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Syrian Refugee Young Adults as Community Mental Health Workers-Lebanon

Primary Purpose

Mental Health, Stress, Psychological

Status
Recruiting
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
low intensity psychosocial intervention - Problem Management Plus (PM+)
Tutoring
Sponsored by
Rema Afifi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Health focused on measuring Lebanon, Refugee, Problem Management Plus, RCT, Psychosocial intervention

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Syrian refugee
  2. 18-24 years
  3. have at least ten years of education
  4. at the time of screening, live in one of the selected Informal Tented Settlements in the Bekaa region of Lebanon
  5. have been involved in NGOs or service to their community'
  6. not working at the time of enrollment
  7. motivation to be a Community Mental Health Worker

Exclusion Criteria:

Sites / Locations

  • American University of Beirut, Faculty of Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Young Adult Community Mental Health Worker

Young Adult Tutors

Young Adut Control Group

Arm Description

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.

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.

Syrian refugee young adults in the control group will only complete the surveys. They will complete 4 surveys to measure outcomes and mechanisms.

Outcomes

Primary Outcome Measures

Wellbeing
Self report through survey
Stress
Self report through survey and Hair Cortisol
Coping/Resilience
Self report through survey

Secondary Outcome Measures

Mechanism-Positive emotions
Self report through survey
Mechanism-Supportive relationships
Self report through survey
Mechanism-Engagement
Self report through survey
Mechanism-Accomplishments
Self report through survey
Mechanism-Optimism/Hope
Self report through survey
Mechanism-Meaning/Purpose in life
Self report through survey
Mechanism-Control/Autonomy
Self report through survey

Full Information

First Posted
February 22, 2022
Last Updated
August 14, 2023
Sponsor
Rema Afifi
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1. Study Identification

Unique Protocol Identification Number
NCT05265611
Brief Title
Syrian Refugee Young Adults as Community Mental Health Workers-Lebanon
Official Title
Youth as Community Mental Health Workers in Humanitarian Settings: A Pilot Test of the Mechanisms of Effect on Their Own Well Being
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rema Afifi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this pilot study, we aim to evaluate the feasibility, acceptability and fidelity of Syrian refugee young adults as community mental health workers (Y-CMHW), and the impact of this work on outcomes of wellbeing, coping and stress. In addition, we aim to assess the mechanisms leading to any changes in these outcomes.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health, Stress, Psychological
Keywords
Lebanon, Refugee, Problem Management Plus, RCT, Psychosocial intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Young Adult Community Mental Health Worker
Arm Type
Experimental
Arm Description
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.
Arm Title
Young Adult Tutors
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Young Adut Control Group
Arm Type
No Intervention
Arm Description
Syrian refugee young adults in the control group will only complete the surveys. They will complete 4 surveys to measure outcomes and mechanisms.
Intervention Type
Behavioral
Intervention Name(s)
low intensity psychosocial intervention - Problem Management Plus (PM+)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tutoring
Intervention Description
Young adults will be trained to tutor students in elementary school.
Primary Outcome Measure Information:
Title
Wellbeing
Description
Self report through survey
Time Frame
Year 2 month 6- Year 3 month 12
Title
Stress
Description
Self report through survey and Hair Cortisol
Time Frame
Year 2 month 6 - Year 3 month 12
Title
Coping/Resilience
Description
Self report through survey
Time Frame
Year 2 month 6 - Year 3 month 12
Secondary Outcome Measure Information:
Title
Mechanism-Positive emotions
Description
Self report through survey
Time Frame
Year 2 month 6 - Year 3 month 12
Title
Mechanism-Supportive relationships
Description
Self report through survey
Time Frame
Year 2 month 6 - Year 3 month 12
Title
Mechanism-Engagement
Description
Self report through survey
Time Frame
Year 2 month 6 - Year 3 month 12
Title
Mechanism-Accomplishments
Description
Self report through survey
Time Frame
Year 2 month 6 - Year 3 month 12
Title
Mechanism-Optimism/Hope
Description
Self report through survey
Time Frame
Year 2 month 6 - Year 3 month 12
Title
Mechanism-Meaning/Purpose in life
Description
Self report through survey
Time Frame
Year 2 month 6 - Year 3 month 12
Title
Mechanism-Control/Autonomy
Description
Self report through survey
Time Frame
Year 2 month 6 - Year 3 month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rima A Afifi, PhD
Phone
3193841472
Email
rima-afifi@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rima T Nakkash, DrPH
Email
rnakkash@gmu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rima A Afifi, PhD
Organizational Affiliation
University of Iowa College of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
American University of Beirut, Faculty of Health Sciences
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lilian Ghandour, PhD
Email
lg01@aub.edu.lb
First Name & Middle Initial & Last Name & Degree
Malak Tleis, PhD
Email
mt99@aub.edu.lb

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified IPD that underlie results reported in publications will be shared with researchers.
IPD Sharing Time Frame
Beginning 6 months and ending 36 months after article publication.
IPD Sharing Access Criteria
"Access to trial IPD can be requested by researchers conducting independent scientific research, and will be provided following review and approval of a research proposal and analysis plan and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact the Principal Investigator."

Learn more about this trial

Syrian Refugee Young Adults as Community Mental Health Workers-Lebanon

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