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 range
4 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Disorder of Initiating and Maintaining Sleep (DIMS) Score
. 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)
. 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