NCT04110236

Pilot of Enhanced Child Adult Relationship Enhancement in Pediatric Primary Care

Pilot Evaluation of Enhanced Child Adult Relationship Enhancement in Pediatric Primary Care (PriCARE) Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Accepted

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).

Conditions

• Child Behavior Problem
• Parent-Child Relations

Interventions

Type	Name	Description
BEHAVIORAL	PriCARE	PriCARE 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 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 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. Since PriCARE's initial and successful pilot, the intervention has been enhanced in order to increase engagement and effectiveness.
BEHAVIORAL	Positive Discipline Module	The PriCARE Positive Discipline Module is a pilot group caregiver training program designed to teach caregivers positive discipline techniques, including appropriate timeout procedures. The sessions are offered in the primary care setting or virtually. This training will supplement the content of the main PriCARE intervention and provide caregivers with skills for addressing difficult behaviors not reduced through positive attention and strategic ignoring. This module will be offered to a subset of CHOP participants who were randomized to the intervention arm, successfully completed the main study interviews, and attended at least 4 out of the 6 PriCARE sessions.

Timeline

• Start date: 2019-12-03
• Primary completion: 2022-06-22
• Completion: 2022-08-04
• First posted: 2019-10-01
• Last updated: 2023-03-20

Locations

2 sites across 1 country: United States