Enhancing Parent-Child Relationships with PriCARECARIO to Reduce Child Maltreatment and Stress
Led by University of North Carolina, Chapel Hill · Updated on 2026-05-01
1932
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of PriCARECARIO, a caregiver training program, to reduce child maltreatment, improve parent-child interactions, and decrease harsh or neglectful parenting, parent stress, and child behavior problems. This randomized controlled trial involves children aged 18 months to 6 years and their caregivers, focusing on reducing Child Protective Services investigations and child maltreatment risk measured by the Brief Child Abuse Potential Inventory BCAP.
Participants are randomly assigned to either the PriCARECARIO plus usual care group or the usual care group. Those in the intervention group attend weekly group sessions for six weeks, each lasting about 80 minutes, led by trained mental health professionals. Caregivers learn skills to praise positive behaviors, give effective commands, and manage stress. They are encouraged to practice these skills with their children between sessions. The usual care group receives standard care without the additional intervention.
Throughout the study, caregivers and children undergo assessments at baseline and 6 to 8 months after starting, measuring child behavior, parenting stress, parent-child relationship quality, and parenting tactics. Child Protective Services investigations are tracked from 4 months after enrollment up to 52 months. The study measures various outcomes using validated tools like the Eyberg Child Behavior Inventory, Dyadic Parent-Child Interaction Coding System, and Parenting Stress Index. Participation lasts up to several years for long-term monitoring of child safety and family dynamics.
CONDITIONS
Brief Title
Child-Adult Relationship Enhancement in Primary Care (PriCARE) / Criando Niños Con CARIÑO (CARIÑO)
Research Team
S
Samantha Schilling, MD, MSHP
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
How This Trial Compares With Other Options
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
PriCARE/CARIÑO plus Usual Care
Usual Care
What it is
A group‑based caregiver training program (PriCARE or its culturally adapted Spanish version CARIÑO) given in primary care or virtually alongside usual care.
The standard care normally provided without the PriCARE/CARIÑO training.
Role in the trial
Investigational behavioural intervention arm.
Control arm receiving usual care.
Primary purpose
To prevent child maltreatment through structured caregiver training.
To monitor and compare against the standard care pathway without added intervention.
How it is given or performed
Group sessions delivered in clinic or virtually teaching parenting skills (Praise, Paraphrase, Point‑out‑Behavior) with practice and stress education.
Caregivers receive the standard services offered in primary care without the structured PriCARE/CARIÑO training.
Evidence status
Under investigation in this randomized trial; effectiveness to prevent maltreatment is not yet established.
Represents current standard care pathway; effectiveness evidence varies and structured prevention programs are not currently recommended in primary care.
Important risks
No specific safety risks identified in the trial registry.
No specific safety issues beyond routine care.
Important limitations
Effectiveness for reducing child maltreatment outcomes remains unproven until trial results are available.
Existing evidence in primary care settings is insufficient to support structured prevention programs.
Patient impact
Not yet known; impact will depend on trial outcomes.
Impact on maltreatment prevention unclear due to limited primary care evidence.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Months - 99Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Caregiver is age 18 years or older
Caregiver speaks English or Spanish
Caregiver is the legal guardian of the child
Caregiver provides informed consent
Caregiver is available to attend scheduled PriCARE/CARIÑO group sessions
Caregiver has a cell phone with text messaging
Caregiver has access to technology to participate in virtual sessions
Child is between 18 months and 6 years old
Child receives care at a participating primary care center
Child has Medicaid, CHIP, or no insurance
Child lives in North Carolina or Philadelphia
You will not qualify if you...
Caregiver or another caregiver in the household has previously participated in PriCARE/CARIÑO
Child has cognitive functioning below a 2-year-old level
Child has a diagnosis of autism
Child is receiving individual behavioral health treatment or medication for a behavioral health problem
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Treatment
Duration - 6 weeks
Participants in the intervention group attend weekly group caregiver training sessions designed to improve child behaviors, caregiver-child relationships, and reduce caregiver stress. The training lasts 6 weeks with weekly sessions of about 80 minutes each. Participants practice learned skills with their child between sessions. Participants in the control group receive usual care without these sessions.
Weekly visits for 6 weeks (in-person or virtual)
Follow-up
Duration - Up to 52 months after baseline
Participants are assessed approximately 6 to 8 months after baseline to measure changes in child maltreatment risk, parenting stress, child behavior, and parent-child relationship quality. Child Protective Services investigations are monitored starting 4 months after baseline up to 52 months.
1 to 2 visits for assessments; ongoing monitoring of Child Protective Services investigations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Enhancing Parent-Child Relationships with PriCARECARIO to Reduce Child Maltreatment and Stress
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Published Research Related To This Trial
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.
Samantha Schilling, Byron J Powell, Paul W Stewart...