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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05265611
Other study ID # 202107337
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 11, 2023
Est. completion date August 31, 2024

Study information

Verified date May 2024
Source University of Iowa
Contact Rima A Afifi, PhD
Phone 3193841472
Email rima-afifi@uiowa.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 115
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility Inclusion Criteria: 1. Syrian refugee 2. 18-24 years 3. have completed high school 4. 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 5. have been involved in NGOs or service to their community' 6. motivation to be a Community Mental Health Worker

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
low intensity psychosocial intervention - Problem Management Plus (PM+)
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.
Tutoring
Young adults will be trained to tutor students in elementary school.

Locations

Country Name City State
Lebanon American University of Beirut, Faculty of Health Sciences Beirut

Sponsors (1)

Lead Sponsor Collaborator
Rema Afifi

Country where clinical trial is conducted

Lebanon, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wellbeing Self report through survey Year 2 month 6- Year 3 month 12
Primary Stress Self report through survey and Hair Cortisol Year 2 month 6 - Year 3 month 12
Primary Coping/Resilience Self report through survey Year 2 month 6 - Year 3 month 12
Secondary Mechanism-Positive emotions Self report through survey Year 2 month 6 - Year 3 month 12
Secondary Mechanism-Supportive relationships Self report through survey Year 2 month 6 - Year 3 month 12
Secondary Mechanism-Engagement Self report through survey Year 2 month 6 - Year 3 month 12
Secondary Mechanism-Accomplishments Self report through survey Year 2 month 6 - Year 3 month 12
Secondary Mechanism-Optimism/Hope Self report through survey Year 2 month 6 - Year 3 month 12
Secondary Mechanism-Meaning/Purpose in life Self report through survey Year 2 month 6 - Year 3 month 12
Secondary Mechanism-Control/Autonomy Self report through survey Year 2 month 6 - Year 3 month 12
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