RealConsent: A Web-based Program to Reduce College Women's Risk of Sexual Violence by Targeting Alcohol Use, Communication and Consent, and Building Supportive Networks
Phase: NA
Conditions: Sexual Violence
Sponsor: Georgia State University

 
Study Title: 
 
 
RealConsent: A web-based program to reduce college women's 
risk of sexual violence by targeting alcohol use, communication and consent, and building 
supportive networks. 
 
Date of Document: 
 
July 31, 2018 
 
 
 
 
 

Georgia State University 
Department of Health Promotion and Behavior 
School of Public Health 
 
Research Protocol and Statistical Analyses 
 
Title: Testing the efficacy of a web-based program for college women 
Principal Investigator: Dr. Laura F. Salazar 
Sponsor: National Institute of Alcohol Abuse and Alcoholism 
 
I. 
Project Summary and Project Goals 
 
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-F, a sexual violence risk reduction program for college 
women, compared to an attention-placebo comparison condition. 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. Our expected 
outcomes are demonstrated feasibility and efficacy of a technologically novel risk reduction 
program for female college students. 
 
II. 
Rationale and Background Information 
 
Epidemic of Sexual Violence Against College Women: Recent statistics on sexual violence 
against women in college have revealed a serious and complex public health problem: 6% of 
female college students report experiences of rape each year14 and one in five women report that 
she was sexually assaulted while in college.1 Assaults typically occur during freshman or 
sophomore year2 and, in most cases (75-80%), women state that they know their attacker, 
whether as an acquaintance, classmate, friend or (ex)boyfriend.2 Many women report 
experiencing an “incapacitated assault” meaning they were sexually abused while they, the 
victims, were drugged, drunk, passed out, or otherwise incapacitated.3,4 These data demonstrate 
the high level of sexual assault occurring among young adult college women. To reduce 
incidence rates, comprehensive approaches involving evidence-based, easily-disseminated 
educational products are greatly needed by institutions of higher learning to prevent male 
perpetration and reduce risk of sexual assault among women; however, evidence-based 
prevention and risk reduction programming is greatly lacking.5-7 
 
In 2014 the Centers for Disease Control and Prevention (CDC) conducted a review of 140 
published sexual violence primary prevention interventions and concluded only three were 

effective in preventing sexual violence perpetration. [Note: RealConsent male version 
(RealConsent-M) was not included in this review as the publication was “in press” at the time the 
review was conducted]. Of the three effective programs, none were specific to college students.5 
To reduce sexual violence perpetration, best practices for prevention entail theoretically-driven 
activities that focus on improving 1) knowledge of consent and understanding the impact of 
alcohol; 2) addressing hyper-male ideology; 3) reducing hostility toward women; 4) reducing 
adherence to prescribed gender roles; 5) changing social norms to reduce acceptance of sexual 
violence; 6) dispelling rape myths; and 7) enhancing communication skills between men and 
women around sex. RealConsent-M incorporated segments that addressed all seven best 
practices. Using a randomized controlled trial (RCT), RealConsent-M demonstrated significant 
reductions in sexual violence perpetration;13 thus, RealConsent is the first effective prevention 
program for male college students. 
 
III. 
Methods 
 
This study plans to conduct a randomized controlled trial with 750 female freshmen between 18-
20 years of age from three universities in the state of Georgia (n=250 from each school) to test 
the efficacy of RealConsent-F compared to an attention-placebo comparison condition. Inclusion 
criteria for all proposed research activities are: female, aged 18-20 years, full time freshman, 
and single. Exclusion criteria are: other education levels, married, and/or graduate status. 
Participants will be randomized to either the intervention or attention-placebo study conditions. 
To control for Hawthorne effects, women in the RCT will be compared to women in an 
attention- placebo control condition—a general health promotion web-based program called 
“Stress Management.” Below are descriptions of the intervention, RealConsent and the 
attention-placebo program. 
 
