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| Name | Class |
|---|---|
| Behavioral Science Technologies, LLC | INDUSTRY |
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This study evaluates the efficacy of a web-based program for female college freshmen ("RealConsent") in reducing their risk of sexual violence victimization. Half the participants will receive RealConsent-F and half will receive an attention-placebo control ("Stress and Mood Management").
Sexual assault of college women is a serious and complex public health problem: one in five college women report being sexually assaulted. The purpose of this study is to conduct a randomized controlled trial study with 750 female college students from three universities to test the efficacy of RealConsent, a sexual violence risk reduction program for college women, compared to an attention-placebo control. RealConsent is a multi-media 3-hour program based on social cognitive theory and alcohol myopia theory. The primary outcome will be self-reported sexual violence victimization and the secondary outcomes will be alcohol and dating protective- and risk-related behaviors and resistance strategies. The investigators expect that women in the treatment group will report less sexual violence victimization than women in the control group. Expected outcomes are demonstrated feasibility and efficacy of a technologically novel risk reduction program for female college students.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RealConsent | Experimental | A 3-hour web-based program designed to teach female college freshmen strategies to reduce their risk of sexual violence victimization. |
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| Stress and Mood Management | Placebo Comparator | A 3-hour general mental health web-based program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RealConsent | Behavioral | This 3-hour web-based program consists of four 45-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama ("Squad"), which allow for the modeling of positive behaviors and illustrate both positive and negative outcome expectations. Behaviors modeled include drinking safely (e.g., eating before drinking, pacing, and drinking water), having a game plan before going out, communicating with male sex partners, engaging in protective dating behaviors, use of resistance strategies, self-defense strategies and bystander intervention with the goal of reducing risk of being sexually assaulted. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Sexual Violence Victimization at 6-months Follow-up | Sexual assault victimization was assessed with Revised Sexual Experience Survey. Participants were asked how often they experienced 7 unwanted sexual experiences. Also, the tactic that was used ("using force") was also noted. Response options ranged from 0 (never) to 3 (3+times). An overall score for the SES, was calculated by summing each outcome and tactic score ("SOTS") with a range from 0 to 135- with higher scores indicating more sexual violence victimization. The 2nd method combines several of the outcomes, but keeps tactics separate, resulting in a potential range of 0 to 63. | Baseline to 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Alcohol Protective Behaviors at 6 Months | Alcohol protective behaviors was measured by a scale developed by Martens et al., 2005 that included 15 protective strategies (e.g.., "alternate alcoholic and non-alcoholic drinks") that asked participants if they had engaged in within the last 3 months. with response options of Never (1) to Always (5). Responses were summed across the 15 items. Potential range was 15 to 75. Higher scores indicated MORE protective strategies were used. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura F. Salazar, PhD | Georgia State University | Principal Investigator |
| Anne Marie Schipani-McLaughlin, PhD | Georgia State University | Study Director |
| George Cavagnaro, MBA | Behavioral Science Technologies, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia State University | Atlanta | Georgia | 30303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37342080 | Derived | Salazar LF, Schipani-McLaughlin AM, Sebeh Y, Nizam Z, Hayat M. A Web-Based Sexual Violence, Alcohol Misuse, and Bystander Intervention Program for College Women (RealConsent): Randomized Controlled Trial. J Med Internet Res. 2023 Jun 21;25:e43740. doi: 10.2196/43740. |
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De-identified data from approximately 750 female freshmen participating in this study will be made available. The final dataset will include self-reported sexual violence victimization experiences, risk behaviors and scale measures of secondary outcomes.
Data will be available within 6 months of study completion.
The study principal investigator will review all data requests. Requestors will be required to sign a Data Access Agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | RealConsent | A 3-hour web-based program designed to teach female college freshmen strategies to reduce their risk of sexual violence victimization. RealConsent: This 3-hour web-based program consists of four 45-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama ("Squad"), which allow for the modeling of positive behaviors and illustrate both positive and negative outcome expectations. Behaviors modeled include drinking safely (e.g., eating before drinking, pacing, and drinking water), having a game plan before going out, communicating with male sex partners, engaging in protective dating behaviors, use of resistance strategies, self-defense strategies and bystander intervention with the goal of reducing risk of being sexually assaulted. |
| FG001 | Stress and Mood Management | A 3-hour general mental health web-based program. Stress and Mood Management: This 3-hour general health promotion web-based program consists of four 45-minute modules ("Stress Management", "Managing Depression", "Managing Anxiety", and "Treatments that work") that provide a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | RealConsent | A 3-hour web-based program designed to teach female college freshmen strategies to reduce their risk of sexual violence victimization. RealConsent: This 3-hour web-based program consists of four 45-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama ("Squad"), which allow for the modeling of positive behaviors and illustrate both positive and negative outcome expectations. Behaviors modeled include drinking safely (e.g., eating before drinking, pacing, and drinking water), having a game plan before going out, communicating with male sex partners, engaging in protective dating behaviors, use of resistance strategies, self-defense strategies and bystander intervention with the goal of reducing risk of being sexually assaulted. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Sexual Violence Victimization at 6-months Follow-up | Sexual assault victimization was assessed with Revised Sexual Experience Survey. Participants were asked how often they experienced 7 unwanted sexual experiences. Also, the tactic that was used ("using force") was also noted. Response options ranged from 0 (never) to 3 (3+times). An overall score for the SES, was calculated by summing each outcome and tactic score ("SOTS") with a range from 0 to 135- with higher scores indicating more sexual violence victimization. The 2nd method combines several of the outcomes, but keeps tactics separate, resulting in a potential range of 0 to 63. | Intent-to-treat population (all RealConsent and Stress and Mood Management participants from whom we had data at 6-month follow-up). | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6-months |
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All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RealConsent | A 3-hour web-based program designed to teach female college freshmen strategies to reduce their risk of sexual violence victimization. RealConsent: This 3-hour web-based program consists of four 45-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama ("Squad"), which allow for the modeling of positive behaviors and illustrate both positive and negative outcome expectations. Behaviors modeled include drinking safely (e.g., eating before drinking, pacing, and drinking water), having a game plan before going out, communicating with male sex partners, engaging in protective dating behaviors, use of resistance strategies, self-defense strategies and bystander intervention with the goal of reducing risk of being sexually assaulted. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laura Salazar | GEORGIA STATE UNIVERSITY | 4044131396 | lsalazar1@gsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2018 | Oct 29, 2018 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 6, 2018 | Oct 27, 2018 | ICF_000.pdf |
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Participants were told that study was to determine efficacy of a web-based health promotion program for female freshmen.
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| Stress and Mood Management | Behavioral | This 3-hour general health promotion web-based program consists of four 45-minute modules ("Stress Management", "Managing Depression", "Managing Anxiety", and "Treatments that work") that provide a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise. |
|
| Baseline to 6 months |
| Change From Baseline in Dating Risk Behaviors at 6-months Follow-up | Dating Risk Behaviors were measured by the Dating Behavior Survey created by Hanson & Gidycz, 1993. The scale consists of 15 items that assess different situational variables (e.g., "consuming alcohol on the first date") that have been found to be related to sexual violence victimization. Participants are asked to respond how often they have engaged in the behavior on the first few dates with a new partner. Response options ranged from Never (1) to Always (5). Scores are summed and higher scores indicate engaging in MORE risk behaviors. Overall scores can range from 15 to 75. | Baseline to 6 months |
| Change From Baseline in "Number of Times Engaged in Binge Drinking" to 6-months | Participants were asked at baseline and at 6-month follow-up, to report: "In the past 30 days, the number of times four or more drinks were consumed in one setting." | Baseline to 6-months |
| Change From Baseline in "Average Number of Alcoholic Drinks Per Occasion in Last 30 Days" to 6-months | Participants were asked at baseline and at 6-month follow-up to report, "the average number of alcoholic drinks consumed per occasion in the last 30 days." | baseline to 6-months |
| Change From Baseline in Bystander Behavior at 6-months | Bystander behavior was assessed using the 20-item Bystander Behavior Scale. Items assessed whether participants engaged in bystander behaviors in the past three months and included items such as, "If I saw someone taking a very intoxicated person up to their room, I said something and asked what the friend was doing." Higher scores indicate a better outcome of engaging in more prosocial behaviors. Min value=0; Max value=60. | Baseline to 6-months |
| BG001 | Stress and Mood Management | A 3-hour general mental health web-based program. Stress and Mood Management: This 3-hour general health promotion web-based program consists of four 45-minute modules ("Stress Management", "Managing Depression", "Managing Anxiety", and "Treatments that work") that provide a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Sexual Violence Victimization | Sexual assault victimization was assessed with Revised Sexual Experiences Survey. Participants were asked how often they experienced 7 unwanted sexual experiences. Also, the tactic that was used ("using force") was also noted. Response options ranged from 0 (never) to 3 (3+times). An overall score for the SES, was calculated by summing each outcome and tactic score ("SOTS") with a range from 0 to 135- with higher scores indicating more sexual violence victimization. The 2nd method combines several of the outcomes, but keeps tactics separate, resulting in a potential range of 0 to 63. | Mean | Standard Deviation | scores on a scale |
|
| Alcohol Protective Behaviors | Alcohol protective behaviors was measured by a scale developed by Martens et al., 2005 that included 15 protective strategies (e.g.., "alternate alcoholic and non-alcoholic drinks") that asked participants if they had engaged in within the last 3 months. with response options of Never (1) to Always (5). Responses were summed across the 15 items. Potential range was 15 to 75. Higher scores indicated MORE protective strategies were used. | Mean | Standard Deviation | scores on a scale |
|
| Dating Risk Behaviors | Dating Risk Behaviors were measured by the Dating Behavior Survey created by Hanson & Gidycz, 1993. The scale consists of 15 items that assess different situational variables (e.g., "consuming alcohol on the first date") that have been found to be related to sexual violence victimization. Participants are asked to respond how often they have engaged in the behavior on the first few dates with a new partner. Response options ranged from Never (1) to Always (5). Scores are summed and higher scores indicate engaging in MORE risk behaviors. Overall scores can range from 15 to 75. | Mean | Standard Deviation | scores on a scale |
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A 3-hour web-based program designed to teach female college freshmen strategies to reduce their risk of sexual violence victimization.
