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Sleeping Sound with Autism Spectrum Disorder (ASD)

Not Applicable
Completed
Conditions
Autism Spectrum Disorder
Mental and Behavioural Disorders
Registration Number
ISRCTN14077107
Lead Sponsor
The Royal Children’s Hospital
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)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
246
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)
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).
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)

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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