Sexual Violence
Conditions
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALRealConsent
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.
BEHAVIORALStress 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.
Sponsors
Behavioral Science Technologies, LLC
Georgia State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants were told that study was to determine efficacy of a web-based health promotion program for female freshmen.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 20 Years
Healthy volunteers
Yes
Inclusion criteria
* female, aged 18-20 years, full-time freshmen, matriculated at Georgia State University, Emory University, or University of Georgia, and single (i.e., not in a committed dating relationship).
Exclusion criteria
* other education levels, married, and/or graduate status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Sexual Violence Victimization at 6-months Follow-up | Baseline to 6-months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Alcohol Protective Behaviors at 6 Months | Baseline to 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. |
| Change From Baseline in Dating Risk Behaviors at 6-months Follow-up | Baseline to 6 months | 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. |
| Change From Baseline in Number of Times Engaged in Binge Drinking to 6-months | Baseline 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. |
| Change From Baseline in Average Number of Alcoholic Drinks Per Occasion in Last 30 Days to 6-months | baseline 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. |
| Change From Baseline in Bystander Behavior at 6-months | Baseline to 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 444 |
| 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. | 437 |
| Total | 881 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 85 | 76 |
Baseline characteristics
| Characteristic | Stress and Mood Management | Total | RealConsent |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 437 Participants | 881 Participants | 444 Participants |
| Alcohol Protective Behaviors | 53.97 scores on a scale STANDARD_DEVIATION 11.4 | 53.76 scores on a scale STANDARD_DEVIATION 11.76 | 53.53 scores on a scale STANDARD_DEVIATION 12.2 |
| Dating Risk Behaviors | 35.08 scores on a scale STANDARD_DEVIATION 4.8 | 35.12 scores on a scale STANDARD_DEVIATION 4.96 | 35.16 scores on a scale STANDARD_DEVIATION 5.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 90 Participants | 181 Participants | 91 Participants |
| Race (NIH/OMB) Black or African American | 110 Participants | 213 Participants | 103 Participants |
| Race (NIH/OMB) More than one race | 37 Participants | 84 Participants | 47 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 196 Participants | 394 Participants | 198 Participants |
| Region of Enrollment United States | 437 participants | 881 participants | 444 participants |
| Sex: Female, Male Female | 437 Participants | 881 Participants | 444 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Sexual Violence Victimization Sexual Violence Vict. COSTS | 3.8 scores on a scale STANDARD_DEVIATION 9.8 | 3.7 scores on a scale STANDARD_DEVIATION 9.4 | 3.7 scores on a scale STANDARD_DEVIATION 8.9 |
| Sexual Violence Victimization Sexual Violence Vict. SOTS | 5.7 scores on a scale STANDARD_DEVIATION 17.1 | 5.7 scores on a scale STANDARD_DEVIATION 16.4 | 5.6 scores on a scale STANDARD_DEVIATION 15.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Baseline to 6-months
Population: Intent-to-treat population (all RealConsent and Stress and Mood Management participants from whom we had data at 6-month follow-up).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RealConsent | Change From Baseline in Sexual Violence Victimization at 6-months Follow-up | Baseline score of SOTS | 5.64 score on a scale | Standard Deviation 15.67 |
| RealConsent | Change From Baseline in Sexual Violence Victimization at 6-months Follow-up | Baseline score of COSTS | 3.69 score on a scale | Standard Deviation 8.93 |
| RealConsent | Change From Baseline in Sexual Violence Victimization at 6-months Follow-up | 6-Month score of SOTS | 5.52 score on a scale | Standard Deviation 18.4 |
| RealConsent | Change From Baseline in Sexual Violence Victimization at 6-months Follow-up | 6-Month score of COSTS | 3.52 score on a scale | Standard Deviation 10.55 |
| Stress and Mood Management | Change From Baseline in Sexual Violence Victimization at 6-months Follow-up | 6-Month score of COSTS | 4.95 score on a scale | Standard Deviation 13.63 |
| Stress and Mood Management | Change From Baseline in Sexual Violence Victimization at 6-months Follow-up | Baseline score of SOTS | 5.68 score on a scale | Standard Deviation 17.1 |
| Stress and Mood Management | Change From Baseline in Sexual Violence Victimization at 6-months Follow-up | 6-Month score of SOTS | 8.15 score on a scale | Standard Deviation 25.36 |
| Stress and Mood Management | Change From Baseline in Sexual Violence Victimization at 6-months Follow-up | Baseline score of COSTS | 3.78 score on a scale | Standard Deviation 9.77 |
p-value: 0.000295% CI: [0.33, 0.69]Mixed Models Analysis
p-value: 0.3195% CI: [0.47, 1.28]Mixed Models Analysis
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.
