This trial is active, not recruiting.

Condition child behavior problems
Treatment immediate care
Sponsor Children's Hospital of Philadelphia
Collaborator University of Pennsylvania
Start date May 2014
End date June 2016
Trial size 160 participants
Trial identifier NCT02049749, IRB 13-010728


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
(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.
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.
immediate care Child Adult Relationship Enhancement (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.

Primary Outcomes

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

Secondary Outcomes

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
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

Eligibility Criteria

Male or female participants at least 2 years old.

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)

Additional Information

Official title Improving Child Behavior Problems in the Primary Care Setting
Principal investigator Joanne N Wood, MD, MSHP
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Children's Hospital of Philadelphia.