BACKGROUND An estimated 63.4 million Indian children under 5 years are at risk of poor development. Home visits that use a structured curriculum to help caregivers enhance the quality of the home stimulation environment improve developmental outcomes. However, achieving effectiveness in poor urban contexts through scalable models remains challenging. METHODS Using a cluster randomised controlled trial, we evaluated a psychosocial stimulation intervention, comprising weekly home visits for 18 months, in urban slums of Cuttack, Odisha, India. The intervention is complementary to existing early childhood services in India and was run and managed through a local branch of a national NGO. The study ran from August 2013 to July 2015. We enrolled 421 children aged 10-20 months from 54 slums. Slums were randomised to intervention or control. Primary outcomes were children's cognitive, receptive language, expressive language and fine motor development assessed using the Bayley-III. Prespecified intent-to-treat analysis investigated impacts and heterogeneity by gender. TRIAL REGISTRATIONS ISRCTN89476603, AEARCTR-0000169. RESULTS Endline data for 378 (89.8%) children were analysed. Attrition was balanced between groups. We found improvements of 0.349 of a standard deviation (SD; p = .005, stepdown p = .017) to cognition while impacts on receptive language, expressive language and fine motor development were, respectively, 0.224 SD (p = .099, stepdown p = .184), 0.192 SD (p = .085, stepdown p = .184) and 0.111 (p = .385, stepdown p = .385). A child development factor improved by 0.301 SD (p = .032). Benefits were larger for boys. The quality of the home stimulation environment also improved. CONCLUSIONS This study shows that a potentially scalable home-visiting intervention is effective in poor urban areas.

中文翻译：

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可扩展的家访干预对印度城市贫民窟儿童发育的影响：来自随机对照试验的证据。

背景 估计有 6340 万印度 5 岁以下儿童面临发育不良的风险。家访使用结构化课程来帮助护理人员提高家庭刺激环境的质量，从而改善发展成果。然而，通过可扩展的模型在恶劣的城市环境中实现有效性仍然具有挑战性。方法 使用集群随机对照试验，我们评估了在印度奥里萨邦卡塔克城市贫民窟进行的心理社会刺激干预，包括为期 18 个月的每周家访。该干预措施是对印度现有幼儿服务的补充，并通过一个全国性非政府组织的当地分支机构运行和管​​理。该研究从 2013 年 8 月持续到 2015 年 7 月。我们招募了来自 54 个贫民窟的 421 名 10-20 个月的儿童。贫民窟被随机分配到干预组或控制组。主要结果是使用 Bayley-III 评估的儿童认知、接受性语言、表达性语言和精细运动发展。预先指定的意向治疗分析按性别调查了影响和异质性。试用注册 ISRCTN89476603，AEARCTR-0000169。结果 分析了 378 名 (89.8%) 儿童的终点数据。各组之间的损耗是平衡的。我们发现对认知的标准差 (SD; p = .005, stepdown p = .017) 提高了 0.349，而对接受性语言、表达性语言和精细运动发展的影响分别为 0.224 SD (p = .099, stepdown p = .184）、0.192 SD（p = .085，降压 p = .184）和 0.111（p = .385，降压 p = .385）。儿童发展因素提高了 0.301 SD (p = .032)。男孩的好​​处更大。家庭刺激环境的质量也有所提高。结论 本研究表明，潜在可扩展的家访干预在贫困城市地区是有效的。