- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05265611
Syrian Refugee Young Adults as Community Mental Health Workers-Lebanon
Youth as Community Mental Health Workers in Humanitarian Settings: A Pilot Test of the Mechanisms of Effect on Their Own Well Being
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Involving youth and young adults (YYA) in work that impacts their communities has positive outcomes for youth wellbeing; and for their communities. But, YYA are often marginalized, particularly in humanitarian settings. YYA wellbeing is linked to seven key protective factors: positive emotions, hope, relationships, meaning, accomplishments, autonomy, and engagement. Understanding protective factors as potential mechanisms for intervention-related change in wellbeing is a priority for research in humanitarian settings.
Humanitarian crises increase mental health disorders; and 'normal' distress and psychological reactions affect a large percentage of the population. Yet, human resources for health are often insufficient to meet needs. Understanding the capacities of YYA to support communities in the context of disasters has been noted as a research imperative. Globally, task-sharing interventions train non-professional lay community members to provide mental health care. As one example, Problem Management Plus (PM+) trains community mental health workers (CMHW) and is effective in humanitarian settings for common mental disorders and other problems that emerge in response to crises.
The investigators propose to engage Syrian refugee young adults (YA) - aged 18-24 years, as YA CMHW, to implement PM+ with at-risk adults (18+ years) in their communities. The Syrian refugee crises, one of the worst humanitarian crises in recent history, provides a relevant setting to implement this project. Lebanon hosts ~1.5 million Syrian refugees, and about 60% of Syrian refugees aged 15-24 years are not employed, and not in school. The Specific Aims are:
Aim 1: Assess the effectiveness of being a YA-CMHW on their wellbeing, coping, and stress levels; as compared to (i) an active comparator group of Syrian refugee peers providing tutoring services; and (ii) a group of Syrian refugee peers that receives no intervention.
Aim 2: Identify the mechanisms associated with changes in wellbeing, coping, and stress. The conceptual model describes links between the intervention, the mechanisms, and outcomes.
Aim 3: Evaluate the feasibility, acceptability and fidelity of Syrian refugee YA as CMHW implementing PM+ with clients.
Results will (a) elucidate critical mechanisms through which engagement of YYA to support their community enhances their own wellbeing; (b) inform research around humanitarian/refugee settings, mental health, and Y-CMHW interventions; and (c) provide a robust basis for a follow-up study via a larger RCT.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beirut, Lebanon
- American University of Beirut, Faculty of Health Sciences
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Syrian refugee
- 18-24 years
- have completed high school
- at the time of screening, live in one of the 3 catchment areas of the field-based NGO partner (MAPs) in the Bekaa region of Lebanon
- have been involved in NGOs or service to their community'
- motivation to be a Community Mental Health Worker
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Young Adult Community Mental Health Worker
Syrian refugee young adults will be trained to implement Problem Management Plus (PM+): a WHO evidence-based low intensity mental health intervention to Syrian refugee adults in their community.
They will complete 4 surveys to measure outcomes and mechanisms.
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Syrian refugee young adults will be trained to implement Problem Management Plus (PM+).
PM+ is a low-intensity mental health intervention, developed by WHO, and delivered by non-specialized CMHW.
It is a transdiagnostic treatment approach that includes four evidence-based problem solving and behavioral treatment techniques: managing stress, managing problems, get going/get doing, and social support.
These strategies are implemented over five weekly sessions, of 90 minutes each.
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Active Comparator: Young Adult Tutors
Syrian refugee young adults will be trained to tutor elementary school students in their community.They will complete 4 surveys to measure outcomes and mechanisms.
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Young adults will be trained to tutor students in elementary school.
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No Intervention: Young Adut Control Group
Syrian refugee young adults in the control group will only complete the surveys.
They will complete 4 surveys to measure outcomes and mechanisms.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wellbeing
Time Frame: Year 2 month 8- Year 4 month 8
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Self report through survey
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Year 2 month 8- Year 4 month 8
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Stress
Time Frame: Year 2 month 8 - Year 4 month 8
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Self report through survey and Hair Cortisol
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Year 2 month 8 - Year 4 month 8
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Coping/Resilience
Time Frame: Year 2 month 8 - Year 4 month 8
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Self report through survey
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Year 2 month 8 - Year 4 month 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mechanism-Positive emotions
Time Frame: Year 2 month 8 - Year 4 month 8
|
Self report through survey
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Year 2 month 8 - Year 4 month 8
|
|
Mechanism-Supportive relationships
Time Frame: Year 2 month 8 - Year 4 month 8
|
Self report through survey
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Year 2 month 8 - Year 4 month 8
|
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Mechanism-Engagement
Time Frame: Year 2 month 8 - Year 4 month 8
|
Self report through survey
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Year 2 month 8 - Year 4 month 8
|
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Mechanism-Accomplishments
Time Frame: Year 2 month 8 - Year 4 month 8
|
Self report through survey
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Year 2 month 8 - Year 4 month 8
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Mechanism-Optimism/Hope
Time Frame: Year 2 month 8 - Year 4 month 8
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Self report through survey
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Year 2 month 8 - Year 4 month 8
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Mechanism-Meaning/Purpose in life
Time Frame: Year 2 month 8 - Year 4 month 8
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Self report through survey
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Year 2 month 8 - Year 4 month 8
|
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Mechanism-Control/Autonomy
Time Frame: Year 2 month 8 - Year 4 month 8
|
Self report through survey
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Year 2 month 8 - Year 4 month 8
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rima A Afifi, PhD, University of Iowa College of Public Health
Publications and helpful links
General Publications
- Nakkash R, Fares M, Tleis M, Mugharbil A, Antaby M, Al Masri H, Ghandour L, Al Halabi F, Najjar Y, Louis B, Afifi RA. (2024). Power Sharing in Community-Engaged Research with Syrian Refugees in Lebanon: Using community engagement to shape Intervention Fit to Context. Social Science and Medicine, Mental Health; 6(4): 100358, https://doi.org/10.1016/j.ssmmh.2024.100358.
- Ghandour L, Brown G, Tleis M, Al Masri H, Fares M, Al Halabi F, Najjar Y, Louis B, Afifi RA, Nakkash R. Structural and political determinants of health among Syrian refugee young adults in the Bekaa, Lebanon: a prospective cohort study of the impact of security raids on perceived discrimination and well-being. BMJ Open. 2024 Dec 5;14(12):e087777. doi: 10.1136/bmjopen-2024-087777.
- Nakkash R, Ghandour L, Brown G, Panter-Brick C, Bomar H, Tleis M, Al Masri H, Fares M, Al Halabi F, Najjar Y, Louis B, Hodroj M, Chamoun Y, Zarzour M, Afifi RA. Syrian refugee young adults as community mental health workers implementing problem management plus: Protocol for a pilot randomized controlled trial to measure the mechanisms of effect on their own wellbeing, stress and coping. Contemp Clin Trials Commun. 2024 Jun 28;40:101325. doi: 10.1016/j.conctc.2024.101325. eCollection 2024 Aug.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202107337
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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