Efficacy of a Group-based and Digital Parent Sleep Intervention in HK Preschoolers With NDDs
2026年9月10日 更新者：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.
研究概览
地位
尚未招聘
详细说明
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.
研究类型
介入性
注册 (估计的)
150
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Rachel Ngan Yin Chan, PhD
- 电话号码：+85239197792
- 邮箱：rachel.chan@cuhk.edu.hk
研究联系人备份
- 姓名：Cho Lam Ngan, MSocSc
- 电话号码：+85239197792
- 邮箱：ncholam@link.cuhk.edu.hk
学习地点
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Shatin、香港
- Department of Psychiatry, The Chinese University of Hong Kong
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接触：
- Rachel Ngan Yin Chan, PhD
- 电话号码：+85239197792
- 邮箱：rachel.chan@cuhk.edu.hk
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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The group face-to-face intervention will cover sleep psychoeducation, sleep hygiene, attachment-based strategies, and behavioral circadian anchoring.
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实验性的：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.
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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.
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无干预：Usual Care
Control group.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Severity of Child Sleep Disturbances
大体时间：1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
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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).
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1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Child Sleep-wake Pattern
大体时间：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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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.
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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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Child Actigraphy-Derived Objective Sleep-wake Pattern
大体时间：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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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
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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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Child Chronotype
大体时间：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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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.
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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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Child Behavioral Symptoms
大体时间：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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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).
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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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Child Behavioral and Emotional Symptoms
大体时间：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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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).
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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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Child Attentional Capacities
大体时间：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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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.
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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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Child Autistic Traits
大体时间：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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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).
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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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Parent Sleep-wake Pattern
大体时间：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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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.
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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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Parent Actigraphy-Derived Objective Sleep-wake pattern
大体时间：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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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.
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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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Severity of Parental Insomnia
大体时间：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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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).
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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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Parental Sleep Quality
大体时间：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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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).
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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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Parental Sleep Hygiene
大体时间：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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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).
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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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Parental Chronotype
大体时间：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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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").
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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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Severity of Parental Depressive Symptoms
大体时间：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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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).
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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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Severity of Parental Anxiety Symptoms
大体时间：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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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).
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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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Levels of Parental Stress
大体时间：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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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).
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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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Parenting Styles
大体时间：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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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).
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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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Rachel Ngan Yin Chan, PhD、Department of Psychiatry, The Chinese University of Hong Kong
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月15日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2028年12月31日
研究注册日期
首次提交
2026年8月30日
首先提交符合 QC 标准的
2026年9月10日
首次发布 (实际的)
2026年9月16日
研究记录更新
最后更新发布 (实际的)
2026年9月16日
上次提交的符合 QC 标准的更新
2026年9月10日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.