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

NCT07822490 | Not Yet Recruiting

• 1 other identifier: 2025.435
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sleep; Neurodevelopmental Disorders (NDD); Preschool Child Development

Keywords

Randomized Controlled Trial; Neurodevelopmental Disorders; Early Childhood; Sleep; Parent-Based Intervention; Actigraphy; Digital Intervention

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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

  Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).

• 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

  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

  Baseline, 1-week post-treatment/post-wait, 3-month post-treatment/post-wait, and 12-month post-treatment (intervention groups only).

Study Arms (3)

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.

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.

Behavioral: Digital Self-help Intervention

Usual Care

NO INTERVENTION

Control group.

Interventions

Parent-based Group Face-to-face Intervention BEHAVIORAL

The group face-to-face intervention will cover sleep psychoeducation, sleep hygiene, attachment-based strategies, and behavioral circadian anchoring.

Parent-based Group Face-to-face Intervention + Usual Care

Digital Self-help Intervention BEHAVIORAL

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.

Digital Self-help Intervention + Usual Care

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Psychiatry, The Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Rachel Ngan Yin Chan, PhD

  Department of Psychiatry, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Ngan Yin Chan, PhD

CONTACT

+85239197792; rachel.chan@cuhk.edu.hk

Cho Lam Ngan, MSocSc

CONTACT

+85239197792; ncholam@link.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 16, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)