Sexual Assault Resistance Education for University Women

Study Overview
=================
Brief Summary
-----------------
More than one in six women will be sexually assaulted in their lifetimes, most by men they know. The risk of sexual assault by men is greatest for girls and women between the ages of 14 and 24 making this a critical time for intervention. Sexual assault has many immediate and long-term negative consequences for victims. Even a small increase in the ability of women to resist sexual assault will result in a substantial improvement in the mental and physical health of women. Recent research has suggested that many young women delay their resistance to unwanted sexual advances because they are not sure that they are reading the situation correctly, they do not want to hurt the man's feelings, or they are unsure whether they have the right to say no to some sexual activity and say yes to other activity. Earlier work from the researchers resulted in the development of a program affecting these critical areas. This program was shown to be effective in helping participants build skills and a knowledge base to help them resist sexual assault and to prepare them for better recovery following sexual assault. The randomized controlled trial (RCT) builds on this prior work. We will establish whether the demonstrated short term effectiveness of this theoretically and empirically sound rape resistance intervention for university women extends to longer periods. We will determine whether the program can reduce the one year incidence of sexual assault by 30% among women attending Canadian universities. The results will also be used to indicate how long the effects of the program last and will indicate at which point in time refresher sessions may be necessary. A lay summary of the findings of the trial with a focus on application will be provided to all Canadian universities and to Provincial/Territorial Ministries of Education. This will be followed up with contact with those most likely to be involved in current campus education efforts.

Detailed Description
-----------------
Violence against women costs Canadians at least $1.5 billion each year in health related expenses (Day, 1995). The associated physical and mental health effects are extensive and the social and economic costs are staggering. The aim of this project is to reduce a very common form of violence against women, sexual assault, at Canadian universities. At least 1 in 6 women will experience an attempted or completed rape in their lifetimes (Tjaden & Thoennes, 2000). The situation on university campuses is even more startling with as many as 1 in 4 women experiencing rape or attempted rape while enrolled in university (Fisher, Cullen, & Turner, 2000). Reductions in sexual assault will have a direct impact on the mental and physical health of university women. The proposed trial builds on the Principal Investigator's CIHR-funded research which developed, revised, and then tested the basic sexual assault resistance program against a non-random control. It also builds on the Ontario Women's Health Council funded RCT which evaluated the basic program against an enhanced version, and a no-program control. Our pilot work (N=214) revealed that women who had the program experienced lower rates of completed sexual assault (40 - 50% lower) at 3 and 6 months than women who did not. The program also produced measurable improvements in knowledge, attitudes, and skills related to sexual assault resistance and to better recovery following sexual assault. This testing was within one university setting and with only short-term (1 week,3 and 6 month post) follow-up. This RCT extends this evaluation by expanding the participant population and examining the longer term efficacy of the program. First year female students from three Canadian universities will be randomized to receive our education program or to be part of a current practice exposure condition. Outcome measures will be completed at baseline, 1 week, 6, 12 months. The four session sexual assault resistance program under study is based on the best theories and evidence available.Three of the four sessions address steps in a woman's emotional and cognitive processes as they relate to male acquaintances who are acting in a way that makes sexual coercion or sexual assault more likely. The units provide information, skills, and practice aimed at a) decreasing the time needed for women to assess the situation as dangerous and take action, b) reducing emotional obstacles to taking action, and c) increasing the use of the most effective methods of verbal and physical self-defense. The enhanced program piloted in the OWHC project includes a fourth unit which focuses on facilitating a stronger positive sexuality from which women may resist sexual coercion by male intimates more successfully. The primary objective of this study is to establish whether a novel, small-group education program can reduce the one-year incidence of sexual assault by 30% (absolute difference of 7.5%). The secondary objectives are to assess whether changes in knowledge, attitudes, and skills related to the process of sexual assault resistance are improved in the short term, and, along with the primary outcome, maintained for the longer term. The tertiary objective is to assess whether the education program can also reduce the one-year incidence of forced sexual contact and sexual coercion. The results of the trial will be used either to: (a) produce a maximally effective rape resistance education program package which can be adopted by universities across Canada or; (b) provide direction for further research into which aspects of the program need to be strengthened before such broad dissemination. The results will also be used to indicate how long the effects of the program last and will indicate at which point in time refresher sessions may be necessary.

