Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Trans Care Intervention Specific Feasibility and Acceptability Score
研究概览
简要总结
The current project aims to improve the well-being of trans and nonbinary (TNB) individuals through an online intervention (Trans Care) targeting the reduction of symptoms of gender dysphoria. The Trans Care intervention will involve the creation of an online intervention comprised of eight modules intended to reduce symptoms of gender dysphoria, increase active coping, and improve the well-being of TNB individuals. Aim 1 is a feasibility and acceptability study of the proposed intervention and will enroll 100 TNB participants to provide feedback to inform a follow-up randomized controlled trial.
详细描述
The overall purpose of this project is to create a free intervention that can be disseminated widely throughout TNB communities to improve well-being in an easy, accessible way. Development and execution of the Trans Care intervention involves two primary aims:
- Aim 1) Feasibility and acceptability analysis (FAA) [represented by this study record]
- Aim 2) A pilot randomized controlled trial (RCT) of Trans Care's efficacy [to be registered to a separate study record]
Aim 1 involves qualitative and quantitative feedback regarding the content of the Trans Care intervention modules, impact on TNB participants well-being, and feasibility and acceptability of Trans Care intervention. Results from the FAA study will then be analyzed and presented to our community partners who will help us develop modifications to Trans Care to increase its efficacy and ease of use.
Aim 1 Hypotheses:
- The investigators expect that qualitative responses from participants in the FAA study overall will reflect that the Trans Care intervention was feasible and helpful. Any proposed changes from participants' qualitative responses will be incorporated into the final Trans Care intervention presented in the RCT.
- The investigators expect that participants in the FAA study will endorse high scores three scale assessment of feasibility and acceptability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Identify as transgender, transsexual, nonbinary, and/or have a transgender history.
- •Experience gender dysphoria.
- •Time available to commit to completing a 4-5-hour online intervention and 1-2 hours to complete follow up surveys
排除标准
- •under 18 years old
- •individual does not identify as transgender, transsexual, nonbinary, and/or have a transgender history
- •does not experience gender dysphoria
- •is unable to commit to the time requirements of the study
- •does not have access to an internet compatible device
结局指标
主要结局
Trans Care Intervention Specific Feasibility and Acceptability Score
时间窗: post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
This measure is score from 0 to 4 in each of 5 domains: overall assessment, helpfulness, instructions, videos, and activities. Higher scores indicate higher feasibility and acceptability.
Acceptability of Intervention Measure (AIM) Score
时间窗: post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
The AIM is a 4-item measure of intervention acceptability, each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. Total mean scores range from 1 - 5, higher scores indicate higher acceptability.
Intervention Appropriateness Measure (IAM) Score
时间窗: post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
IAM is a 4-item measure of intervention appropriateness, each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. A total mean score ranges from 1 - 5, higher scores indicate higher appropriateness.
Summary of Qualitative Prompts
时间窗: post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
Participants will be given four prompts to qualitatively assess their experience with the intervention. What you liked most? What would you change? What was most helpful? and What was least helpful? Thematic analysis will be conducted to analyze participants' responses to determine predominant changes suggested by participants
Feasibility of Intervention Measure (FIM) Score
时间窗: post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
FIM is a 4-item measure of intervention feasibility, each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable, with a total mean score ranging from 1 to 5, higher scores indicate higher feasibility.
Digital Working Alliance Inventory (D-WAI) Score
时间窗: post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
The D-WAI is scored from 7-point Likert-type scale from 1 (strongly disagree) to 7 (strongly agree), for a total range of scores from 7-42 where higher scores indicate higher perceived app effectiveness.
次要结局
- Gender Congruence and Life Satisfaction Scale (GCLS) Score(baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it))
- Trans and Nonbinary Coping Measure (TNCM) Score(baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it))
- Modified Gender Minority Stress and Resilience Measure (M-GMSRM) Score(baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it))
- Brief Cope Score(baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it))
- Alcohol Use Disorder Identification Test(baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it))
- Number of Days in the Past Week You Consumed Alcohol(baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it))
- Quantity of Alcohol Use(baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it))
- Depression, Anxiety, and Stress Scale (DASS-21) Score(baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it))