About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
gender is woman/transgender feminine/female
assigned male sex at birth
speak/read English
Disqualifiers
Enrolled in mental health treatment or a controlled consequential environment (e.g. mental health transitional living environment)
Trial design
Single group
Treatments tested in this trial
Adaptive Intervention Approach
BehavioralThis is an adaptive intervention approach with 7 module-based sessions selected on the basis of post-session assessments of acceptability and satisfaction; 1. weekly group sessions will be co-led by a community member with expertise in working with transgender women and a public health nurse, 2. supplemental educational content will be available for individual consumption via an online portal or application (and tracked via participant click counts), and 3. additional social resources will be available through the online portal or app.
Treatment groups
Trial outcomes
Primary outcomes
Intervention Retention Rate
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);
Average time delay from screening to enrollment and average time to enroll enough participants to form cohorts
The average time it takes for participants to be screened and complete enrollment depending on the study cohorts
Overall attendance/adherence
Session attendance ≥67%; online engagement with educational material via click counts
Changes in the intervention fidelity
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.
Secondary outcomes
Change in PTSD symptoms
Psychological distress symptom severity will be measured using the PCL-5 which is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including monitoring symptoms, and changes during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Evidence for the PCL for the diagnostic and Statistical Manual of Mental Disorders (DSM)-IV suggests that a 5-10-point change represents reliable change (i.e., change not due to chance) and a 10-20-point change represents a clinically significant change. Therefore, it was recommended to use 5 points as a minimum threshold for determining whether the improvements are clinically meaningful using the PCL for DSM-IV.
Change in Beck Depression Inventory II (BDI-II)
The BDI-II consists of 21 items assessing symptoms of depression experienced during the past 2 weeks. Each item contains four statements reflecting varying degrees of symptom severity. Respondents are instructed to circle the number (ranging from zero to three, indicating increasing severity) that corresponds with the statement that best describes them. Ratings are summed to calculate a total BDI-II score, which can range from 0 to 63. (BDI-II total score, alpha-0.90; cognitive factor, alpha .81; Somatic factor, alpha .87) Scoring the Beck Depression Inventory: Low (1-10)-Normal ups and downs; (11-16)-Mild mood disturbance Mild mood disturbance (17-20) Borderline clinical depression; (21-30)=Moderate depression Significant (31-40)-Severe depression; over 40-extreme depression
Other outcomes
Changes in the transgender community connection scale (TCC)
Participants will answer questions about community connectedness. Response options: 5-point scale from strongly disagree to strongly agree.
Changes in the multidimensional scale of perceived social support (MSPSS)
Participants will answer 12 items about their feelings regarding certain statements. Options range from 1-Very strongly disagree to 7-very strongly agree.
Changes in the coping strategies inventory short form (CSI-SF)
Questions ask to categorize the degree of avoidant and approach coping behaviors used. 5-point Likert
Changes in the coping self-efficacy scale (CSE)
Participants will be asked about their confidence or certainty that they can do 26 questions. Cannot do all=0 1,2,3,4,5=Moderately certain can do 6,7,8,9,10=at certain can do
Sponsors and contacts
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Emory University
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator