School of Public Health, University of California at Berkeley, Berkeley, California, USA.
Stanford Center on China's Economy and Institutions, Stanford University, Stanford, California, USA.
BMJ Open. 2023 Nov 28;13(11):e076644. doi: 10.1136/bmjopen-2023-076644.
The high incidences of both the developmental delay among young children and the mental health problems of their caregivers are major threats to in low-income and middle-income countries. Parental training interventions during early childhood have been shown to benefit early development, yet evidence on strategies to promote caregiver mental health remains limited. In addition, evidence on the optimal design of scalable interventions that integrate early child development and maternal mental health components is scarce.
We design a single-blind, factorial, cluster-randomised controlled, superiority trial that will be delivered and supervised by local agents of the All China Women's Federation (ACWF), the nationwide, government-sponsored social protection organisation that aims to safeguard the rights and interests of women and children. We randomise 125 villages in rural China into four arms: (1) a parenting stimulation arm; (2) a caregiver mental health arm; (3) a combined parenting stimulation and caregiver mental health arm and (4) a pure control arm. Caregivers and their children (aged 6-24 months at the time of baseline data collection) are selected and invited to participate in the 12-month-long study. The parenting stimulation intervention consists of weekly, one-on-one training sessions that follow a loose adaptation of the Reach Up and Learn curriculum. The caregiver mental health intervention is comprised of fortnightly group activities based on an adaptation of the Thinking Healthy curriculum from the WHO. Primary outcomes include measures of child development and caregiver mental health. Secondary outcomes include a comprehensive set of physical, psychological and behavioural outcomes. This protocol describes the design and evaluation plan for this programme.
This study received approval from the Institutional Review Board of Stanford University (IRB Protocol #63680) and the Institutional Review Board of the Southwestern University of Finance and Economics in Chengdu, Sichuan, China. Informed oral consent will be obtained from all caregivers for their own and their child's participation in the study. The full protocol will be publicly available in an open-access format. The study findings will be published in economics, medical and public health journals, as well as Chinese or English policy briefs.
AEA RCT Registry (AEARCTR-0010078) and ISRCTN registry (ISRCTN84864201).
儿童发育迟缓发生率高和照顾者心理健康问题是低收入和中等收入国家面临的主要威胁。幼儿期父母培训干预已被证明有益于早期发展，但促进照顾者心理健康的策略证据仍然有限。此外，关于整合早期儿童发展和产妇心理健康内容的可扩展干预措施的最佳设计的证据也很少。
我们设计了一项单盲、析因、整群随机对照优效试验，将由中国全国性政府资助的社会保护组织——中华全国妇女联合会（ACWF）的当地机构进行实施和监督，该组织旨在维护妇女和儿童的权益。我们将中国农村的 125 个村庄随机分为四组：（1）育儿刺激组；（2）照顾者心理健康组；（3）育儿刺激和照顾者心理健康联合组；（4）单纯对照组。在基线数据收集时，选择和邀请照顾者及其子女（6-24 个月龄）参加为期 12 个月的研究。育儿刺激干预包括每周一次的一对一培训课程，课程遵循“Reach Up and Learn”课程的松散改编版。照顾者心理健康干预由基于世界卫生组织“Thinking Healthy”课程改编的每两周一次的小组活动组成。主要结果包括儿童发展和照顾者心理健康的衡量标准。次要结果包括一套全面的身体、心理和行为结果。本方案描述了该方案的设计和评估计划。
本研究已获得斯坦福大学机构审查委员会（IRB 协议 #63680）和中国四川成都西南财经大学机构审查委员会的批准。将从所有照顾者那里获得知情口头同意，以同意他们自己和他们孩子参与研究。完整的方案将以开放获取的形式公开。研究结果将发表在经济学、医学和公共卫生期刊上，以及中文或英文的政策简报中。
AEA RCT 注册中心（AEARCTR-0010078）和 ISRCTN 注册中心（ISRCTN84864201）。
