An Individualized Approach to Promote Nurturing Care in Low and Middle Income Countries: A Hybrid Effectiveness/Implementation Trial of the International Guide for Monitoring Child Development

促进低收入和中等收入国家养育护理的个性化方法：《国际儿童发展监测指南》的混合有效性/实施试验

• 批准号: 10611318
• 负责人: Peter Rohloff
• 金额: $ 49.4万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10611318
• 关键词: 2 year old; Address; Adoption; Affect; Age; Caregiver support; Caregivers; Caring; Characteristics; Child; Child Development; Cluster randomized trial; Collaborations; Communication; Communities; Community Health Aides; Consolidated Framework for Implementation Research; Cost Analysis; Cost Effectiveness Analysis; Data; Development; Dropout; Early identification; Education; Effectiveness; Effectiveness of Interventions; Environment; Evaluation; Family; Focus Groups; Funding; Goals; Guatemala; Health; Home; Hour; India; Individual; Infant Development; Institution; International; Intervention; Interview; Learning; Maintenance; Malnutrition; Measurement; Monitor; Outcome; Participant; Patient-Focused Outcomes; Phase; Policy Maker; Population; Poverty; Preventive healthcare; Protocols documentation; Provider; Qualitative Evaluations; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Research; Research Training; Resource Allocation; Risk; Risk Factors; Rural; Rural Community; Sensitivity and Specificity; Supportive care; System; Testing; UNICEF; United States National Institutes of Health; Visit; Work; World Health Organization; aged; arm; contextual factors; cost; cost effective intervention; cost effectiveness; economic evaluation; effectiveness evaluation; effectiveness outcome; effectiveness/implementation hybrid; effectiveness/implementation trial; empowerment; human capital; impaired brain development; implementation barriers; implementation evaluation; implementation facilitators; implementation framework; implementation intervention; implementation process; implementation science; improved; improved outcome; instrument; intervention cost; low and middle-income countries; patient home care; personalized approach; programs; resource guides; social; success; therapy development; treatment as usual

PROJECT SUMMARY More than 40% of children under 5 years in low- and middle-income countries (LMICs) are at risk of not reaching their developmental potential. One of the most effective and proven strategies for supporting early child development in these settings is to empower caregivers and communities to support their children’s development. However, evidence on the effectiveness and the barriers and facilitators to implementation of interventions to promote this nurturing care are need. In this study, we will use an implementation science framework to evaluate an individualize intervention to promote nurturing care—the international Guide for Monitoring Child Development (GMCD), in rural India and Guatemala. We will conduct a hybrid effectiveness/implementation cluster randomized trial, where children aged 0-2 years will receive individualized visits from frontline health workers administering the GMCD. The study will have three parts: In Part 1, we will randomize clusters to receive either the GMCD or usual care for 12 months. After 12 months, control clusters will cross-in and all children will receive an additional 12 months of intervention. We will assess the impact of the intervention at 12 and 24 months on developmental outcomes and on the home care environment. In Part 2, we will use the RE-AIM implementation science framework to assess the Reach, Effectiveness, Adoption, Implementation, Maintenance of the intervention. We will also use the CFIR (Consolidated Framework for Implementation Research) framework to conduct in-depth complementary qualitative evaluation of implementation barriers and facilitators in high- and low- performing clusters from Part 1. In Part 3, we will assess cost effectiveness of the intervention. In conclusion, the study will answer three important questions: (1) Is the GMCD effective at improving developmental outcomes and the home care environment for children at risk in rural India and Guatemala? (2) What real-world institutional and contextual factors influence the impact of the intervention and might affect its potential ability to sustainably reach children and families? (3) Is the intervention cost-effective? The project will generate globally relevant evidence on community-based early child development interventions in LMICs.

项目摘要 在低收入和中等收入国家，超过40%的5岁以下儿童 有可能无法发挥他们的发展潜力。一个最有效的和证明 在这些环境中支持儿童早期发展的战略是 照顾者和社区，以支持他们的孩子的发展。然而，证据 执行干预措施的有效性、障碍和促进因素， 促进这种养育护理是必要的。在这项研究中，我们将使用一种实现科学， 框架，以评估个性化的干预，以促进养育护理- 《监测儿童发展国际指南》，在印度农村， 危地马拉.我们将进行一个混合有效性/实施随机分组 试验，0-2岁的儿童将接受一线卫生部门的个性化访问 管理GMCD的工人。研究将分为三个部分：第一部分，我们将 随机分组接受GMCD或常规护理12个月。经过12 个月，对照组将交叉，所有儿童将获得额外的12个月 干预。我们将在12个月和24个月时评估干预的影响， 发展成果和家庭护理环境。在第2部分中，我们将使用 RE-AIM实施科学框架，以评估覆盖范围、有效性、采用率， 干预的实施和维持。我们还将使用CFIR（综合 框架实施研究）框架进行深入互补 对高、低、中、低三个阶段的执行障碍和促进因素的质量评价 执行第1部分中的群集。在第3部分，我们将评估 干预总之，本研究将回答三个重要问题：（1） GMCD有效改善儿童的发育结果和家庭护理环境 印度和危地马拉农村的危险儿童？(2)现实世界的制度和 背景因素影响干预的效果，并可能影响其潜力 可持续地接触儿童和家庭的能力？(3)干预是否具有成本效益？的 该项目将产生全球相关的证据， 对中低收入国家的发展干预。