- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07706322
Adapting a Sexual Assault Prevention Intervention for Transgender Undergraduates: A One-Arm Pilot Trial (TEA3)
July 10, 2026 updated by: Sarah Peitzmeier
Adapting a Sexual Assault Prevention Intervention for Transgender Undergraduates
The purpose of this study is to adapt and pilot a sexual assault prevention intervention for transgender and nonbinary (trans) undergraduate students.
Forty percent of trans individuals (i.e., individuals whose gender identity does not align with their sex assigned at birth, inclusive of nonbinary people) are sexually assaulted during their time in college.
Despite the magnitude of this issue, there are no sexual assault prevention interventions that have lowered victimization of trans students.
The Enhanced Assess, Acknowledge, Act (EAAA) intervention is recommended by the Centers for Disease Control and Prevention (CDC) and is the only intervention proven to lower rape victimization by over 50% among cisgender female undergraduates.
However, trans-specific vulnerabilities to violence are not addressed in EAAA, nor in the online adaptation of EAAA recently piloted by the study team called internet-delivered EAAA (IDEA3).
This project will adapt and pilot IDEA3 for trans and nonbinary students to develop one of the first evidence-based sexual assault prevention interventions for trans and nonbinary young adults.
We will adapt IDEA3 for trans students ages 18-25 and test it in an initial group which we will use to make revisions to the program.
Then, we will collect participant survey and focus group data on feasibility and acceptability from 4 more groups of participants, revising the intervention between groups.
Finally, we will collect preliminary data on whether the program increased participants' confidence in their ability to defend themselves.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sarah Peitzmeier, PhD
- Phone Number: 301-405-2463
- Email: speitzme@umd.edu
Study Contact Backup
- Name: Michelle Choi, MA
- Phone Number: 301-405-8740
- Email: mmchoi@umd.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion criteria:
- Participants must be adults ages 18 to 25, AND
- Have a gender identity that differs from their sex assigned at birth (e.g. trans or nonbinary) AND
- Be an undergraduate student AND
- Be available during the program times, AND
- Provide the contact information for another trans or nonbinary undergraduate who they would be willing to participate in the intervention with OR express willingness to being partnered with another trans or nonbinary undergraduate at their university AND
- Have access to and willingness to use the videoconferencing software Zoom for the program AND
- Consent to being recorded while participating.
Exclusion Criteria:
- Participant is less than 18 years of age or older than 25 years of age, OR
- Does not identify as a trans or nonbinary individual, OR
- Is not an undergraduate student, OR
- Is not available during the program times, OR
- Does not provide the contact information for another trans or nonbinary undergraduate student 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 recorded while participating.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TEA3 Intervention
|
Delivery of TEA3 intervention, a 15-hour online sexual assault resistance intervention for transgender undergraduates.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Within one week of the final intervention session
|
|
Feasibility of TEA3 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 TEA3 went well and what pieces need to be further adapted in the future.
|
Within one week of the final intervention session
|
|
Acceptability of TEA3 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.
|
Within one week of the final intervention session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy of TEA3 intervention
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 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.
The sexual assault victimization outcome measure for a future RCT, a validated trans adaptation of the Sexual Experiences Survey, will also be used.
|
Within one week of the final intervention session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sarah Peitzmeier, PhD, University of Maryland, College Park
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 2, 2026
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
June 1, 2027
Study Registration Dates
First Submitted
July 10, 2026
First Submitted That Met QC Criteria
July 10, 2026
First Posted (Actual)
July 15, 2026
Study Record Updates
Last Update Posted (Actual)
July 15, 2026
Last Update Submitted That Met QC Criteria
July 10, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- #1670-1
- N/A (Internal grant) (Other Grant/Funding Number: University of Maryland)
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 reasonable request and with IRB approval.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of FloridaCompletedSensitivityUnited States
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