Clinical Trial: Child Adult Relationship Enhancement in Pediatric Primary Care Parenting Group to Reduce Child Behavior Problems

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Child Adult Relationship Enhancement in Pediatric Primary Care Parenting Group to Reduce Child Behavior Problems

Brief Summary: The purpose of this study is to evaluate the effectiveness of PriCARE in decreasing child behavior problems and improving parenting capacity and skills at 2 primary care clinics in Philadelphia.

Detailed Summary: Child behavioral concerns are common among families served by The Children's Hospital of Philadelphia (CHOP) urban primary care centers. To address this, we developed Child Adult Relationship Enhancement Model in Primary Care Parenting Program (PriCARE), a scaled down version of Parent Child Interaction Therapy designed for urban primary care clinics. The objectives of this study are to 1) evaluate the efficacy of the modified PriCARE to decrease child behavior problems and improve parenting capacity and skills and 2) understand parents' perceptions of the efficacy of PriCARE and strategies for improving its implementation and dissemination. We will perform a randomized controlled trial (RCT) of the effectiveness of the modified PriCARE on decreasing child behavior problems and improving positive parenting among 2- to 6-year-old children with behavior problems and their parents at CHOP's South Philadelphia Primary Care Center and Karabots Pediatric Care Center. We intend to randomize 120 child-parent pairs (240 subjects) to receive PriCARE immediately plus usual treatment (intervention group) and 60 child-parent pairs (120 subjects) to receive PriCARE at a later time plus usual treatment (control group) for a total of 180 child-parent pairs (360 subjects). All child-parent pairs randomized to the control group will be placed on a waitlist and offered PriCARE after completion of data collection. Child behavior and parenting style will be measured at baseline (time 1), at 6-19 weeks (time 2), and at 14-27 weeks (time 3).
Sponsor: Children's Hospital of Philadelphia

Current Primary Outcome: Change in Eyberg Child Behavior Inventory (ECBI) score between baseline and time 3. [ Time Frame: baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3) ]

The primary objective of this study is to determine if the modified PriCARE program decreases the intensity and frequency of behavior problems in 2- to 6-year-old children as measured by the change in ECBI score after 3-7 months compared to usual treatment for child behavior problems at CHOP's South Philadelphia Primary Care Center or Karabots Pediatric Care Center. As sub-analyses, we will determine 1) the impact of caregiver depression (as measured by the Brief Symptom Inventory, BSI) on the efficacy of PriCARE intervention to decrease behavioral problems and 2) the impact of the number of PriCARE sessions attended on the efficacy of the PriCARE intervention to decrease behavioral problems.


Original Primary Outcome: Change in Eyberg Child Behavior Inventory (ECBI) score between baseline and time 3. [ Time Frame: baseline (time 1), 6-15 weeks (time 2), and 14-23 weeks (time 3) ]

The primary objective of this study is to determine if the modified PriCARE program decreases the intensity and frequency of behavior problems in 2- to 6-year-old children as measured by the change in ECBI score after 3-6 months compared to usual treatment for child behavior problems at CHOP's South Philadelphia Primary Care Center or Karabots Pediatric Care Center. As sub-analyses, we will determine 1) the impact of caregiver depression (as measured by the Brief Symptom Inventory, BSI) on the efficacy of PriCARE intervention to decrease behavioral problems and 2) the impact of the number of PriCARE sessions attended on the efficacy of the PriCARE intervention to decrease behavioral problems.


Current Secondary Outcome:

  • Change in Adult Adolescent Parenting Inventory-2 (AAPI-2) score between baseline and time 3 [ Time Frame: baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3) ]
    We will assess the efficacy of the modified PriCARE on decreasing harsh parenting as measured by the AAPI-2.
  • Change in Parenting Stress Index (PSI) score between baseline and time 3 [ Time Frame: baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3) ]
    We will assess the efficacy of the modified PriCARE on decreasing parenting stress as measured by the PSI.
  • Association between the Therapeutic Attitude Inventory (TAI) score and the change in ECBI score from baseline to time 2 and 3 in the immediate PriCARE group. [ Time Frame: 14-27 weeks (time 3) ]
    We will assess parents' perceptions of the efficacy of the modified PriCARE on improving parenting skills and child behavior as measured by the TAI.
  • Conceptual model of facilitators and barriers to participation in behavioral interventions in primary care as well as the strengths and weaknesses of the PriCARE program [ Time Frame: 6-27 weeks ]
    We will conduct a qualitative interview with up to 20 parents randomized to the immediate PriCARE group to gain an understanding of how implementation and dissemination of the modified PriCARE can be improved in order to increase attendance and maximize effectiveness.
  • Change in The Keys to Interactive Parenting Scale (KIPS) score between baseline and time 3 [ Time Frame: baseline (time 1) and 14-27 weeks (time 3) ]
    As an exploratory aim, we will pilot the use of a video observation measure of parent-child interaction (KIPS) in assessing the impact of PriCARE on parenting behaviors with a subset of subjects.


Original Secondary Outcome:

  • Change in Adult Adolescent Parenting Inventory-2 (AAPI-2) score between baseline and time 3 [ Time Frame: baseline (time 1), 6-15 weeks (time 2), and 14-23 weeks (time 3) ]
    We will assess the efficacy of the modified PriCARE on decreasing harsh parenting as measured by the AAPI-2.
  • Change in Parenting Stress Index (PSI) score between baseline and time 3 [ Time Frame: baseline (time 1), 6-15 weeks (time 2), and 14-23 weeks (time 3) ]
    We will assess the efficacy of the modified PriCARE on decreasing parenting stress as measured by the PSI.
  • Association between the Therapeutic Attitude Inventory (TAI) score and the change in ECBI score from baseline to time 2 and 3 in the immediate PriCARE group. [ Time Frame: 14-23 weeks (time 3) ]
    We will assess parents' perceptions of the efficacy of the modified PriCARE on improving parenting skills and child behavior as measured by the TAI.
  • Conceptual model of facilitators and barriers to participation in behavioral interventions in primary care as well as the strengths and weaknesses of the PriCARE program [ Time Frame: 6-23 weeks ]
    We will conduct a qualitative interview with up to 20 parents randomized to the immediate PriCARE group to gain an understanding of how implementation and dissemination of the modified PriCARE can be improved in order to increase attendance and maximize effectiveness.
  • Change in The Keys to Interactive Parenting Scale (KIPS) score between baseline and time 3 [ Time Frame: baseline (time 1) and 14-23 weeks (time 3) ]
    As an exploratory aim, we will pilot the use of a video observation measure of parent-child interaction (KIPS) in assessing the impact of PriCARE on parenting behaviors with a subset of subjects.


Information By: Children's Hospital of Philadelphia

Dates:
Date Received: May 17, 2016
Date Started: May 2016
Date Completion: December 2018
Last Updated: November 18, 2016
Last Verified: November 2016