RealConsent-F 
RealConsent includes 18 of 40 well-known behavioral change techniques. The program 1) 
provides information on the targeted behavior; 2) provides instruction on how to perform the 
behavior; 3) demonstrates or models the behavior; 4) demonstrates positive outcomes for 
engaging in the behavior or negative outcomes for failing to change behavior; and 5) provides 
encouragement and positive feedback as reinforcement.12,35-38 RealConsent-F uses didactic 
methods involving presentation of material via video; problem-based learning via quizzes 
with interactivity; short videos and animation to model the behavior. RealConsent-F is 
unique in that it includes serial drama episodes (i.e. “Squad”) featuring four college women 
going through their freshman year and experiencing issues related to alcohol use, sexual 
assault, stalking, and dating violence. This program is grounded in educational 
entertainment to provide educational content within entertainment programming (e.g., 
Sesame Street or Law and Order). 
 

 
Attention-Placebo Condition 
Stress Management was developed by ISA Group (www.isagroup.com) and is a multi-media 
web-based program designed to help manage stress levels. The program is dynamic and 
interactive with substantial use of video/audio. Each of 4 program modules is ≈30 minutes 
involving interactive and didactic activities. Thus, it approximates RealConsent-F in format 
and duration.  
 
 
Recruitment of N=750 Female College Freshmen  
We have agreements with each of the three colleges to test RealConsent-F among female 
freshmen and they have agreed to provide a list of female students. We will send out email 
invites from Salazar’s email account to a random sample of 500 students per school to ask 
for their participation in a research project. To control for demand characteristics, we will 
blind participants to the research question and indicate the purpose is to “test multimedia, 
web-based interactive programs designed for female college students.” If the first round of 
500 emails does not produce a 50% response rate, we will send out another batch of 500 
email invites to reach our target goal of n=250 at each college. Salazar used this recruitment 
strategy for testing RealConsent-M.13 Female freshmen who are interested in the research 
will be able to access our online eligibility screener through a hyperlink in the body of the 
email that takes them to our study website.  Mr. Long, a computer scientist and programmer, 
will develop the study website and a web-based application that will help our project 
director with recruitment and retention efforts. Long developed a website and app for 
Salazar’s current online study of 1,800 male freshmen. 
 
Informed Consent 
The website will provide a short description of the study and, if interested, participants can 
click on a button to assess their eligibility followed by the informed consent process. The 
informed consent process is a crucial aspect of any study, but especially so when conducting 
web-based research involving sensitive topics. Special consideration must be made to ensure 
that participants are aware of their rights as participants in such research.94 A hyperlink will 
be displayed following the eligibility screener directing eligible participants to the informed 
consent form. Those not eligible will receive a message saying they are not eligible. An 
interactive process will be designed to secure informed consent. As part of registration, we 
will collect name, preferred email, mailing address, and cell phone number to maximize 
retention although identifying information will not be linked with survey data. The web app 
will allow us to collect key data for CONSORT.95 All participants are eligible to receive up 
$105 in Amazon e-gift cards for completing RealConsent-F and all surveys, which in our 
experience of 10 years of conducting online studies is feasible and necessary.13,96-98 
 

Baseline Assessment, Randomization, and Completion of RealConsent or Stress 
Management: 
Once a participant is registered, she will get a confirmation email; her response will trigger 
another email that contains a link to the online baseline survey and a password for accessing. 
To enhance confidentiality of responses, we will encourage participants to choose a private 
location, use a secure, encrypted Internet connection, and close their web-browser after they 
have completed a survey. Once an individual completes the baseline survey, she will be 
randomized using an automated stratified block randomization program to either 
RealConsent-F or to Stress Management programs. Stratified block randomization will 
ensure equal numbers between conditions and that 125 participants from each university are 
assigned to each condition. 
 
We will communicate to the research participants and encourage them to complete their 
assigned task (RealConsent-F or Stress Management) within two weeks. Participants can 
complete the modules at their own pace within the 2-week window and are able to leave a 
module and finish it later. Email prompts will be sent every 48 hours to remind participants 
to complete the modules. Participants will be contacted by email and/or text message prior 
to 6 months post-intervention (Spring 2019) to complete the posttest. 
 
