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

NCT ID: NCT05233150

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1932 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-18
• Study Completion Date: 2027-07-01

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.

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).

Conditions

Parent-Child Relations; Child Maltreatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

PriCARE/CARIÑO

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Child Adult Relationship Enhancement in Primary Care; Criando Niños con CARIÑO

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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samantha Schilling, MD, MSHP

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Samantha Schilling, MD, MSHP

Role: CONTACT

samantha_schilling@med.unc.edu

919-966-2504

Facility Contacts

Samantha Schilling, MD, MSHP

Role: primary

samantha_schilling@med.unc.edu

919-966-2504

Joanne Wood, MD, MSHP

Role: primary

woodjo@chop.edu

267-426-3107

References

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.

Reference Type: DERIVED

PMID: 36823526 (View on PubMed)

Other Identifiers

1R01HD103902-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-2605

Identifier Type: -

Identifier Source: org_study_id