Transgender Health: an Educational RCT

Health Attitude Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05080335
• Other study ID #: 2000028980_c
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: April 1, 2022

Study information

• Verified date: April 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• English-speaking

• Living in the US

• Ages GE 18

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Health Attitude
• Transgender

Intervention

Other:
• Short videos
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.

Locations

Country	Name	City	State
United States	Yale Child Center	New Haven	Connecticut
United States	Yale Child Study Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SOCIAL TOLERANCE Item 1 (SOC_01)	Response to the stem: Transgender people should have the opportunity to undergo operations to change their anatomy.; Scoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	SOCIAL TOLERANCE Item 2 (SOC_02)	Response to the stem: Transgender people should be accepted completely into our society.; Scoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	SOCIAL TOLERANCE Item 3 (SOC_03)	Response to the stem: Transgender people should have the opportunity to change their name.; Scoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	SOCIAL TOLERANCE Item 4 (SOC_04)	Response to the stem: Organizations that promote transgender rights are necessary.; Scoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	SOCIAL TOLERANCE Item 5 (SOC_05)	Response to the stem: It should be illegal for people to have their genitalia surgically altered. (R); Scoring on a 6-point Likert REVERSED scale ranging from 1 ("Strongly agree") to 6 ("Strongly disagree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	SOCIAL TOLERANCE Item 6 (SOC_06)	Response to the stem: Being transgender is a sin. (R); Scoring on a 6-point Likert REVERSED scale ranging from 1 ("Strongly agree") to 6 ("Strongly disagree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	SOCIAL TOLERANCE Item 7 (SOC_07)	Response to the stem: Transgender people are a worthwhile part of our society.; Scoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	COMFORT and CONTACT Item 8 (CC_08)	Response to the stem: I avoid interacting with people whose gender is unclear to me. (R); Scoring on a 6-point Likert REVERSED scale ranging from 1 ("Strongly agree") to 6 ("Strongly disagree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	COMFORT and CONTACT Item 9 (CC_09)	Response to the stem: People with both breasts and a penis make me uncomfortable. (R); Scoring on a 6-point Likert REVERSED scale ranging from 1 ("Strongly agree") to 6 ("Strongly disagree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	COMFORT and CONTACT Item 10 (CC_10)	Response to the stem: When I meet someone, it is important for me to be able to identify them as a man or a woman. (R); Scoring on a 6-point Likert REVERSED scale ranging from 1 ("Strongly agree") to 6 ("Strongly disagree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	COMFORT and CONTACT Item 11 (CC_11)	Response to the stem: I feel uncomfortable when I cannot tell if someone is a man or a woman. (R); Scoring on a 6-point Likert REVERSED scale ranging from 1 ("Strongly agree") to 6 ("Strongly disagree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	COMFORT and CONTACT Item 12 (CC_12)	Response to the stem: I would feel uncomfortable if a close family member were dating a transgender person. (R); Scoring on a 6-point Likert REVERSED scale ranging from 1 ("Strongly agree") to 6 ("Strongly disagree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	COMFORT and CONTACT Item 13 (CC_13)	Response to the stem: I would feel comfortable if I learned a friend is transgender.; Scoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	COMFORT and CONTACT Item 14 (CC_14)	Response to the stem: I would feel comfortable if I learned my neighbor is transgender.; Scoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	ACCEPTANCE Item 15 (ACC_15)	Response to the stem: A person with a vagina can be a man.; Scoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better acceptance of the gender spectrum.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	ACCEPTANCE Item 16 (ACC_16)	Response to the stem: A person with a penis can be a woman.; Scoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better acceptance of the gender spectrum.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	ACCEPTANCE Item 17 (ACC_17)	Response to the stem: Female-to-male transgender people are real men.; Scoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better acceptance of the gender spectrum.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	ACCEPTANCE Item 18 (ACC_18)	Response to the stem: Male-to-female transgender people are real women.; Scoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better acceptance of the gender spectrum.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	ACCEPTANCE Item 19 (ACC_19)	Response to the stem: A person transitioning from female to male should be able to use a men's bathroom.; Scoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better acceptance of the gender spectrum.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	ACCEPTANCE Item 20 (ACC_20)	Response to the stem: There are only two genders: male and female.; Scoring on a 6-point Likert REVERSED scale ranging from 1 ("Strongly agree") to 6 ("Strongly disagree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	ACCEPTANCE Item 21 (ACC_21)	Response to the stem: Sex and gender are the same thing.; Scoring on a 6-point Likert REVERSED scale ranging from 1 ("Strongly agree") to 6 ("Strongly disagree"), resulting in a score ranging from 1 to 6 with higher numbers representing better comfort and contact related to transgender individuals.	Before / after viewing videos (within 60 minutes), and after 30 days.
Other	ACCEPTANCE Item 22 (ACC_22)	Response to the stem: A person transitioning from male to female should be able to use a women's bathroom.; Scoring on a 6-point Likert scale ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"), resulting in a score ranging from 1 to 6 with higher numbers representing better acceptance of the gender spectrum.	Before / after viewing videos (within 60 minutes), and after 30 days.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

External Links

•   Clark, K.A., Hughto, J.M. Development and Psychometric Evaluation of the Transgender Knowledge, Attitudes, and Beliefs (T-KAB) Scale. Sex Res Soc Policy 17, 353-363 (2020).