Retention Activities 
Based on the experience and expertise of Salazar and her team, we will employ a number of 
activities to maximize retention. In a preliminary study of N=1,153 college male freshmen 
assessed three times over 12 months, Salazar and colleagues implemented activities to 
enhance recruitment: 1) sending touch-point emails in between assessments; 2) enabling 
participants to update changes in contact information via the web application; 3) providing 
full incentive amount for those who completed assessments on time as a “bonus;” 4) sending 
email and text reminders prior to due dates; and 5) emailing, texting and making phone calls 
up until final date. Our response rates were: 80% at wave 2 (6-months), and 81% at wave 3 
(12-months). To ensure we maintain at least 80% retention rate, we will employ these 
strategies and those used previously by Salazar in other studies involving follow-up 
assessments of adolescents and adults. 
 
Study Measures 
The table below displays the measures that will be used in all study assessments. 
 
Table 1. Measures of Study Variables 
 
Variable 
Measure 
# Items 
α 
Primary Outcome: 
Sexual Victimization 
 
Revised Sexual Experiences Survey-SFV (SES)81 
35 
.74
Secondary Outcomes: 
Dating behaviors 
 
The Dating Behavior Survey (DBS)82,83 
15 
.67

 
The Dating Self-Protection Against Rape Scale83,84 
15 
.88
Alcohol Protective Behaviors 
Protective Behavioral Strategies Survey26,85 
15 
.94
Use of resistance tactics 
Use of Resistance Tactics23 
6 
n/a
Mediators: 
Alcohol use 
 
Weekly Drinking and Heavy Episodic Drinking28,86 
2 
n/a
Perceptions of Alcohol-Related Risk 
Likelihood of nonconsensual sex due to alcohol87 
1 
n/a
Alcohol Expectancy 
Revised Alcohol Expectancy Questionnaire87,88 
40 
.72
Alcohol Use Norms 
Drinking norms rating form26,89 
1 
n/a 
Bystander Behavior 
Knowledge of legal definitions of rape 
Bystander Behavior Scale 
Legal Knowledge Scale13 
10 
7 
.89
.69
Perceptions of informed consent 
Informed Consent Index13 
14 
n/a
Empathy for rape victims 
Rape Empathy Scale90 
19 
.84
Communication with partner about sex 
Communication subscale of SSBQ91 
7 
.80
Sexual Assertiveness 
Sexual Communication Survey82 
10 
.90
Self-efficacy to discuss sex 
Communication Self-Efficacy92 
4 
.84
Self-efficacy to use assertive responses 
Self Efficacy Scale93 
7 
.97
Use of risk reduction strategies 
Personal and Social Risk Reduction Strategies 
Scale 
34 
n/a
 
IV. 
Safety Considerations 
 
There are some potential risks for participating in the RealConsent program. Participants may 
experience some adverse psychological reactions such as feeling upset or discomfort as they 
undergo the intervention modules. For example, a potential risk is that a participant may gain a 
new awareness of an unwanted sexual experience that hitherto she thought of as “her fault for 
getting drunk”, but she now may indicate she was a victim of date rape. Although these instances 
represent some degree of risk, we have designed the procedures to minimize adverse reactions. 
Our project director, Dr. Anne Marie Schipani-McLaughlin will conduct a check-in with each 
participant after completion of each intervention module. Participants can freely elect to 
terminate participation in the Web-based intervention if so desired. We anticipate that some 
participants may require counseling and we will be prepared to help these participants with 
appropriate referrals. Dr. Schipani-McLaughlin has extensive experience in addressing 
participants’ concerns during randomized trials will also undergo training by Dr. Salazar and if 
needed, the principal investigator will address adverse reactions should they arise. Also, we will 
include on our study website a (800 715 4225) number that can be accessed 24/7 for immediate 
crisis counseling in GA (GA Crisis and Access Line):  
http://www.armstrong.edu/Departments/counseling_center/counseling_georgia_crisis_and_acces
s_line).   
  
