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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT04402528
Eligibility Criteria:
Inclusion Criteria:
* Child has been diagnosed with ADHD, or shows significant signs and symptoms of ADHD.
* If child is being prescribed ADHD medication, child must currently be on a stable dosage of medication for 1 month.
* Child meets criteria for a research diagnosis of ADHD\* based on the ADHD Rating Scale IV Preschool-Version and Impairment Rating Scale assessments that the parent completes.
* Children will be given a research diagnosis of ADHD if the following criteria are met: 1) parents endorse that children have 6 or more symptoms in either the inattentive or hyperactive-impulsive domains present "often" or "very often" on the ADHD Rating Scale IV-Preschool Version (ADHD-RS-IV-P) or Vanderbilt ADHD Rating Scale; or have inattentive symptom scores and/or hyperactive symptom scores \>93th percentile for sex on the ADHD-RS-IV-P AND 2) child is experiencing ADHD-related impairment as shown by the parent or a teacher/childcare provider/additional adult scoring one or more items on the Impairment Rating Scale as a 3 or higher. Note: child behavior ratings from a teacher/childcare provider/additional adult on the ADHD-RS-IV-P and Impairment Rating Scale will not be required for study inclusion and children will not be excluded from the study on the basis of these ratings. Parents of children with a research diagnosis of ADHD will be eligible for study participation.
Exclusion Criteria:
* Parent does not have access to a computer or smartphone.
* Child has global developmental delay.
* Child has been diagnosed with autism spectrum disorder.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
5 Years
Study:
NCT04402528
Study Brief:
Protocol Section:
NCT04402528