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
- 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
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