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Trial details
Young adults as community mental health workers in humanitarian settings
Current status:
Approved
|
Date registered:
24/01/2023
Trial version(s)
Current: 24/11/2022
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2023015206
Protocol number
R34MH121558
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
24/11/2022
Primary sponsor
American University of Beirut
Primary sponsor: Country of origin
Lebanon
Public title
Young adults as community mental health workers in humanitarian settings
Acronym
Scientific title
Young adults as community mental health workers in humanitarian settings: A pilot test of the mechanisms of effect on their own well-being
Acronym
Brief summary of the study: English
Young adults are resources and agents of change in their communities when they are employed efficiently. Involving young adults in work that influences their communities has positive outcomes for young adults’ wellbeing; and for their communities. Still, young adults are often marginalized, particularly in humanitarian settings. If young adults are to be meaningfully engaged as intervention agents, their work should focus on a community need. In the context of a humanitarian crises, has shed light on the need for human resources supporting mental health distress. For this reason, a team of researchers in the United stated and Lebanon in partnership with MAPs a Lebanese local NGO, decided to utilize the youth vibrant capacities in Lebanon; targeting Syrian Refugee youths residing in the Beqaa region in particular. Training 25 Young adults (18-24 years of age) on providing an attenuated form of mental health support through the intervention of Problem management plus (PM+) to 400 adults exposed to mental health distress. The aim is to observe the effectiveness of being elements of support to their communities on their own wellbeing, coping mechanisms, and stress. In comparison to being community mental health workers, the team will employ also a group of 20 young adults, who will be trained of tutoring techniques and topics, to deliver tutoring sessions to 200 students from families of the same community and an additional control group of 40 young adults who will only submit survey data.
Brief summary of the study: Arabic
الشباب هم موارد وعوامل للتغيير في مجتمعاتهم. إن إشراك الشباب في العمل الذي يؤثر على مجتمعاتهم له نتائج إيجابية على رفاهية الشباب ؛ ولمجتمعاتهم. ومع ذلك ، غالبًا ما يتم تهميش الشباب ، لا سيما في سياق الأزمات الإنسانية. إذا كان الشباب سيشاركون بشكل هادف كوكلاء تدخل ، يجب أن يرتكز توجيه عملهم على حاجة المجتمع. في سياق الأزمات الإنسانية ، الموارد البشرية التى تدعم ضائقة الصحة النفسية لا تكفي. ستعمل هذه الدراسة على تدريب 20 لاجئًا سوريًا شابًا ليكونوا عاملين في مجال الصحة النفسية المجتمعية لتوفير تدخل دعم نفسي واجتماعي منخفض الكثافة يسمى المعالجة المطورة للمشكلات (PM +) إلى 400 بالغ في مجتمعهم. تهدف الدراسة إلى تقييم فعالية كون الشباب عاملين مجتمعيين على عايتهم النفسية و نسب التوتر والتعامل على الشباب أنفسهم من خلال جمع البيانات و عينات الشعر لتحليل نسب الكورتيزول. سيتم تقييم هذه النتائج بين العاملين المجتمعيين الشباب ومجموعتين للمقارنة: (1) 20 شابًا سيتم تدريبهم لتقديم الدعم التعليمي إلى 200 طالب في الصفوف 1-6 في نفس المجتمع ، و (2) 40 شابًا سيقدمون بيانات المسح فقط. ستقيم الدراسة أيضًا جدوى ومقبولية الشباب الذين يقدمون الدعم النفسي والاجتماعي للبالغين في مجتمعاتهم.
Health conditions/problem studied: Specify
Managing stress and improving mental health in vulnerable communities through problem management interventions.
Interventions: Specify
In this pilot study, we aim to evaluate the feasibility, acceptability and fidelity of Syrian refugee young adults as community mental health workers (YA-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.
Key inclusion and exclusion criteria: Inclusion criteria
Inclusion Criteria: a) being Syrian refugee, (b) being18-24 years; (c) having completed high school (44); (d) living in one of catchment areas (ITS) in the Bekaa at the time of screening; (e) having been involved in NGOs or service to their community; (f) expressed motivation to serve their community.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
24
Key inclusion and exclusion criteria: Exclusion criteria
Exclusion criteria: acute mental distress assessed through clinical interview and scales (PHQ9 and PSYCHLOPS) administered by psychiatrist.
