Recruiting

PriCARE & CARIÑO

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT05233150

Conditions

Parent-Child Relations

Child Maltreatment

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Accepted

Interventions

PriCARE/CARIÑO

Study Details

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

Study ID

NCT05233150

Start date

May 18, 2022

Status verified date

Apr, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1932 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: PriCARE/CARIÑO plus Usual Care

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.

no intervention: Usual care

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

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.

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Samantha Schilling, MD, MSHP

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

Locations

University of North Carolina Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Samantha Schilling, MD, MSHP

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

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-05-01.