Another potential risk for participating is the administered assessments that may cause some 
participants to experience adverse psychological reaction such as distress, discomfort, or anxiety 
responding to explicit questions regarding their unwanted sexual experiences. We will state 
explicitly that participants can refuse to answer any questions, decline to answer any questions, 
or be allowed to skip any questions of the survey; they can also elect to terminate their 
participation immediately. The project director will be prepared to provide resources for 
participants should they request a referral, or as they respond to explicit questions regarding their 
unwanted sexual experiences.  

  
One last risk entails a loss of confidentiality. A number of steps will be taken to secure sensitive 
data. These include the required use of personal identification numbers, access codes, and 
passwords on the study web site and on all web-administered surveys and assessments. Only the 
PI and the project director will have access to the online survey data through our Qualtrics 
account. Qualtrics web-survey platform employs a high level of data encryption. We will also 
secure the web site, which will deliver the RealConsent program. All data and recruitment 
materials will be stored on the PI’s password-protected desktop located in her locked office at 
GSU.   
 
V. 
Data Management and Statistical Analysis 
 
Data Management 
Data will be stored on servers that are protected by high-end firewall systems, data are 
encrypted so that information cannot be decoded, and IP addresses will not be collected 
(every computer that communicates over the Internet is assigned an IP address that uniquely 
identifies the device). Data files, once downloaded, will be stored on Dr. Salazar’s 
password-protected computer located in her locked office.  
 
Statistical Analysis 
The complex empirical methods described below will be conducted by Dr. Hayat, an 
experienced statistician and colleague of Dr. Salazar’s. Data analysis will be performed 
using the SAS Software System. Descriptive statistics for all measurements will be 
estimated and reported. Frequency distributions will be created to screen for any errors and 
will be used to summarize categorical data; measures of central tendency and dispersion will 
be used to summarize continuous data. All data will be examined for bivariate relationships 
and results used to build a multivariate statistical model. 
 
We will analyze our study data with an intent-to-treat and per protocol analyses. An intent-
to-treat analysis includes all participants who were randomized, regardless of compliance, 
withdrawal, and anything that happens after randomization. An advantage is that it is an 
analysis based on original randomization; however, effect estimation may be conservative 
and misleading with increasing attrition. A per protocol analysis considers only participants 
who fully complied and completed the study. Per protocol is less conservative and may 
reflect true treatment differences for those with full compliance. Including an intent-to-treat 
and per protocol analysis will provide a more complete understanding of treatment effects. 
Because we will most likely encounter incomplete data due to dropouts and non-response, 
multiple imputation of missing data will be used to impute missing values based on other 
available covariates.  
 

Outcomes, including victimization and frequency of risky dating behaviors and alcohol-
protective behaviors will be modeled using a general linear mixed model. This is an 
appropriate statistical model to use with repeated measures data collected over time.101 A 
random effect for subject will be included to account for the multiple measurements taken at 
baseline and 6-month follow-up on each subject. Treatment group and demographics will be 
included as fixed effects in the model. Mediation models will be tested with a two-tiered 
approach for mediation testing, with bootstrapping to generate estimates of the indirect 
effect and 95% confidence intervals. 
 
Sample Size 
Primary outcome will be report of victimization; secondary outcomes are protective- and 
risk- related behaviors. Sample size is based on the number per group needed to detect 
clinically meaningful treatment effects on victimization. Calculations were based on 80% 
power, level of significance of .05, and two- tailed statistical tests. Clinically meaningful 
treatment efficacy was defined for our outcome variable as having between a small and 
moderate effect size (Cohen’s h ≥ .35). This effect size was considered as a 9% point 
difference between groups, at a minimum, and could potentially translate to a clinically 
significant reduction in the number of victimizations on those college campuses that 
implement RealConsent. Based on previous research with female college 
students,22,23,26,28,104-107 assuming incidence of 0.22 without intervention and .13 with 
intervention, a total of 558 participants are needed (279 in each group). We expect 20% 
attrition based on previous work. To achieve adequate power, we estimate a needed sample 
size of at least 670; however, we are increasing sample size to 750 participants (375 in each 
group) to increase power. 
 
