TransgenderNCT05080335
Transgender Health: an Educational RCT
A study testing Short videos in people with Transgender and Health Attitude, run by Yale University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Transgender, Health Attitude
- What is being tested?
- Short videos
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2022to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking
- Living in the US
- Ages GE 18
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale Child Center
New Haven, Connecticut, 06510
Yale Child Study Center
New Haven, Connecticut, 06510
About this study
Official title: Transgender and Gender-expansive Youth: Randomized Controlled Trial of a Healthcare Didactic Enhanced by Simulated Patient Video Clips
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.
Read the 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.
- Conditions
- Transgender, Health Attitude
- Being tested
- Short videos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short videosOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before / after viewing videos (within 60 minutes), and after 30 days.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before / after viewing videos (within 60 minutes), and after 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Feb 2022
- Primary completion1 Mar 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransgenderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT of three different education / training approaches
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andres Martin, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080335
- Sponsor's protocol ID
- 2000028980_c
- Status last verified
- Apr 2022
- First submitted
- 22 Sep 2021
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transgender and Gender-expansive Youth: Randomized Controlled Trial of a Healthcare Didactic Enhanced by Simulated Patient Video Clips
- ClinicalTrials.gov ID
- NCT05080335
- Acronym / sponsor ID
- 2000028980_c
- Conditions
- Transgender, Health Attitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- RCT of three different education / training approaches
| Arm | Type | Receives |
|---|---|---|
| TRANS-gender female instructor, with videos (TV) | Active comparator | Other: Short videosDidactic 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 instructor, with videos (CV) | Active comparator | Other: Short videosDidactic 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 |
| CIS-gender female, with NO videos (CN) | Active comparator | Other: Short videosDidactic 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 |
| 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). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking
- Living in the US
- Ages GE 18
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short videosAs 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. | Other | CIS-gender female instructor, with videos (CV), CIS-gender female, with NO videos (CN), TRANS-gender female instructor, with videos (TV) |
Primary outcome
Change in T-KAB TOTAL score (TOT)
Time frame: 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.
6 secondary outcomes
Change in T-KAB ACCEPTANCE sub-scale (ACC)
Time frame: Before / after viewing videos (within 60 minutes), and after 30 days.
Change in T-KAB SOCIAL TOLERANCE sub-scale (ST)
Time frame: Before / after viewing videos (within 60 minutes), and after 30 days.
Change in T-KAB COMFORT AND CONTACT sub-scale (CC)
Time frame: Before / after viewing videos (within 60 minutes), and after 30 days.
Change in SOCIAL comfort level (SOC)
Time frame: Before / after viewing videos (within 60 minutes), and after 30 days.
Change in PROFESSIONAL comfort level (PROF)
Time frame: Before / after viewing videos (within 60 minutes), and after 30 days.
Change in FAMILIAL comfort level (FAM)
Time frame: Before / after viewing videos (within 60 minutes), and after 30 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- 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).Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andres Martin principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short videos in people with Transgender and Health Attitude, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in T-KAB TOTAL score (TOT) (time frame: Before / after viewing videos (within 60 minutes), and after 30 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022; AzTrials last refreshed its copy on 4 Nov 2026.