Promoting healthy sleep in Chinese kindergarteners through a family-based intervention: protocol of the "Healthy Sleep" randomised controlled trial.

Background: Sleep is instrumental for growth and development in children, making it critical to establish healthy sleep habits from the earliest years of life. Many kindergarteners (3-6 years) in China have inadequate and poor sleep, necessitating targeted interventions. This research protocol details the "Healthy Sleep" intervention that was designed to promote healthy sleep among kindergarteners in China.

Methods: The "Healthy Sleep" intervention will be family-based and will support parents as change agents. The development of the intervention is based on evidence regarding correlates of sleep in young children and guided by Bandura's social cognitive theory. A 12-month randomised controlled trial will be conducted to examine the efficacy of the intervention for promoting healthy sleep in Chinese kindergarteners and the intervention's effects on child development outcomes. A targeted sample of 160 kindergarteners and their parents will be recruited through social media. The intervention group (n = 80) will receive monthly webinars for one year that include multiple intervention components - including educational training, goal setting and planning, as well as follow-up support sessions. The control group (n = 80) will receive videos of the recorded educational sessions after the study end. For primary outcomes, child sleep behaviours will be examined using the Child Sleep Health Questionnaire. For secondary outcomes, communication, fine motor, gross motor, personal-social, and problem-solving development will be examined using the Ages and Stages Questionnaire; executive functions will be examined using the Head, Toes, Knees, and Shoulders Revised tasks. Potential intervention mediators and covariates will be measured using a parental questionnaire. Mixed models will be conducted.

Discussion: This intervention targets sleep behaviours among kindergarteners in China. It has the potential to inform programs to support parents in helping their child establish healthy sleep habits from the earliest years of life. The study will provide high-quality experimental evidence on sleep behaviours in relation to development outcomes in kindergarteners. This evidence will inform family-based strategies to optimise early childhood development and inform national and international updates of the sleep recommendations for young children.

Trial Registration: The trial was registered prospectively at Chinese Clinical Trial Registry (ID: ChiCTR2300072105) on 2 June 2023.