Tailoring a brief sleep intervention for autism spectrum disorder: a randomised controlled trial

The Royal Children’s Hospital0 sites246 target enrollmentMarch 13, 2017

ConditionsAutism Spectrum Disorder Mental and Behavioural Disorders

Overview

Phase: 未知
Intervention: Not specified
Conditions: Autism Spectrum Disorder
Sponsor: The Royal Children’s Hospital
Enrollment: 246
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31748288 results (added 22/11/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36414853/ (added 26/04/2023) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35285017/ (added 26/04/2023) 2024 Results article in https://doi.org/10.1007/s10803-024-06422-2 (added 05/06/2024)

Registry

who.int

Start Date

March 13, 2017

End Date

December 31, 2019

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

The Royal Children’s Hospital

Eligibility Criteria

Inclusion Criteria

•Current inclusion criteria as of 18/02/2019:
•1\. Families of children aged 5\-12 years (all genders) (13 years if attending primary school).
•2\. ASD symptoms meeting criteria for ASD according to the Social Communication Questionnaire. The child must have previously received a conclusive multi\-disciplinary diagnosis of Autistic Disorder or Asperger's Disorder (according to Diagnostic and Statistical manual of Mental Disorders, 4th Edition; DSM\-IV), or ASD (according to Diagnostic and Statistical manual of Mental Disorders, 5th Edition; DSM\-5\). A SCQ cut off score of \>\= 11 will be used.
•3\. Moderate to severe sleep problems, with at least one of the following sleep problems as defined by the American Academy of Sleep Medicine diagnostic criteria (2013\): chronic insomnia (including problems of initiating and maintaining sleep, sleep\-onset association, limit\-setting, and anxiety\-related insomnia) or delayed sleep\-wake phase.
•Previous inclusion criteria as of 18/10/2017:
•1\. Families of children aged 5\-12 years (all genders) (13 years if attending primary school)
•2\. ASD symptoms meeting criteria for ASD according to the Social Communication Questionnaire. The child must have previously received a conclusive multi\-disciplinary diagnosis of Autistic Disorder or Asperger's Disorder (according to Diagnostic and Statistical manual of Mental Disorders, 4th Edition; DSM\-IV), or ASD (according to Diagnostic and Statistical manual of Mental Disorders, 5th Edition; DSM\-5\). A SCQ cut off score of \>\= 11 will be used
•3\. Moderate to severe sleep problems, with at least one of the following sleep problems as defined by the American Academy of Sleep Medicine diagnostic criteria (2013\): chronic insomnia (including problems of initiating and maintaining sleep, sleep\-onset association, limit\-setting, and anxiety\-related insomnia), delayed sleep\-wake phase or parasomnias (including nightmares, sleep terrors and sleepwalking)
•Previous inclusion criteria:
•1\. Families of children aged 5\-12 years (all genders)

Exclusion Criteria

•Current exclusion criteria:
•1\. Intellectual disability
•2\. Have comorbid medical condition that affects sleep (e.g. nocturnal seizures, blindness), or syndromic genetic (e.g. Fragile X) conditions
•3\. Suspected obstructive sleep apnoea as screened by three obstructive sleep apnoea items from the Child Sleep Habits Questionnaire (CSHQ) and interview with a paediatrician
•4\. Non\-English speaking
•Previous exclusion criteria:
•1\. Intellectual disability
•2\. Have comorbid medical (e.g. epilepsy), neuropsychiatric (e.g. Tourette's) or syndromic genetic (e.g. Fragile X) conditions
•3\. Suspected obstructive sleep apnoea as screened by three obstructive sleep apnoea items from the Child Sleep Habits Questionnaire (CSHQ) and interview with a paediatrician
•4\. Non\-English speaking