RecruitingNot ApplicableNCT07398183

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


Sponsor

The University of Hong Kong

Enrollment

195 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called App-based CBT-I with personalised telephone support and a behavioral approach called App-based CBT-I without personalised telephone support for people with autism spectrum disorder (asd) and insomnia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 6 Years to 12 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALApp-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.

BEHAVIORALApp-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.


Locations(1)

Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong

Hong Kong, Hong Kong

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NCT07398183


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