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:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT03499405
Eligibility Criteria:
Inclusion Criteria:
1. FN participants will be current or former HS parents and sampled from urban and suburban HS.Eight FNs will be trained to support and guide caregivers through developmental testing, including 4 African American, 2 Caucasian and 2 bi-lingual Hispanic parents. Each FN will be assigned 1 to 4 caregivers.
2. The study sample of caregiver participants will include 32 eligible HS caregivers of preschoolers between 3 and 4 years old identified with moderate or severe developmental concerns on HS developmental screening, in order to include those at-risk before kindergarten age. Those with moderate developmental concern will have failed 2 domains on developmental screening, whereas those with severe concern have failed 3 or more domains. Those who fail 1 domain (mild concern) will be excluded since often single domain failures are due to limited early learning exposures and/or language barriers, which can be adequately addressed in HS.24,25 Half of those selected will be sampled from the moderate and half from the severe group, with 50% from urban and 50% from suburban HS centers included. Given that the demographics differ slightly in racial and ethnic make-up among the urban and suburban Head Starts, 12 African American, 2 Caucasian and 2 Hispanic caregivers will be sampled from urban HS; in suburban HS, 8 African American, 6 Caucasian and 2 Hispanic caregivers will be sampled.
Exclusion Criteria:
* For FN, not being a former head start parent.
* For caregiver, child not failing more than 2 or more domains on developmental testing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT03499405
Study Brief:
Protocol Section:
NCT03499405