NCT01338428

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
916

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2011

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 19, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 24, 2014

Status Verified

November 1, 2014

Enrollment Period

2.7 years

First QC Date

April 13, 2011

Last Update Submit

November 21, 2014

Conditions

Keywords

rapesexual assaultinterventionfemale university students

Outcome Measures

Primary Outcomes (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)

    12 months

Secondary Outcomes (8)

  • Change from baseline in perception of risk of sexual assault by male acquaintances and maintenance to 6 and 12 months

    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

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

  • Knowledge of effective rape resistance strategies

    1 week post-intervention

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

    1 week post-intervention

  • Change from baseline in beliefs and attitudes about rape

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

  • +3 more secondary outcomes

Study Arms (2)

Brochure

ACTIVE COMPARATOR
Behavioral: Brochure

Enhanced AAA Sexual Assault Education

EXPERIMENTAL
Behavioral: Enhanced AAA Sexual Assault Resistance Education

Interventions

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.

Also known as: rape education
Enhanced AAA Sexual Assault Education
BrochureBEHAVIORAL

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.

Also known as: pamphlet
Brochure

Eligibility Criteria

Age17 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

University of Guelph

Guelph, Ontario, N1G 2W1, Canada

Location

Related Publications (17)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 2324938BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 8113482BACKGROUND
  • 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.

    PMID: 16847534BACKGROUND
  • 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.

    BACKGROUND
  • 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.

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

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

    BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

Study Officials

  • Charlene Y Senn, PhD

    University of Windsor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 13, 2011

First Posted

April 19, 2011

Study Start

September 1, 2011

Primary Completion

May 1, 2014

Study Completion

November 1, 2014

Last Updated

November 24, 2014

Record last verified: 2014-11

Locations