Rima Nakkash , Lilian Ghandour , Grant Brown , Catherine Panter-Brick , Hailey Bomar , Malak Tleis , Hanan Al Masri , Marwa Fares , Fadi Al Halabi , Yamen Najjar , Bayan Louis , Maha Hodroj , Yara Chamoun , Myriam Zarzour , Rima A. Afifi
{"title":"叙利亚青年难民作为社区心理健康工作者实施问题管理加:试点随机对照试验协议,以衡量对其自身福祉、压力和应对的影响机制","authors":"Rima Nakkash , Lilian Ghandour , Grant Brown , Catherine Panter-Brick , Hailey Bomar , Malak Tleis , Hanan Al Masri , Marwa Fares , Fadi Al Halabi , Yamen Najjar , Bayan Louis , Maha Hodroj , Yara Chamoun , Myriam Zarzour , Rima A. Afifi","doi":"10.1016/j.conctc.2024.101325","DOIUrl":null,"url":null,"abstract":"<div><p>This pilot randomized controlled trial protocol aims to (1) assess the impact on the wellbeing of Syrian refugee young adults (18–24 years) of being a community mental health worker (CMHW) implementing WHO's evidence-based psychosocial intervention - Problem Management Plus (PM+) - with adults in their community, and (2) identify the mechanisms associated with the outcomes of enhanced wellbeing and coping, and reduced stress among these CMHWs. Over 108 million people have been forcibly displaced as of the end of 2022. Mental health consequences of these displacements are significant, yet human resources for health are not sufficient to meet the needs. A large proportion of refugee populations are youth and young adults (YA). Evidence indicates their engagement in supporting their communities leads to their own enhanced wellbeing and that of their community. This trial trains Syrian refugees to serve their communities as CMHW (n=19) or tutors (n=19) and compare wellbeing, stress and coping outcomes between these two groups and a control group (n = 40). We will also assess 7 mechanisms as potential pathways for the interventions to influence outcomes. Surveys will assess outcomes and mechanisms, hair samples will measure stress cortisol. The primary analysis will use a Bayesian Hierarchical Model approach to model the trajectories of the mechanisms and primary study endpoints over time for individuals in each of the arms. Our results will elucidate critical mechanisms in which engagement of young adults to support their community enhances their own wellbeing.</p></div><div><h3>Trial registration</h3><p>National Institutes of Mental Health, NCT05265611, Registered prospectively in 2021.</p></div><div><h3>Lebanon clinical trials registry #</h3><p>LBCTR2023015206, Registered in 2023.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"40 ","pages":"Article 101325"},"PeriodicalIF":1.4000,"publicationDate":"2024-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000723/pdfft?md5=4b712e04c6ae6e8c53d18045363324eb&pid=1-s2.0-S2451865424000723-main.pdf","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"Rima Nakkash , Lilian Ghandour , Grant Brown , Catherine Panter-Brick , Hailey Bomar , Malak Tleis , Hanan Al Masri , Marwa Fares , Fadi Al Halabi , Yamen Najjar , Bayan Louis , Maha Hodroj , Yara Chamoun , Myriam Zarzour , Rima A. Afifi\",\"doi\":\"10.1016/j.conctc.2024.101325\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>This pilot randomized controlled trial protocol aims to (1) assess the impact on the wellbeing of Syrian refugee young adults (18–24 years) of being a community mental health worker (CMHW) implementing WHO's evidence-based psychosocial intervention - Problem Management Plus (PM+) - with adults in their community, and (2) identify the mechanisms associated with the outcomes of enhanced wellbeing and coping, and reduced stress among these CMHWs. Over 108 million people have been forcibly displaced as of the end of 2022. Mental health consequences of these displacements are significant, yet human resources for health are not sufficient to meet the needs. A large proportion of refugee populations are youth and young adults (YA). Evidence indicates their engagement in supporting their communities leads to their own enhanced wellbeing and that of their community. This trial trains Syrian refugees to serve their communities as CMHW (n=19) or tutors (n=19) and compare wellbeing, stress and coping outcomes between these two groups and a control group (n = 40). We will also assess 7 mechanisms as potential pathways for the interventions to influence outcomes. Surveys will assess outcomes and mechanisms, hair samples will measure stress cortisol. The primary analysis will use a Bayesian Hierarchical Model approach to model the trajectories of the mechanisms and primary study endpoints over time for individuals in each of the arms. Our results will elucidate critical mechanisms in which engagement of young adults to support their community enhances their own wellbeing.</p></div><div><h3>Trial registration</h3><p>National Institutes of Mental Health, NCT05265611, Registered prospectively in 2021.</p></div><div><h3>Lebanon clinical trials registry #</h3><p>LBCTR2023015206, Registered in 2023.</p></div>\",\"PeriodicalId\":37937,\"journal\":{\"name\":\"Contemporary Clinical Trials Communications\",\"volume\":\"40 \",\"pages\":\"Article 101325\"},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2024-06-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2451865424000723/pdfft?md5=4b712e04c6ae6e8c53d18045363324eb&pid=1-s2.0-S2451865424000723-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary Clinical Trials Communications\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2451865424000723\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary Clinical Trials Communications","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2451865424000723","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
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
This pilot randomized controlled trial protocol aims to (1) assess the impact on the wellbeing of Syrian refugee young adults (18–24 years) of being a community mental health worker (CMHW) implementing WHO's evidence-based psychosocial intervention - Problem Management Plus (PM+) - with adults in their community, and (2) identify the mechanisms associated with the outcomes of enhanced wellbeing and coping, and reduced stress among these CMHWs. Over 108 million people have been forcibly displaced as of the end of 2022. Mental health consequences of these displacements are significant, yet human resources for health are not sufficient to meet the needs. A large proportion of refugee populations are youth and young adults (YA). Evidence indicates their engagement in supporting their communities leads to their own enhanced wellbeing and that of their community. This trial trains Syrian refugees to serve their communities as CMHW (n=19) or tutors (n=19) and compare wellbeing, stress and coping outcomes between these two groups and a control group (n = 40). We will also assess 7 mechanisms as potential pathways for the interventions to influence outcomes. Surveys will assess outcomes and mechanisms, hair samples will measure stress cortisol. The primary analysis will use a Bayesian Hierarchical Model approach to model the trajectories of the mechanisms and primary study endpoints over time for individuals in each of the arms. Our results will elucidate critical mechanisms in which engagement of young adults to support their community enhances their own wellbeing.
Trial registration
National Institutes of Mental Health, NCT05265611, Registered prospectively in 2021.
期刊介绍:
Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.