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

ConditionsChild Sleep Promotion Digital Intervention

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age3-6

SponsorThe University of Hong Kong

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

122 Participants

are divided into 2 treatment groups

Group A: Sleep Island WeChat Mini-Program Intervention GroupExperimental treatment 1 intervention

Group B: Waitlist ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

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

Time frame

Baseline to immediately post-intervention (approximately 4 weeks)

Secondary outcomes

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

Same actigraphy-derived measure as the primary outcome, used to evaluate maintenance of intervention effects.

Time frame

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

Change From Baseline in Actigraphy-Measured Sleep Efficiency

Mean nocturnal sleep efficiency will be derived from 7 consecutive days of wrist actigraphy at each assessment.

Time frame

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

Change From Baseline in Actigraphy-Measured Night Wakings

Mean number of nocturnal awakenings will be derived from wrist actigraphy recordings across valid recording nights.

Time frame

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

Change From Baseline in Children's Sleep Habits Questionnaire Score

Parent-reported child sleep problems will be assessed using the validated Chinese version of the Children's Sleep Habits Questionnaire (CSHQ). The 33 scored items are summed to produce a total sleep disturbance score ranging from 33 to 99, with higher scores indicating more severe sleep problems. Only the CSHQ total score will be reported for this Outcome Measure.

Time frame

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

Other outcomes

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

Number of Days With Completed Sleep Diary Entries

Time frame

During the interention period

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

The proportion of intervention-group participants who completed at least five diary entries per week, and access to both sleep-trend page and sleep silkbag page, and tried at least one recommendation from the sleep silkbag.

Time frame

During the intervention.

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

The proportion of intervention-group participants who experience or report at least one technical problem when using sleep island will be calculated as the number of participants experiencing one or more technical problems divided by the number of participants who access Sleep Island, multiplied by 100. The outcome will be reported as a percentage of participants.

Time frame

During the intervention

Proportion of LLM-generated individualized recommendations requiring researcher revision before release to participants

Each individualized Sleep Silkbag recommendation generated by the large language model will be reviewed by a member of the research team before release to the participant. The proportion requiring revision will be calculated as the number of generated recommendations modified during researcher review divided by the total number of generated recommendations reviewed, multiplied by 100. The outcome will be reported as a percentage of recommendations.

Time frame

During the intervention

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov

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