Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-02 @ 1:18 PM
Study NCT ID:
NCT05080335
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
2021-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transgender Health: an Educational RCT
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Transgender and Gender-expansive Youth: Randomized Controlled Trial of a Healthcare Didactic Enhanced by Simulated Patient Video Clips
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: