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

NCT02778022 | Completed

• 1 other identifier: 15-012604
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Behavior Disorders

Keywords

Child behavior disorders; Parent child relationship; Primary care

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3)

Secondary Outcomes (5)

• Change in Adult Adolescent Parenting Inventory-2 (AAPI-2) score between baseline and time 3

  baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3)

• Change in Parenting Stress Index (PSI) score between baseline and time 3

  baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 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.

  14-27 weeks (time 3)

• 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

  6-27 weeks

• Change in The Keys to Interactive Parenting Scale (KIPS) score between baseline and time 3

  baseline (time 1) and 14-27 weeks (time 3)

Other Outcomes (1)

• Description of study groups

  baseline

Study Arms (2)

Immediate PriCARE

EXPERIMENTAL

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.

Behavioral: PriCARE

Delayed PriCARE

NO INTERVENTION

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.

Interventions

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.

Also known as: Child Adult Relationship Enhancement in Pediatric Primary Care

Immediate PriCARE

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Oscar G. & Elsa S. Mayer Family Foundation: collaborator
• The Pew Charitable Trusts: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (14)

• 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.

  PMID: 25624375 BACKGROUND

• 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.

  PMID: 26289564 BACKGROUND

• 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.

  PMID: 12056110 BACKGROUND

• 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.

  PMID: 26259143 BACKGROUND

• 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.

  PMID: 21196418 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 9561935 BACKGROUND

• 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.

  PMID: 9669164 BACKGROUND

• 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.

  PMID: 9811126 BACKGROUND

• 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.

  PMID: 16406026 BACKGROUND

• Eyberg SM, Ross AW. Assessment of Child Behavior Problems: The Validation of a New Inventory. J Clin Child Psycho. 1978.

  BACKGROUND

• Abidin RR. Parenting Stress Index. 4th ed. Lutz, FL: PAR; 2012.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Child Behavior Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Joanne N Wood, MD, MSHP

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 19, 2016
• Study Start: July 18, 2016
• Primary Completion: November 4, 2018
• Study Completion: November 4, 2018
• Last Updated: December 24, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)