Image

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

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

Recruiting
18-99 years
All
Phase N/A

Powered by AI

Overview

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.

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

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

Study details
    Parent-Child Relations
    Child Maltreatment

NCT05233150

University of North Carolina, Chapel Hill

15 June 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.