This publication is a protocol for a cluster randomized controlled superiority trial designed to evaluate an enhanced early childhood development (ECD) program. The study is set in primary health care facilities across 3 counties in China. The target population includes children aged 6-23 months and their families, with a planned sample size of 1044 participants. The intervention consists of a multifaceted enhanced ECD program that includes improved facilities, capacity building for health care providers, age-adapted clinical consultations focusing on nutrition and stimulation, age-specific parenting group sessions, home visits, referrals for children identified as needing additional support, and an electronic data platform to track and coordinate care. The comparator is usual care, which is not further specified in the protocol. The primary outcome is children's overall development as measured by the Global Scale of Early Development combined form at 12 months of follow-up. Secondary outcomes are not reported in this protocol. The total follow-up period is 23 months, with the primary outcome assessed at 12 months. As this is a protocol, no results are available. Safety data, including adverse events, serious adverse events, discontinuations, and tolerability, are not reported. The study is funded in 2023, and ethical approval was obtained from the Institutional Review Board of Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine. The protocol notes that the study findings will guide government policies and reforms for strengthening the health system to scale up ECD services. However, because this is a protocol, no comparisons to prior landmark studies can be made, and no methodological limitations or biases are discussed. The clinical implications are not yet known, and many questions remain unanswered until the trial results are published. In summary, this protocol outlines a rigorous cluster randomized trial that may provide valuable evidence on the effectiveness of an enhanced ECD program in a Chinese primary care setting, but no conclusions can be drawn at this time.
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BACKGROUND: Early childhood development (ECD) programs refer to policies and programs aimed at protecting young children's rights to achieve their full potential. Parenting interventions are effective at improving children's cognitive development and overall well-being. However, there is limited evidence on how to effectively implement and integrate such programs into routine service delivery at scale. The Government of China launched the ECD program in 2013 and the ECD scale-up program in 2023.
OBJECTIVE: Our study aims to design, implement, and evaluate an enhanced ECD program embedded in the primary health care system in order to provide ECD policy recommendations for future national scale-up.
METHODS: This study involves a multicenter cluster randomized controlled superiority trial in 3 counties with different levels of socioeconomic development in China. Fifty-eight clusters will be randomly assigned in a 1:1 ratio to intervention and control groups, stratified by county. In each cluster, 18 families with children aged 6-23 months will be recruited. Our intervention aims to implement an enhanced ECD program in primary care facilities. Intervention group participants will receive usual care alongside enhanced ECD services, including improved facilities, capacity building, and improved ECD services (age-adapted clinical consultations on nutrition and stimulation, age-specific parenting group sessions, home visits, and referrals for children in need). Moreover, an electronic data platform will be used. Control group participants will receive usual care. Our primary outcome is children's overall development, as measured by the Global Scale of Early Development combined form at 12 months of follow-up. Evaluation data will be collected in both arms. Additionally, a process evaluation and an incremental cost-effectiveness analysis will be conducted. Primary analysis will follow the intention-to-treat principle, and it will use generalized estimating equations to assess the population average intervention effect, with adjustment for corresponding baseline outcomes, selected individual variables, county, cluster variables, and variables differing at baseline. Qualitative data will be collected through semistructured interviews and focus groups, guided by the Capability, Opportunity, Motivation, and Behavior framework to explore implementation-related factors. Data will be transcribed for analysis using NVivo 14 (Lumivero). Ethical approval has been obtained from the Institutional Review Board of Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine.
RESULTS: This study was funded in 2023 and registered in April 2024. The recruitment of 1044 participants was completed on September 14, 2024. Data collection was completed on January 31, 2026.
CONCLUSIONS: We aim to design an enhanced ECD service delivery model that can be embedded into the routine primary health care system. The study findings will guide government policies and reforms for strengthening the health system to scale up ECD services. Furthermore, this project may provide policy evidence to support countries in establishing or expanding their ECD services.
