Behavioral Intervention to Reduce Stress Among Black Gender Minority Women

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorEmory University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Adaptive Intervention Approach

    Behavioral

    This 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

40 Participants
are divided into 1 treatment group
Group A: intervention educational contentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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);

Time frame
Throughout the intervention (up to 12 weeks)
2

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

Time frame
From screening to Baseline
3

Overall attendance/adherence

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

Time frame
2 weeks post-intervention
4

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.

Time frame
Throughout the intervention (up to 12 weeks)

Secondary outcomes

1

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.

Time frame
Baseline, Mid-intervention (3-6 weeks from baseline assessment) , 2 weeks post intervention, 3 months post-intervention
2

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

Time frame
Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention

Other outcomes

1

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.

Time frame
Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention
2

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.

Time frame
Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention
3

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

Time frame
Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention
4

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

Time frame
Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention

Sponsors and contacts

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Emory University

Lead sponsor

National Institute of Nursing Research (NINR)

Collaborator