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

Primary Purpose

Child Behavior Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PriCARE
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child Behavior Disorders focused on measuring Child behavior disorders, Parent child relationship, Primary care

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • The Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immediate PriCARE

Delayed PriCARE

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in Eyberg Child Behavior Inventory (ECBI) score between baseline and 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

Change in Adult Adolescent Parenting Inventory-2 (AAPI-2) score between baseline and time 3
We will assess the efficacy of the modified PriCARE on decreasing harsh parenting as measured by the AAPI-2.
Change in Parenting Stress Index (PSI) score between baseline and time 3
We will assess the efficacy of the modified PriCARE on decreasing parenting stress as measured by the PSI.
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.
We will assess parents' perceptions of the efficacy of the modified PriCARE on improving parenting skills and child behavior as measured by the TAI.
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
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.
Change in The Keys to Interactive Parenting Scale (KIPS) score between baseline and 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.

Full Information

First Posted
May 17, 2016
Last Updated
December 20, 2018
Sponsor
Children's Hospital of Philadelphia
Collaborators
Oscar G. & Elsa S. Mayer Family Foundation, The Pew Charitable Trusts
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1. Study Identification

Unique Protocol Identification Number
NCT02778022
Brief Title
Child Adult Relationship Enhancement in Pediatric Primary Care Parenting Group to Reduce Child Behavior Problems
Acronym
PriCARE
Official Title
Child Adult Relationship Enhancement in Pediatric Primary Care Parenting Group to Reduce Child Behavior Problems
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 18, 2016 (Actual)
Primary Completion Date
November 4, 2018 (Actual)
Study Completion Date
November 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
Oscar G. & Elsa S. Mayer Family Foundation, The Pew Charitable Trusts

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Behavior Disorders
Keywords
Child behavior disorders, Parent child relationship, Primary care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate PriCARE
Arm Type
Experimental
Arm 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.
Arm Title
Delayed PriCARE
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
PriCARE
Other Intervention Name(s)
Child Adult Relationship Enhancement in Pediatric Primary Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Eyberg Child Behavior Inventory (ECBI) score between baseline and time 3.
Description
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.
Time Frame
baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3)
Secondary Outcome Measure Information:
Title
Change in Adult Adolescent Parenting Inventory-2 (AAPI-2) score between baseline and time 3
Description
We will assess the efficacy of the modified PriCARE on decreasing harsh parenting as measured by the AAPI-2.
Time Frame
baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3)
Title
Change in Parenting Stress Index (PSI) score between baseline and time 3
Description
We will assess the efficacy of the modified PriCARE on decreasing parenting stress as measured by the PSI.
Time Frame
baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3)
Title
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.
Description
We will assess parents' perceptions of the efficacy of the modified PriCARE on improving parenting skills and child behavior as measured by the TAI.
Time Frame
14-27 weeks (time 3)
Title
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
Description
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.
Time Frame
6-27 weeks
Title
Change in The Keys to Interactive Parenting Scale (KIPS) score between baseline and time 3
Description
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.
Time Frame
baseline (time 1) and 14-27 weeks (time 3)
Other Pre-specified Outcome Measures:
Title
Description of study groups
Description
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.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne N Wood, MD, MSHP
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25624375
Citation
Weitzman C, Wegner L; Section on Developmental and Behavioral Pediatrics; Committee on Psychosocial Aspects of Child and Family Health; Council on Early Childhood; Society for Developmental and Behavioral Pediatrics; American Academy of Pediatrics. Promoting optimal development: screening for behavioral and emotional problems. Pediatrics. 2015 Feb;135(2):384-95. doi: 10.1542/peds.2014-3716. Erratum In: Pediatrics. 2015 May;135(5):946.
Results Reference
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PubMed Identifier
26289564
Citation
Bultas MW, McMillin SE, Broom MA, Zand DH. Brief, Rapid Response, Parenting Interventions Within Primary Care Settings. J Behav Health Serv Res. 2017 Oct;44(4):695-699. doi: 10.1007/s11414-015-9479-2.
Results Reference
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PubMed Identifier
12056110
Citation
Querido JG, Warner TD, Eyberg SM. Parenting styles and child behavior in African American families of preschool children. J Clin Child Adolesc Psychol. 2002 Jun;31(2):272-7. doi: 10.1207/S15374424JCCP3102_12.
Results Reference
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PubMed Identifier
26259143
Citation
Asarnow JR, Rozenman M, Wiblin J, Zeltzer L. Integrated Medical-Behavioral Care Compared With Usual Primary Care for Child and Adolescent Behavioral Health: A Meta-analysis. JAMA Pediatr. 2015 Oct;169(10):929-37. doi: 10.1001/jamapediatrics.2015.1141.
Results Reference
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PubMed Identifier
21196418
Citation
Meadows T, Valleley R, Haack MK, Thorson R, Evans J. Physician "costs" in providing behavioral health in primary care. Clin Pediatr (Phila). 2011 May;50(5):447-55. doi: 10.1177/0009922810390676. Epub 2010 Dec 30.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
9561935
Citation
Schuhmann EM, Foote RC, Eyberg SM, Boggs SR, Algina J. Efficacy of parent-child interaction therapy: interim report of a randomized trial with short-term maintenance. J Clin Child Psychol. 1998 Mar;27(1):34-45. doi: 10.1207/s15374424jccp2701_4.
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PubMed Identifier
9669164
Citation
Sherin KM, Sinacore JM, Li XQ, Zitter RE, Shakil A. HITS: a short domestic violence screening tool for use in a family practice setting. Fam Med. 1998 Jul-Aug;30(7):508-12.
Results Reference
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PubMed Identifier
9811126
Citation
Morlan KK, Tan SY. Comparison of the Brief Psychiatric Rating Scale and the Brief Symptom Inventory. J Clin Psychol. 1998 Nov;54(7):885-94. doi: 10.1002/(sici)1097-4679(199811)54:73.0.co;2-e.
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Citation
Conners NA, Whiteside-Mansell L, Deere D, Ledet T, Edwards MC. Measuring the potential for child maltreatment: the reliability and validity of the Adult Adolescent Parenting Inventory--2. Child Abuse Negl. 2006 Jan;30(1):39-53. doi: 10.1016/j.chiabu.2005.08.011. Epub 2006 Jan 6.
Results Reference
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Citation
Eyberg SM, Ross AW. Assessment of Child Behavior Problems: The Validation of a New Inventory. J Clin Child Psycho. 1978.
Results Reference
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Abidin RR. Parenting Stress Index. 4th ed. Lutz, FL: PAR; 2012.
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Child Adult Relationship Enhancement in Pediatric Primary Care Parenting Group to Reduce Child Behavior Problems

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