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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT04018404
Eligibility Criteria:
Inclusion Criteria: Experimental group
\- 1. Children born at 32 weeks or greater between the ages of 18 to 36 months and their biological mothers.
2\. Present to a morning ULPS General Pediatric clinic for a well-child check and newly enrolled that day into the FRI Clinical program (requires at least one ACE or SDH disclosed on screening of child and agrees to clinical program) 3. Mother English speaking
Exclusion Criteria:
* 1\. Previously enrolled in FRI Clinical Program 2. Previously enrolled as a control in an afternoon clinic 3. Previously identified serious chronic health problems (e.g. complex congenital heart disease)
Inclusion Criteria: Control group
1. Children born at 32 weeks or greater between the ages of 18 to 36 months and their biological mothers.
2. Presenting to an afternoon ULPS General Pediatric clinic for a well- child check
3. Has at least one ACE or SDH on pre-enrollment screening
4. Mother English speaking
Exclusion Criteria:
4\. Previously enrolled in FRI Clinical Program 5. Previously identified serious chronic health problems (e.g. complex congenital heart disease)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
36 Months
Study:
NCT04018404
Study Brief:
Protocol Section:
NCT04018404