NCT05233150

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

Child-Adult Relationship Enhancement in Primary Care: Supporting Parents and Children

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,932 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Months – 99 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary objective of this study is to evaluate the effectiveness of PriCARE/CARIÑO to reduce investigations of suspected Child Maltreatment (CM) by Child Protective Services (CPS), and CM risk as measured by the Brief Child Abuse Potential Inventory (BCAP). The secondary objectives of this study are to measure the impact of PriCARE/CARIÑO on: 1. Parent-reported child behavior problems as assessed by the Eyberg Child Behavior Inventory (ECBI). 2. The quality of the parent-child relationship as measured by the Dyadic Parent-Child Interaction Coding System (DPICS). 3. Parenting stress as measured by the Parenting Stress Index-Short From (PSI). 4. Harsh parenting as measured by Conflict Tactics Scales, Parent-Child version (CTS) and the Parenting Scale (PS) The investigators will perform a randomized controlled trial (RCT) of the effectiveness of the PriCARE/CARIÑO on objectives listed above among 2- to 6-year-old children and their parents at 3 Children's Hospital of Philadelphia (CHOP) Primary Care Centers and 10 pediatric clinics in North Carolina. The investigators intend to randomize 966 child-caregiver dyads (1932 subjects) to receive PriCARE/CARIÑO plus usual care (intervention group) and 966 child-parent dyads (1932 subjects) to receive usual care (control group). CM risk, parenting attitudes and skills, child behavior, and quality of the child-caregiver relationship will be measured at baseline and approximately 6-8 months after randomization for both the intervention and control groups. CPS investigations will be collected starting 4 months after randomization until the end of the study (up to 52 months).

Conditions

• Parent-Child Relations
• Child Maltreatment

Interventions

Type	Name	Description
BEHAVIORAL	PriCARE/CARIÑO	PriCARE/CARIÑO is a group caregiver training program designed to improve child behaviors, caregiver-child relationships, parenting capacity, and reduce caregiver stress. Sessions occur in the primary care clinic or virtually. PriCARE/CARIÑO uses the 3 P skills (Praise, Paraphrase and Point-out-Behavior). The training starts with skills on giving attention to children's positive, pro-social behaviors, while ignoring minor misbehaviors. The second part of the training teaches skills for giving effective commands in order to set age-appropriate limits and increase compliance. PriCARE/CARIÑO includes a stress education section that contextualizes the use of these skills with the types of behaviors and problems exhibited by many children living with psychosocial adversity and familial stress. Caregivers are encouraged to practice the skills with their child in between sessions. CARIÑO is the culturally adapted version of PriCARE for Spanish speaking participants.

Timeline

• Start date: 2022-05-18
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2022-02-10
• Last updated: 2025-02-27

Locations

2 sites across 1 country: United States