Type of Study
Type
Interventional
Type of intervention
Behavioral treatment
Trial scope
Other
Trial scope: Specify scope
prevention
Study design: Allocation
Randomized controlled trial
Study design: Masking
N/A
Study design: Control
Active
Study phase
0 (explanatory trials)
Study design: Purpose
Prevention
Study design: Assignment
Parallel
Pharmaceutical class
N/A
Therapeutic indication
N/A
Therapeutic benefit
N/A
Biospecimen retention
Samples without DNA
Biospecimen description
Hair cortisol samples will be collected to monitor stress level over the period of the study
Target sample size
40
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
01/02/2023
Date of study closure: Type
Anticipated
Date of study closure: Date
30/08/2024
Recruitment status
Pending
Date of completion
IPD sharing statement plan
Yes
IPD sharing statement description
Oversight responsibility: Drs. Afifi and Nakkash (co-PIs) will provide oversight to the trial and the ultimate responsibility for all data safety issues rest with them. The overall framework for safety monitoring and what information will be monitored: Study data will be accessible at all times to the co-PIs, the site PI (Dr. Ghandour) and to our mental health team. We will be monitoring mental health indicators for the YA-CMHW and ECG groups. The frequency of monitoring, including any plans for interim analysis and stopping rules (if applicable): For both groups (YA-CMHW and ECG), we will be collecting survey data at 4 points in times but also experience sampling method (ESM) data every three weeks (2-3 questions). This will allow the identification of acute distress or imminent threat of harm to self or others. The data will be reviewed within 24 hours of receipt by our psychiatrist and one of the co-PIs or site PI (Afifi or Nakkash or Ghandour). In addition, the psychologist will be meeting with the YA-CMHW group weekly in group and individual meetings. S/he will assess acute distress or imminent threat of harm to self or others at these meetings. If s/he identifies any CHMW with such outcomes, s/he will immediately refer to MDM, and inform our project psychiatrist and Afifi or Nakkash or Ghandour. If more than 1/3 of the YA-CMHW exhibit acute distress or imminent threat of harm to self or others at any time during the implementation of the intervention, we will stop this trial. Any adverse or serious adverse event, or unanticipated problems will be reported within 24 hours to the IRB by Dr. Ghandour and to the chair of the DSMB by Dr. Afifi or Nakkash. The project mental health team (psychiatrist and psychologist) will provide immediate guidance on management of the AEs and SAEs. We have a letter of commitment/support from Médecins Du Monde to provide mental health care free of charge to those referred (see letter of support).Data Safety Monitoring Board (DSMB): We will establish an independent data monitoring and safety board that meets quarterly or more frequently as needed. The board will consist of 5 faculty or staff with expertise in biostatistics and research ethics and/or humanitarian settings; as well as at least 2 community advocates. Three of the faculty/staff board members will be from Lebanon, and 2 from the US; all community advocates will be from Lebanon, and Syrian if possible. The DMSB will also monitor and evaluate the progress of the trial, recruitment of participants, retention, processes and timeliness of data collection, risk and benefits, and other aspects of the progress of the study that might affect outcomes. The DSMB will also highlight external factors that may be important to the progress of our research trials, including concerns about repercussions based on the socio-political situation in Lebanon, or related to scientific advancements relevant to the project. Adverse events involving risks to participants will be reported by the PIs (Nakkash or Afifi) to the DMSB and to the University’s IRB as per their policy. Finally, the DMSB will guide any decisions related to continuation or discontinuing the trials. All the above will, of course, be done with utmost attention to the confidentiality of all trial data.
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Sources of Monetary or Material Support
Name
NIH
Secondary Sponsors
Name
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Lilian
Ghandour
Lebanon
Lebanon
+961 3 644 544
lg01@aub.edu.lb
AUB
Scientific
Rima
Afifi
USA
Lebanon
+1 (319) 471-5333
rima-afifi@uiowa.edu
IOWA university
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
American University of Beirut Medical Center
13/12/2022
Lina Onsi
le08@aub.edu.lb
1-350000 or 1 374374, ext: 5445
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Interventions
Intervention
Description
Keyword
delivering PM+
Effect of delivering PM+ on the mental health and wellbeing of young adults delivering it to members of their community
PM+
delivering tutoring
effect of doing a task (tutoring school kids) on the mental health and wellbeing of young adults delivering it
social intervention
Primary Outcomes
Name
Time points
Measure
wellbeing
4 and 6
survey and hair samples
stress
4 and 6
survey and hair samples
resilience
4 and 6
survey and hair samples
Key Secondary Outcomes
Name
Time points
Measure
autonomy
4
survey
Engagement
4
survey
Hope
4
survey
meaning
4
survey
accomplishment
4
survey
positive emotions
4
survey
relationships
4
survey
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial