Effects of a Sleep Health Education Program for Children and Parents on Child Sleep Duration and Difficulties: A Stepped-Wedge Cluster Randomized Clinical Trial.

Importance: Preschool-aged children often lack sufficient sleep and experience sleep difficulties. A consistent bedtime routine, falling asleep alone, and other sleep practices reduce difficulties and increase sleep duration. Objective: To evaluate the effects of a preschool-based sleep health literacy program on children's sleep duration and difficulties and on parent sleep knowledge, attitudes, self-efficacy, and beliefs 9 and 12 months after the program. Design, Setting, and Participants: This stepped-wedge cluster randomized clinical trial was implemented across the 2018-2019 school year. Head Start preschool personnel delivered interventions and collected outcomes data at baseline and 4 follow-ups. Seven Head Start agencies across New York State were randomized to implement interventions in either fall 2018 or winter and spring 2019. Outcomes were ascertained at 9- and 12-month follow-up. From March 19 through September 28, 2018, Head Start staff recruited (a) English- or Spanish-speaking parents (b) of children 3 years of age on or about September 2018 (c) who planned to remain at the site through the school year. Altogether, 519 parent-child (aged 3 years) dyads completed baseline and (any) follow-up data. Interventions: A 2-week classroom curriculum for children, a 1-hour parent workshop, and 1-on-1 parent discussions at home or school. Main Outcomes and Measures: Outcomes were the pre- vs postintervention differences measured at baseline and 9-month follow-up for parent-reported child school-night sleep duration per sleep logs, mild or moderate sleep difficulties per a validated questionnaire, and the total and domain scores for parent sleep knowledge, attitudes, self-efficacy, and beliefs. A modified intention-to-treat analysis excluding participants with only baseline data was used. Results: The mean (SD) age at enrollment of 519 children was 2.7 (0.1) years, 264 (50.9%) were girls, 196 (37.8%) lived in Spanish-speaking households, and 5 (0.9%) identified as Alaskan Native or American Indian, 17 (3.2%) as Asian American or Pacific Islander, 57 (10.8%) as Black, 199 (37.8%) as White, and 63 (12.0%) as other. Mean sleep durations increased nonsignificantly from baseline by 5.6 minutes (95% CI, -2.3 to 13.6 minutes; P = .17) at 9-month follow-up and by 6.8 minutes (95% CI, 0.2-13.7 minutes; P = .06) at 12-month follow-up. There was a slight improvement in parental knowledge (1.13 unit increase from baseline; 95% CI, 0.13-2.12 units), but no significant outcomes for parent sleep attitudes (0.16 unit increase from baseline; 95% CI, -0.46 to 0.77 units), self-efficacy (-0.13 unit decrease from baseline; 95% CI, -1.02 to 0.76 units) and beliefs (-0.20 unit decrease from baseline; 95% CI, -0.56 to 0.16 units). Intervention effects for child sleep difficulties were not significant (odds ratio, 1.13; 95% CI, 0.62-2.09). Fewer than 1 in 4 parents accurately perceived their child's sleep difficulty at 12 months. Conclusions and Relevance: The findings of this large pragmatic, stepped-wedge cluster randomized clinical trial, albeit largely negative, may have implications for the sustained impact, focus, and potential population-level effects of sleep education programs. Future research should evaluate the effects of more recurrent programming that emphasizes recognition of sleep problems and whether small increments of sleep across months and years in early childhood have meaningful effects. Trial Registration: ClinicalTrials.gov Identifier: NCT03556462.