An interventional study of Parent-based Group Face-to-face Intervention and Digital Self-help Intervention in Neurodevelopmental Disorders (NDD), Preschool Child Development and Sleep, sponsored by Chinese University of Hong Kong. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 2 Years to 7 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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.
Preschoolers diagnosed with neurodevelopmental disorders (NDDs), including autism spectrum disorders, intellectual disabilities, and attention-deficit/hyperactivity disorder, exhibit high rates of sleep disturbances (40% to 80%) compared to typically developing children. In early childhood, poor sleep quality and reduced sleep duration significantly exacerbate daytime behavioral problems (e.g., temper tantrums, hyperactivity, aggression, and emotional dysregulation), hinder cognitive development, and heighten parental stress. Although parent-based behavioral sleep hygiene interventions have demonstrated effectiveness in improving sleep parameters and daytime behavior, clinical implementation is often hindered by high parental drop-out rates in face-to-face formats. Digital self-help interventions present a flexible, low-cost delivery model that can improve intervention retention. However, there is a lack of rigorous RCTs evaluating the comparative efficacy of face-to-face versus digital sleep interventions specifically tailored for preschoolers across NDDs.
This study is a three-arm randomized controlled trial (1:1:1 allocation ratio) designed to evaluate and compare the efficacy of a parent-based sleep intervention delivered via face-to-face group sessions (+ UC) and a digital mobile application (+ UC) against usual care (UC) alone in Hong Kong preschoolers with NDDs. The primary aim is to test whether both face-to-face and digital parent-based sleep interventions lead to significantly greater improvements in children's sleep disturbances and sleep diary parameters compared to UC alone, and whether the digital format demonstrates comparable efficacy to the face-to-face format. The secondary aims are to evaluate treatment effects on children's daytime behavioral symptoms, parenting stress, and parents' own sleep and mood conditions, as well as to determine whether treatment gains are maintained across 3-month and 12-month follow-up periods.
It is hypothesized that both active intervention arms will yield significantly greater improvements in child sleep metrics compared to UC alone, with face-to-face delivery showing similar efficacy to the digital format. Additionally, intervention gains in child sleep are hypothesized to mediate improvements in daytime behaviors and parental stress at the 3-month and 12-month follow-ups.
352 studies on the registry are indexed under Neurodevelopmental Disorders; 141 are open to participants now.
This study's planned enrollment of 150 is above the median of 88 across 217 interventional studies indexed under Neurodevelopmental Disorders.
Browse Neurodevelopmental Disorders studies →Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A total of 4 weekly sessions of face-to-face parent-based group therapy will be provided. Each session will last 90-120 mins, with each group 6-8 subjects.
Behavioral: Parent-based Group Face-to-face Intervention
A total of 4 weely sessions of digital self-help intervention will be provided on our mobile application developed. Each session is comprised of small quizzes to ensure compliance.
Behavioral: Digital Self-help Intervention
Control group.
The group face-to-face intervention will cover sleep psychoeducation, sleep hygiene, attachment-based strategies, and behavioral circadian anchoring.
The intervention will cover sleep psychoeducation, sleep hygiene, attachment-based strategies, and behavioral circadian anchoring, but in digital self-help format on our mobile application.
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).
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).
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).
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).
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).
Child Behavioral and Emotional Symptoms
Strengths and Difficulties Questionnaire (SDQ) is used to assess child behavioral and emotional symptoms at school and home. SDQ derives a Total Difficulties score ranges from 0 to 40, with higher scores indicating a worse outcome (greater psychological difficulties).
Time frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
Child Attentional Capacities
Strengths and Weaknesses of ADHD-Symptoms and Normal-Behavior Scale (SWAN) is used to assess child attentional capacities. Average item scores range from -3 to +3 (or total score -90 to +90 across 30 items), where higher positive scores indicate a worse outcome (worse attentional strength and behavioral control) and lower negative scores indicate a better outcome.
Time frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
Child Autistic Traits
Children Autism Spectrum Quotient (AQ-Child) is used to measure child autistic traits and features. Total score ranges from 0 to 150, with higher scores indicating a worse outcome (higher degree of autistic traits).
Time frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
Parent Sleep-wake Pattern
Parent-reported sleep diary is recorded for 7 consecutive days to assess subjective 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).
Parent Actigraphy-Derived Objective Sleep-wake pattern
Parent 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).
Severity of Parental Insomnia
Insomnia Severity Index (ISI) is used to measure the severity of parental insomnia. Total score ranges from 0 to 28, with higher scores indicating a worse outcome (more severe insomnia).
Time frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
Parental Sleep Quality
Pittsburgh Sleep Quality Index (PSQI) is used to assess overall parental sleep quality. Global score ranges from 0 to 21, with higher scores indicating a worse outcome (poorer sleep quality).
Time frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
Parental Sleep Hygiene
Sleep Hygiene Index (SHI) is used to assess parental sleep hygiene habits and behaviors. Total score ranges from 0 to 52, with higher scores indicating a worse outcome (poorer sleep hygiene practice).
Time frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
Parental Chronotype
Morningness-Eveningness Questionnaire (MEQ) is used to measure parental circadian preference/chronotype. Total score ranges from 16 to 86; higher scores indicate a morning-type preference ("lark") and lower scores indicate an evening-type preference ("owl").
Time frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
Severity of Parental Depressive Symptoms
Patient Health Questionnaire-9 (PHQ-9) is used to measure parental depressive symptoms. Total score ranges from 0 to 27, with higher scores indicating a worse outcome (more severe depression).
Time frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
Severity of Parental Anxiety Symptoms
General Anxiety Disorder-7 (GAD-7) will be used to assess anxiety symptoms and severity. Total score ranges from 0 to 21, with higher scores indicating a worse outcome (more severe anxiety).
Time frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
Levels of Parental Stress
Parental Stress Scale (PSS) is adopted to evaluate stress levels specifically related to childcare. Total score ranges from 18 to 90, with higher scores indicating a worse outcome (higher parental stress).
Time frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
Parenting Styles
Parenting Styles and Dimensions Questionnaire (PSDQ) is used to evaluate parenting practices and styles. PSDQ assesses parenting practices across Authoritative, Authoritarian, and Permissive dimensions. Mean subscale scores range from 1 to 5. Higher Authoritative scores indicate a better outcome (more positive, supportive parenting), whereas higher Authoritarian and Permissive scores indicate a worse outcome (more dysfunctional parenting practices).
Time frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
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Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.
Of 142 non-industry interventional studies with no phase under Neurodevelopmental Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's planned 15 months is below that.
Counting every sponsor, half of 148 studies reached it within 30 months; a quarter within 15 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Neurodevelopmental Disorders →
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