Title
RealConsent2.0 with Alcohol
Arm Type
Experimental
Arm 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).
Arm Title
RealConsent2.0 with Placebo
Arm Type
Experimental
Arm 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.
Arm Title
Stress Management with Alcohol
Arm Type
Active Comparator
Arm Description
Men assigned to complete a web-based stress management program. Men assigned to alcohol intoxication arm (target BrAC=.08).
Arm Title
Stress Management with Placebo
Arm Type
Active Comparator
Arm Description
Men assigned to complete a web-based stress management program. Men assigned to a no-alcohol placebo control arm.
Intervention Type
Behavioral
Intervention Name(s)
RealConsent1.0
Intervention Description
A web-based multi-media sexual violence prevention program that enhances knowledge and skills for effective consent for sex and for prosocial bystander behaviors.
Intervention Type
Behavioral
Intervention Name(s)
RealConsent2.0
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Alcohol intoxication
Intervention Description
Men assigned to moderate alcohol dose condition (target BrAC .08%) with NIAAA approved alcohol administration procedures
Intervention Type
Behavioral
Intervention Name(s)
No-Alcohol Placebo
Intervention Description
Men assigned to an no-alcohol placebo control condition.
Primary Outcome Measure Information:
Title
Bystander behavior
Description
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.
Time Frame
One-month post-intervention
Title
Self-Reported Bystander Behavior
Description
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).
Time Frame
Change from Baseline at 6-months
Title
Self-Reported Bystander Behavior
Description
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).
Time Frame
Change from Baseline at 12-months
Secondary Outcome Measure Information:
Title
Barriers to Sexual Assault Bystander Intervention
Description
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.
Time Frame
Change from Baseline at 6-months
Title
Barriers to Sexual Assault Bystander Intervention
Description
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.
Time Frame
Change from Baseline at 12-months
Title
Outcome Expectancies for Intervening
Description
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.
Time Frame
Change from Baseline at 6-months
Title
Outcome Expectancies for Intervening
Description
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.
Time Frame
Change from Baseline at 12-months
Title
Bystander Efficacy Scale
Description
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.
Time Frame
Change from Baseline at 6-months
Title
Bystander Efficacy Scale
Description
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.
Time Frame
Change from Baseline at 12-months
Title
Bystander Attitude Scale
Description
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.
Time Frame
Change from Baseline at 6-months
Title
Bystander Attitude Scale
Description
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.
Time Frame
Change from Baseline at 12-months
Title
Sexual Violence Perpetration
Description
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.
Time Frame
Change from Baseline at 6-months
Title
Sexual Violence Perpetration
Description
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.
Time Frame
Change from Baseline at 12-months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Must identify as a man or transgender man
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Salazar, Ph.D.
Phone
404-413-1396
Email
lsalazar1@gsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dominic Parrott, Ph.D.
Phone
404-413-6287
Email
parrott@gsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Salazar, Ph.D.
Organizational Affiliation
Georgia State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia State University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura F Salazar, PhD
Phone
404-413-1396
Email
lsalazar1@gsu.edu
First Name & Middle Initial & Last Name & Degree
Dominic Parrott, PhD
Phone
4044136287
Email
Parrott@gsu.edu
Facility Name
University of Nebraska-Lincoln
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68588
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David DiLillo, PhD
Phone
402-472-3297
Email
ddilillo2@unl.edu
First Name & Middle Initial & Last Name & Degree
Sarah Gervais, PhD
Phone
4024723721
Email
sgervais2@unl.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After the grant period, access to the data will be provided through the Inter- University Consortium for Political and Social Research (ICPSR). Users will be required to agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data source and funders. One year after the study is completed, all data will be compiled and organized into a single repository at ICPSR. Data will be made publicly available through ICPSR's website.
IPD Sharing Time Frame
One year after the study is completed, all data will be compiled and organized into a single repository at ICPSR.
IPD Sharing Access Criteria
Users will be required to agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgment of the data source and funders.

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

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