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NCT05233150NARecruitingAccepts Healthy Volunteers

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

University of North Carolina, Chapel Hill

Start Date

5/18/2022

Completion Date

7/1/2027

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).

Eligibility Criteria

Age Range: No minimum to 99 years

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

Interventions

BEHAVIORAL

PriCARE/CARIÑO

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Conditions

Parent-Child RelationsChild Maltreatment

Locations

University of North Carolina Chapel Hill

Chapel Hill, North Carolina 27599

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19146

United States