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| ID | Type | Description | Link |
|---|---|---|---|
| R21MD019304-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Other | Participants enrolled in the intervention group will begin the intervention 1-2 weeks after group assignment and will complete a baseline survey before the start of the intervention, satisfaction surveys at the end of each session, and an endline survey. At the end of the intervention, a subset of participants will also take part in in-depth interviews |
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| Wait-List Control Group | Other | A wait-list control design ensures the ethical treatment of participants by guaranteeing that all individuals will have access to the potentially impactful intervention after a brief waiting period. Participants in the wait-list control group will begin the full intervention starting at month 4 following their enrollment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weyera Intervention | Behavioral | Weyera intervention is an eight-week program featuring weekly, two-hour facilitated group sessions with 6-10 participants in each group, led by trained lay facilitators. Each session will address the weekly topic and introduce an evidence-based coping strategy (e.g., mindfulness, positive refocusing) that participants can practice over the following week. Within this outline, we will create intervention activities based on theory-based change methods and practical applications matched to objectives and determinants in the Logic Model of Change. Outline of major modules for the eight weeks:
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| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction Survey | Acceptability will be measured using satisfaction surveys at the end of each session. | 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline). |
| Acceptability of the intervention is a subset of participants | 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. | 6 months (endline). |
| Recruitment Rates | 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). | 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline). |
| Retention | Retention of participants throughout the 8 sessions will be monitored using attendance logs during each visit. This will help determine feasibility of the program. | Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline). |
| Fidelity | 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. | Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline). |
| Adverse Events | Adverse event tracking forms will be used to track any safety related issues with the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Center for Epidemiologic Studies Depression (CES-D) Scale | 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. | Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophia Hussen, MD, MPH | Contact | (404) 616-2440 | shussen@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sophia Hussen, MD, MPH | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rollins School of Public Health | Recruiting | Atlanta | Georgia | 30322 | United States | |
The research team will share the results of surveys and clinical abstracted data in a de-identified dataset.
The de-identified dataset will be available after the study and data analysis are complete.
All requests accompanied by a methodologically sound proposal must be emailed to the principal investigator.
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| Delayed intervention (waitlist control) | Behavioral | Wait-list control participants will be assigned to a group for initiation of the full intervention beginning at month 4 after their enrollment (i.e., beginning after they, and their corresponding intervention group, have completed their intervention and two follow-up surveys). Wait-list control participants will complete surveys at enrollment (baseline), 2 months (pre-intervention), 4 months (pre-intervention), 6 months (immediate post-intervention), and 8 months (post-intervention). |
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| Throughout study participation up to 6 month (endline) |
| Generalized Anxiety Disorder 7-item scale | 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. | Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline). |
| Posttraumatic Stress Disorder (PTSD) Checklist (PCL-5) | 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. | Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline). |
| Perceived social support | 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). | Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline) |
| Affirming ethnic identity beliefs | This outcome will be explored using qualitative interviews upon completion of the study. There are no units of measurement | 6 months (endline). |
| Mental Health Service Utilization assessed using a structured self-report questionnaire | 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. | Throughout study participation up to 6 month (endline) |
| Perceived resilience | 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). | Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline) |
| Ethiopian Community Association In Atlanta |
| Recruiting |
| Clarkston |
| Georgia |
| 30021 |
| United States |
| Eritrean-American Community Association of Georgia | Recruiting | Stone Mountain | Georgia | 30083 | United States |