NCT05738837

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
343

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

March 18, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2026

Completed
Last Updated

April 14, 2026

Status Verified

February 1, 2026

Enrollment Period

2.3 years

First QC Date

February 12, 2023

Last Update Submit

April 9, 2026

Conditions

Keywords

interventionadolescentssexual assaultrapedating violencegender-based violencegirls' healthprevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Attempted Rape

    Six months after randomization

Other Outcomes (8)

  • Other Forms of Sexual Assault

    Six months after randomization

  • Self-Defense Self-Efficacy

    1-week post-intervention, six months after randomization

  • Perception of Personal Risk

    1-week post-intervention, six months after randomization

  • +5 more other outcomes

Study Arms (2)

A-EAAA (Adolescent Enhanced Assess, Acknowledge, Act) immediately

EXPERIMENTAL

Adolescent adaptation of EAAA sexual assault resistance education (4, 3-hr sessions) begun immediately after baseline randomization

Behavioral: A-EAAA Sexual Assault Resistance Education Program immediately

Waitlist Control

ACTIVE COMPARATOR

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

Behavioral: Usual care + A-EAAA at 6 months

Interventions

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.

Waitlist Control

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.

Also known as: Girls -- Flip the Script with EAAA
A-EAAA (Adolescent Enhanced Assess, Acknowledge, Act) immediately

Eligibility Criteria

Age14 Years - 18 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsindividuals must self-identify as girls/young women
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Windsor

Windsor, Ontario, N9B3P4, Canada

Location

Related Publications (2)

  • 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.

    PMID: 26061837BACKGROUND
  • 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.

    PMID: 29503496BACKGROUND

Study Officials

  • Charlene Y Senn, PhD

    University of Windsor

    PRINCIPAL INVESTIGATOR
  • Sara E Crann, PhD

    University of Windsor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
All participants are blind to allocation at baseline assessment. Randomization occurs after in-person survey completion and is initially masked (using colour coded room assignments). Allocation is revealed to participants by intervention staff once they arrive at their assigned intervention room. All data analysis is done by a Co-I who has no contact with participants.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Approximately 900 self-identified girls/young women age 14-18 (who have not already graduated high school) will be recruited from 3 communities in Ontario over two years. Participants will be randomly assigned to either receive the A-EAAA program immediately (treatment group) or 6 months later (waitlist control group). Control group participants will attend a brief 'usual care' session providing them with basic information on SV and consent in parallel with the treatment group's first session. All participants will complete surveys at 4 timepoints: baseline, 1-week post-intervention (control group matched to treatment group timing), and 6 and 12 months after baseline. The control group will take the A-EAAA program following the 6-month post-survey and complete one additional survey, 1-week after their final program session.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished University Professor

Study Record Dates

First Submitted

February 12, 2023

First Posted

February 22, 2023

Study Start

March 18, 2023

Primary Completion

June 23, 2025

Study Completion

February 3, 2026

Last Updated

April 14, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Qualified researchers will be allowed to access de-identified survey responses upon request to the PIs.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
from first publication (estimated 2026) for 5 years.
Access Criteria
Request submitted to one of the PIs from qualified university researcher.

Locations