Clinical trial NCT02778022: Child Adult Relationship Enhancement in Pediatric Primary Care Parenting Group to Reduce Child Behavior Problems
Official title: Child Adult Relationship Enhancement in Pediatric Primary Care Parenting Group to Reduce Child Behavior Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior Disorders
Keywords: Child behavior disorders
Parent child relationship
Primary care
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Oscar G. & Elsa S. Mayer Family Foundation
name: The Pew Charitable Trusts
First posted: 2016-05-19
Enrollment: 199
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility 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 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)

Primary outcomes:
measure: Change in Eyberg Child Behavior Inventory (ECBI) score between baseline and time 3.
timeFrame: baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3)
Secondary outcomes:
measure: Change in Adult Adolescent Parenting Inventory-2 (AAPI-2) score between baseline and time 3
timeFrame: baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3)
measure: Change in Parenting Stress Index (PSI) score between baseline and time 3
timeFrame: baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3)
measure: 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.
timeFrame: 14-27 weeks (time 3)
measure: 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
timeFrame: 6-27 weeks
measure: Change in The Keys to Interactive Parenting Scale (KIPS) score between baseline and time 3
timeFrame: baseline (time 1) and 14-27 weeks (time 3)
Other outcomes:
measure: Description of study groups
timeFrame: baseline
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Joanne N Wood, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
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