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 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT03546504
Eligibility Criteria:
Inclusion Criteria:
1. aged 5-12
2. able to follow 1-step verbal directions
3. able to reliably answer simple yes/no questions
4. have sensory processing difficulties as indicated by atypical scores on the Sensory Processing Measure \[ref\]
5. has difficulty completing oral hygiene and dental visits
6. has sufficient motor skills to brush own teeth
7. family is fluent in English
8. has a caregiver willing to adhere to home program
7\) caregiver is willing to bring child to clinic 8 weekly occupational therapy clinic sessions
Exclusion Criteria:
1. unable to communicate
2. unable to physically handle toothbrush to brush teeth
3. requires extensive restorative dental work or has had such work within the past 3 months
4. has braces, temporary orthodontic prosthesis (e.g., retainers)
5. Greater than mild uncorrected hearing or visual impairments
6. uncontrolled seizures
7. has additional other neurodevelopmental conditions other than ADHD and Anxiety
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
12 Years
Study:
NCT03546504
Study Brief:
Protocol Section:
NCT03546504