Transgender Health: an Educational RCT

Study Overview
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Brief Summary
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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
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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.

Official Title
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Transgender and Gender-expansive Youth: Randomized Controlled Trial of a Healthcare Didactic Enhanced by Simulated Patient Video Clips

Conditions
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Transgender, Health Attitude

Intervention / Treatment
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* Other: Short videos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-speaking Living in the US Ages GE 18 Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT of three different education / training approaches
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TRANS-gender female instructor, with videos (TV)<br>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 | Other: Short videos<br>* As an educational RCT, the didactic content will be the same across the four arms, but its deliver will vary by: TRANS- vs CIS-gender female instructors With or without short videos of transgender youth embedded into the didactic [TV or CV]; for the group with no embedded videos [NV], the same videos will be shown AFTER completion of the post measures) No-intervention control, in which TV will be delivered *after* collection of pre/post measures.<br>|
| Active Comparator: CIS-gender female instructor, with videos (CV)<br>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 | Other: Short videos<br>* As an educational RCT, the didactic content will be the same across the four arms, but its deliver will vary by: TRANS- vs CIS-gender female instructors With or without short videos of transgender youth embedded into the didactic [TV or CV]; for the group with no embedded videos [NV], the same videos will be shown AFTER completion of the post measures) No-intervention control, in which TV will be delivered *after* collection of pre/post measures.<br>|
| Active Comparator: CIS-gender female, with NO videos (CN)<br>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 | Other: Short videos<br>* As an educational RCT, the didactic content will be the same across the four arms, but its deliver will vary by: TRANS- vs CIS-gender female instructors With or without short videos of transgender youth embedded into the didactic [TV or CV]; for the group with no embedded videos [NV], the same videos will be shown AFTER completion of the post measures) No-intervention control, in which TV will be delivered *after* collection of pre/post measures.<br>|
| No Intervention: No intervention control<br>Subjects randomized to this arm will complete the baseline assessment and the post assessment thirty days later, but just *before* receiving the intervention (TV). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in T-KAB TOTAL score (TOT) | 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. | Before / after viewing videos (within 60 minutes), and after 30 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in T-KAB ACCEPTANCE sub-scale (ACC) | 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. | Before / after viewing videos (within 60 minutes), and after 30 days. | 
| Change in T-KAB SOCIAL TOLERANCE sub-scale (ST) | 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. | Before / after viewing videos (within 60 minutes), and after 30 days. | 
| Change in T-KAB COMFORT AND CONTACT sub-scale (CC) | 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. | Before / after viewing videos (within 60 minutes), and after 30 days. | 
| Change in SOCIAL comfort level (SOC) | 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. | Before / after viewing videos (within 60 minutes), and after 30 days. | 
| Change in PROFESSIONAL comfort level (PROF) | 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. | Before / after viewing videos (within 60 minutes), and after 30 days. | 
| Change in FAMILIAL comfort level (FAM) | 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. | Before / after viewing videos (within 60 minutes), and after 30 days. |