Parent Program to Improve Child Behavior Problems

NCT02049749 | Completed Results

• 1 other identifier: 13-010728
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Child Behavior Problems

Keywords

Child Behavior Problems; Parent Training Program

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes From Baseline in Parental Disciplinary Practices Assessed at Different Time Points (Baseline up to 18 Weeks)

  Mean change in scores from baseline to 14-18 weeks. Increases in scores indicate decreased risk for abuse and better outcomes.

Study Arms (2)

Delayed CARE

NO INTERVENTION

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.

Immediate CARE

EXPERIMENTAL

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

Interventions

Immediate CARE BEHAVIORAL

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.

Also known as: Child Adult Relationship Enhancement (CARE)

Immediate CARE

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator

Study Sites (1)

CHOP Primary Care, South Philadelphia

Philadelphia, Pennsylvania, 19145, United States

Location

Results Point of Contact

• Title: Dr. Joanne Wood, PI
• Organization: Children's Hospital of Philadelphia

woodjo@email.chop.edu

267-426-3107

Study Officials

• Joanne N Wood, MD, MSHP

  CHOP

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: January 30, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 12, 2019
• Results First Posted: April 12, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)