Weyera Mental Health Pilot Intervention

Официальное название

Piloting Resilience Focused Mental Health Intervention (Weyera) With Ethiopian and Eritrean Youth

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Weyera Intervention
  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 objecti
• Поведенческое Delayed intervention (waitlist control)
  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).

Первичные конечные точки

• Satisfaction Survey [Срок оценки: 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).]
• Acceptability of the intervention is a subset of participants [Срок оценки: 6 months (endline).]
• Recruitment Rates [Срок оценки: 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).]
• Retention [Срок оценки: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).]
• Fidelity [Срок оценки: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).]
• Adverse Events [Срок оценки: Throughout study participation up to 6 month (endline)]

Вторичные конечные точки (7)

• Center for Epidemiologic Studies Depression (CES-D) Scale [Срок оценки: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).]
• Generalized Anxiety Disorder 7-item scale [Срок оценки: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).]
• Posttraumatic Stress Disorder (PTSD) Checklist (PCL-5) [Срок оценки: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).]
• Perceived social support [Срок оценки: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline)]
• Affirming ethnic identity beliefs [Срок оценки: 6 months (endline).]
• Mental Health Service Utilization assessed using a structured self-report questionnaire [Срок оценки: Throughout study participation up to 6 month (endline)]
• Perceived resilience [Срок оценки: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Age < 18 or > 29 years old
• Unwilling or unable to provide informed consent.
• Not a resident of the Atlanta Metropolitan Statistical Area

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 3 центра

• Rollins School of Public Health — Atlanta
• Ethiopian Community Association In Atlanta — Clarkston
• Eritrean-American Community Association of Georgia — Stone Mountain

Идентификаторы

NCT: NCT06960187 · STUDY00008231 · R21MD019304-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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