Trial Outcomes & Findings for Efficacy of a Web-based Sexual Violence Risk Reduction Program for Female College Students (NCT NCT03726437)
NCT ID: NCT03726437
Last Updated: 2023-02-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
881 participants
Primary outcome timeframe
Baseline to 6-months
Results posted on
2023-02-13
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
444
|
437
|
|
Overall Study
COMPLETED
|
359
|
361
|
|
Overall Study
NOT COMPLETED
|
85
|
76
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
85
|
76
|
Baseline Characteristics
Efficacy of a Web-based Sexual Violence Risk Reduction Program for Female College Students
Baseline characteristics by cohort
| Measure |
RealConsent
n=444 Participants
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.
|
Stress and Mood Management
n=437 Participants
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.
|
Total
n=881 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
444 Participants
n=5 Participants
|
437 Participants
n=7 Participants
|
881 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
444 Participants
n=5 Participants
|
437 Participants
n=7 Participants
|
881 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
91 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
103 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
198 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
394 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
47 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
444 participants
n=5 Participants
|
437 participants
n=7 Participants
|
881 participants
n=5 Participants
|
|
Sexual Violence Victimization
Sexual Violence Vict. "SOTS"
|
5.6 scores on a scale
STANDARD_DEVIATION 15.7 • n=5 Participants
|
5.7 scores on a scale
STANDARD_DEVIATION 17.1 • n=7 Participants
|
5.7 scores on a scale
STANDARD_DEVIATION 16.4 • n=5 Participants
|
|
Sexual Violence Victimization
Sexual Violence Vict. "COSTS"
|
3.7 scores on a scale
STANDARD_DEVIATION 8.9 • n=5 Participants
|
3.8 scores on a scale
STANDARD_DEVIATION 9.8 • n=7 Participants
|
3.7 scores on a scale
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Alcohol Protective Behaviors
|
53.53 scores on a scale
STANDARD_DEVIATION 12.2 • n=5 Participants
|
53.97 scores on a scale
STANDARD_DEVIATION 11.4 • n=7 Participants
|
53.76 scores on a scale
STANDARD_DEVIATION 11.76 • n=5 Participants
|
|
Dating Risk Behaviors
|
35.16 scores on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
35.08 scores on a scale
STANDARD_DEVIATION 4.8 • n=7 Participants
|
35.12 scores on a scale
STANDARD_DEVIATION 4.96 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6-monthsPopulation: Intent-to-treat population (all RealConsent and Stress and Mood Management participants from whom we had data at 6-month 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.
Outcome measures
| Measure |
RealConsent
n=359 Participants
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.
|
Stress and Mood Management
n=361 Participants
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.
|
|---|---|---|
|
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
|
5.68 score on a scale
Standard Deviation 17.10
|
|
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
|
8.15 score on a scale
Standard Deviation 25.36
|
|
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
|
3.78 score on a scale
Standard Deviation 9.77
|
|
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
|
4.95 score on a scale
Standard Deviation 13.63
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Intent-to-treat
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.
Outcome measures
| Measure |
RealConsent
n=359 Participants
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.
|
Stress and Mood Management
n=361 Participants
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.
|
|---|---|---|
|
Change From Baseline in Alcohol Protective Behaviors at 6 Months
Baseline
|
53.53 score on a scale
Standard Deviation 12.17
|
53.97 score on a scale
Standard Deviation 11.35
|
|
Change From Baseline in Alcohol Protective Behaviors at 6 Months
6 months
|
56.8 score on a scale
Standard Deviation 11.7
|
55.0 score on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Intent-to-treat
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.
Outcome measures
| Measure |
RealConsent
n=359 Participants
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.
|
Stress and Mood Management
n=361 Participants
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.
|
|---|---|---|
|
Change From Baseline in Dating Risk Behaviors at 6-months Follow-up
Baseline
|
35.16 score on a scale
Standard Deviation 5.11
|
35.08 score on a scale
Standard Deviation 4.80
|
|
Change From Baseline in Dating Risk Behaviors at 6-months Follow-up
6 months
|
36.2 score on a scale
Standard Deviation 7.3
|
36.1 score on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Baseline to 6-monthsPopulation: Intent-to-treat
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."
Outcome measures
| Measure |
RealConsent
n=359 Participants
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.
|
Stress and Mood Management
n=361 Participants
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.
|
|---|---|---|
|
Change From Baseline in "Number of Times Engaged in Binge Drinking" to 6-months
Baseline
|
1.71 Binge drinking events
Standard Deviation 2.53
|
1.25 Binge drinking events
Standard Deviation 1.8
|
|
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
|
1.05 Binge drinking events
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: baseline to 6-monthsPopulation: Intent-to-treat
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."
Outcome measures
| Measure |
RealConsent
n=359 Participants
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.
|
Stress and Mood Management
n=361 Participants
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.
|
|---|---|---|
|
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
|
1.3 Average number of drinks/occasion
Standard Deviation 1.3
|
|
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
|
1.45 Average number of drinks/occasion
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: Baseline to 6-monthsPopulation: 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).
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.
Outcome measures
| Measure |
RealConsent
n=305 Participants
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.
|
Stress and Mood Management
n=415 Participants
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.
|
|---|---|---|
|
Change From Baseline in Bystander Behavior at 6-months
Baseline
|
7.14 score on a scale
Standard Deviation 9.02
|
6.58 score on a scale
Standard Deviation 9.03
|
|
Change From Baseline in Bystander Behavior at 6-months
6 Months
|
6.03 score on a scale
Standard Deviation 8.1
|
7.6 score on a scale
Standard Deviation 11.14
|
Adverse Events
RealConsent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stress and Mood Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place