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

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Child Behavior Disorders

Treatments: Behavioral: PriCARE

Study type: Interventional

Funder types: Other

Identifiers

NCT02778022

15-012604

Details and patient eligibility

About

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.

Full 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).

Enrollment: 199 patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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199 participants in 2 patient groups

Immediate PriCARE

Experimental group

Description:

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.

Treatment:

Behavioral: PriCARE

Delayed PriCARE

No Intervention group

Description:

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.