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

University of North Carolina (UNC)

Status: Enrolling

Conditions: Parent-Child Relations; Child Maltreatment

Treatments: Behavioral: PriCARE/CARIÑO

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05233150

20-2605

1R01HD103902-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,932 estimated patients

Sex: All

Ages: 18 months to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,932 participants in 2 patient groups

PriCARE/CARIÑO plus Usual Care

Experimental group

Description:

Caregiver-child dyads assigned to the PriCARE/CARIÑO plus usual care group will receive the PriCARE/CARIÑO intervention within 4 months of randomization plus usual care. The intervention will last 6 weeks. Each group, administered by 1-2 trained mental health professionals, will have approximately 4-10 caregiver participants and will meet weekly for 6 weeks. Each of the 6 sessions is approximately 80 minutes. Caregivers are expected to practice the skills they learn with their children between sessions.

Treatment:

Behavioral: PriCARE/CARIÑO

Usual care

No Intervention group

Description:

Caregiver-child dyads assigned to the usual care group will receive usual care and will not be aware of being in a group of about 8-10 recently-enrolled subjects.