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Adapting a Sexual Assault Prevention Intervention for Transgender Undergraduates: A One-Arm Pilot Trial (TEA3)

10. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Sarah Peitzmeier, PhD
  • Telefonnummer: 301-405-2463
  • E-mail: speitzme@umd.edu

Undersøgelse Kontakt Backup

  • Navn: Michelle Choi, MA
  • Telefonnummer: 301-405-8740
  • E-mail: mmchoi@umd.edu

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TEA3 Intervention
Andet: TEA3 Intervention
Delivery of TEA3 intervention, a 15-hour online sexual assault resistance intervention for transgender undergraduates.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Interventionsdeltageres selvforsvars-self-efficacy
Tidsramme: Inden for en uge efter den sidste interventionssession
Dette vil blive vurderet ud fra deltagernes svar på baseline- og post-testundersøgelser, der bruger validerede skalaer til at måle selvforsvars-selveffektivitet (dvs. tillid til, at man kunne forsvare sig mod seksuelle overgreb)
Inden for en uge efter den sidste interventionssession
Feasibility of TEA3 intervention
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Efficacy of TEA3 intervention
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sarah Peitzmeier

Efterforskere

  • Ledende efterforsker: Sarah Peitzmeier, PhD, University of Maryland, College Park

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

2. september 2026

Primær færdiggørelse (Anslået)

30. april 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

10. juli 2026

Først indsendt, der opfyldte QC-kriterier

10. juli 2026

Først opslået (Faktiske)

15. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • #1670-1
  • N/A (Internal grant) (Andet bevillings-/finansieringsnummer: University of Maryland)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med TEA3 Intervention

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in France

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner