Adapting a Sexual Assault Prevention Intervention for Transgender Undergraduates: A One-Arm Pilot Trial

NCT07706322 | Not Yet Recruiting

• 2 other identifiers: #1670-1N/A (Internal grant)
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sexual Assault and Rape

Outcome Measures

Primary Outcomes (3)

• Feasibility of TEA3 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 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

  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 Outcomes (1)

• Efficacy of TEA3 intervention

  Within one week of the final intervention session

Study Arms (1)

TEA3 Intervention

EXPERIMENTAL

Other: TEA3 Intervention

Interventions

TEA3 Intervention OTHER

Delivery of TEA3 intervention, a 15-hour online sexual assault resistance intervention for transgender undergraduates.

TEA3 Intervention

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: This study is designed specifically for undergraduates who identify as trans or nonbinary.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sarah Peitzmeier: lead

Related Publications (1)

• 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.

  PMID: 42237318 BACKGROUND

Study Officials

• Sarah Peitzmeier, PhD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Peitzmeier, PhD

CONTACT

301-405-2463; speitzme@umd.edu

Michelle Choi, MA

CONTACT

301-405-8740; mmchoi@umd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start (Estimated): September 2, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share