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NCT07822490
NA

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

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - 7 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-09-15

Completion Date

2028-12-31

Last Updated

2026-09-16

Healthy Volunteers

No

Interventions

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.

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.

Locations (1)

Department of Psychiatry, The Chinese University of Hong Kong

Shatin, Hong Kong