Efficacy of a Group-based and Digital Parent Sleep Intervention in HK Preschoolers With NDDs
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-7
SponsorChinese University of Hong Kong
About this trial
Neurodevelopmental disorders (NDDs) in preschoolers are frequently accompanied by persistent sleep disturbances, such as delayed sleep onset and reduced sleep duration, which exacerbate behavioral problems, impair cognitive development, and increase parental stress. While behavioral parent education effectively improves sleep hygiene, access to in-person clinical programs remains limited by high parent dropout rates. Digital delivery offers a flexible, scalable alternative, yet randomized controlled trials (RCTs) evaluating both face-to-face and self-help mobile app formats specifically for preschoolers across NDDs remain scarce. This study is a three-arm RCT designed to evaluate and compare the efficacy of a parent-based sleep intervention delivered via face-to-face group sessions combined with usual care (UC) versus a digital self-help mobile application combined with UC, against UC alone in Hong Kong preschoolers with NDDs. The study also assesses downstream effects on child daytime behaviors, parental stress, and parent sleep/mood outcomes over a 12-month period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Cantonese-speaking preschoolers aged 2 to 7 years and their parents
Children currently studying in a kindergarten in Hong Kong
Clinical DSM-5 diagnosis within the category of neurodevelopmental disorders (NDDs)
Presence of child sleep disturbances, defined as a score ≥52 on the Children's Sleep Habits Questionnaire (CSHQ)
Disqualifiers
Children with a prominent medical condition known to interfere with sleep continuity and quality (e.g., severe eczema)
Children or parents with a physical or mental condition requiring more intensive clinical intervention (e.g., parental intellectual disability)
Children currently receiving regular medical or psychological treatment for existing sleep problems
Children with a past history of physical or psychological abuse
Trial design
Design model
Parallel
Treatments tested in this trial
Parent-based Group Face-to-face Intervention
BehavioralThe group face-to-face intervention will cover sleep psychoeducation, sleep hygiene, attachment-based strategies, and behavioral circadian anchoring.
Digital Self-help Intervention
BehavioralThe intervention will cover sleep psychoeducation, sleep hygiene, attachment-based strategies, and behavioral circadian anchoring, but in digital self-help format on our mobile application.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Parent-based Group Face-to-face Intervention + Usual CareExperimental treatment 1 intervention
Group B: Digital Self-help Intervention + Usual CareExperimental treatment 1 intervention
Group C: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Severity of Child Sleep Disturbances
Children's Sleep Habit Questionnaire (CSHQ) will be used to assess the severity of overall sleep disturbances in preschoolers. The total score ranges from 33 to 99, with higher scores indicating worse sleep outcomes (more severe sleep disturbances).
Time frame
1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).Secondary outcomes
1
Child Sleep-wake Pattern
Parent-reported sleep diary is recorded for 7 consecutive days to assess subjective child sleep-wake pattern including sleep duration, wake up time, bedtime and sleep latency.
Time frame
Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).2
Child Actigraphy-Derived Objective Sleep-wake Pattern
Child objective movement data recorded via wrist-worn motion sensor (Actiwatch) over 7 days to estimate sleep-wake pattern including sleep duration, wakeup time, bedtime and sleep latency
Time frame
Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).3
Child Chronotype
Munich Chronotype Questionnaire (MCTQ) is used to assess the child's chronotype. The mid-sleep corrected for sleep debt (MSFsc) measured in local time is derived. It is a continuous time variable where a later time reflects higher eveningness in child chronotype.
Time frame
Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).4
Child Behavioral Symptoms
Behavior Problems Index (BPI) is used to assess child behavioral symptoms at school and home. Total score ranges from 0 to 84, with higher scores indicating a worse outcome (greater behavioral problems).
Time frame
Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).Sponsors and contacts
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Source ClinicalTrials.gov
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