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

NCT07792577 | Not Yet Recruiting

• 1 other identifier: 72404063
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Nocturnal Sleep Duration at 4 Weeks

  Child nocturnal sleep duration will be objectively assessed using parental report and/or wrist actigraphy worn for 7 consecutive days at each assessment. Mean nightly sleep duration will be calculated across valid recording nights. The primary endpoint is the between-group difference in change in mean nocturnal sleep duration from baseline to immediately after the intervention

  Baseline to immediately post-intervention (approximately 4 weeks)

Secondary Outcomes (5)

• Change From Baseline in Mean Nocturnal Sleep Duration at 3- and 6-Month Follow-up

  Baseline, 3 months post-intervention, and 6 months post-intervention

• Change From Baseline in Actigraphy-Measured Sleep Efficiency

  Baseline, immediately post-intervention, 3 months, and 6 months post-intervention.

• Change From Baseline in Actigraphy-Measured Night Wakings

  Baseline, immediately post-intervention, 3 months, and 6 months post-intervention.

• Change From Baseline in Children's Sleep Habits Questionnaire Score

  Baseline, immediately post-intervention, 3 months, and 6 months post-intervention.

• Change From Baseline in Parental Knowledge, Attitudes, Self-Efficacy, and Beliefs About Child Sleep

  Baseline, immediately post-intervention, 3 months, and 6 months post-intervention.

Other Outcomes (4)

• Mini-program engagement: Number of Days With Completed Sleep Diary Entries

  During the interention period

• Adherence: proportion of participants meeting the prespecified sleep island adherence criterion

  During the intervention.

• Proportion of participants experiencing at least one technical problems when using the sleep island

  During the intervention

Study Arms (2)

Sleep Island WeChat Mini-Program Intervention Group

EXPERIMENTAL

Behavioral: Sleep Island (安睡岛) Digital Behavioral Sleep Promotion Program

Waitlist Control

NO INTERVENTION

Participants assigned to the waitlist control arm will receive routine sleep-health education but will not receive access to the Sleep Island behavioral intervention during the controlled intervention period. Participants will complete the same outcome assessments as the intervention group.

Interventions

Sleep Island (安睡岛) Digital Behavioral Sleep Promotion Program BEHAVIORAL

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.

Sleep Island WeChat Mini-Program Intervention Group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parent or primary caregiver of a child aged 3 to 6 years.
• Child is generally healthy and living with the participating parent/caregiver.
• Parent/caregiver is responsible for the child's daily care and sleep-related routines.
• Parent/caregiver has access to a smartphone and is able to use WeChat and the Sleep Island mini-program.
• Parent/caregiver is willing to participate in the study procedures and follow-up assessments.
• Parent/caregiver provides informed consent for participation.

You may not qualify if:

• Child has a history of major perinatal complications, including significant birth resuscitation, asphyxia, hypoxic-ischemic encephalopathy, intracranial hemorrhage, or preterm birth.
• Child has a serious congenital or physiological disease that may substantially affect development or sleep.
• Child has a neurodevelopmental disorder or developmental delay.
• Child has a medical condition known to substantially affect sleep.
• Parent/caregiver has a severe mental disorder or other condition that would substantially impair their ability to report the child's sleep or participate in the intervention.
• Parent/caregiver is unwilling or unable to complete study procedures.

Sponsors & Collaborators

• The University of Hong Kong: lead

Central Study Contacts

Ying Dai, PhD

CONTACT

+852-39103878; yindai@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: This is a single-center, two-arm, parallel-group randomized controlled trial. Eligible parent-child dyads will be randomly assigned in a 1:1 ratio to either the Sleep Island digital behavioral sleep-promotion intervention plus routine health education or a waitlist control condition receiving routine health education. Participants will be followed from baseline through 6 months after completion of the intervention

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share