Epidemiology and impact

By conservative estimates, between 18 and 25 percent of women will experience rape or attempted rape in their lifetimes (i.e., experience sexual penetration by the use of threats, force or drugging) [1–3]. If sexual assault not including penetration (i.e., forced, threatened or drugged non-consensual sexual touching) and sexual coercion (i.e., using tactics other than physical force or threats, such as “continual arguments and pressure”) are included, the percentage increases dramatically [4–6]. The incidence of sexual assault and coercion on Canadian and American university campuses are even more startling [6–8]. As many as 1 in 4 female students are estimated to be victims of rape or attempted rape during the relatively short time they are enrolled in post-secondary education [8]. First year students are most at risk [9], probably because university entrance is a transition time for adult intellectual, social, and sexual development, both healthy and unhealthy.

The physical and mental health effects of rape and other forms of sexual coercion have both acute and chronic negative consequences for victims, as well as extensive social and economic consequences. Physical consequences include unwanted pregnancies and sexually transmitted diseases, including HIV and Hepatitis C, [10], cigarette smoking, and alcohol and drug consumption [11, 12]. Short and long-term psychological consequences include depression, post-traumatic stress disorder, suicidal ideation, lack of sexual enjoyment, and fear [13–15]. In Canada alone, sexual assault and other forms of violence against women cost at least $1.5 billion each year in health-related expenses [16] and substantially more in social services, legal processes, and lost time from employment [17]. Fear of rape also affects the quality of life of a high proportion of women who are not rape victims [18–20]. This fear is connected to precautionary strategies that restrict women’s movements at certain times and in certain spaces [21–23], and consequently limits women’s employment and recreational opportunities [20, 22].

Girls and women between the ages of 14 and 24, regardless of their sexual orientation, are most at risk of being sexually assaulted by a man [1, 3, 24–26]. It, therefore, makes sense that efforts to protect women from sexual assault should take place prior to, or within, this ten-year time window. Although many sexual assaults occur prior to age 18 [27, 28], restrictions on the types of sexual content that can be presented in schools make them a difficult site for implementing and evaluating rape prevention programs. In contrast, university campuses are ideal environments as students are adults, and therefore the restrictions are fewer.

Rape prevention efforts on university campuses

There has been a long history of educational efforts to attempt to prevent rape on and off campus [29, 30]. Historically, the most common approach on university campuses, due in large part to structural practicalities, has been to present coeducational audiences with correct information about rape (e.g., most rapes are committed by male acquaintances, undermining rape myths such as that women ‘provoke’ rape if they wear revealing clothes, etc.). These “universal” approaches try to reach both men and women but are not tailored for either [31] and have been shown to result in temporary improvement in rape knowledge and attitudes at best [32–35]. Moreover, most of these programs do not measure incidence or severity of sexual assaults (perpetration or victimization) following the program. In Canada, at the time the present trial began, universities’ rape prevention education appeared to range from provision of brochures to a five minute section of a play done for student orientation (e.g., Single & Sexy, University of Windsor) to 60–90 minute workshops for students (e.g., Queen’s University) unaccompanied by evaluation research.

The authors of most reviews of rape prevention efforts conclude that theoretically-based programs targeted at single-sex audiences have more promise than mixed-sex programs [29, 31, 34, 35]. The exception to this recommendation is seen in more recent educational efforts, where men and women in the audience are being approached as potential bystanders to situations that are developing rather than as perpetrators or victims [36–38]. Even in these circumstances, the same programming is normally offered to men and women in single-sex groups. Educating men to reduce their perpetration is a necessary goal but one that has so far been met with very limited success [39, 40]. Until such time as there is widespread social change or better programming for men, effective rape resistance education (also known as risk reduction programs) for female students is the most promising option [41].

