Transgender Health: an Educational RCT

Not Applicable

Completed

• Conditions: Transgender; Health Attitude
• Interventions: Other: Short videos

• Registration Number: NCT05080335
• Lead Sponsor: Yale University

Brief Summary

The investigators will conduct a randomized controlled trial (RCT) comparing two different educational approaches on the healthcare of transgender and gender expansive (TGE) youth. Finding best practices to educate healthcare providers and the community at large stand to make an impact on the mental health of TGE youth by helping them feel more welcome and better understood by the communities in which they live.

The study aims are to evaluate two educational interventions: 1) The inclusion of a video clip component of two TGE youth (Video \[V\] vs No video \[N\]) into a one-hour didactic; and 2) The delivery of the same didactic content by a cis- \[C\] vs a trans-gender \[TG\] woman.

Detailed Description

This will be a randomized control trial (RCT) of equal allotment to one of four parallel didactic conditions. The investigators will randomly assign participants to one of three teaching conditions: 1) Trans Video \[TV\]; 2) Cis Video \[CV\]; and 3) Cis No video \[CN\]. Participants will complete a baseline assessment (PRE) before the start of the same didactic content, but delivered in the three different ways described above. This design will help the investigators make comparisons across video use (yes/no), about type of presenter (trans/cis), and about the interaction of the two approaches. For the 'no video' condition (CN), the didactic will not include the videos until after completion of the POST assessment.

The study design will ensure that all participants will receive the exact same didactic content during whichever session they attend. All participants will then receive a follow up questionnaire two weeks later (2WK POST) to assess content retention.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-15
• Study Start: 2022-02-01
• Primary Completion: 2022-03-01
• Status Verified: 2022-04
• Study Completion: 2022-04-01
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• English-speaking
• Living in the US
• Ages GE 18

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CIS-gender female instructor, with videos (CV)	Short videos	Didactic materials use embedded WITH short videos of transgender youth; lesson led by a CIS-gender woman with extensive experience as an educator on transgender health
TRANS-gender female instructor, with videos (TV)	Short videos	Didactic materials use embedded WITH short videos of transgender youth; lesson led by a TRANS-gender woman with extensive experience as an educator on transgender health
CIS-gender female, with NO videos (CN)	Short videos	Didactic materials do NOT use short videos of transgender youth \[until AFTER completion of the POST outcome measures\]; lesson is led by a CIS-gender woman with extensive experience as an educator on transgender health

Primary Outcome Measures

Name	Time	Method
Change in T-KAB TOTAL score (TOT)	Before / after viewing videos (within 60 minutes), and after 30 days.	The T-KAB (Clark and Hughto, 2020) is a 22-item, 3-factor measure representing: acceptance of the gender spectrum (ACC), social tolerance (ST), and comfort and contact (CC) related to transgender people. The total score (TOT) is the sum of it three sub-scales.; The adjusted T-KAB It is scored on a 6-point Likert scale (instead of the 4-point original) ranging from 1 ("Strongly disagree") to 4 ("Strongly agree"). An even-number scale was utilized to ensure that participants choose either agreement or disagreement, and thus, a neutral option was not included in the scale.; This results in an item-level score ranging from 1 to 6, and an overall TOT range from 22 to 132, with higher numbers representing better outcomes.; We changed the wording and reverse-scoring of 6 items, which due to double-negative wording, proved confusing in pilot testing. This resulted in 9/22 reverse-scored items (R), from the original scale with 15/22 R's.

Secondary Outcome Measures

Name	Time	Method
Change in T-KAB ACCEPTANCE sub-scale (ACC)	Before / after viewing videos (within 60 minutes), and after 30 days.	The T-KAB ACCEPTANCE sub-scale (ACC) is an 8-item measure representing acceptance of the gender spectrum; The adjusted ACC is scored on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"). This adjustment resulted in an item-level score ranging from 1 to 6, and an overall TOT ranging from 8 to 48, with higher numbers representing better acceptance of the gender spectrum.; Of note, all six items changed from double negative wording were part of the ACC sub-scale. As one example, we changed ACC item 1 from: A person with a vagina cannot can be a man. (R); to: A person with a vagina can can be a man.
Change in T-KAB SOCIAL TOLERANCE sub-scale (ST)	Before / after viewing videos (within 60 minutes), and after 30 days.	The T-KAB SOCIAL TOLERANCE sub-scale (ST) is a 7-item measure representing social tolerance (ST) related to transgender people.; The adjusted ST is scored on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"). This adjustment resulted in an item-level score ranging from 1 to 6, and an overall TOT ranging from 7 to 42, with higher numbers representing better social tolerance related to transgender individuals.
Change in T-KAB COMFORT AND CONTACT sub-scale (CC)	Before / after viewing videos (within 60 minutes), and after 30 days.	The T-KAB COMFORT AND CONTACT sub-scale (CC) is a 7-item measure representing social tolerance (ST) related to transgender people.; The adjusted ST is scored on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"). This adjustment resulted in an item-level score ranging from 1 to 6, and an overall TOT ranging from 7 to 42, with higher numbers representing better comfort and contact related to transgender individuals.
Change in SOCIAL comfort level (SOC)	Before / after viewing videos (within 60 minutes), and after 30 days.	This item uses a slider ranging continuously from 0 ("Very uncomfortable") to 100 ("Very comfortable") in response to the question "How comfortable would you be interacting SOCIALLY with transgender individuals?") Higher numbers indicate higher comfort level.
Change in PROFESSIONAL comfort level (PROF)	Before / after viewing videos (within 60 minutes), and after 30 days.	This item uses a slider ranging continuously from 0 ("Very uncomfortable") to 100 ("Very comfortable") in response to the question "How comfortable would you be interacting in a PROFESSIONAL or EDUCATIONAL setting with transgender individuals?") Higher numbers indicate higher comfort level.
Change in FAMILIAL comfort level (FAM)	Before / after viewing videos (within 60 minutes), and after 30 days.	This item uses a slider ranging continuously from 0 ("Very uncomfortable") to 100 ("Very comfortable") in response to the question "How comfortable would you be interacting with a transgender individual in your FAMILY ") Higher numbers indicate higher comfort level.

Trial Locations

Locations (2)

Yale Child Center; 🇺🇸 New Haven, Connecticut, United States

Yale Child Study Center; 🇺🇸 New Haven, Connecticut, United States