Sexual Assault Clinical Trial
— SARE-AOfficial title:
A Phase III Randomized Wait-list Controlled Trial of the Efficacy of the Adolescent Adaptation of the EAAA Sexual Assault Resistance Education Program
Sexual violence (SV) perpetrated by dating partners and male acquaintances is common among adolescent girls in high school. Girls and young women who experience SV are likely to encounter negative mental and physical health consequences as well as lowered academic performance. While educational interventions to address the problem of SV are numerous, when evaluated, few show any capacity to reduce sexual violence victimization or perpetration. The Enhanced Assess, Acknowledge, Act (EAAA) sexual assault resistance program for female university students (ages 17-24) is a rare exception; in a rigorous trial, EAAA reduced attempted and completed rape by 50% in the following year. The current randomized controlled trial (RCT) will test whether a version of EAAA that has been adapted for younger girls (age 14-18) who have not graduated high school (called the Adolescent Enhanced Assess, Acknowledge, Act [A-EAAA]) will result in similar benefits within a 6-month follow-up. The current RCT will be conducted across three sites in Ontario, Canada.
Status | Recruiting |
Enrollment | 900 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years to 18 Years |
Eligibility | Inclusion Criteria: - Self-identified girls aged 14 to 18 years; - have not graduated high school; - competence in spoken and written English; - provide informed consent; - able to attend one of the scheduled programs in the data collection period in which they are enrolled. Exclusion Criteria: None |
Country | Name | City | State |
---|---|---|---|
Canada | University of Windsor | Windsor | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Windsor | Public Health Agency of Canada (PHAC) |
Canada,
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. — View Citation
Senn CY, Eliasziw M, Hobden KL, Newby-Clark IR, Barata PC, Radtke HL, Thurston WE. Secondary and 2-Year Outcomes of a Sexual Assault Resistance Program for University Women. Psychol Women Q. 2017 Jun;41(2):147-162. doi: 10.1177/0361684317690119. Epub 2017 Mar 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Other Forms of Sexual Assault | The SES-SFV will also be used to measure tertiary sexual assault outcomes:
Non-penetrative forced sexual contact will have occurred when a participant indicates she has had at least one such experience of non-penetrative sexual contact by any perpetrator strategy - answered 'once' or more to any of 5 questions (1a, 1b, 1c, 1d, 1e). Completed sexual coercion will have occurred when a participant indicates she has had at least one experience of coerced (not forced) completed sexual activity (oral, anal, or vaginal intercourse - answered 'once' or more to any of 6 questions (2a, 2b, 3a, 3b, 4a, 4b). Attempted sexual coercion will have occurred when a participant indicates she has had at least one experience of coerced (not forced) attempted (not completed) sexual activity (oral, anal, or vaginal intercourse - answered 'once' or more to any of 6 questions (5a, 5b, 6a, 6b, 7a, 7b). |
Six months after randomization | |
Other | Self-Defense Self-Efficacy | Measured with a questionnaire adapted by Senn et al. (2011) from Marx, Calhoun, Wilson, & Meyerson (2001) will be used to assess changes from baseline in girls' confidence that they could defend themselves if confronted with a sexual assault situation. | 1-week post-intervention, six months after randomization | |
Other | Perception of Personal Risk | A single item adapted from Gray, Lesser, & Brounds (1990) will be used to measure girls' and young women's perception of their personal risk of sexual assault by male acquaintances. | 1-week post-intervention, six months after randomization | |
Other | Detection of Risk Cues | Scenario measures will be used to assess participants' ability to detect risk in hypothetical acquaintance scenarios. At 1-week post-intervention (measure adapted from Testa et al. (2006)), at 6- -months (acquaintance scenario adapted from Messman-Moore & Brown (2006)). Each measure can only be used once. | 1-week post intervention, 6-months | |
Other | Knowledge/Willingness to use Effective Self-Defense Strategies | Direct Resistance subscale of Testa et al. (2006)'s measure used at 1-week post intervention. A survey adapted from Senn, Gee, & Thake (2011) will be used to measure changes from baseline in participants' knowledge of the most effective self-defense strategies. | 1-week post-intervention, six months after randomization | |
Other | Rape Beliefs | The Updated Illinois Rape Myth Acceptance scale (Payne et al., 1999; McMahon & Farmer, 2011), the Perceived Causes of Rape scale (Cowan & Campbell, 1995; Cowan & Quinton, 1997), and the Attitudes Toward Male Sexual Violence scale (Prince et al., 1999) will be used to measure girls' beliefs about rape. | 1-week post-intervention, six months after randomization | |
Other | Experience of Embodiment | Girls' sense of embodiment (i.e., the extent to which they feel in tune and comfortable with their bodies), measured via Piran & Teall (2012)'s questionnaire. | 1-week post-intervention, six months after randomization | |
Other | Self-Blame Following Sexual Assault | Behavioral self-blame subscale from Frazier et al. (2005) will be used to assess the extent to which girls who are sexually assaulted in the follow-up timeframe of the trial blame themselves for the incident(s). | six months after randomization | |
Primary | Completed Rape | The Sexual Experiences Survey Short Form Victimization (SES-SFV) will be used to measure the primary sexual assault outcomes. Completed 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 6-month survey measurement. | Six months after randomization | |
Secondary | Attempted Rape | The SES-SFV will also be used to measure secondary sexual assault outcomes: Attempted rape will have occurred when a participant indicates she has had at least one experience of threatened, forced, or drugged attempted (not completed) sexual activity (oral, anal, or vaginal intercourse - answered 'once' or more to any of 9 questions (5c, 5d, 5e, 6c, 6d, 6e, 7c, 7d, or 7e) in the period between the baseline and the 6-month survey. | Six months after randomization |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04160702 -
Using VR to Assess the Efficacy of a Motivational Interviewing Intervention to Increase Bystander Behaviors
|
N/A | |
Completed |
NCT01338428 -
Sexual Assault Resistance Education for University Women
|
Phase 2 | |
Completed |
NCT01907126 -
HIV/STI Risk Reduction for Incarcerated Women With Interpersonal Violence
|
Phase 2 | |
Active, not recruiting |
NCT05206994 -
Evaluation of the Close to Home Program in California
|
N/A | |
Enrolling by invitation |
NCT05281874 -
Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students
|
N/A | |
Recruiting |
NCT06058455 -
An Evaluation of an Online Sexual Assault Resistance Program (IDEA3)
|
N/A | |
Completed |
NCT05773027 -
Integrated Alcohol and Sexual Assault Intervention for College Men
|
N/A | |
Completed |
NCT05892692 -
Nexus of Risk: Sexual Assault, Alcohol Use, and Risky Sex Among College Women
|
N/A | |
Completed |
NCT05065918 -
Text Message Intervention for Alcohol Use and Sexual Violence in College Students
|
N/A | |
Recruiting |
NCT05345405 -
Clinical Trial of a Supporter-Targeted Intervention to Improve Outcomes in Recent Sexual Assault Survivors
|
N/A | |
Completed |
NCT04089137 -
Alcohol and Violence Prevention for College Students
|
N/A | |
Completed |
NCT03820609 -
Interactive Digital Intervention to Prevent Violence Among Young Adults
|
N/A | |
Completed |
NCT02384642 -
Creating Opportunities Through Mentoring, Parenting and Safe Spaces - Democratic Republic of Congo
|
N/A | |
Completed |
NCT04797741 -
Adapting an Evidence-based Sexual Assault Prevention Intervention for Women Undergraduates for Online Delivery
|
N/A | |
Active, not recruiting |
NCT04564599 -
The Rise of Ride Sharing Companies and Trends in Impaired Driving Accidents
|
||
Completed |
NCT04950686 -
Study of Long-term Efficacy and Mechanisms Underlying the Impact of a Web-based Sexual and Relationship Health Promotion Program With Young Adult Community College Students
|
N/A | |
Completed |
NCT04691492 -
Protecting Allies in Risky Situations
|
N/A | |
Completed |
NCT03111056 -
Web-Based Treatment of Heavy Drinking Among Women With a History of Sexual Trauma
|
N/A | |
Not yet recruiting |
NCT06183385 -
Detection of Saliva by Immunoaffinity and Mass Spectrometry
|
N/A | |
Not yet recruiting |
NCT06101056 -
Code of Respect (X-CoRe): Trial of a Multi-level Sexual Assault and Sexual Harassment Prevention Intervention for Active Duty Airmen
|
N/A |