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

NCT07792577 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2026-08-28

No results posted yet for this study

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.

Conditions

  • Child
  • Sleep
  • Promotion
  • Digital Intervention

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.

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-12-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07792577 on ClinicalTrials.gov