Clinical Trial: Parent Program to Improve Child Behavior Problems

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Improving Child Behavior Problems in the Primary Care Setting

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.

Detailed Summary:

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.

Sponsor: Children's Hospital of Philadelphia

Current Primary Outcome: Change from baseline in the Eyberg Child Behavior Inventory (ECBI) score at different time points (baseline up to 18 weeks) [ Time Frame: Baseline, 6-8 weeks and 14-18 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. 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes from baseline in parental disciplinary practices assessed at different time points (baseline up to 18 weeks) [ Time Frame: Baseline, 6-8 weeks and 14-18 weeks ]
    Investigators want to determine the effect of the CARE intervention on diminishing harsh parenting as measured by the Conflict Tactics Scales, Parent-Child version (CTSPC). Investigators will look at the CTSPC change score (time 3-time 1). The three core scales of the CTSPC measure non-violent discipline, psychological aggression, and physical assault. The supplemental scales measure weekly discipline, neglect, and sexual abuse. Reliability measures demonstrate strong internal consistency and test-retest reliability of the CTSPC.
  • Change from baseline in parent satisfaction of the program assessed at different time points (6 weeks up to 18 weeks) [ Time Frame: 6-8 weeks and 14-18 weeks ]
    Investigators would also like to determine whether there is an association between parent perception of CARE training efficacy on improving child behavior (measured by the Therapy Attitude Inventory, TAI) and the change in ECBI score for subjects randomized to the intervention. The TAI is a brief satisfaction measure of parent training and parent-child treatments. Psychometric evaluation of the TAI has demonstrated excellent internal consistency and test-retest reliability, and moderate correlation between TAI scores and pre to post treatment difference scores on the ECBI.


Original Secondary Outcome: Same as current

Information By: Children's Hospital of Philadelphia

Dates:
Date Received: January 28, 2014
Date Started: May 2014
Date Completion: February 2017
Last Updated: September 19, 2016
Last Verified: September 2016