ISRCTN50834814
Completed
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 sites320 target enrollmentNovember 17, 2014
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Attention deficit hyperactivity disorder (ADHD)
- Sponsor
- Murdoch Children's Research Institute (Australia)
- Enrollment
- 320
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
- 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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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