Research on rape resistance education programs and guiding frameworks

Within the past fifteen years, a consensus view of the necessary elements of rape resistance education has emerged. Comprehensive critical reviews [29, 35] stress the importance of the process of education and claim that effective rape prevention programs are likely to be those that actively involve participants and create a sense of high personal relevance. Building on social psychological theories of attitude change and persuasion, such as Eagly and Chaiken’s attitude change model [42, 43], recommendations for program design include the use of expert status and positive consensus information to address cognitive, emotional, and behavioural aspects of attitude processes while ensuring personal motivation and decreased distractions and negative emotional states.

In 1996, Nurius and Norris [44] “offer[ed] a theoretical model that consolidates background, environmental, and intrapersonal variables related to women’s experience of sexual coercion in dating into a coherent ecological framework and present[ed] for the first time a cognitive analysis of the processes women use to formulate responses to sexual coercion” (p. 117). A key article synthesizing a decade of research on rape [41] based its recommendations for rape resistance education programs largely on the Nurius and Norris model expanding it with self-defence training based on research examining tactics predicting successful resistance, [45]. This program plan, named by them “AAA: Assess, Acknowledge, and Act”, expands on the cognitive appraisal model.

Previous trials of rape resistance programs

A systematic review of the literature confirms that despite the size of the ‘at risk’ population and the seriousness of health impacts of rape and sexual assault, a rigorous randomized controlled trial (RCT) of a rape resistance education program has not been conducted. Among the published studies of programs for female university students, only three have demonstrated a positive impact on completed rape rates. However, they have mixed effectiveness and lack the detail to allow a full evaluation of the processes and practices [46, 47].

In their study, Hanson and Gidycz [48] found lower completed rape rates for women in the subsequent two months, but the benefit was only for women who had not been sexually victimized previously. This benefit for non-victimized women was not replicated in a later study that attempted to strengthen the program [49]. Increasing the focus on cognitive and emotional obstacles to resistance also did not improve the outcomes [50]. In an expanded 3-hour program with an increased emphasis on personal relevance to participants and changes expected to enhance processing of information, Gidycz et al. [51] reported a delayed benefit (occurring between 2 and 6 months following the program) for some women only. Women who took the program, and who were sexually assaulted but not raped in the two months after the program, were less likely to be assaulted in the next 4 months than were any other group of women. Gidycz et al. [46] expanded their program to two sessions and added a booster session at 3 months. The 7-hour program included a greater focus on problem solving related to reducing risk and self-defence training but was unable to produce any change in sexual assault outcomes. Orchowski et al.’s [47] addition of self-defence training was successful in producing short term (2 month) reductions in completion of sexual assault for women with and without a sexual assault history. Effects were not maintained 4 months later even with a booster session. Yeater et al. [52] tested the efficacy of reading a “skills-based” self-help book against a wait-list control with 110 college women and demonstrated a number of positive outcomes but no reduction in sexual assaults.

The few other RCTs that also emerged were evaluations of treatment or prevention programs for sexual assault survivors. For example, an RCT of the effectiveness of a self-defence program for female veterans with PTSD following sexual trauma was conducted, but only a discussion of ethical concerns related to the project was found in the published literature [53].

Development and pilot testing of a sexuality-enhanced AAA sexual assault resistance program

Based upon the models of Nurius and Norris [44] and Rozee and Koss [41], a three-session AAA sexual assault resistance program was developed by the principal investigator of the present trial and pilot tested in the fall of 2005 and winter of 2006 on a total of 34 female students against a quasi-experimental control [54]. Positive outcomes at 1 week for women in the intervention compared to controls included increases in the perception of risk, increased self-defence self-efficacy, and higher generation of effective self-defence strategies in hypothetical sexual assault and coercion situations; negative beliefs relating to rape myths and victim provocation in sexual assault were reduced. An unplanned 3-month follow-up with approximately 50% of participants revealed that 21% of women who took the program versus 39% of controls became victims of sexual coercion or assault. Based upon these results, a revised AAA program was conceived to include additional self-defence scenarios and practice.

