Enhancing parent-child relationships in primary care settings
Official title: Child-Adult Relationship Enhancement in Primary Care: Supporting Parents and Children
Run by University of North Carolina, Chapel Hill · NCT05233150 · Data updated 2026-11-12
This study is testing a new program to see if it can help improve relationships between parents and their young children while also reducing child maltreatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Months to 99 Years |
| Sex | All |
| Enrollment | 1932 (estimated) |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 2 sites (Chapel Hill, North Carolina and 1 other locations) |
| Status | Recruiting |
| Started | May 18, 2022 |
| Main results expected | July 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT05233150 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include English or Spanish-speaking caregivers aged 18 or older with children between 18 months and 6 years who are enrolled in Medicaid, CHIP, or are uninsured.
✕Probably not a fit
Patients who may not benefit include those whose children have a cognitive functioning below a 2-year-old level or have a diagnosis of autism.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of the PriCARE/CARIÑO program in reducing child maltreatment and improving parent-child interactions among families with children aged 2 to 6 years. It involves a randomized controlled trial where 966 child-caregiver dyads will receive the PriCARE/CARIÑO intervention alongside usual care, while another 966 dyads will receive only usual care. The study measures various outcomes, including child behavior problems, parenting stress, and the quality of parent-child relationships, using established assessment tools. The intervention will take place at multiple pediatric clinics in North Carolina and Children's Hospital of Philadelphia.
Why it matters
Potential benefit: If successful, this program could significantly reduce instances of child maltreatment and improve the overall quality of parent-child relationships.
How similar studies have gone: Other studies have shown success with similar interventions aimed at improving parent-child relationships and reducing maltreatment, indicating a promising approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States Recruiting -
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States Not yet recruiting
Study contacts
- Principal investigator: Samantha Schilling, MD, MSHP — University of North Carolina, Chapel Hill
- Study coordinator: Samantha Schilling, MD, MSHP
- Email: samantha_schilling@med.unc.edu
- Phone: 919-966-2504
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.