Effectiveness and cost-effectiveness of a group-based intervention to improve social-emotional development of young children in poverty-stricken areas: A cluster randomized controlled trial.

Background: Social-emotional ability is key to the well-being and future success of children; however, disparities in social-emotional development during an individual's early age can last a lifetime, which is particularly evident among children living in poverty-stricken areas. We aimed to determine the effectiveness, cost-effectiveness, and feasibility of a group-based intervention called the Care Group on social-emotional development for families living in poverty-stricken counties. Methods: We conducted a cluster (township) randomized controlled trial (C-RCT) every two weeks from July 2019 to June 2020 in a poverty-stricken area located in Shanxi, China. The outbreak of the COVID-19 pandemic suspended the implementation of the intervention in January 2020. The caregiver-child pairs in the intervention group participated in 12 group-based sessions with a structured curriculum and learning materials emphasizing nurturing ability and early childhood development. We applied a difference-in-differences (DID) model to estimate the intervention's impact. The analysis follows the intention-to-treat (ITT) principle. We used standard economic costing methods to estimate the cost of implementing the Care Group over the intervention period and adopted a societal perspective in the analysis. Results: We included 322 eligible caregiver-child pairs in the baseline (intervention n = 136, control n = 186) and surveyed 258 pairs in the endline (intervention n = 117, control n = 141). Compared with the control group, children in the intervention group had significantly fewer social-emotional problems (adjusted mean difference of Z score = -0.374, 95% CI = -0.718, -0.030, P = 0.033) six months after intervention. In the first year, the annual cost of implementing Care Group was US$146.10 per child, reduced to US$47.20 per child in the second year due to the exclusion of non-recurrent costs. The incremental cost-effectiveness ratio (ICER) was US$390.60. Conclusions: Care Group is an effective approach for promoting children's social-emotional development in poverty-stricken areas at an affordable cost and with high feasibility for scale-up. Considering the planned per capita health expenditure of the Chinese government for 2022, we believe that the presented evidence makes a solid scientific and financial case for integrating the Care Group intervention into the basic public health services (BPHS) package. Registration: Chinese Clinical Trials Registry (ChiCTR): ChiCTR1900022894.