Clinical trial NCT02049749: Parent Program to Improve Child Behavior Problems
Official title: Improving Child Behavior Problems in the Primary Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior Problems
Keywords: Child Behavior Problems
Parent Training Program
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2014-01-30
Enrollment: 240
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline in the Eyberg Child Behavior Inventory (ECBI) Score at Different Time Points (Baseline up to 18 Weeks)
timeFrame: Mean Change in ECBI Scores from Baseline to 14-18 weeks. Decreases in ECBI scores reflect improvements in behavior.
Secondary outcomes:
measure: Changes From Baseline in Parental Disciplinary Practices Assessed at Different Time Points (Baseline up to 18 Weeks)
timeFrame: Mean change in scores from baseline to 14-18 weeks. Increases in scores indicate decreased risk for abuse and better outcomes.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: CHOP Primary Care, South Philadelphia
state: Pennsylvania
Study officials:
affiliation: CHOP
name: Joanne N Wood, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
References: