NCT05233150 · University of North Carolina, Chapel Hill
Child-Adult Relationship Enhancement in Primary Care (PriCARE) / Criando Niños Con CARIÑO (CARIÑO)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Chapel Hill, North Carolina
- Philadelphia, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations