JMIR Publications

ABSTRACT

Background:

Early Childhood Development (ECD) programs refer to policies and programs aimed at protecting young children's rights to develop 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 primary health care system, aiming to provide ECD policy recommendations for future national scale-up.

Methods:

This study employs a multi-center, cluster-randomized controlled superiority trial in three counties with different levels of socioeconomic development in China. A total of 58 clusters is randomly assigned in a 1:1 ratio to the intervention or the control group, 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. Participants in the intervention clusters will receive usual care and enhanced ECD services including facility improvements, capacity building, improved ECD services (age-adapted clinical consultations on nutrition and stimulation, biweekly age-specific parenting group sessions, home visits and referrals only for children in need), and an electronic data platform. Participants in the control group will receive usual care. Our primary outcome is children’s overall development, as measured by the Global Scale of Early Development (GSED) 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 be based on intention-to-treat, employing generalized estimating equations (GEE), adjusted by the corresponding baseline outcomes, selected individual variables, county, cluster variables and variables that are significantly different at baseline to assess the population average intervention effect. Quantitative data will be transcribed and analyzed using NVivo 14. Ethical approval was 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 on April 2024. 1044 participants recruitment were completed on September, 2024. Data collection is expected to be completed by January 31, 2026.

Conclusions:

We aim to design an enhanced ECD service delivery model that can be embedded into routine primary health care system. The findings will guide health system strengthening policies and reforms for governments in scaling up ECD services. Furthermore, this project may provide policy evidence for countries in establishing or expanding their ECD services. Clinical Trial: Chinese Clinical Trial Registry, ChiCTR2400083465 (Registered on 25 April 2024).