Mental HealthNCT05265611
Syrian Refugee Young Adults as Community Mental Health Workers-Lebanon
A study testing low intensity psychosocial intervention - Problem Management Plus (PM+) and Tutoring in people with Mental Health and Stress, Psychological, run by Rema Afifi at 1 site in Lebanon.
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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Stress, Psychological
- What is being tested?
- low intensity psychosocial intervention - Problem Management Plus (PM+) and Tutoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteLebanon
- Study dates
- 11 Mar 2023to 25 Mar 2025
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Lebanon1 site
American University of Beirut, Faculty of Health Sciences
Beirut
About this study
Official title: Youth as Community Mental Health Workers in Humanitarian Settings: A Pilot Test of the Mechanisms of Effect on Their Own Well Being
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.
Read the 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.
- Conditions
- Mental Health, Stress, Psychological
- Being tested
- low intensity psychosocial intervention - Problem Management Plus (PM+), Tutoring
- Keywords
- Lebanon, Refugee, Problem Management Plus, RCT, Psychosocial intervention
- Medical subject headings
- Psychological Well-Being, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low intensity psychosocial intervention - Problem Management Plus (PM+)Behavioural
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.
TutoringBehavioural
Young adults will be trained to tutor students in elementary school.
| Study group | Role | What they receive |
|---|---|---|
| Young Adult Community Mental Health Worker | Experimental | 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. Receives: Behavioral: low intensity psychosocial intervention - Problem Management Plus (PM+) |
| Young Adult Tutors | Active comparator | 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. Receives: Behavioral: Tutoring |
| Young Adut Control Group | No intervention | Syrian refugee young adults in the control group will only complete the surveys. They will complete 4 surveys to measure outcomes and mechanisms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wellbeing
Self report through survey
Measured: Year 2 month 8- Year 4 month 8
Stress
Self report through survey and Hair Cortisol
Measured: Year 2 month 8 - Year 4 month 8
Coping/Resilience
Self report through survey
Measured: Year 2 month 8 - Year 4 month 8
Secondary outcomes (7)
Mechanism-Positive emotions
Self report through survey
Measured: Year 2 month 8 - Year 4 month 8
Mechanism-Supportive relationships
Self report through survey
Measured: Year 2 month 8 - Year 4 month 8
Mechanism-Engagement
Self report through survey
Measured: Year 2 month 8 - Year 4 month 8
Mechanism-Accomplishments
Self report through survey
Measured: Year 2 month 8 - Year 4 month 8
Mechanism-Optimism/Hope
Self report through survey
Measured: Year 2 month 8 - Year 4 month 8
Mechanism-Meaning/Purpose in life
Self report through survey
Measured: Year 2 month 8 - Year 4 month 8
Mechanism-Control/Autonomy
Self report through survey
Measured: Year 2 month 8 - Year 4 month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start11 Mar 2023
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rema Afifi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rema Afifi, University of Iowa
- Investigators
- Rima A Afifi, PhD, Principal investigator, University of Iowa College of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265611
- Sponsor's protocol ID
- 202107337
- Status last verified
- Dec 2025
- First submitted
- 22 Feb 2022
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD that underlie results reported in publications will be shared with researchers.
Publications
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.
PubMed 39045391Ghandour 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.
PubMed 39638591Nakkash R, Fares M, Tleis M, Mugharbil S, Antaby M, Al Masri H, Ghandour L, Al Halabi F, Najjar Y, Louis B, Afifi R. Power sharing in community-engaged research with Syrian refugees in Lebanon: Using community engagement to shape intervention fit to context. SSM Ment Health. 2024 Dec;6:100358. doi: 10.1016/j.ssmmh.2024.100358. Epub 2024 Nov 7.
PubMed 41625166
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Youth as Community Mental Health Workers in Humanitarian Settings: A Pilot Test of the Mechanisms of Effect on Their Own Well Being
- ClinicalTrials.gov ID
- NCT05265611
- Acronym / sponsor ID
- 202107337
- Conditions
- Mental Health, Stress, Psychological
- Keywords
- Lebanon, Refugee, Problem Management Plus, RCT, Psychosocial intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Rema AfifiUniversity, hospital or other
- Study start
- 11 Mar 2023 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 3 Mar 2022 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Young Adult Community Mental Health Worker | Experimental | Behavioral: low intensity psychosocial intervention - Problem Management Plus (PM+)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. |
| Young Adult Tutors | Active comparator | Behavioral: TutoringSyrian refugee young adults will be trained to tutor elementary school students in their community.They will complete 4 surveys to measure outcomes and mechanisms. |
| Young Adut Control Group | No intervention | –Syrian refugee young adults in the control group will only complete the surveys. They will complete 4 surveys to measure outcomes and mechanisms. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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'
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| 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. | Behavioural | Young Adult Community Mental Health Worker |
| TutoringYoung adults will be trained to tutor students in elementary school. | Behavioural | Young Adult Tutors |
Primary outcome
Wellbeing
Time frame: Year 2 month 8- Year 4 month 8
Self report through survey
Stress
Time frame: Year 2 month 8 - Year 4 month 8
Self report through survey and Hair Cortisol
Coping/Resilience
Time frame: Year 2 month 8 - Year 4 month 8
Self report through survey
7 secondary outcomes
Mechanism-Positive emotions
Time frame: Year 2 month 8 - Year 4 month 8
Mechanism-Supportive relationships
Time frame: Year 2 month 8 - Year 4 month 8
Mechanism-Engagement
Time frame: Year 2 month 8 - Year 4 month 8
Mechanism-Accomplishments
Time frame: Year 2 month 8 - Year 4 month 8
Mechanism-Optimism/Hope
Time frame: Year 2 month 8 - Year 4 month 8
Mechanism-Meaning/Purpose in life
Time frame: Year 2 month 8 - Year 4 month 8
Mechanism-Control/Autonomy
Time frame: Year 2 month 8 - Year 4 month 8
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 29 Dec 2025.
- Results publication: PubMed 39045391Nakkash 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.
- Results publication: PubMed 39638591Ghandour 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.
- Results publication: PubMed 41625166Nakkash R, Fares M, Tleis M, Mugharbil S, Antaby M, Al Masri H, Ghandour L, Al Halabi F, Najjar Y, Louis B, Afifi R. Power sharing in community-engaged research with Syrian refugees in Lebanon: Using community engagement to shape intervention fit to context. SSM Ment Health. 2024 Dec;6:100358. doi: 10.1016/j.ssmmh.2024.100358. Epub 2024 Nov 7.
- Individual participant dataSharing planned: Yes. De-identified IPD that underlie results reported in publications will be shared with researchers.
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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.
Rima A Afifi, PhD principal investigator
University of Iowa College of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low intensity psychosocial intervention - Problem Management Plus (PM+) and Tutoring in people with Mental Health and Stress, Psychological, run by Rema Afifi at 1 site in Lebanon.
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 6 inclusion and 0 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 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. 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?
Wellbeing (time frame: Year 2 month 8- Year 4 month 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05265611, which also lists 3 linked publications.
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 29 Dec 2025.