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NOT YET RECRUITING
NCT07792577
NA

Effectiveness of the Sleep Island WeChat Mini-Program for Promoting Sleep in Preschool Children

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

Summary

Behavioral sleep problems are common during the preschool years and are strongly influenced by parental sleep-related practices and the home environment. This randomized controlled trial aims to evaluate the effectiveness of Sleep Island, a parent-focused WeChat mini-program adapted from a theory- and evidence-based parent-child collaborative behavioral sleep promotion program. A total of 122 families with preschool children will be randomly assigned in a 1:1 ratio to either the Sleep Island intervention plus routine sleep-health education or a waitlist control condition receiving routine sleep-health education. The intervention will be delivered over 4 weeks. Sleep Island incorporates electronic sleep monitoring, visualization of sleep patterns, individualized sleep-behavior feedback, sleep-health education, and personalized behavioral recommendations. Recommendations are generated using a large language model supported by retrieval-augmented generation from a curated pediatric sleep knowledge base and are reviewed by the research team before release. Outcomes will be assessed at baseline, immediately after the intervention, and at 3- and 6-month follow-up. The primary outcome will be objectively measured child nocturnal sleep duration. Secondary outcomes will include other objective and parent-reported indicators of child sleep health, parental sleep-related practices, sleep environment, behavioral sleep problems, and parental knowledge, attitudes, self-efficacy, and beliefs regarding child sleep.

Official title: The Effectiveness of "Sleep Island": an LLM-enhanced Mini-Program to Promote Sleep in Preschool Children: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

3 Years - 6 Years

Study Type

INTERVENTIONAL

Enrollment

122

Start Date

2026-10-01

Completion Date

2027-12-31

Last Updated

2026-08-28

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Sleep Island (安睡岛) Digital Behavioral Sleep Promotion Program

Participants in the intervention group will receive routine sleep-health education plus access to Sleep Island, a parent-focused WeChat mini-program delivered over 4 weeks. The program includes electronic sleep monitoring, graphical sleep-trend visualization, individualized sleep-behavior feedback, sleep-health education, and personalized behavioral recommendations. Parents record their child's sleep and bedtime behaviors using an electronic sleep diary. These data inform recommendations addressing sleep schedules, bedtime routines, sleep environment, parent-child bedtime interactions, and common behavioral sleep difficulties. Personalized recommendations are generated using a large language model with retrieval-augmented generation based on a curated pediatric sleep-health knowledge base and are reviewed by the research team before release.