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, dis-parities in social-emotional development during an in-dividual's early age can last a lifetime, which is particu-larly evident among children living in poverty-stricken areas. We aimed to determine the effectiveness, cost-ef-fectiveness, 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) random-ized 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 pandem-ic suspended the implementation of the intervention in January 2020. The caregiver-child pairs in the inter-vention group participated in 12 group-based sessions with a structured curriculum and learning materials emphasizing nurturing ability and early childhood de-velopment. We applied a difference-in-differences (DID) model to estimate the intervention's impact. The anal-ysis follows the intention-to-treat (ITT) principle. We used standard economic costing methods to estimate the cost of implementing the Care Group over the in-tervention 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, chil-dren 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 incre-mental cost-effectiveness ratio (ICER) was US$390.60.Conclusions Care Group is an effective approach for promoting children's social-emotional develop-ment 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 pre-sented 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.