Clinical trial NCT04110236: Pilot of Enhanced Child Adult Relationship Enhancement in Pediatric Primary Care
Official title: Pilot Evaluation of Enhanced Child Adult Relationship Enhancement in Pediatric Primary Care (PriCARE) Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior Problem
Parent-Child Relations
Keywords: Child behavior problems
Caregiver child relationship
Primary care
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Annie E. Casey Foundation
name: The Pew Charitable Trusts
First posted: 2019-10-01
Enrollment: 238
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of the enhanced PriCARE intervention in improving parenting capacity, decreasing child behavior problems, and reducing risk of child maltreatment at several primary care clinics in Philadelphia and 2 primary care clinics in North Carolina.

Detailed description: Child behavioral concerns are common among families served by Children's Hospital of Philadelphia (CHOP) and University of North Carolina (UNC) pediatric primary care centers. To address this, Child Adult Relationship Enhancement in Pediatric Primary Care (PriCARE) was developed. PriCARE has been evaluated in primary care centers at CHOP and UNC with promising findings with regards to reductions in child behavioral problems. The PriCARE curriculum has now been enhanced with strategies to increase participant engagement, retention of skills, and attendance. Efficacy of this enhanced PriCARE curriculum has not yet been evaluated. Nor has the impact of the PriCARE intervention on child maltreatment risk been explored.

The primary objective of this study is to evaluate the efficacy of the enhanced PriCARE program to improve parenting capacity as measured by the Parenting Scale total score and 3 sub-scales.

The secondary objectives are to:

1. Measure the impact of PriCARE on parent-reported child behavior problems as assessed by the Eyberg Child Behavior Inventory intensity and problems scales.
2. Measure the impact of PriCARE on the quality of the parent-child relationship as measured by the Dyadic Parent-Child Interaction Coding.
3. Measure the impact of PriCARE on the risk of child maltreatment as measured by the Child Abuse Potential Inventory.
4. Identify and describe predictors of attendance in PriCARE groups.
5. Identify and describe modifiers of the efficacy of PriCARE including but not limited to caregiver and child demographics.
6. Assess caregivers' perceptions of the efficacy of PriCARE on improving parenting skills and child behavior as measured by the Therapeutic Attitude Inventory (TAI).
7. Develop and pilot a new PriCARE Positive Discipline Module.
8. Collect pilot data on added benefit of completing the PriCARE Positive Discipline Module.

The investigators will perform a randomized controlled trial (RCT) of the effectiveness of the enhanced PriCARE on objectives listed above among 2- to 6-year-old children and their parents at several CHOP Primary Care Centers and two University of North Carolina primary care sites. The investigators intend to randomize up to 119 child-caregiver pairs (238 subjects) to receive PriCARE immediately plus usual treatment (intervention group) and up to 119 child-parent pairs (238 subjects) to receive PriCARE at a later time plus usual treatment (control group) for a total of up to 238 child-caregiver pairs (476 subjects). All child-caregivers pairs randomized to the control group will be placed on a waitlist and offered PriCARE after completion of data collection. Child maltreatment risk, parenting attitudes and skills, child behavior, and quality of the child-caregiver relationship will be measured at baseline (time 1) and approximately 8-17 weeks after randomization (time 2) for both the intervention and control groups. The follow up interview will also include a brief satisfaction questionnaire for participants randomized to the intervention group. For the subgroup of participants who complete the Positive Discipline Module, these measurements will be repeated approximately 2-4 weeks after completion of the Positive Discipline intervention (time 3).

Eligibility criteria: Inclusion Criteria:

* Caregiver is 18 years or older
* Caregiver is English speaking
* Caregiver is legal guardian of child and provides informed consent
* Caregiver has cellular phone with text messaging capacity
* Caregiver is available for scheduled times PriCARE hosts groups
* Child is 2-6 years old
* Caregiver must have the appropriate technological tools and access to participate when in-person sessions are not available
* Child attends one of the CHOP primary care sites in Pennsylvania or one of two University of North Carolina (UNC Children's Primary Care and UNC Pediatrics at Panther Creek) primary care sites

Exclusion Criteria:

* Caregiver has already completed the PriCARE program
* Child has already received a behavioral health diagnosis or is already receiving individualized behavior health therapy or associated medication for Oppositional Defiance Disorder, Conduct Disorder, or Attention- Deficit/Hyperactivity Disorder
* Child is being evaluated for or has been diagnosed with autism
* Child has a cognitive age less than 2 years old as determined by screening questions and/or the referring clinician.
* Child has caused physical injuries, such as bruises or cuts, more than once and on purpose to their caregiver, him/herself, or other children or people

Primary outcomes:
measure: Change in the Parenting Scale (PS) score from time 1 to time 2
timeFrame: Baseline (time 1), 8-17 weeks (time 2)
Secondary outcomes:
measure: Change in the Eyberg Child Behavior Inventory (ECBI) score from time 1 to time 2
timeFrame: Baseline (time 1), 8-17 weeks (time 2)
measure: Change in the Dyadic Parent-Child Interaction Coding (DPICS) score from time 1 to time 2
timeFrame: Baseline (time 1), 8-17 weeks (time 2)
measure: Change in the Child Abuse Potential Inventory (CAPI) score from time 1 to time 2
timeFrame: Baseline (time 1), 8-17 weeks (time 2)
measure: Therapeutic Attitudes Inventory (TAI)
timeFrame: 8-17 weeks (time 2)
Other outcomes:
measure: Change in the Parenting Scale (PS) score from time 2 to time 3
timeFrame: 8-17 weeks (time 2) to 16-30 weeks (time 3)
measure: Change in the Eyberg Child Behavior Inventory (ECBI) score from time 2 to time 3
timeFrame: 8-17 weeks (time 2), 16-30 weeks (time 3)
measure: Change in the Dyadic Parent-Child Interaction Coding (DPICS) score from time 2 to time 3
timeFrame: 8-17 weeks (time 2), 16-30 weeks (time 3)
measure: Therapeutic Attitudes Inventory (TAI) at time 3
timeFrame: 16-30 weeks (time 3)
measure: Change in the Child Abuse Potential Inventory (CAPI) score from baseline to time 2 to time 3
timeFrame: 8-17 weeks (time 2), 16-30 weeks (time 3)
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Joanne Wood, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
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