Department of Community Medicine, Dr. Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Maharashtra, India.
Department of Pediatrics, Acibadem Maslak Private Hospital, Istanbul, Turkey.
BMJ Paediatr Open. 2021 Sep 15;5(1):e001254. doi: 10.1136/bmjpo-2021-001254. eCollection 2021.
More than 40% of children under 5 years of age in low-income and middle-income countries are at risk of not reaching their developmental potential. The international Guide for Monitoring Child Development (GMCD) early intervention package is a comprehensive programme to address developmental difficulties using an individualised intervention plan for young children and their families. We will conduct a hybrid type 1 effectiveness-implementation evaluation of the GMCD intervention in rural India and Guatemala.
Using a cluster-randomised design, 624 children aged 0-24 months in 52 clusters (26 in India, 26 in Guatemala) will be assigned to usual care or the GMCD intervention plus usual care delivered by frontline workers for 12 months. After 12 months, the usual care arm will cross over to the intervention, which will continue for 12 additional months (24 total). The intervention will be delivered using a digital mobile device interface. Effectiveness will be assessed for developmental functioning (Bayley Scales of Infant Development, 3rd edition) and nurturing care (Home Observation for Measurement of the Environment Scale) outcomes. Implementation will be assessed using the Reach, Effectiveness, Adoption, Implementation, Maintenance framework. Explanatory qualitative analysis guided by the Consolidated Framework for Implementation Research will explore determinants between clusters with high versus low implementation effectiveness.
The study has been approved by the Institutional Review Boards of Brigham and Women's Hospital, Mahatma Gandhi Institute of Medical Sciences and Maya Health Alliance; and by the Indian Council of Medical Research/Health Ministry Screening Committee. Key study findings will be published in international open-access journals.
NCT04665297, CTRI/2020/12/029748.
1.0 (12 November 2020).
在低收入和中等收入国家，40%以上的 5 岁以下儿童有发育潜能受损的风险。国际儿童发育监测指南（GMCD）早期干预方案是一个综合项目，通过为幼儿及其家庭制定个性化的干预计划来解决发育问题。我们将在印度农村和危地马拉对 GMCD 干预措施进行混合 1 型有效性-实施评估。
采用集群随机设计，将 624 名 0-24 个月大的儿童（印度 26 名，危地马拉 26 名）分为 52 个集群，分配到常规护理或 GMCD 干预加常规护理组，由一线工作人员提供 12 个月的干预措施。12 个月后，常规护理组将交叉到干预组，再继续干预 12 个月（共 24 个月）。干预将通过数字移动设备界面进行。有效性将通过贝利婴幼儿发育量表（第三版）和养育关怀（家庭观察测量环境量表）的结果进行评估。实施将使用实施有效性、可接受性、适用性、实施、维持框架进行评估。根据实施研究综合框架进行的解释性定性分析将探索实施有效性高和低的群组之间的决定因素。
该研究已获得布莱根妇女医院、圣雄甘地医学科学研究所和玛雅健康联盟的机构审查委员会、印度医学研究理事会/卫生部筛选委员会的批准。主要研究结果将发表在国际开放获取期刊上。
NCT04665297， CTRI/2020/12/029748。
1.0（2020 年 11 月 12 日）。
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