Mental Health IssueNCT06960187
Weyera Mental Health Pilot Intervention
A study testing Weyera Intervention in people with Mental Health Issue, run by Emory University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Weyera Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Sep 2025to 21 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Age < 18 or > 29 years old
- Unwilling or unable to provide informed consent.
- Not a resident of the Atlanta Metropolitan Statistical Area
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rollins School of Public Health
Atlanta, Georgia, 30322
Ethiopian Community Association In Atlanta
Clarkston, Georgia, 30021
Eritrean-American Community Association of Georgia
Stone Mountain, Georgia, 30083
About this study
Official title: Piloting Resilience Focused Mental Health Intervention (Weyera) With Ethiopian and Eritrean Youth
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.
Read the 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.
- Conditions
- Mental Health Issue
- Being tested
- Weyera Intervention, Delayed intervention (waitlist control)
- Keywords
- Eritrean origin, Ethiopian, Psychoeducation, Coping skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weyera InterventionBehavioural
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:
- Introduction to mental health
- Stress and family pressure
- Self-exploration and critical reflection
- Intersectional Identities
- Family Relationships
- Discussing mental health in the Ethiopian and Eritrean communities
- Trauma and Abuse
- Navigating mental health services
Delayed intervention (waitlist control)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Weyera Intervention |
| 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. Receives: Behavioral: Delayed intervention (waitlist control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction Survey
Acceptability will be measured using satisfaction surveys at the end of each session.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Throughout study participation up to 6 month (endline)
Secondary outcomes (7)
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.
Measured: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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).
Measured: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start22 Sep 2025
- Primary completion21 Aug 2026
- Study completion21 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Sophia Hussen, Emory University
- Investigators
- Sophia Hussen, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960187
- Sponsor's protocol ID
- STUDY00008231
- Other IDs
- R21MD019304-01A1, 2025P011115
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will share the results of surveys and clinical abstracted data in a de-identified dataset.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting Resilience Focused Mental Health Intervention (Weyera) With Ethiopian and Eritrean Youth
- ClinicalTrials.gov ID
- NCT06960187
- Acronym / sponsor ID
- STUDY00008231
- Conditions
- Mental Health Issue
- Keywords
- Eritrean origin, Ethiopian, Psychoeducation, Coping skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 21 Aug 2026 (actual)
- Study completion
- 21 Aug 2026 (actual)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Weyera InterventionParticipants 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 |
| Wait-List Control Group | Other | Behavioral: Delayed intervention (waitlist control)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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Age < 18 or > 29 years old
- Unwilling or unable to provide informed consent.
- Not a resident of the Atlanta Metropolitan Statistical Area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weyera InterventionWeyera 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 | Behavioural | Intervention |
| 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). | Behavioural | Wait-List Control Group |
Primary outcome
Satisfaction Survey
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Adverse Events
Time frame: Throughout study participation up to 6 month (endline)
Adverse event tracking forms will be used to track any safety related issues with the intervention.
7 secondary outcomes
Center for Epidemiologic Studies Depression (CES-D) Scale
Time frame: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).
Generalized Anxiety Disorder 7-item scale
Time frame: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).
Posttraumatic Stress Disorder (PTSD) Checklist (PCL-5)
Time frame: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).
Perceived social support
Time frame: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline)
Affirming ethnic identity beliefs
Time frame: 6 months (endline).
Mental Health Service Utilization assessed using a structured self-report questionnaire
Time frame: Throughout study participation up to 6 month (endline)
Perceived resilience
Time frame: Baseline, 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. The research team will share the results of surveys and clinical abstracted data in a de-identified dataset.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia Hussen, MD, MPH principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weyera Intervention in people with Mental Health Issue, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction Survey (time frame: 2 months (immediate post-intervention survey), 4 months (post-intervention), 6 months (endline).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.