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Completed

NCT Number: NCT02778022

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

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.

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Key information

Conditions

Child Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parent is 18 years or older
  • Parent is English speaking
  • Child is 2-6 years old
  • Parent reports that child has a behavior problem
  • Child attends CHOP Urban Primary Care Center 6) Parental/guardian permission is provided (informed consent)

Exclusion criteria

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

Treatment and study plan

PriCARE

Behavioral

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

Primary outcomes

  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 outcomes

  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 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

    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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Oscar G. & Elsa S. Mayer Family Foundation
  • The Pew Charitable Trusts

Registry information

Acronym: PriCARE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 19, 2016
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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