Rape resistance programs alone may not be enough to protect women from sexual assault in the longer term. Normative sexual practices which put men’s (presumed) sexual needs ahead of women’s have also been implicated in acquaintance sexual assault [55]. For an education program to have long-term effectiveness, it is important to integrate what women know about rape and sexual coercion into the development of their healthy sexuality and relationship practices. The Our Whole Lives (OWL) Curriculum [56], was designed: “to advance communication about sexuality and help participants address their own needs … ; to promote safer sexual practices; to build understanding of healthy sexual relationships and activities; … [and] to help participants accept, understand, and affirm their own sexuality…(p. xi)” Because these principles lay the groundwork for a positive sexuality from which unwanted sex may be resisted more successfully, an adaptation of some of the OWL curriculum units was included in a sexuality-enhanced version of the AAA program.

In 2006–2007, a small RCT of the revised AAA program versus a sexuality-enhanced version of the AAA program versus a no-program control was conducted with 214 students [57]. Women who were assigned to the AAA programs had 40 to 50 percent lower rates of completed sexual assault at 3 and 6 months than women who were not (3 month: 12% control, 6% program; 6 month: 8% control, 5% program). When sexual assault history was included as a covariate for the secondary outcomes, the results did not change substantially, suggesting that the program was equally effective for women with and without a history of prior victimization. In addition to this positive outcome, integration of broader sexual education into rape resistance education had unique benefits related to greater perception of risk.

Notwithstanding these successes, the sexuality unit was presented first, followed by the three sexual assault resistance units and we found unacceptably high attrition between the sexuality session and the sexual assault resistance units (25-30%) compared to attrition between units when sexual assault resistance was offered alone (0-23%). Interviews with the women who dropped out of the combined program suggested that there were two main reasons for this elevated attrition rate. There was discomfort with the sexuality content in the absence of a real bond with the facilitators and the group, and disappointment because the first unit was not sexual assault resistance. Based upon these interviews and discussions with other researchers and educators, the sexuality-enhanced version of the AAA program was revised to offer the sexuality unit last and to contextualize it as an integration of the sexual assault resistance knowledge into women’s on-going and future sexual and romantic relationships. In a subsequent pilot study in 2007–2008 with 32 students, this revision resulted in comparable attendance (82%) for the sexuality unit as for any of the other AAA units.

Aims

Study design

This is a multicentre randomized controlled trial. By necessity, the design will be open-label, whereby the participants will be aware of the nature of the assigned sexual assault intervention. There is no evidence from our pilot testing that knowledge of the assignment influences participants’ responses on key outcomes in any way. For example, post-randomization pre-intervention scores did not differ between participants who were assigned to the AAA education programs and those assigned to no-program.

Inclusion and exclusion criteria

Inclusion criteria: (a) female subjects; (b) age 17 to 24 years; (c) first-year university student (completed no more than 10 university courses); (d) able to attend one of four scheduled programs in the semester they are enrolled; (e) provide informed consent. There are no exclusion criteria. Universities require that all attending foreign students have English proficiency; therefore all students will have sufficient English to participate.

Recruitment

Women will be recruited from each of three sites over a 2-year period, Universities of Windsor, Guelph, and Calgary. The universities are in large and small cities, attract different demographics of students and have very different first year cultures. For example, the University of Windsor is in one of the most ethnically diverse cities in Canada, at the University of Guelph almost all first-year students live on campus, and at the University of Calgary less than 10% of first-year students live on campus. We expect total recruitment from all three sites of more than 200 each fall and winter academic term from contacted students and 50 from orientation activities or first year classes. Our pilot testing indicated that the projected rates of recruitment are achievable. When women were contacted in our pilot study, no more than 11% of them declined and this was primarily due to time considerations rather than topic.

