Transgender Health: an Educational RCT

NCT05080335 | Completed DMC

• 1 other identifier: 2000028980_c
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Transgender; Health Attitude

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in T-KAB ACCEPTANCE sub-scale (ACC)

  Before / after viewing videos (within 60 minutes), and after 30 days.

• Change in T-KAB SOCIAL TOLERANCE sub-scale (ST)

  Before / after viewing videos (within 60 minutes), and after 30 days.

• Change in T-KAB COMFORT AND CONTACT sub-scale (CC)

  Before / after viewing videos (within 60 minutes), and after 30 days.

• Change in SOCIAL comfort level (SOC)

  Before / after viewing videos (within 60 minutes), and after 30 days.

• Change in PROFESSIONAL comfort level (PROF)

  Before / after viewing videos (within 60 minutes), and after 30 days.

Other Outcomes (22)

• SOCIAL TOLERANCE Item 1 (SOC_01)

  Before / after viewing videos (within 60 minutes), and after 30 days.

• SOCIAL TOLERANCE Item 2 (SOC_02)

  Before / after viewing videos (within 60 minutes), and after 30 days.

• SOCIAL TOLERANCE Item 3 (SOC_03)

  Before / after viewing videos (within 60 minutes), and after 30 days.

Study Arms (4)

TRANS-gender female instructor, with videos (TV)

ACTIVE COMPARATOR

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

CIS-gender female instructor, with videos (CV)

ACTIVE COMPARATOR

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

CIS-gender female, with NO videos (CN)

ACTIVE COMPARATOR

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

No intervention control

NO INTERVENTION

Subjects randomized to this arm will complete the baseline assessment and the post assessment thirty days later, but just \*before\* receiving the intervention (TV).

Interventions

Short videos OTHER

As an educational RCT, the didactic content will be the same across the four arms, but its deliver will vary by: 1. TRANS- vs CIS-gender female instructors 2. 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) 3. No-intervention control, in which TV will be delivered \*after\* collection of pre/post measures.

CIS-gender female instructor, with videos (CV); CIS-gender female, with NO videos (CN); TRANS-gender female instructor, with videos (TV)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Yale University: lead

Study Sites (2)

Yale Child Center

New Haven, Connecticut, 06510, United States

Location

Yale Child Study Center

New Haven, Connecticut, 06510, United States

Location

Related 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).

Study Officials

• Andres Martin

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will not be aware of which of the four arms they will be assigned to
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT of three different education / training approaches

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 15, 2021
• Study Start: February 1, 2022
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)