Interim results of a randomized trial on the Korea Early Childhood Home-visiting Intervention

Abstract Background In Korea, a nurse-led home visiting program-the Korea Early Childhood Home-visiting Intervention (KECHI)-was developed in 2020 and implemented nationwide. This study evaluated the impact of KECHI on child health and development as well as maternal health outcomes. Methods A randomized controlled trial (RCT) of KECHI was conducted (NCT04749888). Pregnant women under 37 weeks of gestation with a risk factor score of 2 or higher were recruited from 25 district public health centers across Korea. The intervention consisted of an average of 10.8 home visits (SD = 3.1) by trained nurses until the child reached six months of age. Interim analyses at six months postpartum were conducted for three primary outcomes-including Infant/Toddler Home Observation for Measurement of the Environment (IT-HOME)- and ten secondary outcomes. Results Of 1,304 eligible pregnant women, 800 (61.3%) were randomly assigned to either the intervention or control group. At six months postpartum, outcome data were collected from 385 of 392 (98.2%) participants in the control group and 395 of 408 (96.8%) in the intervention group. Compared to the control group, the intervention group showed significantly greater parental involvement on IT-HOME (effect size [ES] 0.14; 95% CI, 0.00-0.27), higher safety knowledge (ES 0.17; 95% CI, 0.02-0.32), lower scores on the Patient Health Questionnaire-9 (PHQ-9) (ES -0.17; 95% CI, -0.32 to -0.02), and lower scores on the Edinburgh Postnatal Depression Scale (ES -0.21; 95% CI, -0.36 to -0.05). Additionally, the intervention group had reduced adjusted odds ratios (AORs) for postnatal depression (AOR 0.55; 95% CI, 0.35-0.86) and suicidal ideation (AOR 0.50; 95% CI, 0.30-0.85). Conclusions KECHI improved the home environment, enhanced maternal safety knowledge, and reduced maternal mental health issues at six months postpartum. With two-year follow-up data forthcoming, this RCT may offer a robust scientific foundation for the national expansion of KECHI. Key messages • A randomized trial of a nurse-led home visiting program in Korea demonstrated significant improvement in home environment, safety knowledge, and maternal mental health at six months postpartum. • With two-year follow-up data forthcoming, this trial may offer a robust scientific foundation for the national expansion of the Korea Early Childhood Home-visiting Intervention.