Jonathan Hall, Herbert E Ainamani, Phaidon T B Vassiliou, Stefan Döring, Gustaf Gredebäck, Kirsi Peltonen, Florian Scharpf, Umay Sen, Matthias Sutter, James I Walsh, Tobias Hecker
{"title":"结合心理健康和气候智能型农业干预措施，改善人道主义环境下的粮食安全：对乌干达Nakivale难民营母亲进行THRIVE集群随机对照试验的研究方案。","authors":"Jonathan Hall, Herbert E Ainamani, Phaidon T B Vassiliou, Stefan Döring, Gustaf Gredebäck, Kirsi Peltonen, Florian Scharpf, Umay Sen, Matthias Sutter, James I Walsh, Tobias Hecker","doi":"10.1186/s13063-025-09042-y","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Climate extremes in Africa threaten the food security of war-affected refugees, who often experience mental health challenges that hinder their capacity for agricultural adaptation. Cost-effective, climate-smart farming interventions are crucial for addressing food insecurity in humanitarian contexts, yet evidence on their effectiveness is limited, and the potential benefits of integrating them with mental health interventions remain unexplored. We hypothesize that the success of agricultural interventions, especially under adversity, is influenced by mental health and psychological functioning.</p><p><strong>Methods: </strong>This study employs a three-arm, parallel-group, cluster-randomized controlled trial (cRCT) in the Nakivale refugee settlement, Uganda. Thirty villages within the settlement will be randomized in a 1:1:1 allocation ratio to one of three conditions: Enhanced Usual Care, a Home Gardening Intervention (HGI) or HGI combined with the peer-delivered psychosocial intervention Self-Help Plus (SH + HGI). A total of 900 refugee mothers and their children (aged 3-4 years) will be enrolled, with 30 dyads per village. The primary outcome is food insecurity at 12 months post-intervention, assessed using the Food Insecurity Experience Scale (FIES). Secondary outcomes include dietary diversity, child malnutrition and mothers' psychological distress. Data will be collected at baseline, 3-month and 12-month follow-ups. Primary analyses will use an intention-to-treat (ITT) approach.</p><p><strong>Discussion: </strong>This study will shed light on the role of mental health in agricultural adaptation for food security, evaluating the efficacy of scalable, cost-effective interventions in a refugee setting. The findings will have implications for the design and implementation of integrated food security and mental health programs in humanitarian and other resource-constrained settings.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06425523. Registered on 24 May 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"331"},"PeriodicalIF":2.0000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12403481/pdf/","citationCount":"0","resultStr":"{\"title\":\"Combining mental health and climate-smart agricultural interventions to improve food security in humanitarian settings: study protocol for the THRIVE cluster-randomized controlled trial with mothers in Nakivale refugee settlement, Uganda.\",\"authors\":\"Jonathan Hall, Herbert E Ainamani, Phaidon T B Vassiliou, Stefan Döring, Gustaf Gredebäck, Kirsi Peltonen, Florian Scharpf, Umay Sen, Matthias Sutter, James I Walsh, Tobias Hecker\",\"doi\":\"10.1186/s13063-025-09042-y\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Climate extremes in Africa threaten the food security of war-affected refugees, who often experience mental health challenges that hinder their capacity for agricultural adaptation. Cost-effective, climate-smart farming interventions are crucial for addressing food insecurity in humanitarian contexts, yet evidence on their effectiveness is limited, and the potential benefits of integrating them with mental health interventions remain unexplored. We hypothesize that the success of agricultural interventions, especially under adversity, is influenced by mental health and psychological functioning.</p><p><strong>Methods: </strong>This study employs a three-arm, parallel-group, cluster-randomized controlled trial (cRCT) in the Nakivale refugee settlement, Uganda. Thirty villages within the settlement will be randomized in a 1:1:1 allocation ratio to one of three conditions: Enhanced Usual Care, a Home Gardening Intervention (HGI) or HGI combined with the peer-delivered psychosocial intervention Self-Help Plus (SH + HGI). A total of 900 refugee mothers and their children (aged 3-4 years) will be enrolled, with 30 dyads per village. The primary outcome is food insecurity at 12 months post-intervention, assessed using the Food Insecurity Experience Scale (FIES). Secondary outcomes include dietary diversity, child malnutrition and mothers' psychological distress. Data will be collected at baseline, 3-month and 12-month follow-ups. Primary analyses will use an intention-to-treat (ITT) approach.</p><p><strong>Discussion: </strong>This study will shed light on the role of mental health in agricultural adaptation for food security, evaluating the efficacy of scalable, cost-effective interventions in a refugee setting. The findings will have implications for the design and implementation of integrated food security and mental health programs in humanitarian and other resource-constrained settings.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06425523. 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Combining mental health and climate-smart agricultural interventions to improve food security in humanitarian settings: study protocol for the THRIVE cluster-randomized controlled trial with mothers in Nakivale refugee settlement, Uganda.
Background: Climate extremes in Africa threaten the food security of war-affected refugees, who often experience mental health challenges that hinder their capacity for agricultural adaptation. Cost-effective, climate-smart farming interventions are crucial for addressing food insecurity in humanitarian contexts, yet evidence on their effectiveness is limited, and the potential benefits of integrating them with mental health interventions remain unexplored. We hypothesize that the success of agricultural interventions, especially under adversity, is influenced by mental health and psychological functioning.
Methods: This study employs a three-arm, parallel-group, cluster-randomized controlled trial (cRCT) in the Nakivale refugee settlement, Uganda. Thirty villages within the settlement will be randomized in a 1:1:1 allocation ratio to one of three conditions: Enhanced Usual Care, a Home Gardening Intervention (HGI) or HGI combined with the peer-delivered psychosocial intervention Self-Help Plus (SH + HGI). A total of 900 refugee mothers and their children (aged 3-4 years) will be enrolled, with 30 dyads per village. The primary outcome is food insecurity at 12 months post-intervention, assessed using the Food Insecurity Experience Scale (FIES). Secondary outcomes include dietary diversity, child malnutrition and mothers' psychological distress. Data will be collected at baseline, 3-month and 12-month follow-ups. Primary analyses will use an intention-to-treat (ITT) approach.
Discussion: This study will shed light on the role of mental health in agricultural adaptation for food security, evaluating the efficacy of scalable, cost-effective interventions in a refugee setting. The findings will have implications for the design and implementation of integrated food security and mental health programs in humanitarian and other resource-constrained settings.
Trial registration: ClinicalTrials.gov NCT06425523. Registered on 24 May 2024.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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