Time frame: Baseline to 6 months
Population: Intent-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RealConsent | Change From Baseline in Alcohol Protective Behaviors at 6 Months | Baseline | 53.53 score on a scale | Standard Deviation 12.17 |
| RealConsent | Change From Baseline in Alcohol Protective Behaviors at 6 Months | 6 months | 56.8 score on a scale | Standard Deviation 11.7 |
| Stress and Mood Management | Change From Baseline in Alcohol Protective Behaviors at 6 Months | Baseline | 53.97 score on a scale | Standard Deviation 11.35 |
| Stress and Mood Management | Change From Baseline in Alcohol Protective Behaviors at 6 Months | 6 months | 55.0 score on a scale | Standard Deviation 11.6 |
p-value: 0.0395% CI: [0.12, 1.22]Mixed Models Analysis
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.
Time frame: baseline to 6-months
Population: Intent-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RealConsent | Change From Baseline in Average Number of Alcoholic Drinks Per Occasion in Last 30 Days to 6-months | Baseline | 1.64 Average number of drinks/occasion | Standard Deviation 1.3 |
| RealConsent | Change From Baseline in Average Number of Alcoholic Drinks Per Occasion in Last 30 Days to 6-months | 6 Months | 1.4 Average number of drinks/occasion | Standard Deviation 1.2 |
| Stress and Mood Management | Change From Baseline in Average Number of Alcoholic Drinks Per Occasion in Last 30 Days to 6-months | Baseline | 1.45 Average number of drinks/occasion | Standard Deviation 1.12 |
| Stress and Mood Management | Change From Baseline in Average Number of Alcoholic Drinks Per Occasion in Last 30 Days to 6-months | 6 Months | 1.3 Average number of drinks/occasion | Standard Deviation 1.3 |
p-value: 0.4395% CI: [0.92, 1.2]Mixed Models Analysis
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.
Time frame: Baseline to 6-months
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RealConsent | Change From Baseline in Bystander Behavior at 6-months | Baseline | 7.14 score on a scale | Standard Deviation 9.02 |
| RealConsent | Change From Baseline in Bystander Behavior at 6-months | 6 Months | 6.03 score on a scale | Standard Deviation 8.1 |
| Stress and Mood Management | Change From Baseline in Bystander Behavior at 6-months | Baseline | 6.58 score on a scale | Standard Deviation 9.03 |
| Stress and Mood Management | Change From Baseline in Bystander Behavior at 6-months | 6 Months | 7.6 score on a scale | Standard Deviation 11.14 |
p-value: 0.00695% CI: [1.17, 2.55]Mixed Models Analysis
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.
Time frame: Baseline to 6 months
Population: Intent-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RealConsent | Change From Baseline in Dating Risk Behaviors at 6-months Follow-up | Baseline | 35.16 score on a scale | Standard Deviation 5.11 |
| RealConsent | Change From Baseline in Dating Risk Behaviors at 6-months Follow-up | 6 months | 36.2 score on a scale | Standard Deviation 7.3 |
| Stress and Mood Management | Change From Baseline in Dating Risk Behaviors at 6-months Follow-up | Baseline | 35.08 score on a scale | Standard Deviation 4.8 |
| Stress and Mood Management | Change From Baseline in Dating Risk Behaviors at 6-months Follow-up | 6 months | 36.1 score on a scale | Standard Deviation 5.7 |
p-value: <0.0595% CI: [-1.27, 0.27]Mixed Models Analysis
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.
Time frame: Baseline to 6-months
Population: Intent-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RealConsent | Change From Baseline in Number of Times Engaged in Binge Drinking to 6-months | Baseline | 1.71 Binge drinking events | Standard Deviation 2.53 |
| RealConsent | Change From Baseline in Number of Times Engaged in Binge Drinking to 6-months | 6 months | 1.11 Binge drinking events | Standard Deviation 1.8 |
| Stress and Mood Management | Change From Baseline in Number of Times Engaged in Binge Drinking to 6-months | Baseline | 1.25 Binge drinking events | Standard Deviation 1.8 |
| Stress and Mood Management | Change From Baseline in Number of Times Engaged in Binge Drinking to 6-months | 6 months | 1.05 Binge drinking events | Standard Deviation 1.8 |
p-value: 0.0295% CI: [0.67, 0.97]Mixed Models Analysis