- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02778022
Child Adult Relationship Enhancement in Pediatric Primary Care Parenting Group to Reduce Child Behavior Problems (PriCARE)
December 20, 2018 updated by: Children's Hospital of Philadelphia
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
199
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- The Children's Hospital of Philadelphia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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:
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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We will assess the efficacy of the modified PriCARE on decreasing harsh parenting as measured by the AAPI-2.
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baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3)
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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)
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We will assess the efficacy of the modified PriCARE on decreasing parenting stress as measured by the PSI.
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baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3)
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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)
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We will assess parents' perceptions of the efficacy of the modified PriCARE on improving parenting skills and child behavior as measured by the TAI.
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14-27 weeks (time 3)
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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
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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.
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6-27 weeks
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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)
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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.
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baseline (time 1) and 14-27 weeks (time 3)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Description of study groups
Time Frame: baseline
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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.
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baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Joanne N Wood, MD, MSHP, Children's Hospital of Philadelphia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Eyberg SM, Ross AW. Assessment of Child Behavior Problems: The Validation of a New Inventory. J Clin Child Psycho. 1978.
- Abidin RR. Parenting Stress Index. 4th ed. Lutz, FL: PAR; 2012.
- Brestan EV JJ, Rayfield AD, Eybert SM. A consumer satisfaction measure for parent-child treatments and its relation to measures of child behavior change. Behavior Therapy. 1999;30:17-30.
- Comfort M, Gordon PR. The Keys to Interactive Parenting Scale (KIPS): A practical observational assessment of parenting behavior. NHSA Dialog: A Research-To-Practice Journal for the Early Intervention Field. Vol 9(1). Alexandria, VA: National Head Start Association Research and Evaluation Department; 2006:22-48.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 18, 2016
Primary Completion (Actual)
November 4, 2018
Study Completion (Actual)
November 4, 2018
Study Registration Dates
First Submitted
May 17, 2016
First Submitted That Met QC Criteria
May 17, 2016
First Posted (Estimate)
May 19, 2016
Study Record Updates
Last Update Posted (Actual)
December 24, 2018
Last Update Submitted That Met QC Criteria
December 20, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-012604
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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