Sexual Assault Clinical Trial
Official title:
Sexual Assault Resistance Education for University Women: A Trial in Three Canadian Universities
Verified date | November 2014 |
Source | University of Windsor |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Canadian Institutes of Health Research |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 916 |
Est. completion date | November 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 17 Years to 24 Years |
Eligibility |
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: |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary | Calgary | Alberta |
Canada | University of Guelph | Guelph | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Windsor | Canadian Institutes of Health Research (CIHR) |
Canada,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
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