Clinical trial NCT04797741: Adapting an Evidence-based Sexual Assault Prevention Intervention for Women Undergraduates for Online Delivery
Official title: Adapting Internet Delivery of Enhanced Assess, Acknowledge, Act (IDEA3), an Evidence-based Sexual Assault Prevention Intervention for Women Undergraduates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Assault
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Sexual assault on college campuses is a prevalent public health problem, with 1 in 3 women experiencing sexual assault during her time in college. It is a major cause of injury, mental health concerns, sexually transmitted infections, and poor educational outcomes in youth and young adults. The Enhanced Assess, Acknowledge, Act (EAAA) sexual assault resistance intervention is the only intervention that has been shown to reduce sexual assault victimization for college women in a randomized controlled trial. EAAA is a 12-hour, peer facilitator-led, in-person intervention proven to reduce attempted or completed rape victimization by over 50% among female undergraduates, with durable effects lasting more than two years. Despite its unique efficacy, uptake of EAAA has been limited, in large part because universities prefer less costly interventions that can be administered online; unfortunately, no online intervention has been proven to reduce victimization.

This project seeks to adapt the existing EAAA intervention for online delivery to groups of students by live facilitators using a systematic adaptation process called ADAPT-ITT. After adapting and refining the intervention, the proposed work seeks to collect feasibility, acceptability, and efficacy-related outcome data.

The project has three aims:

1. Aim 1: Following the ADAPT-ITT framework, pilot a minimally adapted internet-delivered EAAA (IDEA3) with undergraduate women (n=12), collecting data on acceptability immediately following the intervention.
2. Aim 2: Produce a fully adapted IDEA3 intervention that retains core elements of the in-person intervention crucial for efficacy, while capitalizing on unique strengths of the online modality.
3. Aim 3: Test the feasibility and acceptability of IDEA3 through a pilot trial and examine intermediary outcomes shown to be strong mediators of EAAA's effect on reducing victimization (n=64).

The investigators hope this intervention may prevent as many as 50% of sexual assaults experienced by college women, comparable to the existing in-person intervention from which this online intervention is being adapted. Once the intervention has been finalized, the investigators plan to disseminate the intervention and make it widely available to institutions through the SARE Centre, a non-profit partner on the study that currently disseminates the in-person version of the intervention, EAAA.


Eligibility criteria: Inclusion Criteria:

* Participants must be adults ages 18 to 24, AND
* Identify as a woman, AND
* Be a first-year or second-year undergraduate student at the University of Michigan - Ann Arbor, AND
* Reside in Ann Arbor during the program, AND
* Be available during the program times, AND
* Provide the contact information for another woman undergraduate who they would be willing to participate in the intervention with OR express willingness to being partnered with another woman undergraduate at their university AND
* Have access to and willingness to use the videoconferencing software Zoom for the program AND
* Consent to being observed while participating.

Exclusion Criteria:

* Participant is less than 18 years of age or older than 24 years of age, OR
* Does not identify as a woman, OR
* Is not a first-year or second-year undergraduate student at the University of Michigan Ann Arbor, OR
* Does not reside in Ann Arbor, MI during the program, OR
* Is not available during the program times, OR
* Does not provide the contact information for another woman undergraduate who they would be willing to participate in the intervention with AND does not express a willingness to being partnered with another undergraduate OR
* Does not have access to and or is unwilling to use the videoconferencing software Zoom, OR
* Does not consent to being observed while participating.

Primary outcomes:
measure: Feasibility of IDEA3 intervention
timeFrame: Within one week of the final intervention session
measure: Acceptability of IDEA3 intervention
timeFrame: Within one week of the final intervention session
measure: Intervention participants' self-defense self-efficacy
timeFrame: Within one week of the final intervention session
Secondary outcomes:
measure: Efficacy of IDEA3 intervention
timeFrame: Within one week of the final intervention session
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Nursing
state: Michigan
Study officials:
affiliation: University of Michigan
name: Sarah Peitzmeier, PhD
role: PRINCIPAL_INVESTIGATOR
References: