Sexual AssaultNCT04797741
Adapting an Evidence-based Sexual Assault Prevention Intervention for Women Undergraduates for Online Delivery
A study testing IDEA3 Intervention in people with Sexual Assault, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Assault
- What is being tested?
- IDEA3 Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Nursing
Ann Arbor, Michigan, 48104
About this study
Official title: 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.
Read more
The project has three aims:
- 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.
- 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.
- 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.
- Conditions
- Sexual Assault
- Being tested
- IDEA3 Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDEA3 InterventionOther
Delivery of IDEA3 intervention, a 12-hour online sexual assault resistance intervention for college women.
| Study group | Role | What they receive |
|---|---|---|
| IDEA3 Intervention | Experimental | Not described Receives: Other: IDEA3 Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: Within one week of the final intervention session
Secondary outcomes (1)
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.
Measured: Within one week of the final intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start14 Jun 2021
- Primary completion30 Apr 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual AssaultStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Melissa Peitzmeier, University of Michigan
- Investigators
- Sarah Peitzmeier, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797741
- Sponsor's protocol ID
- HUM00183965
- Other IDs
- 0920-1301
- Status last verified
- Jul 2022
- First submitted
- 10 Mar 2021
- Last updated
- 15 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Peitzmeier SM, Ashwell L, Adams MP, Edwards K, Senn CY. The IDEA3 pilot trial: feasibility, acceptability, and preliminary efficacy of an online adaptation of an evidence-based intervention for campus sexual assault prevention. BMC Womens Health. 2026 Jun 3. doi: 10.1186/s12905-026-04551-7. Online ahead of print.
PubMed 42237318
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Internet Delivery of Enhanced Assess, Acknowledge, Act (IDEA3), an Evidence-based Sexual Assault Prevention Intervention for Women Undergraduates
- ClinicalTrials.gov ID
- NCT04797741
- Acronym / sponsor ID
- HUM00183965
- Conditions
- Sexual Assault
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IDEA3 Intervention | Experimental | Other: IDEA3 Intervention |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDEA3 InterventionDelivery of IDEA3 intervention, a 12-hour online sexual assault resistance intervention for college women. | Other | IDEA3 Intervention |
Primary outcome
Feasibility of IDEA3 intervention
Time frame: Within one week of the final intervention session
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.
Acceptability of IDEA3 intervention
Time frame: Within one week of the final intervention session
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.
Intervention participants' self-defense self-efficacy
Time frame: Within one week of the final intervention session
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)
1 secondary outcome
Efficacy of IDEA3 intervention
Time frame: Within one week of the final intervention session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Derived from this study: PubMed 42237318Peitzmeier SM, Ashwell L, Adams MP, Edwards K, Senn CY. The IDEA3 pilot trial: feasibility, acceptability, and preliminary efficacy of an online adaptation of an evidence-based intervention for campus sexual assault prevention. BMC Womens Health. 2026 Jun 3. doi: 10.1186/s12905-026-04551-7. Online ahead of print.
- Individual participant dataSharing planned: No. 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.
Related trials for Sexual Assault
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Peitzmeier, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IDEA3 Intervention in people with Sexual Assault, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of IDEA3 intervention (time frame: Within one week of the final intervention session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04797741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.