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Clinical Trials/ISRCTN50834814
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

  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)
Registry
who.int
Start Date
November 17, 2014
End Date
December 31, 2017
Last Updated
7 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Murdoch Children's Research Institute (Australia)

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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