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 @ 5:07 PM
Ignite Modification Date:
2025-12-24 @ 5:07 PM
NCT ID:
NCT05233150
Eligibility Criteria:
Inclusion Criteria:
* Caregiver is age 18 years or older
* Caregiver is English or Spanish Speaking
* Caregiver is legal guardian of child subject
* Caregiver provides informed consent
* Caregiver is available to attend scheduled times of PriCARE/CARIÑO groups
* Caregiver has cellular phone with text messaging capacity
* Caregiver has appropriate technological tools and access to participate in virtual intervention
* Child is between 18 months and 6 years old
* Child receives care at participating primary care center
* Child has Medicaid/Children's Health Insurance Program (CHIP)/no insurance
* Child lives in North Carolina or Philadelphia
Exclusion Criteria:
* Caregiver or another caregiver in the household has previously participated in PriCARE/CARIÑO
* Child has a cognitive functioning below 2-year-old level, as determined by the screening questions and/or the referring clinician
* Child has a diagnosis of autism
* Child is receiving individual behavioral health treatment or medication for a behavioral health problem
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
99 Years
Study:
NCT05233150
Study Brief:
Protocol Section:
NCT05233150