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临床试验/NCT06960187
NCT06960187招募中不适用

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

Emory University6 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月22日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
6
主要终点
Adverse Events

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Adverse Events

时间窗: Throughout study participation up to 6 month (endline)

Adverse event tracking forms will be used to track any safety related issues with the intervention.

Satisfaction Survey

时间窗: 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.

Acceptability of the intervention is a subset of participants

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sophia Hussen

Associate Professor of Public Health and Medicine

Emory University

研究点 (6)

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