Weyera Mental Health Pilot Intervention
- Conditions
- Mental Health Issue
- Registration Number
- NCT06960187
- Lead Sponsor
- Emory University
- Brief Summary
This study aims to pilot a group-level intervention focused on mental health and resilience among Ethiopian and Eritrean youth. The study follows previous work that showed high rates of mental health outcomes (depression, anxiety, post-traumatic stress disorder (PTSD)) among Ethiopian and Eritrean youth in Atlanta. The goal is to determine the acceptability, feasibility, and safety of this culturally relevant group-level intervention before a larger trial to improve resilience processes that support mental wellness in a community-based setting.
- Detailed Description
The goal of this study is to develop and pilot test a Wellness: Ethiopian/Eritrean Youth Exploring Resilience and Awareness (Weyera), mental health-focused, culturally targeted, group-level intervention. This intervention aims to provide psychoeducation, develop coping skills, and create a space for open discussion.
The study will use a waitlist control design, recruiting participants randomly assigned to either the intervention or control (delayed intervention) group.
Participants will attend 8 weekly sessions (\~2 hours each) that include psychoeducation, interactive activities, and coping skills practice. Sessions will be facilitated by trained community health workers. Participants will also complete baseline and follow-up surveys at 2-, 4-, and 6-month post-enrollment, as well as post-session evaluation surveys after each session.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Age 18 to 29 years old
- Ethiopian and/or Eritrean ethnicity by self-report
- Able to read and understand English
- Resident of Atlanta Metropolitan Statistical Area
- Available and interested to participate in 2-hour weekly sessions over 8 weeks and complete relevant surveys
- Age < 18 or > 29 years old
- Unwilling or unable to provide informed consent.
- Not a resident of the Atlanta Metropolitan Statistical Area
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Adverse Events Throughout study participation up to 6 month (endline) Adverse event tracking forms will be used to track any safety related issues with the intervention.
Acceptability of the intervention is a subset of participants 6 months (endline). A subset of participants will complete qualitative interviews: Open-ended questions at the end of the study. There is no measuring scale for these interviews.
Recruitment Rates 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline). Feasibility will be measured by monitoring the recruitment rate (the number of screenings conducted, along with the proportion of eligible individuals who agree to enroll).
Retention Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline). Retention of participants throughout the 8 sessions will be monitored using attendance logs during each visit. This will help determine feasibility of the program.
Fidelity Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline). Fidelity will be measured using the intervention logs to assess the extent to which the intervention components (number of sessions completed, length of sessions, topics discussed) adhere to the intervention protocol.
Satisfaction Survey 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline). Acceptability will be measured using satisfaction surveys at the end of each session.
- Secondary Outcome Measures
Name Time Method Center for Epidemiologic Studies Depression (CES-D) Scale Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline). Depression will be assessed using the CES-D scale, with the total score being the sum of the 20 questions. The possible score range is 0 to 60, with a score of 16 or higher indicating depression. Higher scores reflect a greater severity of symptoms.
Generalized Anxiety Disorder 7-item scale Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline). The Generalized Anxiety Disorder 7-item scale (GAD-7) is a widely used, self-administered diagnostic tool designed to screen for and assess the severity of generalized anxiety disorder (GAD). The GAD-7 consists of seven items that measure the severity of various symptoms of GAD, with response categories assigned specific point values. The response options range from "not at all" (0 points), "several days" (1 point), "more than half the days" (2 points), to "nearly every day" (3 points), with a total score range of 0 to 21 points. Scores of 5, 10, and 15 are used as cut-off points for mild, moderate, and severe anxiety, respectively.
Posttraumatic Stress Disorder (PTSD) Checklist (PCL-5) Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline). The Post-Traumatic Stress Disorder (PTSD) Checklist, commonly referred to as the PCL-5, is a widely used screening tool for diagnosing PTSD. The PCL-5 is a self-report assessment consisting of 20 items, rated on a 5-point Likert scale (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score, ranging from 0 to 80, is obtained by summing the scores for each of the 20 items. Higher scores reflect a greater severity of symptoms.
Perceived social support Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline) Perceived social support will be assessed using the Multidimensional Scale of Social Support, a 12-item scale that measures various aspects of social support. Each item has response categories of 1-7, with higher scores indicating higher levels of social support. A mean scale score is calculated by averaging the score for each item and categorized as follows: Low social support (1- 2.9), moderate support (3 - 5), and high support (5.1 - 7).
Affirming ethnic identity beliefs 6 months (endline). This outcome will be explored using qualitative interviews upon completion of the study. There are no units of measurement
Mental Health Service Utilization assessed using a structured self-report questionnaire Throughout study participation up to 6 month (endline) Mental health care-seeking attitudes, intentions, and the frequency and type of mental health services utilized by participants will be assessed using a structured, self-report questionnaire developed for this study. This is a descriptive measure and does not use a scored scale.
Perceived resilience Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline) This outcome will be measured using the brief resilience scale, a 6-item scale with each item responses ranging 1 - 5. Scores are averaged across items and categorized as low resilience (1 - 2.99), normal resilience (3 - 4.3) and high resilience (4.31 - 5).
Trial Locations
- Locations (3)
Rollins School of Public Health
🇺🇸Atlanta, Georgia, United States
Ethiopian Community Association In Atlanta
🇺🇸Clarkston, Georgia, United States
Eritrean-American Community Association of Georgia
🇺🇸Stone Mountain, Georgia, United States