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NCT04797741 · ClinicalTrials.gov registry record · NA
Adapting an Evidence-based Sexual Assault Prevention Intervention for Women Undergraduates for Online Delivery
A NA study of Sexual Assault, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 76
- Enrollment target
- 1
- Study location
NCT04797741 is a NA study of Sexual Assault that has completed, run by University of Michigan. The registered enrollment target is 76 participants, below the 744-participant average among 12 other Sexual Assault trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04797741, a NA study of Sexual Assault, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 76 participants
- Enrollment target
- 1
- Study location
Study 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 as
Conditions Studied
Interventions
- OTHER IDEA3 Intervention
Study Locations (1)
Michigan
- University of Michigan School of Nursing - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2021-06-14 |
| Est. Completion | 2022-06-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04797741
The ClinicalTrials.gov registry entry for NCT04797741 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 744-participant average among 12 other Sexual Assault trials with a reported enrollment target (90% lower). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Sexual Assault appearing as the primary indexed condition, and to 1 intervention - of which IDEA3 Intervention is the first listed.
NCT04797741 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT04797741 about?
NCT04797741 is a clinical study titled "Adapting an Evidence-based Sexual Assault Prevention Intervention for Women Undergraduates for Online Delivery". 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 Enha...
What is the current status of trial NCT04797741?
This trial is currently completed. It is a NA study. The enrollment target is 76 participants. The study started on 2021-06-14. Estimated completion is 2022-06-01.
What conditions does trial NCT04797741 study?
This clinical trial studies the following conditions: Sexual Assault.
What interventions are being tested in trial NCT04797741?
The interventions under investigation include: IDEA3 Intervention (OTHER).
Who is sponsoring clinical trial NCT04797741?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04797741 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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