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

Sponsor
Children's Hospital of Philadelphia (Other)
Overall Status
Completed
CT.gov ID
NCT02778022
Collaborator
Oscar G. & Elsa S. Mayer Family Foundation (Other), The Pew Charitable Trusts (Other)
199
1
2
27.6
7.2

Study Details

Study Description

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 4 primary care clinics in Philadelphia.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PriCARE
N/A

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 urban Primary Care Centers. 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 Design

Study Type:
Interventional
Actual Enrollment :
199 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
The study team member who will administer the follow-up study interviews will remain blinded to the group status throughout the duration of the study.
Primary Purpose:
Treatment
Official Title:
Child Adult Relationship Enhancement in Pediatric Primary Care Parenting Group to Reduce Child Behavior Problems
Actual Study Start Date :
Jul 18, 2016
Actual Primary Completion Date :
Nov 4, 2018
Actual Study Completion Date :
Nov 4, 2018

Arms and Interventions

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 approximately 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 Names:
  • Child Adult Relationship Enhancement in Pediatric Primary Care
  • No Intervention: Delayed PriCARE

    The delayed PriCARE group will not receive the PriCARE intervention until after their 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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in Eyberg Child Behavior Inventory (ECBI) score between baseline and time 3. [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 [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 [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. [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 [6-27 weeks]

      We will conduct a qualitative interview with up to 30 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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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 Urban Primary Care Center 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • Children's Hospital of Philadelphia
    • Oscar G. & Elsa S. Mayer Family Foundation
    • The Pew Charitable Trusts

    Investigators

    • Principal Investigator: Joanne N Wood, MD, MSHP, Children's Hospital of Philadelphia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Children's Hospital of Philadelphia
    ClinicalTrials.gov Identifier:
    NCT02778022
    Other Study ID Numbers:
    • 15-012604
    First Posted:
    May 19, 2016
    Last Update Posted:
    Dec 24, 2018
    Last Verified:
    Dec 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Children's Hospital of Philadelphia
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 24, 2018