Recruiting

Mental Health Intervention

Sponsor:

Emory University

Code:

NCT06960187

Conditions

Mental Health Issue

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Accepted

Interventions

Weyera Intervention

Delayed intervention (waitlist control)

Study Details

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.

Conditions

Mental Health Issue

Study ID

NCT06960187

Start date

Sep 22, 2025

Status verified date

Oct, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Intervention

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

other: Wait-List Control Group

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.

Interventions

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 objectives and determinants in the Logic Model of Change.

Outline of major modules for the eight weeks:

1. Introduction to mental health
2. Stress and family pressure
3. Self-exploration and critical reflection
4. Intersectional Identities
5. Family Relationships
6. Discussing mental health in the Ethiopian and Eritrean communities
7. Trauma and Abuse
8. Navigating mental health services

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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sophia Hussen, MD, MPH

(404) 616-2440shussen@emory.edu

Locations

Rollins School of Public Health

Recruiting

Atlanta, Georgia, United States, 30322

Ethiopian Community Association In Atlanta

Recruiting

Clarkston, Georgia, United States, 30021

Eritrean-American Community Association of Georgia

Recruiting

Stone Mountain, Georgia, United States, 30083

More Information

Sponsor

Emory University

Last update posted

Oct 8, 2025

Last verified

Oct, 2025

Keywords

  • Eritrean origin
  • Ethiopian
  • Psychoeducation
  • Coping skills

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-10-08.