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PriCARE/CARIÑO for Child Maltreatment Prevention

This study is evaluating a group training program called PriCARE/CARIÑO. This program aims to improve how caregivers and children interact, reduce stress for caregivers, and decrease child behavior problems. It also seeks to lower the risk of child maltreatment (harm or neglect to a child). You may be able to join if you are a caregiver aged 18 or older, speak English or Spanish, are the legal guardian of a child between 18 months and 6 years old, and can attend group sessions either in person or virtually. The study will measure if PriCARE/CARIÑO reduces Child Protective Services (CPS) investigations and the potential for child abuse.

Study design
This study is a randomized controlled trial involving 1932 participants (966 caregiver-child pairs). Participants will either receive the PriCARE/CARIÑO program plus usual care, or usual care alone.
What's involved
Caregivers need to be available to attend scheduled PriCARE/CARIÑO group sessions. You will also need a cellular phone with text messaging and appropriate technology for virtual participation.
Compensation
Not stated in the trial record.
Follow-up
The study will track Child Protective Services investigations for up to 52 months after the start of the study. Changes in child abuse potential will be measured for 6-8 months after the study begins.

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NCT05233150

Child-Adult Relationship Enhancement in Primary Care (PriCARE) / Criando Niños Con CARIÑO (CARIÑO)

Recruiting
NAAges 18–99InterventionalPrevention
University of North Carolina, Chapel Hill
~1,932 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:PriCARE/CARIÑO

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Child Protective Services Investigations from time 3 to time 5
Measured over 4 month after baseline (time 3) up to 52 months after baseline (time 5)
+1 more outcome measured

Conditions

Parent-Child Relations
Child Maltreatment

Explore related trials

Child abuseParent-Child Relations

Where it's being run

2 sites across 2 states
North Carolina1
Pennsylvania1

Study leadership

  • Samantha Schilling, MD, MSHP · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill

Who to contact

Samantha Schilling, MD, MSHP
[email protected]
919-966-2504
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Child Protective Services Investigations from time 3 to time 54 month after baseline (time 3) up to 52 months after baseline (time 5)

    The primary outcome variable is a binary indicator of whether or not the child experienced at least one investigation from Child Protective Services (CPS) during follow-up. Beginning 4 months after randomization, each child will be followed for a period of 12 to 48 months to document all CPS investigations of suspected child maltreatment. The length of the follow-up interval will depend on the dyad's time of enrollment in the study.

  • Change in the Brief Child Abuse Potential Inventory (BCAP) score from time 1 to time 4Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)

    Change in BCAP scores from time 1 to time 4 will be measured. BCAP, a 34-item survey, measures traits and parenting styles typical of known physical child abusers. Each item has a unweighted value based on if agree vs. disagree is chosen and then the values are summed. Child abuse risk scores range from 0-24 with higher scores indicating caregiver has traits similar to those of known child abusers and has a higher risk of abuse.