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临床试验/NCT05080335
NCT05080335已完成不适用

Transgender and Gender-expansive Youth: Randomized Controlled Trial of a Healthcare Didactic Enhanced by Simulated Patient Video Clips

Yale University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
Change in T-KAB TOTAL score (TOT)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

盲法说明

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

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

干预措施: Short videos (Other)

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

干预措施: Short videos (Other)

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

干预措施: Short videos (Other)

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).

结局指标

主要结局

Change in T-KAB TOTAL score (TOT)

时间窗: 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.

次要结局

  • 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.)
  • Change in FAMILIAL comfort level (FAM)(Before / after viewing videos (within 60 minutes), and after 30 days.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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