VI. 
Quality Assurance 
 
Data Safety & Monitoring Plan 
In accordance with the NIH recommendations as this is a NIH clinical trial we will have a 
Data Safety Monitoring Board (DSMB). The proposed study is considered to present 
minimal risk to participants, given that they will complete surveys and possibly participate 
in a sexual violence prevention educational program. Members of the DSMB will perform 
the following activities: 
 
1. Review the research protocol and plans for data and safety monitoring. 
2. Review progress of the trial, including analysis of data quality and timeliness; 
subject recruitment and retention; subject risk versus benefit; and other factors 
that may affect outcome. 
3. Review serious adverse event reports, provide commentary, and provide 
oversight to ensure that reports are relayed to individual IRBs and to the Office 
of Human Research Protections (OHRP), as indicated. 
4. Review analyses of outcome data and review reports of related studies to 

determine whether the current study needs to be changed or terminated. 
5. Determine whether the trial should continue as designed, should be changed, 
or should be terminated based on the data and make recommendations to the 
NIH and the Institutional Review Board considering conclusion or 
continuation of the study. 
6. Review proposed modifications to the study prior to their implementation. 
7. Protect the confidentiality of the trial data and the results of the monitoring. 
8. Determine whether and to whom outcome results should be released prior to 
the reporting of study results. 
9. Following DSMB meetings, provide appropriate NIH staff with written 
information concerning their findings. 
 
The DSMB members will be chosen by Dr. Salazar and will be reviewed and approved 
by the NIH Project Officer. The members, who will all be voting members, will be 
chosen based upon their knowledge of clinical trial methodology, their experience with 
the topical area (i.e., sexual violence risk reduction strategies), and absence of conflicts 
of interest. They will be appointed for the life of the project. The Chair of the DSMB 
will be selected from among the DSMB members. The NIH Project Officer will serve as 
an ex-officio member of the DSMB. 
  
DSMB meetings will be held every 12 months beginning in Year 1 of the study. Serious 
adverse events will be reported to the Chair as soon as they occur. The Chair of the 
DSMB will determine whether an in-person meeting or teleconference is needed. Prior 
to the meetings, a written report containing any study preliminary findings will be sent to 
DSMB members. Preliminary findings will not be made available to individuals outside 
of the DSMB. Each meeting will include time to review the progress of the study and to 
answer questions from members of the DSMB. Members of the DSMB will disclose any 
potential conflicts of interest, either pre- existing or those that develop during their 
tenure, to the Principal Investigator and the NIH Project Officer. 
  
In accordance with NIH policy, a data and safety monitoring plan has been developed for 
the proposed study. Dr. Salazar will provide oversight of all recruitment and study 
procedures and quality assurance checks will be conducted as planned. All records 
pertaining to the study and all of the original and electronic files containing collected 
data will be securely stored. Dr. Salazar and will be solely responsible for dissemination 
of study findings through presentation and publication formats. Presentations and 
publications will not disclose the name of the clinics where recruitment occurred. Dr. 
Salazar will also be solely responsible for handling any requests from other investigators 
to examine the data collected during Phase II of this Fast- track proposal. Dr. Salazar 
will present these requests to a Data and Safety Monitoring Board (DSMB) for their 
consideration. 
  
This research team has extensive experience working with college student populations 
and extensive experience confronting ethical issues of subjects in behavioral 

interventions. We will work with all respective IRBs involved to assure compliance with 
ethical and HIPPA standards. Additionally, no incentives (i.e., “finder’s fees) will be 
provided to staff for recruiting or referring subjects into the study. Moreover, we are 
going to make it abundantly clear to subjects that participation in the study will in no 
way affects their standing at their academic institutions. 
  
Procedures for Monitoring Adverse Events. All study personnel, will be trained regarding 
how to handle adverse events. Possible adverse events that are unanticipated will be 
brought to the attention of the PIs, the IRBs, and the NIH project officer. The IRBs who 
will determine whether it is appropriate to stop the study protocol temporarily or will 
provide suggestions/modifications to the study procedures as necessary. Possible 
modifications include adding these possible adverse events to the consent form and re-
consenting all study subjects. The PIs will be responsible for monitoring participant 
safety on a monthly basis at regularly scheduled research meetings. They will keep a 
written log of all events and ensure that the IRBs are contacted immediately. They will 
also keep a log of the outcome of IRB decisions regarding adverse events and apprise the 
research team of any changes that need to occur as a result of IRB decisions. 
 
 
1. Dr. Salazar will provide oversight of all recruitment and study procedures and 
quality assurance checks will be conducted by the Project Director Dr. Schipani-
McLaughlin as planned. These quality assurance checks will occur once a week 
during recruitment and assessment time periods to ensure recruitment goals and 
validity of the data. 
2. All records pertaining to the study and all of the original and electronic files 
containing collected data will be securely stored by Dr. Salazar on her password-
protected desktop computer and/or a locked file cabinet located in her locked 
office on GSU campus. Other than Dr. Salazar, only key study personnel will have 
access to the data files. 
3. Specific procedures to ensure the safety of participants will also occur. The 
proposed research contains some risk for participants; however, the likelihood of 
adverse events (AEs) is low. During the efficacy trial, we will contact participants 
via email and texting to not only check in with them but also to promote 
compliance. All participants who demonstrate they are in need of assistance will be 
given a 800 telephone number to obtain immediate crisis counseling and a referral 
24/7; thus, young women will have access to help in the event they feel distress or 
are upset. 
4. Dr. Salazar will participate in the monitoring of participants during the course of 
the research. Should any AEs occur, the project director will be required to 
immediately contact Dr. Salazar. Dr. Salazar will immediately investigate the 
event and determine the appropriate manner in which to proceed. A report 
describing the AE will be submitted to the participating Institutional Review 
Board and to the project officer from NICHD within 10 days of occurrence. In the 
event a change in procedures is required, an amendment to IRB will occur 

promptly, within 10 days. 
5. To monitor that our recruitment and retention projections are being met, Dr. 
Salazar will hold weekly meetings of the research team to assess recruitment 
and retention of participants. 
6. Drs. Salazar and Hayat will be responsible for dissemination of study findings 
through presentation and publication formats. The setting for this research will not 
be named in publications or presentations. 
7. Dr. Schipani-McLaughlin, the project director will monitor the data on a weekly 
basis during assessment periods. She will serve as the project data manager where 
she will examine the data for accuracy and any inconsistencies. She will rectify 
any errors and she will maintain a data correction log to record any errors and how 
they were resolved. 
8. Dr. Matt Hayat, a Co-investigator and statistician on the study, will also perform 
interim analyses to assess the integrity of the data. 
9. Finally, Dr. Salazar, will monitor the study using the following criteria: 
a) Review progress of the surveys as they occur, including analysis of data quality 
and timeliness; subject recruitment, and other factors that may affect outcome. 
b) Review serious adverse event reports, provide commentary, and provide 
oversight to ensure that reports are relayed to individual IRBs and to the 
Office of Human Research Protections (OHRP), as indicated. 
c) Review analyses of outcome data of the current study and review 
reports of related studies to determine whether the current study needs 
to be changed or terminated. 
d) Review proposed modifications to the study prior to their implementation. 
e) Protect the confidentiality of the accumulated data. 
f) Determine whether and to whom outcome results should be released prior to 
the reporting of study results. 
g) Provide appropriate NIH staff with written information concerning their 
findings relevant to the quality of the data. 
 
 

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