Transgender Health: an Educational RCT

NCT ID: NCT05080335

Last Updated: 2022-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-04-01

Brief Summary

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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

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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

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Transgender Health Attitude

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT of three different education / training approaches
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Participants will not be aware of which of the four arms they will be assigned to

Study Groups

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TRANS-gender female instructor, with videos (TV)

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

Group Type ACTIVE_COMPARATOR

Short videos

Intervention Type 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)

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

Group Type ACTIVE_COMPARATOR

Short videos

Intervention Type 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, with NO videos (CN)

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

Group Type ACTIVE_COMPARATOR

Short videos

Intervention Type 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.

No intervention control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Short videos

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andres Martin

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale Child Center

New Haven, Connecticut, United States

Site Status

Yale Child Study Center

New Haven, Connecticut, United States

Site Status

Countries

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United States

Related Links

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https://doi.org/10.1007/s13178-019-00399-9

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).

Other Identifiers

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2000028980_c

Identifier Type: -

Identifier Source: org_study_id

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