Better Nights, Better Days for Children With Neurodevelopment Disorders (NCT02694003) | Clinical Trial Compass
CompletedNot Applicable
Better Nights, Better Days for Children With Neurodevelopment Disorders
Canada218 participantsStarted 2019-06-10
Plain-language summary
More than 90% of children with neurodevelopmental disorders (NDD) experience sleep problems, whereas less than 25% of typically developing children experience sleep problems. Poor sleep can have significant consequences for children's physical and psychosocial health, as well their caregivers' well-being. The impact of sleep problems on daytime functioning is even greater in children with NDD. Although there are a range of factors that may disturb sleep in children with NDD, the most frequent cause of sleep disturbance is behavioural insomnia. There is some evidence that behavioural interventions can be effective in improving sleep in children with NDD. However, this has not been tested through well-designed, large-scale randomized controlled trials (RCTs). Moreover, there are a number of significant barriers to access for insomnia treatment for children; most importantly, sleep interventions are often only provided by specialists, limiting access to treatment services. Instead, behavioural insomnia is often treated with advice about sleep hygiene and with the supplement melatonin, which is, at best, a short-term solution. The investigators, an interdisciplinary team of researchers, will develop and evaluate the effectiveness of an online sleep intervention that will be widely accessible and sustainable and will have the potential to dramatically improve the health of children with NDD and their families.
Who can participate
Age range4 Years – 12 Years
SexALL
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Inclusion criteria
✓. are the primary caregiver of a child aged 4 to 12 years
✓. live in any province/territory in Canada
✓. have regular access to a high-speed internet connection and an email account
✓. fluent in English or French
✓. have self-reported listening and reading comprehension level of grade 6 or higher
✓. have a child with ASD, CP, FASD, or ADHD, with level of impairment ranging from mild to moderate, in addition to insomnia
Exclusion criteria
✕. caregiver wishes to "bed-share" with child
✕. child has a probable intrinsic sleep disorder (e.g., sleep apnea)
✕. 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)
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What they're measuring
1
Disorder of Initiating and Maintaining Sleep (DIMS) Score
. child has a mental health disorder that has required hospitalization or residential care
✕. child is non-ambulatory
✕. child experiences enuresis at least 3 times per week that requires parental intervention during the night
✕. 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)
✕. 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