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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: Completed NA study of Sexual Assault, sponsored by University of Michigan.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

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

Conditions Studied

Interventions

  • OTHER IDEA3 Intervention

Study Locations (1)

Michigan

  • University of Michigan School of Nursing - Ann Arbor

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2021-06-14
Est. Completion 2022-06-01
Phase NA
University of Michigan

1,327 total trials

What the finished NCT04797741 record still lists

NCT04797741 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 744-participant average among 12 other Sexual Assault trials with a reported enrollment target (90% lower).

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 a single indexed study location in 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.

Similar trials for Sexual Assault

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04797741's enrollment target sits among peer trials

76 9th of 12 higher than 4 of 12 other Sexual Assault trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Sexual Assault trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04797741, the US trial registry maintained by the National Library of Medicine. NCT04797741 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.