Effects of Mobile-Based Multicomponent Infant Sleep Intervention on Infants and Mothers: A Randomized Controlled Trial

Objectives This study evaluated the effects of a mobile-based multicomponent infant sleep intervention on infant and maternal sleep and maternal mental health. Methods In this single-blind randomized controlled trial, mother-infant dyads with infants aged 3–12 months were recruited from an online parenting community in South Korea; 32 dyads were randomized and 29 were analyzed. From February to May 2021, the intervention group used a mobile application for 4 weeks providing infant sleep education, sleep monitoring, and personalized support. Sleep was assessed by actigraphy for 5 consecutive days at baseline, post-intervention (6 weeks), and follow-up (10 weeks). Maternal depression, fatigue, and sleep disturbance were assessed using the Patient-Reported Outcomes Measurement Information System. Linear mixed-effects models examined group differences over time. Results Compared with the control group, infants in the intervention group showed greater improvements from baseline in sleep efficiency and wake after sleep onset at 6 and 10 weeks and in average awake time at 10 weeks. Mothers in the intervention group showed greater improvements in sleep efficiency, wake after sleep onset, and number of awakenings at 10 weeks. They also had a greater decrease in depression scores at 10 weeks and a difference in sleep disturbance scores favoring the intervention at 6 weeks, whereas fatigue did not differ between groups. Conclusions for Practice A mobile-based, family-centered multicomponent sleep intervention was associated with greater improvements in selected infant and maternal sleep outcomes and maternal depression scores. Future studies should evaluate the long-term effectiveness and stability of these effects. Clinical Trial Registration This study was registered with the Clinical Research Information Service, a member of the World Health Organization International Clinical Trials Registry Platform (KCT0005283), registered on August 4, 2020 ( https://cris.nih.go.kr/cris/search/detailSearch.do?seq=22693&search_page=L ).