Clinical trial NCT05233150: Child-Adult Relationship Enhancement in Primary Care (PriCARE) / Criando Niños Con CARIÑO (CARIÑO)
Official title: Child-Adult Relationship Enhancement in Primary Care: Supporting Parents and Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parent-Child Relations
Child Maltreatment
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Children's Hospital of Philadelphia
First posted: 2022-02-10
Enrollment: 1932
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Child Protective Services Investigations from time 3 to time 5
timeFrame: 4 month after baseline (time 3) up to 52 months after baseline (time 5)
measure: Change in the Brief Child Abuse Potential Inventory (BCAP) score from time 1 to time 4
timeFrame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Secondary outcomes:
measure: Change in the Eyberg Child Behavior Inventory (ECBI) intensity scale score from time 1 to time 4
timeFrame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
measure: Change in the Eyberg Child Behavior Inventory (ECBI) problem scale score from time 1 to time 4
timeFrame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
measure: Change in the number of child led play skills in the Dyadic Parent-Child Interaction Coding System (DPICS) from time 1 to time 4
timeFrame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
measure: Change in the number of non-child led skill in Dyadic Parent-Child Interaction Coding System (DPICS) score from time 1 to time 4
timeFrame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
measure: Change in the number of direct commands in Dyadic Parent-Child Interaction Coding System (DPICS) score from time 1 to time 4
timeFrame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
measure: Change in the number child's compliance with commands in Dyadic Parent-Child Interaction Coding System (DPICS) score from time 1 to time 4
timeFrame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
measure: Change in the Parenting Stress Index-Short Form (PSI) total score from time 1 to time 4
timeFrame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
measure: Change in the Parenting Stress Index-Short Form (PSI) Parental Distress subscale score from time 1 to time 4
timeFrame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
measure: Change in the Parenting Stress Index-Short Form (PSI) Parent-Child Dysfunctional Interaction subscale score from time 1 to time 4
timeFrame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
measure: Change in the Parenting Stress Index-Short Form (PSI) Difficult Child subscale score from time 1 to time 4
timeFrame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
measure: Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Nonviolent Discipline score from time 1 to time 4
timeFrame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
measure: Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Psychological Aggression score from time 1 to time 4
timeFrame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
measure: Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Minor Physical Assault score from time 1 to time 4
timeFrame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
measure: Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Weekly Discipline score from time 1 to time 4
timeFrame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
measure: Change in the Parenting Scale (PS) total score from time 1 to time 4
timeFrame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
measure: Change in the Parenting Scale (PS) Laxness subscale score from time 1 to time 4
timeFrame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
measure: Change in the Parenting Scale (PS) Over-Reactivity subscale score from time 1 to time 4
timeFrame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
measure: Change in the Parenting Scale (PS) Hostility subscale score from time 1 to time 4
timeFrame: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Samantha Schilling, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
References: