- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05738837
An Evaluation of a Sexual Assault Resistance Program for Adolescent Girls (SARE-A)
April 3, 2023 updated by: Dr. Charlene Y. Senn, University of Windsor
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.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Sexual violence (SV), which occurs along a continuum from unwanted sexual contact to rape, is common among adolescent girls and young women: research suggests 1 in 7 teen girls experiences SV.
Perpetrators of SV are overwhelmingly male; however, the programs that exist to address boys'/men's perpetration are not sufficiently effective nor are they widely available.
Other approaches to sexual assault prevention for adolescents, such as bystander programs, have not been shown to reduce sexual violence victimization or perpetration.
Given the numerous negative consequences associated with SV, developing effective SV prevention and resistance programs targeting teens is critical for reducing victimization and improving health outcomes for adolescent girls.
The Enhanced Assess, Acknowledge, Act (EAAA) sexual assault resistance program has been shown to substantially reduce rates of SV (50% for rape and attempted rape) in young women attending university (ages 17-24), but since it was designed for university students in a different developmental stage, an evidence-based adaptation was necessary.
The purpose of the current study is to test the efficacy of the newly adapted Adolescent Enhanced Assess, Acknowledge, Act (A-EAAA) program in reducing sexual violence victimization among adolescent girls within 6-months of trial entry.
We will continue to follow participants for one-year to evaluate whether changes in tertiary outcomes (e.g., mediators) are maintained to 12-months.
A-EAAA is a 12-hour psychoeducational intervention that provides information, skills, and practice aimed at a) decreasing the time needed for girls to assess sexually coercive situations as dangerous and to take action, b) reducing emotional obstacles to taking action, c) increasing the use of the most effective methods of verbal and physical self-defense, and d) identifying sexual and relationship values and boundaries and reinforcing the right to defend them.
Study Type
Interventional
Enrollment (Anticipated)
900
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Charlene Y Senn, PhD
- Phone Number: 2255 (519) 253-3000
- Email: csenn@uwindsor.ca
Study Contact Backup
- Name: Sara E Crann, PhD
- Phone Number: (416) 573-4881
- Email: Sara.Crann@uwindsor.ca
Study Locations
-
-
Ontario
-
Windsor, Ontario, Canada, N9B3P4
- Recruiting
- University of Windsor
-
Contact:
- Research Coordinator, MA
- Phone Number: 3501 (519) 253-3000
- Email: marina.sadik@uwindsor.ca
-
Contact:
- Charlene Y Senn, PHD
- Phone Number: 2255 (519)253-3000
- Email: csenn@uwindsor.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A-EAAA (Adolescent Enhanced Assess, Acknowledge, Act) immediately
Adolescent adaptation of EAAA sexual assault resistance education (4, 3-hr sessions) begun immediately after baseline randomization
|
Adapted from the EAAA program created for university women, A-EAAA is designed for teen girls of all sexual identities and experience levels.
It focuses on resisting sexual assault (SA) committed by male acquaintances with 4, 3-hour units: Unit 1(Assess) strengthens girls' ability to detect risk in contexts involving male acquaintances and helps develop strategies to reduce it.
Unit 2(Acknowledge) helps girls explore ways to overcome their own emotional barriers preventing them from acknowledging risk and employing effective resistance strategies with males they know.
Unit 3(Act) provides evidence on effectiveness of various resistance strategies and teaches verbal and physical self-defense focused on common acquaintance SA situations.
Unit 4 (Relationships&Sexuality) is an adaptation of Our Whole Lives curriculum and aims to increase girls' comfort talking about sex/sexuality and identify their sexual values/desires and explore possibilities for sexual practices beyond intercourse.
Other Names:
|
Active Comparator: Waitlist Control
Usual care 30-min session (brief presentation on consent/sexual assault; access to local resource pamphlets) immediately after baseline randomization; A-EAAA (4, 3-hr sessions) at 6-months post-randomization
|
Participants assigned to the waitlist control group will immediately receive a brief educational session on sexual assault that represents the current 'standard of care' at Canadian high schools (often presented by local Sexual Assault Centres or Public Health nurses).
This 30-min session will involve a brief 15 - 20-minute presentation on sexual consent, respect in relationships, and sexual assault (e.g., definitions, prevalence statistics).
This will be conducted by a well-trained and knowledgeable Research Assistant.
Following the presentation, participants will be invited to take and read brochures provided on sexual assault, and to ask questions about the content of the presentation and brochures.
At 6-months, participants will be scheduled to receive A-EAAA.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Completed Rape
Time Frame: Six months after randomization
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attempted Rape
Time Frame: Six months after randomization
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Other Forms of Sexual Assault
Time Frame: Six months after randomization
|
The SES-SFV will also be used to measure tertiary sexual assault outcomes:
|
Six months after randomization
|
Self-Defense Self-Efficacy
Time Frame: 1-week post-intervention, six months after randomization
|
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
|
Perception of Personal Risk
Time Frame: 1-week post-intervention, six months after randomization
|
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
|
Detection of Risk Cues
Time Frame: 1-week post intervention, 6-months
|
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
|
Knowledge/Willingness to use Effective Self-Defense Strategies
Time Frame: 1-week post-intervention, six months after randomization
|
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
|
Rape Beliefs
Time Frame: 1-week post-intervention, six months after randomization
|
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
|
Experience of Embodiment
Time Frame: 1-week post-intervention, six months after randomization
|
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
|
Self-Blame Following Sexual Assault
Time Frame: six months after randomization
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Charlene Y Senn, PhD, University of Windsor
- Principal Investigator: Sara E Crann, PhD, University of Windsor (on leave Feb 2023-Jan 2024)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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, 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 2023
Primary Completion (Anticipated)
May 31, 2025
Study Completion (Anticipated)
September 30, 2025
Study Registration Dates
First Submitted
February 12, 2023
First Submitted That Met QC Criteria
February 12, 2023
First Posted (Actual)
February 22, 2023
Study Record Updates
Last Update Posted (Actual)
April 4, 2023
Last Update Submitted That Met QC Criteria
April 3, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1819-HQ-000057
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified researchers will be allowed to access de-identified survey responses upon request to the PIs.
IPD Sharing Time Frame
from first publication (estimated 2026) for 5 years.
IPD Sharing Access Criteria
Request submitted to one of the PIs from qualified university researcher.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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