Adapting an Evidence-based Sexual Assault Prevention Intervention for Women Undergraduates for Online Delivery

Adapting Internet Delivery of Enhanced Assess, Acknowledge, Act (IDEA3), an Evidence-based Sexual Assault Prevention Intervention for Women Undergraduates

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.

Study Overview

• Status: Completed
• Conditions: Sexual Assault
• Intervention / Treatment: Other: IDEA3 Intervention

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • University of Michigan School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDEA3 Intervention	Other: IDEA3 Intervention; Delivery of IDEA3 intervention, a 12-hour online sexual assault resistance intervention for college women.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of IDEA3 intervention	This will be assessed by reviewing speed of recruitment and noting no-shows (at first session), overall session attendance, and retention rates for the online intervention to determine whether incentives are sufficient for a future larger trial; reviewing fidelity to the original intervention based on reviewing recordings of all online intervention sessions; reviewing and cataloging deviations from the manual; and final review of what pieces of IDEA3 went well and what pieces need to be further adapted in the future.	Within one week of the final intervention session
Acceptability of IDEA3 intervention	This will be assessed from summary statistics calculated from survey questions completed by participants relating to dimensions of affective attitude (how the individual feels about the intervention); burden (perceived effort required to participate); ethicality (extent to which the intervention fits with the individual's value system), perceived effectiveness, and whether they would recommend the intervention to a friend.	Within one week of the final intervention session
Intervention participants' self-defense self-efficacy	This will be assessed from participant answers to baseline and post-test surveys that use validated scales to measure self-defense self-efficacy (i.e. confidence that one could defend oneself against sexual assault)	Within one week of the final intervention session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of IDEA3 intervention	This will be assessed from participant answers to baseline and post-test surveys that use validated scales to measure five intermediary outcomes that account for EAAA's effect on reducing victimization: earlier detection of risk in coercive situations; greater risk perception of acquaintance rape; lower rape myth acceptance; knowledge of, and willingness to use evidence-based forceful verbal and physical resistance in a hypothetical situation; and earlier identification of 'discomfort' and earlier willingness to leave a hypothetical situation.	Within one week of the final intervention session

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Sarah Peitzmeier, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HUM00183965; 0920-1301 (Other Grant/Funding Number: Centers for Disease Control and Prevention)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data from video recordings contain identifiers including participant images and names which cannot be removed, and will therefore remain non-public. Deidentified survey data from initial screener surveys can be made available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No