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| Name | Class |
|---|---|
| University of Nebraska Lincoln | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RealConsent 1.0 with Alcohol | Active Comparator | 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). |
|
| RealConsent 1.0 with Placebo | Active Comparator | 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. |
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| RealConsent2.0 with Alcohol | Experimental | 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). |
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| RealConsent2.0 with Placebo | Experimental | 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. |
|
| Stress Management with Alcohol |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RealConsent1.0 | Behavioral | A web-based multi-media sexual violence prevention program that enhances knowledge and skills for effective consent for sex and for prosocial bystander behaviors. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Must identify as a man or transgender man
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| Name | Affiliation | Role |
|---|---|---|
| Laura Salazar, Ph.D. | Georgia State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia State University | Atlanta | Georgia | 30303 | United States | ||
| University of Nebraska-Lincoln |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38087306 | Derived | Salazar LF, Parrott DJ, DiLillo D, Gervais S, Schipani-McLaughlin AM, Leone R, Swartout K, Simpson L, Moore R, Wilson T, Flowers N, Church H, Baildon A. Study protocol for a randomized controlled trial of RealConsent2.0: a web-based intervention to promote prosocial alcohol-involved bystander behavior in young men. Trials. 2023 Dec 12;24(1):804. doi: 10.1186/s13063-023-07797-w. |
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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.
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One year after the study is completed, all data will be compiled and organized into a single repository at 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 acknowledgment of the data source and funders.
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Men assigned to complete a web-based stress management program. Men assigned to alcohol intoxication arm (target BrAC=.08). |
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| Stress Management with Placebo | Active Comparator | Men assigned to complete a web-based stress management program. Men assigned to a no-alcohol placebo control arm. |
|
| RealConsent2.0 | Behavioral | 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. |
|
| Stress Management | Behavioral | 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. |
|
| Alcohol intoxication | Behavioral | Men assigned to moderate alcohol dose condition (target BrAC .08%) with NIAAA approved alcohol administration procedures |
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| No-Alcohol Placebo | Behavioral | Men assigned to an no-alcohol placebo control condition. |
|
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 |
| Lincoln |
| Nebraska |
| 68588 |
| United States |
| ID | Term |
|---|---|
| D000435 | Alcoholic Intoxication |
| D006379 | Helping Behavior |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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