Efficacy of a Group-based and Digital Parent Sleep Intervention in HK Preschoolers With NDDs
10 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
150
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Rachel Ngan Yin Chan, PhD
- Número de teléfono: +85239197792
- Correo electrónico: rachel.chan@cuhk.edu.hk
Copia de seguridad de contactos de estudio
- Nombre: Cho Lam Ngan, MSocSc
- Número de teléfono: +85239197792
- Correo electrónico: ncholam@link.cuhk.edu.hk
Ubicaciones de estudio
-
-
-
Shatin, Hong Kong
- Department of Psychiatry, The Chinese University of Hong Kong
-
Contacto:
- Rachel Ngan Yin Chan, PhD
- Número de teléfono: +85239197792
- Correo electrónico: rachel.chan@cuhk.edu.hk
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
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.
|
|
Sin intervención: Usual Care
Control group.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Severity of Child Sleep Disturbances
Periodo de tiempo: 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).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Child Sleep-wake Pattern
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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).
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Rachel Ngan Yin Chan, PhD, Department of Psychiatry, The Chinese University of Hong Kong
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de septiembre de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
30 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de septiembre de 2026
Publicado por primera vez (Actual)
16 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025.435
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .