Parent Program to Improve Child Behavior Problems

Improving Child Behavior Problems in the Primary Care Setting

The purpose of this research study is to learn whether or not a brief parenting program called Child Adult Relationship Enhancement (CARE) offered at a primary care office can help improve behavior problems in children who are 2-6 years old.

Study Overview

• Status: Completed
• Conditions: Child Behavior Problems
• Intervention / Treatment: Behavioral: Immediate CARE

Detailed Description

The study will be a randomized controlled trial (RCT) of the CARE intervention. The study will include 2-6 year old children who receive their primary care at the Children's Hospital of Philadelphia, South Philadelphia Primary Care clinic and whose caregiver and/or doctor has concern about a behavior problem in the child. The caregivers will also be subjects in the study.

Child-caregiver pairs who agree to be in the study will be randomly assigned to receive the CARE training immediately or in 3-4 months.

The CARE intervention will last 6 weeks and child behavior and parenting will be measured at baseline, 6-8 weeks, and 14-18 weeks. Investigators will also measure parent satisfaction with the CARE intervention.

• Child Adult Relationship Enhancement (CARE) is a group parent training program.
• The goals of the program are to teach parents skills that help their children successfully reach developmental milestones while increasing positive behaviors.
• The program also was designed to help parents manage and decrease negative child behaviors.
• Each training will be led by 2 therapists and 4-10 parents will attend the CARE program together.
• Children do not attend the training but parents are encouraged to practice the skills learned at CARE between the sessions.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19145
      • CHOP Primary Care, South Philadelphia

Participation Criteria

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:

1. Caregiver is 18 years or older
2. Caregiver is English speaking
3. Child is 2-6 years old
4. Caregiver reports that child has a behavior problem
5. Child attends CHOP South Philadelphia Primary Care for primary care
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 Attention Deficit Hyperactivity Disorder)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Delayed CARE; 40 child-caregiver pairs will be randomized to usual treatment plus delayed CARE (control). 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. Following the final interview (3-4 months after enrollment for each subject) all participants randomized to the control arm (usual treatment plus delayed CARE) will receive the CARE training, if desired.
Experimental: Immediate CARE; 40 child-caregiver pairs will be randomized to usual treatment plus immediate CARE. The trainings are administered to groups of 4-10 caregivers at a time and are led by two mental health providers trained in the CARE curriculum. The children do not attend the training; however, caregivers are expected to practice the skills that they learn in CARE with their child between sessions. The curriculum involves 6 sessions over 6-8 weeks. Each session will be 1-2 hours.	Behavioral: Immediate CARE; CARE is a group parent training informed by the principles of Parent Child Interaction Therapy and was developed by Trauma Treatment Training Center and CHOP Policy Lab. CARE has been used in many populations including residential treatment center/domestic violence shelter staff, daycare providers, graduate students, biological parents, and foster parents/caseworkers. Goals are to decrease stress for caregivers, improve child behavior, and enhance the caregiver-child relationship, family stability, and wellness. The training teaches parents to follow a child's lead thus building a connection and promoting positive behaviors. The focus is on giving attention to child's pro-social behavior and ignoring minor misbehavior. The second phase teaches techniques for giving effective commands.; Other Names: Child Adult Relationship Enhancement (CARE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Eyberg Child Behavior Inventory (ECBI) Score at Different Time Points (Baseline up to 18 Weeks)	Behavior will be measured by the Eyberg Child Behavior Inventory (ECBI). The primary outcome is the ECBI change score (time 3-time1). The ECBI is a parent rating scale designed to measure conduct problem behaviors in children ages 2-16 years. The instrument contains 36 items that assess behavior on two scales. The problem scale provides a yes/no problem identification rating for each item, and the sum of yes responses yields a problem score with a potential range from 0 to 36 with a clinical cutoff of 15. The intensity scale provides a frequency-of-occurrence rating for each item, ranging from never (1) to always (7) and the ratings are summed to yield an intensity score with a potential range from 36 to 252 with a clinical cutoff of 131. Higher scores indicate worse outcomes. The ECBI has demonstrated strong internal consistency, test-retest reliability, and discriminant validity and has been shown to be a sensitive indicator of intervention efficacy for child behavior problems.	Mean Change in ECBI Scores from Baseline to 14-18 weeks. Decreases in ECBI scores reflect improvements in behavior.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes From Baseline in Parental Disciplinary Practices Assessed at Different Time Points (Baseline up to 18 Weeks)	Investigators want to determine the effect of the CARE intervention on diminishing harsh parenting as measured by the Adult Adolescent Parenting Inventory-2. The Adult Adolescent Parenting Inventory-2 (AAPI-2) is a 40 item parent-report measure that assesses parenting attitudes along 5 dimensions: inappropriate expectations of children, parental lack of empathy towards children's needs, strong belief in the use of corporal punishment as a means of discipline, reversing parent-child role responsibilities, and oppressing children's power and independence. Parents respond to each item on a five point Likert Scale of Strongly Agree, Agree, Disagree, Strongly Disagree and Uncertain. This measure yields a score of 1-10 for each construct. Higher scores indicate lower risk parenting.	Mean change in scores from baseline to 14-18 weeks. Increases in scores indicate decreased risk for abuse and better outcomes.

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: University of Pennsylvania
• Investigators: Principal Investigator: Joanne N Wood, MD, MSHP, CHOP

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 28, 2014
• First Submitted That Met QC Criteria: January 28, 2014
• First Posted (Estimate): January 30, 2014

Study Record Updates

• Last Update Posted (Actual): April 12, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Child Behavior Problems; Parent Training Program
• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior
• Other Study ID Numbers: 13-010728

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