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:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-03-26 @ 3:21 PM
NCT ID:
NCT05862727
Eligibility Criteria:
Inclusion Criteria:
* child must be ages 3-5 years at intake
* child with score of 30 on the Child Sleep Habits Survey-Short Form and a caregiver rating of child's sleep problems as moderate/severe
* child with ≥80th percentile on the clinician-rated ADHD-RS based on age and sex norms, with at least 4 symptoms in the clinically significant range (scores of 2-3) in either the inattention or hyperactive/impulsive domains
* parent/caregiver must have ability to speak, read, and write in English
* parent/caregiver must have access to a device with internet and/or smartphone to access telehealth visits
* parent/caregiver must have ability to follow written and verbal instructions
* parent/caregiver must have ability and willingness to comply with study procedures.
Exclusion Criteria:
* child with suspected obstructive sleep apnea or restless legs syndrome (via screening questionnaires)
* child with current use of stimulant medication, other psychotropics, or medications for sleep (prescription or over-the-counter, including melatonin)
* child with caregiver report of psychiatric disorder other than ADHD requiring treatment (medication and/or therapy), Autism Spectrum Disorder, or intellectual disability
* parent/caregiver is currently participating in another parent training intervention or have previously participated in another parent training intervention in the past 6 months.
* Severe and/or uncontrolled medical condition (e.g., pulmonary and neurological conditions such as cystic fibrosis and seizure disorder) that would interfere with sleep and/or study participation according to the study team
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
5 Years
Study:
NCT05862727
Study Brief:
Protocol Section:
NCT05862727