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临床试验/ISRCTN14077107
ISRCTN14077107已完成未知

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

The Royal Children’s Hospital0 个研究点目标入组 246 人开始时间: 2017年3月13日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
246

研究概览

简要总结

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)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 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)

排除标准

  • 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

研究者

发起方
The Royal Children’s Hospital

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