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Sexual AssaultPhase 2NCT01338428

Sexual Assault Resistance Education for University Women

A Phase 2 study testing Enhanced AAA Sexual Assault Resistance Education and Brochure in people with Sexual Assault, run by University of Windsor at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 17 to 24 years, women onlyHealthy volunteers can take part
Conditions the study is for
Sexual Assault
What is being tested?
Enhanced AAA Sexual Assault Resistance Education and Brochure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
916 participants
Where
2 sitesCanada
Study dates
Sep 2011to Nov 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 24 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • None

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

  • University of Guelph

    Guelph, Ontario, N1G 2W1

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Sexual Assault
Being tested
Enhanced AAA Sexual Assault Resistance Education, Brochure
Keywords
rape, sexual assault, intervention, female university students

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced AAA Sexual Assault Resistance EducationBehavioural

    Also called rape education

    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.

  • BrochureBehavioural

    Also called pamphlet

    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.

Study groups in NCT01338428
Study groupRoleWhat they receive
BrochureActive comparatorNot described
Receives: Behavioral: Brochure
Enhanced AAA Sexual Assault EducationExperimentalNot described
Receives: Behavioral: Enhanced AAA Sexual Assault Resistance Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 12 months

Secondary outcomes (8)

  1. 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.

    Measured: baseline, 1 week post-intervention, 6 and 12 months

  2. 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

    Measured: baseline, 1 week and 6 and 12 months post-intervention

  3. 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).

    Measured: 1 week post-intervention

  4. Ability to realistically assess risk of harm in hypothetical scenarios where acquaintance sexual assault is likely

    1. Risk perception questionnaire (Testa et al., 2006). B) Risk Perception Survey (RPS) (Messman-Moore \& Brown, 2006)

    Measured: 1 week post-intervention

  5. 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.

    Measured: baseline, 1 week, 6 and 12 months post-intervention

  6. 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.

    Measured: 12 months

  7. 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).

    Measured: 12 months

  8. Maintenance of ability to realistically assess risk of harm in hypothetical scenarios where acquaintance sexual assault is likely

    1. Risk perception questionnaire (Testa et al., 2006). B) Risk Perception Survey (RPS) (Messman-Moore \& Brown, 2006)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionMay 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
916 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01338428
Sponsor's protocol ID
MOP-110976
Status last verified
Nov 2014
First submitted
13 Apr 2011
Last updated
24 Nov 2014
Results posted
No
Data monitoring committee
No

Publications

  • Senn CY, Gee S & Thake J. Emancipatory sexuality education and sexual assault resistance: Does the former enhance the latter? Psychology of Women Quarterly 35(1): 72-91, 2011.

  • Day, T. (1995). The Health-Related Costs of Violence against Women in Canada: The Tip of the Iceberg. London, On.: The Centre for Research on Violence Against Women and Children, 1995.

  • Tjaden P, Thoennes N. Full Report of the Prevalence, Incidence, and Consequences of Violence Against Women: Findings From the National Violence Against Women Survey. U.S. Department of Justice Office of Justice Programs, 2000.

  • Fisher B, Cullen F, Turner M. The Sexual Victimization of College Women: Findings From Two National-Level Studies. Washington, DC: National Institute of Justice and Bureau of Justice Statistics, 2000.

  • Koss MP, Abbey A, Campbell R, Cook S, Norris J, Testa M. et al. Revising the SES: A collaborative process to improve assessment of sexual aggression and victimization. Psychology of Women Quarterly, 31(4), 357-370, 2007.

  • Ozer EM, Bandura A. Mechanisms governing empowerment effects: a self-efficacy analysis. J Pers Soc Psychol. 1990 Mar;58(3):472-86. doi: 10.1037//0022-3514.58.3.472.

    PubMed 2324938

  • Gray DM, Lesser D, Quinn E, Brounds C. The effectiveness of personalizing acquaintance rape prevention: Programs on perception of vulnerability and on reducing risk-taking behavior. Journal of College Student Development, 31, 217-220, 1990.

  • Hanson KA, Gidycz CA. Evaluation of a sexual assault prevention program. J Consult Clin Psychol. 1993 Dec;61(6):1046-52. doi: 10.1037//0022-006x.61.6.1046.

    PubMed 8113482

  • Testa M, Vanzile-Tamsen C, Livingston JA, Buddie AM. The role of women's alcohol consumption in managing sexual intimacy and sexual safety motives. J Stud Alcohol. 2006 Sep;67(5):665-74. doi: 10.15288/jsa.2006.67.665.

    PubMed 16847534

  • Messman-Moore TL, Brown AL. Risk perception, rape and sexual revictimization: A prospective study of college women. Psychology of Women Quarterly, 30, 159-172, 2006.

  • Payne DL, Lonsway KA, Fitzgerald LF. Rape myth acceptance: Exploration of its structure and its measurement using the Illinois Rape Myth Acceptance Scale. Journal of Research in Personality, 33, 27-68, 1999.

  • Cowan G, Campbell RR. Rape causal attitudes among adolescents. Journal of Sex Research, 32, 145-153, 1995.

  • Cowan G, Quinton WJ. Cognitive style and attitudinal correlates of the perceived causes of rape scale. Psychology of Women Quarterly, 21, 227-245, 1997.

  • 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.

    PubMed 33864584

  • 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.

    PubMed 26061837

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enhanced AAA Sexual Assault Resistance Education and Brochure in people with Sexual Assault, run by University of Windsor at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-to-event occurrence of completed sexual assault in one year since randomization (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01338428, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2014.

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