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

Last updated: February 26, 2025
Sponsor: University of North Carolina, Chapel Hill
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

PriCARE/CARIÑO

Clinical Study ID

NCT05233150
20-2605
1R01HD103902-01
  • Ages 18-99
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 virtualintervention

  • 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

Exclusion Criteria:

  • Caregiver or another caregiver in the household has previously participated inPriCARE/CARIÑO

  • Child has a cognitive functioning below 2-year-old level, as determined by thescreening questions and/or the referring clinician

  • Child has a diagnosis of autism

  • Child is receiving individual behavioral health treatment or medication for abehavioral health problem

Study Design

Total Participants: 1932
Treatment Group(s): 1
Primary Treatment: PriCARE/CARIÑO
Phase:
Study Start date:
May 18, 2022
Estimated Completion Date:
July 01, 2027

Study 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).

Connect with a study center

  • University of North Carolina Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19146
    United States

    Site Not Available

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