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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT05874466
Eligibility Criteria:
Inclusion Criteria:
1. Duke Health pediatric patient at enrollment
2. 16-\<37 months of age at enrollment
3. Parent/legal guardian speaks English or Spanish
4. Parent/legal guardian understands and voluntarily provides informed consent
Exclusion Criteria:
1. Severe motor impairment that precludes study measure completion
2. Known genetic disorders
3. Severe hearing or visual impairment as determined on physical examination according to parent report
4. Acute illnesses likely to prevent successful or valid data collection
5. Uncontrolled epilepsy or seizure disorder
6. History or presence of a clinically significant medical disease, or a mental state that could confound the study or be detrimental to the subject as determined by the investigator
7. Acute exacerbations of chronic illnesses likely to prevent successful or valid data collection
8. Receiving therapies that affect vision
9. Parent/legal guardian and/or investigator believes that the child will be unable/unwilling to sit in the parent's lap to watch the app videos
10. Parent/legal guardian indicates that they or their child is unwilling or unable to complete the app administration, surveys, or diagnostic assessment
11. Participants who are otherwise judged as unable to comply with the protocol by the investigator
12. Any other factor that the investigator feels would make the study measures invalid
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Months
Maximum Age:
36 Months
Study:
NCT05874466
Study Brief:
Protocol Section:
NCT05874466