Clinical trial NCT05738837: An Evaluation of a Sexual Assault Resistance Program for Adolescent Girls
Official title: A Phase III Randomized Wait-list Controlled Trial of the Efficacy of the Adolescent Adaptation of the EAAA Sexual Assault Resistance Education Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sexual Assault
Keywords: intervention
adolescents
sexual assault
rape
dating violence
gender-based violence
girls' health
prevention
Lead sponsor: University of Windsor
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Canada (PHAC)
First posted: 2023-02-22
Enrollment: 900
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Completed Rape
timeFrame: Six months after randomization
Secondary outcomes:
measure: Attempted Rape
timeFrame: Six months after randomization
Other outcomes:
measure: Other Forms of Sexual Assault
timeFrame: Six months after randomization
measure: Self-Defense Self-Efficacy
timeFrame: 1-week post-intervention, six months after randomization
measure: Perception of Personal Risk
timeFrame: 1-week post-intervention, six months after randomization
measure: Detection of Risk Cues
timeFrame: 1-week post intervention, 6-months
measure: Knowledge/Willingness to use Effective Self-Defense Strategies
timeFrame: 1-week post-intervention, six months after randomization
measure: Rape Beliefs
timeFrame: 1-week post-intervention, six months after randomization
measure: Experience of Embodiment
timeFrame: 1-week post-intervention, six months after randomization
measure: Self-Blame Following Sexual Assault
timeFrame: six months after randomization
Locations:
city: Windsor
country: Canada
facility: University of Windsor
state: Ontario
Study officials:
affiliation: University of Windsor
name: Charlene Y Senn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Windsor (on leave Feb 2023-Jan 2024)
name: Sara E Crann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.