Efficacy of a Group-based and Digital Parent Sleep Intervention in HK Preschoolers With NDDs

September 10, 2026 updated by: CHAN NGAN YIN, Chinese University of Hong Kong

Efficacy of a Group-based and Digital Parent Sleep Intervention in Hong Kong Preschoolers With Neurodevelopmental Disorders (NDD) on Sleep and Behaviors: A Three-arm Randomized Controlled 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Hong Kong
      • Shatin, Hong Kong
        • Department of Psychiatry, The Chinese University of Hong Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Cantonese-speaking preschoolers aged 2 to 7 years and their parents
  2. Children currently studying in a kindergarten in Hong Kong
  3. Clinical DSM-5 diagnosis within the category of neurodevelopmental disorders (NDDs)
  4. Presence of child sleep disturbances, defined as a score ≥52 on the Children's Sleep Habits Questionnaire (CSHQ)
  5. Written informed consent provided by a parent or legal guardian

Exclusion Criteria:

  1. Children with a prominent medical condition known to interfere with sleep continuity and quality (e.g., severe eczema)
  2. Children or parents with a physical or mental condition requiring more intensive clinical intervention (e.g., parental intellectual disability)
  3. Children currently receiving regular medical or psychological treatment for existing sleep problems
  4. Children with a past history of physical or psychological abuse
  5. Parents lacking parenting capacity or the ability to care for the child's daily living activities due to psychological or medical reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Parent-based Group Face-to-face Intervention + Usual Care
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
The group face-to-face intervention will cover sleep psychoeducation, sleep hygiene, attachment-based strategies, and behavioral circadian anchoring.
Experimental: Digital Self-help Intervention + Usual Care
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
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.
No Intervention: Usual Care
Control group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Severity of Child Sleep Disturbances
Time Frame: 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
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).
1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Child Sleep-wake Pattern
Time Frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
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.
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
Time Frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
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
Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
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).
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.
Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
Child Behavioral Symptoms
Time Frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
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).
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
Time Frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
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).
Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
Child Attentional Capacities
Time Frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
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.
Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
Child 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).
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).
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
Time Frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
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.
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
Time Frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
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.
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
Time Frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
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).
Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
Parental 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).
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).
Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
Parental Sleep Hygiene
Time Frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
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).
Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
Parental Chronotype
Time Frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
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").
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
Time Frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
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).
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
Time Frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
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).
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
Time Frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
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).
Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
Parenting Styles
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 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).
Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rachel Ngan Yin Chan, PhD, Department of Psychiatry, The Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025.435

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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