Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT02694003
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
12 Years
Study:
NCT02694003
Study Brief:
Protocol Section:
NCT02694003