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

NCT ID: NCT02778022

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-18

Study Completion Date

2018-11-04

Brief Summary

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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

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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).

Conditions

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Child Behavior Disorders

Keywords

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Child behavior disorders Parent child relationship Primary care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

PriCARE

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PriCARE

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Child Adult Relationship Enhancement in Pediatric Primary Care

Eligibility Criteria

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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)
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oscar G. & Elsa S. Mayer Family Foundation

UNKNOWN

Sponsor Role collaborator

The Pew Charitable Trusts

OTHER

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joanne N Wood, MD, MSHP

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25624375 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26289564 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12056110 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26259143 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21196418 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 9561935 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9669164 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9811126 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16406026 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND

Other Identifiers

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15-012604

Identifier Type: -

Identifier Source: org_study_id