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Search / Trial NCT02694003

Better Nights, Better Days for Children With Neurodevelopment Disorders

Launched by IWK HEALTH CENTRE · Feb 23, 2016

Trial Information

Current as of May 19, 2025

Completed

Keywords

Autism Spectrum Disorder (Asd) Fetal Alcohol Spectrum Disorder (Fasd) Cerebral Palsy (Cp) Attention Deficit/Hyperactivity Disorder (Adhd) Behavioural Insomnia Neurodevelopmental Disorders

ClinConnect Summary

The purpose of the study is to develop and evaluate a web-based intervention for insomnia among children with neurodevelopmental disabilities (NDD), including Autism Spectrum Disorder (ASD), Fetal Alcohol Spectrum Disorder (FASD), Cerebral Palsy (CP), and Attention-Deficit/Hyperactivity Disorder (ADHD). Using the internet to deliver an intervention program for insomnia in children will address access barriers and provide evidence-based treatment to large numbers of children with NDD.

This study will adapt the Better Nights, Better Days (BNBD) e-intervention that was developed for typically...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. are the primary caregiver of a child aged 4 to 12 years
  • 2. live in any province/territory in Canada
  • 3. have regular access to a high-speed internet connection and an email account
  • 4. fluent in English or French
  • 5. have self-reported listening and reading comprehension level of grade 6 or higher
  • 6. have a child with ASD, CP, FASD, or ADHD, with level of impairment ranging from mild to moderate, in addition to insomnia
  • Exclusion Criteria:
  • 1. caregiver wishes to "bed-share" with child
  • 2. child has a probable intrinsic sleep disorder (e.g., sleep apnea)
  • 3. child has a significant medical disorder that interferes with sleep (e.g., nighttime asthma attacks, tube-feeding, severe developmental disability affecting sensory systems such as vision)
  • 4. child has a mental health disorder that has required hospitalization or residential care
  • 5. child is non-ambulatory
  • 6. child experiences enuresis at least 3 times per week that requires parental intervention during the night
  • 7. child has a functional impairment below the 2nd percentile as determined by a caregiver report measure, the Adaptive Behavior Assessment System, 2nd Edition (ABAS-II)
  • 8. child is currently being treated with anti-epileptic and/or psychotropic medications (e.g., stimulant medication for ADHD) and the medication or dose is not stable and/or expected to change within 6 months

About Iwk Health Centre

IWK Health Centre is a leading pediatric and women's health facility based in Halifax, Nova Scotia, dedicated to providing high-quality care and advancing medical research. As a prominent clinical trial sponsor, IWK Health Centre collaborates with multidisciplinary teams to conduct innovative research aimed at improving health outcomes for children, youth, and women. The center prioritizes patient-centered approaches in its trials, ensuring that the needs and safety of participants are at the forefront of its research initiatives. With a commitment to excellence and ethical standards, IWK Health Centre contributes significantly to the advancement of medical knowledge and the development of effective therapies.

Locations

Halifax, Nova Scotia, Canada

Patients applied

0 patients applied

Trial Officials

Penny Corkum, PhD

Principal Investigator

IWK Health Centre; Dalhousie University

Shelly Weiss, MD

Principal Investigator

The Hospital for Sick Children; University of Toronto

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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