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

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2024-06-28 DOI:10.1016/j.conctc.2024.101325
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
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引用次数: 0

摘要

这项试点随机对照试验方案旨在:(1)评估作为社区心理健康工作者(CMHW)对叙利亚难民中的年轻成年人(18-24 岁)实施世界卫生组织的循证社会心理干预措施--问题管理+(PM+)--对其社区中成年人的幸福感的影响;(2)确定与这些社区心理健康工作者的幸福感和应对能力增强以及压力减轻的结果相关的机制。截至 2022 年底,已有超过 1.08 亿人被迫流离失所。这些流离失所现象对心理健康造成了严重后果,但卫生方面的人力资源却不足以满足这些需求。难民人口中有很大一部分是青年和年轻成年人(YA)。有证据表明,他们参与支持自己的社区可提高自身和社区的福祉。本试验将培训叙利亚难民作为社区医疗卫生工作者(19 人)或辅导员(19 人)为社区服务,并比较这两组与对照组(40 人)之间的福利、压力和应对结果。我们还将评估 7 种机制,作为干预措施影响结果的潜在途径。调查将评估结果和机制,头发样本将测量压力皮质醇。主要分析将使用贝叶斯层次模型方法来模拟每组个体的机制和主要研究终点随时间变化的轨迹。我们的研究结果将阐明年轻成年人参与支持社区提高自身幸福感的关键机制。试验注册美国国家心理卫生研究所,NCT05265611,2021 年进行前瞻性注册。黎巴嫩临床试验注册 #LBCTR2023015206,2023 年注册。
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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.

Lebanon clinical trials registry #

LBCTR2023015206, Registered in 2023.

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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
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.
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