Official Title
-----------------
Sexual Assault Resistance Education for University Women: A Trial in Three Canadian Universities

Conditions
-----------------
Sexual Assault

Intervention / Treatment
-----------------
* Behavioral: Enhanced AAA Sexual Assault Resistance Education
* Behavioral: Brochure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female subjects, aged 18 to 24 years; first-year university student; provide informed consent; able to attend one of four scheduled programs in the semester they are enrolled. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 24 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brochure<br> | Behavioral: Brochure<br>* Current 'standard of care' at Canadian universities. Invitation to take and read brochures on sexual assault selected from those available on their Canadian university campus. All sites' brochures include general information on sexual assault and 'date-rape' drugs and post-rape legal and medical advice. The research assistant (RA) will ask the participants to take brochures, read them over, and to ask any questions they may have. Questions will be answered in a group setting and the participant will take home any brochures that she selected. Interaction between participants and the RA on the topic will be limited to 10-15 minutes and will be audio recorded for verification.<br>* Other names: pamphlet;|
| Experimental: Enhanced AAA Sexual Assault Education<br> | Behavioral: Enhanced AAA Sexual Assault Resistance Education<br>* Resistance Program: 4x3-hour units. Unit 1 (Assess) accurate assessment of sexual assault risk. Provides: empirically-based information on situational and (male) behavioural danger cues; practice identifying risk and counteracting it. Unit 2 'Acknowledge[ment]' of risk when present. Includes: women's sexual rights; emotional barriers; tactics used by coercive men; practice. Unit 3 (Act) includes: assessing whether or not an escape is possible; research evidence on the effectiveness of resistance strategies; physical self-defense training. Unit 4 applies content to longer term relationships covering: comfort talking about sexuality, identification of sexual values, practices beyond intercourse, and articulation of relationship goals.<br>* Other names: rape education;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-event occurrence of completed sexual assault in one year since randomization | Completed sexual assault (rape) will have occurred when a participant indicates she has had at least one experience of threatened, forced, or drugged completed (not attempted) sexual activity (oral, anal, or vaginal intercourse - answered 'once' or more to any of 9 questions (2c, 2d, 2e, 3c, 3d, 3e, 4c, 4d, or 4e) in the period between the baseline measurement and the current day (Sexual Experiences Survey Short Form Victimization (SES-SFV)(Koss et al., 2007) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in perception of risk of sexual assault by male acquaintances and maintenance to 6 and 12 months | Measured by one item (What are your chances of being raped by someone you know?) adapted from Gray et al., (1990) and piloted extensively by Senn. | baseline, 1 week post-intervention, 6 and 12 months | 
| Change from baseline in women's perception of their ability to defend themselves if a sexual assault situation were to arise and maintenance at 6 and 12 months | Self-defense self-efficacy: Ozer & Bandura, 1990 | baseline, 1 week and 6 and 12 months post-intervention | 
| Knowledge of effective rape resistance strategies | number of forceful physical and forceful verbal strategies in response to threatening hypothetical situations (Resistance measure, Testa et al., 2006; qualitative items by Senn) and real situations (items requesting details following sexual assaults experienced, questions added to SES items, Hanson & Gidycz, 1993). | 1 week post-intervention | 
| Ability to realistically assess risk of harm in hypothetical scenarios where acquaintance sexual assault is likely | A) Risk perception questionnaire (Testa et al., 2006). B) Risk Perception Survey (RPS) (Messman-Moore & Brown, 2006) | 1 week post-intervention | 
| Change from baseline in beliefs and attitudes about rape | Indicated by endorsement of rape myths (Illinois Rape Myth Acceptance Scale (IRMA-SF), Payne, et al., 1999) and misinformation about the causes of rape (Perceived Causes of Rape Scale (PCOR), Cowan & Campbell, 1995; revised Cowan & Quinton, 1997); focus on Female Precipitation subscale. | baseline, 1 week, 6 and 12 months post-intervention | 
| Time-to-event occurrence of forced sexual contact and/or sexual coercion in one year since randomization | Using the SES-SFV, forced sexual contact will have occurred when a participant indicates she has had an experience of threatened, forced, or drug facilitated sexual touch not including intercourse - answered 'once' or more to any of 3 questions (1c, 1d, or 1e). Sexual coercion will have occurred when a participant reports one or more incidents of verbally coerced (excluding threats of physical harm) non-consensual oral, vaginal, or anal intercourse - answered 'once' or more to any of 6 questions (2a, 2b, 3a, 3b, 4a, or 4b) in the period between the baseline measurement and the current day. | 12 months | 
| Maintenance of improved knowledge of effective rape resistance strategies | number of forceful physical and forceful verbal strategies in response to threatening hypothetical situations (Resistance measure, Testa et al., 2006; qualitative items by Senn) and real situations (items requesting details following sexual assaults experienced, questions added to SES items, Hanson & Gidycz, 1993). | 12 months | 
| Maintenance of ability to realistically assess risk of harm in hypothetical scenarios where acquaintance sexual assault is likely | A) Risk perception questionnaire (Testa et al., 2006). B) Risk Perception Survey (RPS) (Messman-Moore & Brown, 2006) | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rape, sexual assault, intervention, female university students