Behavioral Intervention to Reduce Psychological Distress Symptoms Among Black Gender Minority Women Experiencing Chronic Stigma
Overview
- Phase
- N/A
- Intervention
- Adaptive Intervention Approach
- Conditions
- Psychological Distress
- Sponsor
- Emory University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Intervention Retention Rate
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Athena DF Sherman
Assistant Professor
Emory University
Eligibility Criteria
Inclusion Criteria
- •18 years or older
- •gender is woman/transgender feminine/female
- •assigned male sex at birth
- •speak/read English
Exclusion Criteria
- •Enrolled in mental health treatment or a controlled consequential environment (e.g. mental health transitional living environment)
Arms & Interventions
intervention educational content
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).
Intervention: Adaptive Intervention Approach
Outcomes
Primary Outcomes
Intervention Retention Rate
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 2 weeks post-intervention
Session attendance ≥67%; online engagement with educational material via click counts
Changes in the Intervention acceptability
Time Frame: 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
Secondary Outcomes
- 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)