Neurodevelopmental Disorders (NDD)NCT07822490
Efficacy of a Group-based and Digital Parent Sleep Intervention in HK Preschoolers With NDDs
A study testing Parent-based Group Face-to-face Intervention and Digital Self-help Intervention in people with Neurodevelopmental Disorders (NDD) and Preschool Child Development, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Neurodevelopmental Disorders (NDD), Preschool Child Development, Sleep
- What is being tested?
- Parent-based Group Face-to-face Intervention and Digital Self-help Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Sep 2026to 31 Dec 2028
- 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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
- Written informed consent provided by a parent or legal guardian
Who cannot join
- 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
- Parents lacking parenting capacity or the ability to care for the child's daily living activities due to psychological or medical reasons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Department of Psychiatry, The Chinese University of Hong Kong
Shatin
Rachel Ngan Yin Chan, PhD, +85239197792, rachel.chan@cuhk.edu.hk
About this study
Official title: 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.
Read the 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.
- Being tested
- Parent-based Group Face-to-face Intervention, Digital Self-help Intervention
- Keywords
- Randomized Controlled Trial, Neurodevelopmental Disorders, Early Childhood, Sleep, Parent-Based Intervention, Actigraphy, Digital Intervention
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-based Group Face-to-face InterventionBehavioural
The group face-to-face intervention will cover sleep psychoeducation, sleep hygiene, attachment-based strategies, and behavioral circadian anchoring.
Digital Self-help InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Parent-based Group Face-to-face Intervention + Usual Care | Experimental | 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. Receives: Behavioral: Parent-based Group Face-to-face Intervention |
| Digital Self-help Intervention + Usual Care | Experimental | 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. Receives: Behavioral: Digital Self-help Intervention |
| Usual Care | No intervention | Control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
Secondary outcomes (17)
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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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").
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental Disorders (NDD)Studies of the same condition, open and under way.
- More trials run by Chinese 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHAN NGAN YIN, Chinese University of Hong Kong
- Investigators
- Rachel Ngan Yin Chan, PhD, Principal investigator, Department of Psychiatry, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822490
- Sponsor's protocol ID
- 2025.435
- Status last verified
- Sep 2026
- First submitted
- 30 Aug 2026
- Last updated
- 16 Sep 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07822490
- Acronym / sponsor ID
- 2025.435
- Keywords
- Randomized Controlled Trial, Neurodevelopmental Disorders, Early Childhood, Sleep, Parent-Based Intervention, Actigraphy, Digital Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Sep 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parent-based Group Face-to-face Intervention + Usual Care | Experimental | Behavioral: Parent-based Group Face-to-face InterventionA 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. |
| Digital Self-help Intervention + Usual Care | Experimental | Behavioral: Digital Self-help InterventionA 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. |
| Usual Care | No intervention | –Control group. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
- Written informed consent provided by a parent or legal guardian
Key exclusion criteria (5 listed)
- 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
- Parents lacking parenting capacity or the ability to care for the child's daily living activities due to psychological or medical reasons
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 |
|---|---|---|
| Parent-based Group Face-to-face InterventionThe group face-to-face intervention will cover sleep psychoeducation, sleep hygiene, attachment-based strategies, and behavioral circadian anchoring. | Behavioural | Parent-based Group Face-to-face Intervention + Usual Care |
| Digital Self-help InterventionThe intervention will cover sleep psychoeducation, sleep hygiene, attachment-based strategies, and behavioral circadian anchoring, but in digital self-help format on our mobile application. | Behavioural | Digital Self-help Intervention + Usual Care |
Primary outcome
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).
17 secondary outcomes
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).
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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
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 16 Sep 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.
Rachel Ngan Yin Chan, PhD principal investigator
Department of Psychiatry, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-based Group Face-to-face Intervention and Digital Self-help Intervention in people with Neurodevelopmental Disorders (NDD) and Preschool Child Development, run by Chinese University of Hong Kong at 1 site in 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 5 inclusion and 5 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 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Rachel Ngan Yin Chan, PhD (+85239197792, rachel.chan@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). 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 16 Sep 2026.