NCT07398183

Sleep Intervention in Children With ASD

Effects of Digitally Delivered Parent-based Behavioural Sleep Intervention in Children With Autism Spectrum Disorder (ASD) - A Randomised Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 195 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomised controlled trial is to examine the following research questions: 1) whether digitally delivered parent-based behavioural sleep intervention with or without personalised support is effective in improving sleep, clinical and daytime symptoms, and 2) whether such interventions can also improve parental sleep, mental health, and parenting stress in children with ASD and insomnia.

Detailed description

A randomised, assessor-blind, parallel-group controlled trial (RCT) will be conducted in children with ASD and insomnia. Eligible participants will be randomised to one of the following groups: app-based cognitive behavioural therapy for insomnia (CBT-I) with personalised support, app-based CBT-I without personalised support, or treatment-as-usual (TAU). Randomisation will be carried out using an automated online system and stratified by gender. Assessments will be conducted at pre-treatment and post-treatment (1 week after intervention completion). The two active treatment groups will be additionally followed up at post-treatment 3 months and posttreatment 6 months.

Conditions

• Insomnia
• Autism Spectrum Disorder (ASD)

Interventions

Type	Name	Description
BEHAVIORAL	App-based CBT-I with personalised telephone support	Participants in this group will be instructed to download a smartphone application. The smartphone app-based intervention, involving six sequential modules, is structured and based on the well-established behavioural sleep intervention elements for managing sleep problems in children, with the consideration of catering to the needs of children with ASD. The main treatment components include: (1) psychoeducation about sleep in the developmental context as well as in the context of ASD, (2) sleep hygiene education, (3) sleep-focused behavioural strategies (e.g., consistent bedtime routine, bedtime fading, extinction, sleep restriction, use of 'bedtime pass'), (4) relaxation strategies, (5) cognitive restructuring (targeting dysfunctional cognitions) and (6) relapse prevention. A weekly phone call support by a trained therapist, using a semi-structured script, will be provided during the intervention period (around 15 mins each time) to the parents.
BEHAVIORAL	App-based CBT-I without personalised telephone support	Participants in this group will be instructed to download the same smartphone application used in the app-based CBT-I with personalised support. No telephone support will be provided to this group.

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: Hong Kong