Status:
COMPLETED
Treatment of Sleep Disturbance in Children With ASD
Lead Sponsor:
Education University of Hong Kong
Collaborating Sponsors:
Chinese University of Hong Kong
Castle Peak Hospital
Conditions:
Physical Exercise
Sleep Disturbance
Eligibility:
All Genders
8-12 years
Phase:
NA
Brief Summary
This RCT study aims to compare effectiveness physical exercise and melatonin supplement on treating sleep disturbance in children with ASD. A four-arm randomized controlled trial with equal allocation...
Detailed Description
Children with ASD are characterized by deficits to some extent - from mild to severe - in social interaction, stereotyped behavior and limited interest. Apart from these core symptoms, sleep disturban...
Eligibility Criteria
Inclusion
- age 8 - 12 years
- clinical diagnosis of ASD from a physician or clinical psychologist based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, (DSM-5) and confirmed with the Autism Diagnostic Interview- Revised (ADI-R)
- pre-puberty as indicated by Tanner stage I through screening by a physician
- being given an average of 8 hours of sleep per night by their parents over the past 3 months
- parents reported sleep onset delays of 30 minutes of longer on three or more nights per week
- free of psychotropic medications (allergy medications and medications for constipation are allowed)
- non-verbal IQ over 40
- able to perform the requested physical intervention.
Exclusion
- with one or co-morbid psychiatric disorders identified with a structured interview based on DSM-5
- with other medical conditions that limit their physical activity participation and sleep (e.g., asthma, seizure, cardiac disease etc)
- with a complex neurologic disorder (e.g., epilepsy, phenylketonuria, fragile X syndrome, tuberous sclerosis)
- participants who are currently meeting physical activity guidelines (more than or equal to 60 minutes of moderate and vigorous physical activity each day).
Key Trial Info
Start Date :
December 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04878198
Start Date
December 2 2022
End Date
December 30 2023
Last Update
February 28 2024
Active Locations (1)
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1
EdUHK
Hong Kong, China, Hong Kong, 0000