跳至主要内容
临床试验/ISRCTN50834814
ISRCTN50834814已完成未知

Does a brief, behavioural sleep intervention, delivered by trained paediatricians and psychologists improve sleep, ADHD symptom severity and behaviour for children with ADHD? A cluster-randomised, translational trial

Murdoch Children's Research Institute (Australia)0 个研究点目标入组 320 人开始时间: 2014年11月17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
320

研究概览

简要总结

  1. 2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28377393 2. 2019 results in https://www.ncbi.nlm.nih.gov/pubmed/30654852 (added 21/01/2019)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • Inclusion criteria as of 13/01/2017
  • Families of children aged 5 - 12 years (either sex) with caregiver report of:
  • 1. Moderate to severe sleep problems
  • 2. ADHD symptoms meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for ADHD (child also needs to have been previously diagnosed with ADHD by a paediatrician)
  • 3. At least one of the following sleep problems as defined by the American Academy of Sleep Medicine diagnostic criteria (2014):
  • 3.1 Chronic insomnia disorder
  • 3.2 Sleep-wake phase disorder
  • 3.3 Sleep-related anxiety”
  • Original inclusion criteria:
  • Families of children aged 5 - 12 years (either sex) with caregiver report of:
  • 1. Moderate to severe sleep problems
  • 2. ADHD symptoms meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for ADHD (child also needs to have been previously diagnosed with ADHD by a paediatrician)
  • 3. At least one of the following sleep problems as defined by the American Academy of Sleep Medicine diagnostic criteria (2005):
  • 3.1. Sleep onset association disorder
  • 3.2. Limit setting disorder
  • 3.3. Delayed sleep phase
  • 3.4. Primary insomnia
  • 3.5 Anxiety-associated insomnia

排除标准

  • Potential participants will be excluded from the study if they meet any of the following conditions:
  • 1. Suspected obstructive sleep apnoea as screened by three obstructive sleep apnoea items from the Child Sleep Habits Questionnaire (CSHQ) and interview with CI Hiscock (paediatrician)
  • 2. Have a major illness (e.g. cerebral palsy) or disability (e.g. intellectual disability)
  • 3. Non-English speaking

研究者

发起方
Murdoch Children's Research Institute (Australia)

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