RealConsent: This 3-hour web-based program consists of four 45-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama ("Squad"), which allow for the modeling of positive behaviors and illustrate both positive and negative outcome expectations. Behaviors modeled include drinking safely (e.g., eating before drinking, pacing, and drinking water), having a game plan before going out, communicating with male sex partners, engaging in protective dating behaviors, use of resistance strategies, self-defense strategies and bystander intervention with the goal of reducing risk of being sexually assaulted.
| OG001 | Stress and Mood Management | A 3-hour general mental health web-based program. Stress and Mood Management: This 3-hour general health promotion web-based program consists of four 45-minute modules ("Stress Management", "Managing Depression", "Managing Anxiety", and "Treatments that work") that provide a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise. |
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| Secondary | Change From Baseline in Alcohol Protective Behaviors at 6 Months | Alcohol protective behaviors was measured by a scale developed by Martens et al., 2005 that included 15 protective strategies (e.g.., "alternate alcoholic and non-alcoholic drinks") that asked participants if they had engaged in within the last 3 months. with response options of Never (1) to Always (5). Responses were summed across the 15 items. Potential range was 15 to 75. Higher scores indicated MORE protective strategies were used. | Intent-to-treat | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 months |
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| Secondary | Change From Baseline in Dating Risk Behaviors at 6-months Follow-up | Dating Risk Behaviors were measured by the Dating Behavior Survey created by Hanson & Gidycz, 1993. The scale consists of 15 items that assess different situational variables (e.g., "consuming alcohol on the first date") that have been found to be related to sexual violence victimization. Participants are asked to respond how often they have engaged in the behavior on the first few dates with a new partner. Response options ranged from Never (1) to Always (5). Scores are summed and higher scores indicate engaging in MORE risk behaviors. Overall scores can range from 15 to 75. | Intent-to-treat | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 months |
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| Secondary | Change From Baseline in "Number of Times Engaged in Binge Drinking" to 6-months | Participants were asked at baseline and at 6-month follow-up, to report: "In the past 30 days, the number of times four or more drinks were consumed in one setting." | Intent-to-treat | Posted | Mean | Standard Deviation | Binge drinking events | Baseline to 6-months |
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| Secondary | Change From Baseline in "Average Number of Alcoholic Drinks Per Occasion in Last 30 Days" to 6-months | Participants were asked at baseline and at 6-month follow-up to report, "the average number of alcoholic drinks consumed per occasion in the last 30 days." | Intent-to-treat | Posted | Mean | Standard Deviation | Average number of drinks/occasion | baseline to 6-months |
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| Secondary | Change From Baseline in Bystander Behavior at 6-months | Bystander behavior was assessed using the 20-item Bystander Behavior Scale. Items assessed whether participants engaged in bystander behaviors in the past three months and included items such as, "If I saw someone taking a very intoxicated person up to their room, I said something and asked what the friend was doing." Higher scores indicate a better outcome of engaging in more prosocial behaviors. Min value=0; Max value=60. | Analysis was performed using dosage were: (1) the RealConsent® group participants at 6-months who completed all four modules (n=305) versus the RealConsent® group participants who had not completed all four modules plus the control group participants (n=415). | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6-months |
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| EG001 | Stress and Mood Management | A 3-hour general mental health web-based program. Stress and Mood Management: This 3-hour general health promotion web-based program consists of four 45-minute modules ("Stress Management", "Managing Depression", "Managing Anxiety", and "Treatments that work") that provide a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise. | 0 | 0 | 0 | 0 | 0 | 0 |
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