Clinical trial NCT05080335: Transgender Health: an Educational RCT
Official title: Transgender and Gender-expansive Youth: Randomized Controlled Trial of a Healthcare Didactic Enhanced by Simulated Patient Video Clips
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transgender
Health Attitude
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT of three different education / training approaches
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in T-KAB TOTAL score (TOT)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
Secondary outcomes:
measure: Change in T-KAB ACCEPTANCE sub-scale (ACC)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: Change in T-KAB SOCIAL TOLERANCE sub-scale (ST)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: Change in T-KAB COMFORT AND CONTACT sub-scale (CC)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: Change in SOCIAL comfort level (SOC)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: Change in PROFESSIONAL comfort level (PROF)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: Change in FAMILIAL comfort level (FAM)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
Other outcomes:
measure: SOCIAL TOLERANCE Item 1 (SOC_01)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: SOCIAL TOLERANCE Item 2 (SOC_02)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: SOCIAL TOLERANCE Item 3 (SOC_03)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: SOCIAL TOLERANCE Item 4 (SOC_04)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: SOCIAL TOLERANCE Item 5 (SOC_05)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: SOCIAL TOLERANCE Item 6 (SOC_06)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: SOCIAL TOLERANCE Item 7 (SOC_07)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: COMFORT and CONTACT Item 8 (CC_08)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: COMFORT and CONTACT Item 9 (CC_09)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: COMFORT and CONTACT Item 10 (CC_10)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: COMFORT and CONTACT Item 11 (CC_11)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: COMFORT and CONTACT Item 12 (CC_12)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: COMFORT and CONTACT Item 13 (CC_13)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: COMFORT and CONTACT Item 14 (CC_14)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: ACCEPTANCE Item 15 (ACC_15)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: ACCEPTANCE Item 16 (ACC_16)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: ACCEPTANCE Item 17 (ACC_17)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: ACCEPTANCE Item 18 (ACC_18)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: ACCEPTANCE Item 19 (ACC_19)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: ACCEPTANCE Item 20 (ACC_20)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: ACCEPTANCE Item 21 (ACC_21)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
measure: ACCEPTANCE Item 22 (ACC_22)
timeFrame: Before / after viewing videos (within 60 minutes), and after 30 days.
Locations:
city: New Haven
country: United States
facility: Yale Child Center
state: Connecticut
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Andres Martin
role: PRINCIPAL_INVESTIGATOR
References: