Child-Adult Relationship Enhancement in Primary Care (PriCARE) / Criando Niños Con CARIÑO (CARIÑO)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PriCARE/CARIÑO.
- Who it may be relevant to
- Registry conditions: Parent-Child Relations, Child Maltreatment. Basic parameters: 18 months — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Child-Adult Relationship Enhancement in Primary Care: Supporting Parents and Children
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.
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).
Interventions
- Behavioral PriCARE/CARIÑO
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 eff
Primary outcome measures
- Child Protective Services Investigations from time 3 to time 5 [Time frame: 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 [Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
Secondary outcome measures (12)
- Change in the Eyberg Child Behavior Inventory (ECBI) intensity scale score from time 1 to time 4 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
- Change in the number child's compliance with commands in Dyadic Parent-Child Interaction Coding System (DPICS) score from time 1 to time 4 [Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
- Change in the Parenting Stress Index-Short Form (PSI) total score from time 1 to time 4 [Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
- Change in the Parenting Stress Index-Short Form (PSI) Parental Distress subscale score from time 1 to time 4 [Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
- Change in the Parenting Stress Index-Short Form (PSI) Parent-Child Dysfunctional Interaction subscale score from time 1 to time 4 [Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
- Change in the Parenting Stress Index-Short Form (PSI) Difficult Child subscale score from time 1 to time 4 [Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
- Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Nonviolent Discipline score from time 1 to time 4 [Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
- Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Psychological Aggression score from time 1 to time 4 [Time frame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- University of North Carolina Chapel Hill — Chapel Hill
- Children's Hospital of Philadelphia — Philadelphia
Publications
- 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
- 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
Identifiers
NCT: NCT05233150 · 20-2605 · 1R01HD103902-01