NCT05233150 Child-Adult Relationship Enhancement in Primary Care (PriCARE) / Criando Niños Con CARIÑO (CARIÑO)
| NCT ID | NCT05233150 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Parent-Child Relations |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,932 participants |
| Start Date | 2022-05-18 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,932 participants in total. It began in 2022-05-18 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is evaluate the effectiveness of PriCARE/CARIÑO to reduce child maltreatment, improve parent-child interactions, and reduce harsh/neglectful parenting, parent stress, and child behaviors.
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
Contact & Investigator
Samantha Schilling, MD, MSHP
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT05233150 clinical trial?
This trial is open to participants of all sexes, aged 18 Months or older, up to 99 Years, studying Parent-Child Relations. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05233150 currently recruiting?
Yes, NCT05233150 is actively recruiting participants. Contact the research team at samantha_schilling@med.unc.edu for enrollment information.
Where is the NCT05233150 trial being conducted?
This trial is being conducted at Chapel Hill, United States, Philadelphia, United States.
Who is sponsoring the NCT05233150 clinical trial?
NCT05233150 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Samantha Schilling, MD, MSHP at University of North Carolina, Chapel Hill. The trial plans to enroll 1,932 participants.