Although recruitment will be site-specific, the information provided to participants in advertisements and in contact with the recruiters will be standardized. Recruitment will begin each year in September with e-mail contact of first year female students by the Registrar, Faculty, or Director of Student Residence. The e-mail will consist of a brief description of the study and the incentives offered and will ask those interested to contact the research assistants by telephone or e-mail. Lists of eligible women in Psychology Participant Pools will also be obtained and research assistants will contact these women. Other advertising will be done by posters in female residence halls and in women’s washrooms on campus, on electronic and physical research posting boards, and flyers left in residence mailboxes. Also, face-to-face recruitment will take place in large first-year classes, at tables in student centres and at orientation and other events.

All interested students will be asked to contact a research assistant who would explain the study in detail prior to scheduling the baseline session. Women will be screened by telephone whenever possible. In instances where women cannot be contacted by telephone they will be provided a detailed description of the study and eligibility criteria by e-mail. All prospective participants will be contacted within the early part of the fall and winter terms. Those who agree to participate will be invited to attend an in-person baseline assessment matching their chosen intervention schedule.

Randomization

The trial biostatistician will set up the centralized randomization using an SSL secured, password-protected web-based technology. Site will be the only stratification factor for administrative reasons. At the time of the recruitment dialogue, the research assistants will be unaware of the arm to which a participant would be assigned. Following signed consent, verbal confirmation of eligibility, and completion of baseline measures, the research assistant will log onto the randomization website, enter each participant’s code number, and will receive the random group assignment. Based upon the assignment, the research assistant will direct the participant to the room where their first intervention session will take place without revealing their assignment to them. Great care will be taken to ensure that agreement to participate and selection of the intervention schedule will be obtained prior to random assignment so that participation could not be affected by the recruiter’s or participant’s knowledge of assignment.

Interventions

Assessments

At baseline, participants will complete computerized surveys prior to being randomized. They will then go immediately to their first intervention session, either to receive their brochures or to attend their first educational unit. To assess knowledge acquisition, intervention participants will have their 1st follow-up assessment 1 week after the last intervention session with control participants matched to the same interval. Subsequent follow-up assessments will occur at 6, 12, 18, and 24 months from the date of randomization. We will measure outcomes using in-person computerized surveys at baseline and 1 week after the last intervention session. All other follow-ups will use secure web-based surveys linked only by participant codes to protect privacy.

Outcome measures

Proposed methods for protecting against sources of bias

Sample size considerations

The primary outcome is completed sexual assault (rape). Our 2006–2007 pilot randomized controlled trial of 214 students yielded the following cumulative incidences. For women in the control arm, the 3- and 6-month rates were 12% and 20%, respectively. For those in the sexual assault resistance education program, they were 6% and 11%, respectively. These figures correspond to a 50% relative risk reduction. This is comparable to the one previous study conducted by Hanson and Gidycz [49], which yielded a rate of 14% of rapes in their control arm and 6% in their intervention arm over a 3-month period, among women with no history of previous victimization. Given that the incremental incidence of sexual assault declines over time we estimate, for the purpose of sample size calculations, the 1-year rates to be 25% in the brochure arm and 17.5% in the educational program arm; a more conservative 30% relative risk reduction. Therefore, a sample size of 932 women (466 per group) will have 80% power to detect an absolute difference of 7.5% (25% versus 17.5% equals a 30% relative reduction) at a two-sided 5% level of significance. This is a meaningful reduction because it implies that for every 14 women who enroll in the program, 1 additional rape could be averted. Aside from power considerations, it is important to note that a sample of this size will yield a significantly positive trial when the observed difference between groups is as small as 5.4% (21.6% relative risk reduction). Although the intracluster correlation was calculated as −0.02 from our pilot study, +0.02 will be used to inflate the sample size with a design effect of 1.38 and a cluster size of 20 women. Assuming a lost-to-follow-up of 10% in the first year and 15% in the second year of follow-up, the total size of the trial will be 1716 women (932×1.38÷0.75).

Statistical analyses

Analyses will be performed after all women have completed their one-year follow-up and at the end of the trial. Following the intention-to-treat principle, a participant will be included in the analysis if she is randomized. Using SAS software [92] the primary (and tertiary) analyses will compare the proportion of women with completed sexual assaults between groups using a Wald test from a log-binomial regression model (PROC GENMOD) that adjusts for compound symmetry (CS) clustering using generalized estimating equations. Covariates will be added to the model if differences among baseline characteristics are observed. In addition, a test for interaction will be performed using the above model to assess whether there is a differential treatment effect depending upon whether the women participated in the weekend versus weekday programs. Women who are lost to follow-up or drop out can affect the validity of the group comparison if (a) sexual assault is related to being lost or dropped and (b) it is differential between groups. Thus, baseline characteristics of women who are lost and drop out will be compared to women who complete the trial. In addition, the missing data mechanism will be formally tested [93] to determine whether it is Missing Completely at Random (MCAR) or is Missing at Random (MAR). Freedom from completed sexual assault will be compared between groups using Cox regression (PROC PHREG) with a robust sandwich covariance matrix to account for the clustering. Women who are lost to follow-up or drop out will have their data censored at the time of last contact.

For the secondary outcomes which are all continuous (or at least ordinal) longitudinal, repeated measures analysis of covariance (ANCOVA) will be used to compare intervention arms across the follow-up periods, adjusting for baseline scores on the instruments. Generalized linear models (PROC MIXED) will be used to correctly adjust the variance estimates for CS clustering. Recognizing that some of the instruments have ordinal responses, a rank-based ANCOVA will also be performed to assess congruency with the parametric analyses. For completeness in assessing the effect of missingness, two additional analyses will be conducted: (a) a ‘per-protocol’ analysis among participants who attend all sessions and respond to the 1-year SES-SFV questions; (b) multiple imputation of five data sets (PROC MI and MIANALYZE) using a discriminant function for binary outcomes and Markov chain Monte Carlo for continuous outcomes, assuming the missing data mechanism is MAR. The literature, for example [49], suggests that prior sexual assault can be a modifier with respect to the effectiveness of sexual assault resistance programs. Accordingly, program effects will be compared for women with and without sexual assault histories at baseline.

Ethical considerations

Ethical approval for the trial was received from the University of Windsor Research Ethics Board on May 31, 2011, from the University of Guelph’s Research Ethics Board on June 14, 2011 and from the University of Calgary’s Conjoint Health Research Ethics Board on September 9, 2011. There are no serious anticipated risks to participants, although the content of the educational interventions and some survey questions on sexual assault could bring up negative feelings for participants, particularly if they have an assault history. The self-defence instruction adds limited physical risk if participants do not follow instructions carefully. In our pilot studies involving over 200 women, none reported adverse effects.

Steering committee and trial oversight

The Steering Committee for the trial will consist of the Principal Investigator and four Co-Investigators. A Data Safety Monitoring Committee is not needed as our psychosocial intervention does not warrant it. The Trial Project Manager will make decisions for all sites on trial issues that arise and communicate with the Site Coordinators to ensure consistency on these issues. The Trial Project Manager will be supervised by the Principal Investigator and the Site Coordinators will be supervised by the Site Investigators. Research Assistants will be supervised by Site Coordinators. The Trial Project Manager, Principal Investigator, and Co-Investigators will meet monthly by teleconference and annually in person.

Intervention conformity will be measured by having site facilitators complete a Session Protocol Issues form at the end of each unit and by review of audio recordings of randomly selected sessions for each facilitator. Audio recordings will be reviewed by the Trial Project Manager and any outstanding issues will be addressed in special meetings. Protocol issues identified by facilitators will be addressed in weekly meetings.

Trial status

The first participant was randomized on September 28, 2011. Currently, 918 women have been enrolled into the on-going trial.