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临床试验/ACTRN12618000619246
ACTRN12618000619246已完成未知

A pilot randomised controlled trial of the Sleeping Sound Intervention on children's sleep difficulties in children with Autism Spectrum Disorder and Intellectual Disability.

Dr Nicole Papadopoulos0 个研究点目标入组 11 人开始时间: 2018年4月20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
11

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
o limit 至 o limit(—)
性别
All

入选标准

  • Parents of children who meet the following criteria will be eligible:
  • * Diagnosis of DSM-IV Autistic Disorder, Asperger’s Disorder or DSM-5 ASD, as indicated by paediatrician or a confirmed diagnosis as cited in a clinical report AND
  • Aged 6-13 years AND
  • A score above the clinical cut off (11 or more) on the Social Communication Questionnaire Lifetime form (10 minutes completion time) AND
  • Having a moderate or severe sleep problem by parent report and need to meet criteria for at least one of the following behavioural sleep problems as defined by the American Academy of Sleep Medicine diagnostic criteria: chronic insomnia (due to problems of sleep onset association, limit setting, prolonged night time waking, primary insomnia, early waking, or anxiety) delayed sleep phase disorder AND
  • Child has an intellectual disability which will be confirmed by citing a diagnostic/clinical report.
  • Participants currently taking melatonin as well as any other medications (SSRI’s etc.) will be included in the trial, if they continue to meet the above eligibility criteria. Information regarding medication will be collected as part of the survey.

排除标准

  • Participants will be excluded if their child has restless leg syndrome or any comorbid medical (e.g., tuberous sclerosis, epilepsy), neuropsychiatric (e.g., Tourette’s) or genetic (e.g., Fragile X disorder) conditions. Non-English speaking families will be excluded. Parents will be excluded if their child has obstructive sleep apnoea.

研究者

发起方
Dr Nicole Papadopoulos

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