ClinicalTrials.gov
ClinicalTrials.gov Menu

Child Adult Relationship Enhancement in Pediatric Primary Care Parenting Group to Reduce Child Behavior Problems (PriCARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02778022
Recruitment Status : Recruiting
First Posted : May 19, 2016
Last Update Posted : November 30, 2017
Sponsor:
Collaborator:
Oscar G. & Elsa S. Mayer Family Foundation
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Child Behavior Disorders Behavioral: PriCARE Not Applicable

Detailed Description:
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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Child Adult Relationship Enhancement in Pediatric Primary Care Parenting Group to Reduce Child Behavior Problems
Study Start Date : May 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
Experimental: Immediate PriCARE
Parent-child dyads assigned to the immediate PriCARE group will receive the PriCARE intervention as soon as possible plus usual treatment. The intervention will last approximately 6-8 weeks. Each group will have 4-13 participants and 2 facilitators and will meet 6 times for 1-2 hours per session. Parents are expected to practice the skills they learn with their children between sessions.
Behavioral: PriCARE
PriCARE is a group parent training program designed to improve child behavior, improve parent-child relationships, and decrease stress for parents. PriCARE utilizes the 3 P skills (Praise, Paraphrase and Point-out-Behavior) and includes a trauma and stress education component. The training starts with parenting skills focused on giving attention to children's positive, pro-social behaviors, while ignoring minor misbehaviors. The second phase of the training teaches techniques for giving children effective commands in order to set age-appropriate limits. We piloted PriCARE and demonstrated promising findings. The PriCARE intervention has been slightly modified from the pilot version to increase engagement and attendance.
Other Name: Child Adult Relationship Enhancement in Pediatric Primary Care

No Intervention: Delayed PriCARE
The delayed PriCARE group will not receive the PriCARE intervention until data collection for this study is complete (in 3-6 months). In addition, they will be immediately offered usual treatment. Under usual treatment, patients will be referred to a behavioral health specialist at the discretion of their pediatrician and the office social worker for additional diagnosis and treatment and/or provided with a 1-2 page informational handout on child behavior problems from the CHOP patient care manual.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  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.

  3. 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.

  4. 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.

  5. 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.


Other Outcome Measures:
  1. Description of study groups [ Time Frame: baseline ]
    Demographics and baseline measures of child behavior (ECBI), parent intimate partner violence (HITS), and parent depression (BSI) for the intervention and control groups will be examined to ensure randomization resulted in comparable populations.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Parent is 18 years or older
  2. Parent is English speaking
  3. Child is 2-6 years old
  4. Parent reports that child has a behavior problem
  5. Child attends CHOP's South Philadelphia Primary Care Center or Karabots Pediatric Care Center for primary care
  6. Parental/guardian permission is provided (informed consent)

Exclusion Criteria:

  1. Child has a cognitive age less than 2 years old as determined by the referring clinician
  2. Child is already receiving behavioral health therapy or medication (other than medication for ADHD)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02778022


Contacts
Contact: Joanne N Wood, MD, MSHP 267-426-3107 woodjo@email.chop.edu
Contact: Christine W Paine, MPH 267-426-0369 painec@email.chop.edu

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Joanne N Wood, MD, MSHP    267-426-3107    woodjo@email.chop.edu   
Contact: Christine W Paine, MPH    267-426-0369    painec@email.chop.edu   
Sub-Investigator: Philip V Scribano, DO, MSCE         
Sub-Investigator: Steven Berkowitz, MD         
Sponsors and Collaborators
Children's Hospital of Philadelphia
Oscar G. & Elsa S. Mayer Family Foundation
Investigators
Principal Investigator: Joanne N Wood, MD, MSHP Children's Hospital of Philadelphia

Publications:
Ward-Zimmerman B, Cannata E. Partnering with pediatric primary care: Lessons learned through collaborative colocation. Professional Psychology: Research and Practice. 2012;43(6):596-605.
Eyberg SM, Ross AW. Assessment of Child Behavior Problems: The Validation of a New Inventory. J Clin Child Psycho. 1978.
Abidin RR. Parenting Stress Index. 4th ed. Lutz, FL: PAR; 2012.
Brestan EV JJ, Rayfield AD, Eybert SM. A consumer satisfaction measure for parent-child treatments and its relation to measures of child behavior change. Behavior Therapy. 1999;30:17-30.
Comfort M, Gordon PR. The Keys to Interactive Parenting Scale (KIPS): A practical observational assessment of parenting behavior. NHSA Dialog: A Research-To-Practice Journal for the Early Intervention Field. Vol 9(1). Alexandria, VA: National Head Start Association Research and Evaluation Department; 2006:22-48.

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02778022     History of Changes
Other Study ID Numbers: 15-012604
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Children's Hospital of Philadelphia:
Child behavior disorders
Parent child relationship
Primary care

Additional relevant MeSH terms:
Mental Disorders
Problem Behavior
Child Behavior Disorders
Behavioral Symptoms
Neurodevelopmental Disorders