Weyera Mental Health Pilot Intervention

BEHAVIORAL

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

BEHAVIORAL

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).

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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.