Effectiveness of the Sleep Island WeChat Mini-Program for Promoting Sleep in Preschool Children (Sleep Island)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Ying Dai, PhD
- Telefoonnummer: +852-39103878
- E-mail: yindai@hku.hk
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Sleep Island WeChat Mini-Program Intervention Group
|
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.
|
|
Geen tussenkomst: Waitlist Control
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change From Baseline in Mean Nocturnal Sleep Duration at 4 Weeks
Tijdsspanne: 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
|
Baseline to immediately post-intervention (approximately 4 weeks)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change From Baseline in Mean Nocturnal Sleep Duration at 3- and 6-Month Follow-up
Tijdsspanne: Baseline, 3 months post-intervention, and 6 months post-intervention
|
Same actigraphy-derived measure as the primary outcome, used to evaluate maintenance of intervention effects.
|
Baseline, 3 months post-intervention, and 6 months post-intervention
|
|
Change From Baseline in Actigraphy-Measured Sleep Efficiency
Tijdsspanne: Baseline, immediately post-intervention, 3 months, and 6 months post-intervention.
|
Mean nocturnal sleep efficiency will be derived from 7 consecutive days of wrist actigraphy at each assessment.
|
Baseline, immediately post-intervention, 3 months, and 6 months post-intervention.
|
|
Change From Baseline in Actigraphy-Measured Night Wakings
Tijdsspanne: Baseline, immediately post-intervention, 3 months, and 6 months post-intervention.
|
Mean number of nocturnal awakenings will be derived from wrist actigraphy recordings across valid recording nights.
|
Baseline, immediately post-intervention, 3 months, and 6 months post-intervention.
|
|
Change From Baseline in Children's Sleep Habits Questionnaire Score
Tijdsspanne: Baseline, immediately post-intervention, 3 months, and 6 months post-intervention.
|
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.
|
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
Tijdsspanne: Baseline, immediately post-intervention, 3 months, and 6 months post-intervention.
|
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.
|
Baseline, immediately post-intervention, 3 months, and 6 months post-intervention.
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Mini-program engagement: Number of Days With Completed Sleep Diary Entries
Tijdsspanne: During the interention period
|
Number of Days With Completed Sleep Diary Entries
|
During the interention period
|
|
Adherence: proportion of participants meeting the prespecified sleep island adherence criterion
Tijdsspanne: During the intervention.
|
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.
|
During the intervention.
|
|
Proportion of participants experiencing at least one technical problems when using the sleep island
Tijdsspanne: During the intervention
|
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.
|
During the intervention
|
|
Proportion of LLM-generated individualized recommendations requiring researcher revision before release to participants
Tijdsspanne: During the intervention
|
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.
|
During the intervention
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 72404063 (Ander subsidie-/financieringsnummer: National Natural Sciences Foundation of China (NSFC))
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .