ChildSleep IslandNCT07792577
Effectiveness of the Sleep Island WeChat Mini-Program for Promoting Sleep in Preschool Children
A study testing Sleep Island (安睡岛) Digital Behavioral Sleep Promotion Program in people with Child and Sleep, run by The University of Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- What is being tested?
- Sleep Island (安睡岛) Digital Behavioral Sleep Promotion Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effectiveness of "Sleep Island": an LLM-enhanced Mini-Program to Promote Sleep in Preschool Children: a Randomized Controlled 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.
Read the detailed description
Behavioral sleep problems during early childhood are influenced by interactions among child characteristics, parental sleep-related practices, parent-child interactions, and the family environment. The original intervention was developed using the Intervention Mapping framework to identify modifiable determinants of preschool children's sleep and to link behavioral objectives with theory- and evidence-based intervention strategies.
Following development of the original program, the intervention was systematically adapted from primarily in-person delivery to a self-guided digital format delivered through a WeChat-accessible mini-program named Sleep Island. The digital adaptation was designed to preserve the principal behavioral targets and active intervention functions of the source program while reducing reliance on scheduled face-to-face contact. Core behavioral targets include establishing regular sleep-wake schedules, developing positive and predictable bedtime routines, improving parent-child bedtime interactions, optimizing the sleep environment, and using evidence-based responses to common behavioral sleep difficulties.
Sleep Island includes four principal intervention components: (1) electronic sleep assessment and monitoring; (2) graphical visualization of sleep patterns; (3) individualized sleep-behavior feedback; and (4) personalized sleep-promotion recommendations provided through the Sleep Silkbag. Additional sleep-health educational materials are available within the mini-program. Parents initially create a child profile and provide baseline sleep information. They then record their child's sleep using the electronic sleep diary. Recorded sleep information is summarized graphically and is used to generate individualized recommendations addressing sleep schedules, bedtime routines and activities, the sleep environment, and parent-child bedtime interactions.
Individualized recommendations are generated using a large language model operating within a retrieval-augmented generation architecture. The model is grounded in a domain-specific knowledge base developed from the original behavioral intervention protocol and pediatric sleep-health guidance. Generated recommendations are reviewed by the research team before being released to families to ensure that the recommendations are consistent with the intervention protocol and do not contain inappropriate or factually inaccurate advice.
In this randomized controlled trial, 122 eligible families will be randomized in a 1:1 ratio to the Sleep Island intervention plus routine health education or to a waitlist control group receiving routine health education. The intervention period will last approximately 4 weeks. Outcomes will be assessed at baseline, immediately after completion of the intervention, 3 months after the intervention, and 6 months after the intervention. The study will primarily evaluate whether the digitally delivered behavioral sleep-promotion program improves preschool children's sleep duration and will additionally examine changes in other dimensions of child sleep health, parental sleep-related practices, the home sleep environment, and parental sleep-related knowledge, attitudes, beliefs, and self-efficacy.
- Conditions
- Child, Sleep, Promotion, Digital Intervention
- Being tested
- Sleep Island (安睡岛) Digital Behavioral Sleep Promotion Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Island (安睡岛) Digital Behavioral Sleep Promotion ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Island WeChat Mini-Program Intervention Group | Experimental | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Same actigraphy-derived measure as the primary outcome, used to evaluate maintenance of intervention effects.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Parental sleep-promotion literacy will be evaluated using the Chinese version of the Parent Knowledge, Attitudes, Self-Efficacy, and Beliefs questionnaire (PKASB), assessing parents' knowledge, attitudes, beliefs, and self-efficacy regarding recommended sleep practices for preschool children. The total score ranged from 0 to 96, with higher scores indicate higher parental sleep-promotion literacy.
Measured: Baseline, immediately post-intervention, 3 months, and 6 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Dai, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792577
- Sponsor's protocol ID
- 72404063
- Other IDs
- 72404063
- Acronym
- Sleep Island
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of "Sleep Island": an LLM-enhanced Mini-Program to Promote Sleep in Preschool Children: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07792577
- Acronym / sponsor ID
- Sleep Island / 72404063
- Conditions
- Child, Sleep, Promotion, Digital Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Behavioral sleep problems during early childhood are influenced by interactions among child characteristics, parental sleep-related practices, parent-child interactions, and the family environment. The original intervention was developed using the Intervention Mapping framework to identify modifiable determinants of preschool children's sleep and to link behavioral objectives with theory- and evidence-based intervention strategies.
Following development of the original program, the intervention was systematically adapted from primarily in-person delivery to a self-guided digital format delivered through a WeChat-accessible mini-program named Sleep Island. The digital adaptation was designed to preserve the principal behavioral targets and active intervention functions of the source program while reducing reliance on scheduled face-to-face contact. Core behavioral targets include establishing regular sleep-wake schedules, developing positive and predictable bedtime routines, improving parent-child bedtime interactions, optimizing the sleep environment, and using evidence-based responses to common behavioral sleep difficulties.
Sleep Island includes four principal intervention components: (1) electronic sleep assessment and monitoring; (2) graphical visualization of sleep patterns; (3) individualized sleep-behavior feedback; and (4) personalized sleep-promotion recommendations provided through the Sleep Silkbag. Additional sleep-health educational materials are available within the mini-program. Parents initially create a child profile and provide baseline sleep information. They then record their child's sleep using the electronic sleep diary. Recorded sleep information is summarized graphically and is used to generate individualized recommendations addressing sleep schedules, bedtime routines and activities, the sleep environment, and parent-child bedtime interactions.
Individualized recommendations are generated using a large language model operating within a retrieval-augmented generation architecture. The model is grounded in a domain-specific knowledge base developed from the original behavioral intervention protocol and pediatric sleep-health guidance. Generated recommendations are reviewed by the research team before being released to families to ensure that the recommendations are consistent with the intervention protocol and do not contain inappropriate or factually inaccurate advice.
In this randomized controlled trial, 122 eligible families will be randomized in a 1:1 ratio to the Sleep Island intervention plus routine health education or to a waitlist control group receiving routine health education. The intervention period will last approximately 4 weeks. Outcomes will be assessed at baseline, immediately after completion of the intervention, 3 months after the intervention, and 6 months after the intervention. The study will primarily evaluate whether the digitally delivered behavioral sleep-promotion program improves preschool children's sleep duration and will additionally examine changes in other dimensions of child sleep health, parental sleep-related practices, the home sleep environment, and parental sleep-related knowledge, attitudes, beliefs, and self-efficacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Island (安睡岛) Digital Behavioral Sleep Promotion ProgramParticipants 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. | Behavioural | Sleep Island WeChat Mini-Program Intervention Group |
Primary outcome
Change From Baseline in Mean Nocturnal Sleep Duration at 4 Weeks
Time frame: Baseline to immediately post-intervention (approximately 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
5 secondary outcomes
Change From Baseline in Mean Nocturnal Sleep Duration at 3- and 6-Month Follow-up
Time frame: Baseline, 3 months post-intervention, and 6 months post-intervention
Change From Baseline in Actigraphy-Measured Sleep Efficiency
Time frame: Baseline, immediately post-intervention, 3 months, and 6 months post-intervention.
Change From Baseline in Actigraphy-Measured Night Wakings
Time frame: Baseline, immediately post-intervention, 3 months, and 6 months post-intervention.
Change From Baseline in Children's Sleep Habits Questionnaire Score
Time frame: 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
Time frame: Baseline, immediately post-intervention, 3 months, and 6 months post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Island (安睡岛) Digital Behavioral Sleep Promotion Program in people with Child and Sleep, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Dai, PhD (+852-39103878, yindai@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mean Nocturnal Sleep Duration at 4 Weeks (time frame: Baseline to immediately post-intervention (approximately 4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.