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临床试验/NCT05436106
NCT05436106招募中不适用

Behavioral Intervention to Reduce Psychological Distress Symptoms Among Black Gender Minority Women Experiencing Chronic Stigma

Emory University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Intervention Retention Rate

研究概览

简要总结

The research objectives of this study are to first, develop a culturally informed community-based intervention with guidance from community members (via focus groups and theater testing) to reduce the effect of chronic stigma exposure on psychological distress symptoms (PTS and depressive symptoms) among transgender women. Second, the research team will conduct a proof-of-concept trial to determine the feasibility and preliminary efficacy of the resulting intervention.

详细描述

The proposed research builds on our previous work with Black gender minority (GM) women and addresses research gaps. The researchers propose to develop and examine the feasibility of an intervention to improve psychological distress symptom management related to chronic stigma exposure among Black GM women. A hybrid delivery model is proposed where a) weekly group sessions will be co-led by a community member with expertise in working with transgender women and a public health nurse, b) supplemental educational content will be available for individual consumption via an online portal or application (and tracked via participant click counts), and c) additional social resources will be available through the online portal or app. Researchers will use an adaptive intervention approach with 7 module-based sessions selected on the basis of post-session assessments of acceptability and satisfaction. The investigators will use standard qualitative and mixed-method approaches (focus groups, key informant interviews with the community advisory board, and a quantitative survey) and iterative design to develop/adapt, refine, and evaluate a culturally informed intervention for transgender women experiencing chronic stigma and psychological distress.

Participants will be recruited via convenience sampling using multiple strategies including passively distributing flyers to LGBTQ+ organizations and clinics, universities, and community colleges; LGBTQ+ and transgender and gender diverse (TGD) group social media platforms; peer referral, and word of mouth; and actively through collaborations with the Casa Ruby case management team and providers at Emory Healthcare and Grady Health Gender Center.

Investigators will use standard qualitative and mixed-method approaches (focus groups, key informant interviews with the community advisory board, and a quantitative survey) and iterative design to develop/adopt, refine, and evaluate a culturally informed intervention for transgender women experiencing chronic stigma and psychological distress. The research team will conduct 4 focus groups of 5 people to address Aim 1. Focus group sessions will last no longer than 2 hours and will be virtual via Zoom.

The research team will conduct a proof-of-concept study to establish the feasibility, including recruitment, retention, and outcome measurement of the developed intervention. Researchers will collect quantitative assessment data on internet-accessible devices via self-administered surveys collected at the time point (T)1; baseline enrollment, T2; Mid-intervention (3-6 weeks from baseline assessment), T3. immediately post-intervention (within 2 weeks of study completion), and T4. 3-months post-intervention.

The phase 2 intervention trial includes transgender women of any race or ethnicity and will be delivered hybrid with 3 in-person sessions (in Atlanta, GA) and 4 online sessions via Zoom.

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 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 years or older
  • gender is woman/transgender feminine/female
  • assigned male sex at birth
  • speak/read English

排除标准

  • Enrolled in mental health treatment or a controlled consequential environment (e.g. mental health transitional living environment)

研究组 & 干预措施

intervention educational content

Experimental

The base intervention design will contain educational content informed by the Transgender Resilience Intervention Model (TRIM) and adapted from Seeking Safety specific to a) identifying symptoms of psychological distress, b) managing symptoms via coping (individual resilience), and c) developing a social network and using social support/community connection (group resilience).

干预措施: Adaptive Intervention Approach (Behavioral)

结局指标

主要结局

Intervention Retention Rate

时间窗: Throughout the intervention (up to 12 weeks)

number screened per month; number enrolled per month and per source; rate of eligibility ≥40%); (≥50% retention rate; reasons for dropouts; acute crisis or avoidance behaviors; incentive structure);

Changes in the proportion of acceptability

时间窗: Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention

assessment acceptability will be assessed by calculating the proportion of planned assessments that are completed and satisfaction ratings ≥75%; duration of assessment visits; reasons for dropouts);

Accessibility of the intervention

时间窗: Throughout the intervention (up to 2 weeks post-intervention)

intervention accessibility (qualitative assessments; reasons for dropouts and adherence; technological literacy; ability to access reliable internet). There is no scale for this instrument.

Average time delay from screening to enrollment and average time to enroll enough participants to form cohorts

时间窗: From screening to Baseline

The average time it takes for participants to be screened and complete enrollment depending on the study cohorts

Changes in the intervention fidelity

时间窗: Throughout the intervention (up to 12 weeks)

Fidelity rates within and between interventionists; range from 0-3, with 2 or higher indicative of high fidelity per domain via the Seeking Safety Adherence Scale (SASS). Tailoring of the SASS will be based on the format used to deliver the intervention content and the focus of the content. For example, the original scale has the following items that may not be appropriate for the created intervention: "Focused on how the topic related to substance use; Gave handouts and made use of them during the session." Thus, these items may be removed or modified to align with content delivery and subject matter. The SASS will be used to periodically assess the fidelity of intervention delivery among each interventionist. Mean scores will be compared between interventionists and scores below 80% will require remediation in the form of individual training with the PI and the interventionist.

Overall attendance/adherence

时间窗: 2 weeks post-intervention

Session attendance ≥67%; online engagement with educational material via click counts

Changes in the Intervention acceptability

时间窗: Throughout the intervention (up to 2 weeks post-intervention)

intervention acceptability (acceptability ≥75%; qualitative assessments; reasons for dropouts; preference/satisfaction ratings ≥75% via Client satisfaction questionnaire); Client satisfaction questionnaire (CSQ-8; Cronbach's alpha .93; 8-item; 4-point Likert) will be administered at the end of every intervention session to address individual session utility and at T3 for overall satisfaction

次要结局

  • Change in Beck Depression Inventory II (BDI-II)(Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention)
  • Change in PTSD symptoms(Baseline, Mid-intervention (3-6 weeks from baseline assessment) , 2 weeks post intervention, 3 months post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Athena DF Sherman

Assistant Professor

Emory University

研究点 (1)

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