Clinical trial NCT01338428: Sexual Assault Resistance Education for University Women
Official title: Sexual Assault Resistance Education for University Women: A Trial in Three Canadian Universities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sexual Assault
Keywords: rape
sexual assault
intervention
female university students
Lead sponsor: University of Windsor
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2011-04-19
Enrollment: 916
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Time-to-event occurrence of completed sexual assault in one year since randomization
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline in perception of risk of sexual assault by male acquaintances and maintenance to 6 and 12 months
timeFrame: baseline, 1 week post-intervention, 6 and 12 months
measure: 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
timeFrame: baseline, 1 week and 6 and 12 months post-intervention
measure: Knowledge of effective rape resistance strategies
timeFrame: 1 week post-intervention
measure: Ability to realistically assess risk of harm in hypothetical scenarios where acquaintance sexual assault is likely
timeFrame: 1 week post-intervention
measure: Change from baseline in beliefs and attitudes about rape
timeFrame: baseline, 1 week, 6 and 12 months post-intervention
measure: Time-to-event occurrence of forced sexual contact and/or sexual coercion in one year since randomization
timeFrame: 12 months
measure: Maintenance of improved knowledge of effective rape resistance strategies
timeFrame: 12 months
measure: Maintenance of ability to realistically assess risk of harm in hypothetical scenarios where acquaintance sexual assault is likely
timeFrame: 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Guelph
country: Canada
facility: University of Guelph
state: Ontario
Study officials:
affiliation: University of Windsor
name: Charlene Y Senn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Hobden KL, Thurston WE, McVey GL, Senn CY. An Evaluation of Strategies Used to Maximize Intervention Fidelity in a Randomized Controlled Trial of a Sexual Assault Resistance Program for University Women. Prev Sci. 2021 Oct;22(7):960-970. doi: 10.1007/s11121-021-01239-2. Epub 2021 Apr 17.
citation: Senn CY, Eliasziw M, Barata PC, Thurston WE, Newby-Clark IR, Radtke HL, Hobden KL. Efficacy of a sexual assault resistance program for university women. N Engl J Med. 2015 Jun 11;372(24):2326-35. doi: 10.1056/NEJMsa1411131.
citation: Senn CY, Eliasziw M, Barata PC, Thurston WE, Newby-Clark IR, Radtke HL, Hobden KL; SARE Study Team. Sexual violence in the lives of first-year university women in Canada: no improvements in the 21st century. BMC Womens Health. 2014 Nov 5;14:135. doi: 10.1186/s12905-014-0135-4.
citation: Senn CY, Eliasziw M, Barata PC, Thurston WE, Newby-Clark IR, Radtke HL, Hobden KL; SARE study team. Sexual assault resistance education for university women: study protocol for a randomized controlled trial (SARE trial). BMC Womens Health. 2013 May 23;13:25. doi: 10.1186/1472-6874-13-25.