Clinical trial NCT06960187: Weyera Mental Health Pilot Intervention
Official title: Piloting Resilience Focused Mental Health Intervention (Weyera) With Ethiopian and Eritrean Youth
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health Issue
Keywords: Eritrean origin
Ethiopian
Psychoeducation
Coping skills
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2025-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Satisfaction Survey
timeFrame: 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).
measure: Acceptability of the intervention is a subset of participants
timeFrame: 6 months (endline).
measure: Recruitment Rates
timeFrame: 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).
measure: Retention
timeFrame: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).
measure: Fidelity
timeFrame: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).
measure: Adverse Events
timeFrame: Throughout study participation up to 6 month (endline)
Secondary outcomes:
measure: Center for Epidemiologic Studies Depression (CES-D) Scale
timeFrame: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).
measure: Generalized Anxiety Disorder 7-item scale
timeFrame: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).
measure: Posttraumatic Stress Disorder (PTSD) Checklist (PCL-5)
timeFrame: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).
measure: Perceived social support
timeFrame: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline)
measure: Affirming ethnic identity beliefs
timeFrame: 6 months (endline).
measure: Mental Health Service Utilization assessed using a structured self-report questionnaire
timeFrame: Throughout study participation up to 6 month (endline)
measure: Perceived resilience
timeFrame: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Rollins School of Public Health
state: Georgia
city: Clarkston
country: United States
facility: Ethiopian Community Association In Atlanta
state: Georgia
city: Stone Mountain
country: United States
facility: Eritrean-American Community Association of Georgia
state: Georgia
Study officials:
affiliation: Emory University
name: Sophia Hussen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: