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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT05233150
Status
Recruiting
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Conditions

  • Child Maltreatment
  • Parent-Child Relations

Eligibility Criteria

Sex
ALL
Age
18 Months - 99 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
May 18, 2022
Status verified
Apr 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
1,932 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

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) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of North Carolina Chapel HillChapel HillNorth Carolina27599
Samantha Schilling, MD, MSHP
[email protected]
919-966-2504
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19146
Joanne Wood, MD, MSHP
[email protected]
267-426-3107

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By research site
University of North Carolina Chapel Hill· Chapel Hill, NCChildren's Hospital of Philadelphia· Philadelphia, PA

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