Bridging access and impact: primary care parenting intervention reduces early behavior problems in both virtual and in-person delivery modes.
Fithi Andom, Joanne N Wood, Li Jiang...
https://pubmed.ncbi.nlm.nih.gov/41756184Actively Recruiting
Phase Not Applicable
Age: 18Months - 99Years
All Genders
Healthy Volunteers
ID05233150
Child-Adult Relationship Enhancement in Primary Care: Supporting Parents and Children
Led by University of North Carolina, Chapel Hill · Updated on 2026-05-01
1932
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of PriCARE/CARIÑO, 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 PriCARE/CARIÑO 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)
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
AI-Screening
AI-Powered Screening
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1
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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
Trial Site Locations
Total: 2 locations
1
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19146
Not Yet Recruiting
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Research Team
S
Samantha Schilling, MD, MSHP
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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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...
https://pubmed.ncbi.nlm.nih.gov/36823526