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

NCT05233150 | Recruiting DMC

• 2 other identifiers: 20-26051R01HD103902-01
• Study Type: interventional
• Target: 1,932
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Parent-Child Relations; Child Maltreatment

Outcome Measures

Primary Outcomes (2)

• Child Protective Services Investigations from time 3 to time 5

  The primary outcome variable is a binary indicator of whether or not the child experienced at least one investigation from Child Protective Services (CPS) during follow-up. Beginning 4 months after randomization, each child will be followed for a period of 12 to 48 months to document all CPS investigations of suspected child maltreatment. The length of the follow-up interval will depend on the dyad's time of enrollment in the study.

  4 month after baseline (time 3) up to 52 months after baseline (time 5)

• Change in the Brief Child Abuse Potential Inventory (BCAP) score from time 1 to time 4

  Change in BCAP scores from time 1 to time 4 will be measured. BCAP, a 34-item survey, measures traits and parenting styles typical of known physical child abusers. Each item has a unweighted value based on if agree vs. disagree is chosen and then the values are summed. Child abuse risk scores range from 0-24 with higher scores indicating caregiver has traits similar to those of known child abusers and has a higher risk of abuse.

  Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)

Secondary Outcomes (18)

• Change in the Eyberg Child Behavior Inventory (ECBI) intensity scale score from time 1 to time 4

  Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)

• Change in the Eyberg Child Behavior Inventory (ECBI) problem scale score from time 1 to time 4

  Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)

• Change in the number of child led play skills in the Dyadic Parent-Child Interaction Coding System (DPICS) from time 1 to time 4

  Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)

• Change in the number of non-child led skill in Dyadic Parent-Child Interaction Coding System (DPICS) score from time 1 to time 4

  Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)

• Change in the number of direct commands in Dyadic Parent-Child Interaction Coding System (DPICS) score from time 1 to time 4

  Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)

Study Arms (2)

PriCARE/CARIÑO plus Usual Care

EXPERIMENTAL

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.

Behavioral: PriCARE/CARIÑO

Usual care

NO INTERVENTION

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.

Interventions

PriCARE/CARIÑO BEHAVIORAL

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.

Also known as: Child Adult Relationship Enhancement in Primary Care, Criando Niños con CARIÑO

PriCARE/CARIÑO plus Usual Care

Eligibility Criteria

• Age: 18 Months - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: collaborator
• University of North Carolina, Chapel Hill: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

NOT YET RECRUITING

Related Publications (2)

• Andom F, Wood JN, Jiang L, Lin FC, Schilling S. Bridging access and impact: primary care parenting intervention reduces early behavior problems in both virtual and in-person delivery modes. Front Pediatr. 2026 Feb 11;14:1709280. doi: 10.3389/fped.2026.1709280. eCollection 2026.

  PMID: 41756184 DERIVED

• Schilling S, Powell BJ, Stewart PW, Wood JN. Child Adult Relationship Enhancement in Primary Care (PriCARE): study design/protocol for a randomized trial of a primary care-based group parenting intervention to prevent child maltreatment. Trials. 2023 Feb 23;24(1):138. doi: 10.1186/s13063-022-07024-y.

  PMID: 36823526 DERIVED

MeSH Terms

Interventions

Primary Health Care

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Samantha Schilling, MD, MSHP

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Schilling, MD, MSHP

CONTACT

919-966-2504; samantha_schilling@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 10, 2022
• Study Start: May 18, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 36 months (3 years) following article (primary aim) publication and ending 60 months (5 years) following article publication.
• Access Criteria: Data will be shared with researchers who (1) provide a methodologically sound proposal that focuses on meta-analysis, (2) have obtained IRB approval for the proposal, and (3) execute a data use agreement. Proposals should be directed to Samantha\ Schilling@med.unc.edu and Woodjo@chop.edu

Locations

US (2)