Behavioral Intervention to Reduce Stress Among Black Gender Minority Women

NCT05436106 | Recruiting

• 3 other identifiers: STUDY000031011K23NR020208-012025P009839
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Distress; Stigma, Social

Keywords

Transgender women

Outcome Measures

Primary Outcomes (7)

• 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);

  Throughout the intervention (up to 12 weeks)

• 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

  From screening to Baseline

• Overall attendance/adherence

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

  2 weeks post-intervention

• 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.

  Throughout the intervention (up to 12 weeks)

• Changes in the proportion of acceptability

  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);

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

• Changes in the Intervention acceptability

  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

  Throughout the intervention (up to 2 weeks post-intervention)

• Accessibility of the intervention

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

  Throughout the intervention (up to 2 weeks post-intervention)

Secondary Outcomes (2)

• Change in PTSD symptoms

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

• 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

Other Outcomes (8)

• Changes in the transgender community connection scale (TCC)

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

• Changes in the multidimensional scale of perceived social support (MSPSS)

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

• Changes in the coping strategies inventory short form (CSI-SF)

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

Study Arms (1)

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).

Behavioral: Adaptive Intervention Approach

Interventions

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.

intervention educational content

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Participant identifies as a woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): collaborator
• Emory University: lead

Study Sites (1)

Emory University School of Nursing

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Athena DF Sherman, PhD, PHN, RN

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Athena DF Sherman, PhD, PHN, RN

CONTACT

408-401-2456; Adfsherman@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 28, 2022
• Study Start: May 2, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Beginning 3 months and ending 5 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to adfsherman@emory.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third-party website (Link to be determined).

Locations

US (1)