Back to resultsEarly Parenting Intervention Comparison (EPIC)
Primary Purpose
Behavior Problems, Child
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chicago Parent Program
Parent-Child Interaction Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Behavior Problems, Child focused on measuring preschool children behavior problems, child between 2 and 5 years old
Eligibility Criteria
Inclusion Criteria:
- child 2 to 5 years old
- parent reports reason for referral is child behavior problems
- parent is a biological or adoptive parent, or legal guardian of child
Exclusion Criteria:
- parent is psychotic or actively abusing substances
- child is autistic or severely developmentally delayed
Sites / Locations
- The Family Center at Kennedy Krieger Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Chicago Parent Program arm
Parent-Child Interaction Therapy
Arm Description
The Chicago Parent Program is a 12-session group-based parenting skills training program
Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems
Outcomes
Primary Outcome Measures
Change in Child Behavior Problems
parent-report measure called The Child Behavior Checklist. Raw scores range from 0 to 198 with lower numbers being better for the child.
Secondary Outcome Measures
Aggregate Cost
Combined provider (based on billing records) and parent cost (based on self-report).
Full Information
NCT ID
NCT01517867
First Posted
January 23, 2012
Last Updated
April 3, 2018
Sponsor
Johns Hopkins University
Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc., University of Iowa, National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT01517867
Brief Title
Early Parenting Intervention Comparison
Acronym
EPIC
Official Title
Comparing Two Parenting Programs for At-Risk Families
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc., University of Iowa, National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the effectiveness of two parenting programs in a mental health clinic serving young children with behavior problems.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior Problems, Child
Keywords
preschool children behavior problems, child between 2 and 5 years old
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
161 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Chicago Parent Program arm
Arm Type
Experimental
Arm Description
The Chicago Parent Program is a 12-session group-based parenting skills training program
Arm Title
Parent-Child Interaction Therapy
Arm Type
Active Comparator
Arm Description
Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems
Intervention Type
Behavioral
Intervention Name(s)
Chicago Parent Program
Intervention Description
The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems
Intervention Type
Behavioral
Intervention Name(s)
Parent-Child Interaction Therapy
Intervention Description
Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems
Primary Outcome Measure Information:
Title
Change in Child Behavior Problems
Description
parent-report measure called The Child Behavior Checklist. Raw scores range from 0 to 198 with lower numbers being better for the child.
Time Frame
baseline, first follow-up (up to 2 years)
Secondary Outcome Measure Information:
Title
Aggregate Cost
Description
Combined provider (based on billing records) and parent cost (based on self-report).
Time Frame
through end of study (up to 2 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
child 2 to 5 years old
parent reports reason for referral is child behavior problems
parent is a biological or adoptive parent, or legal guardian of child
Exclusion Criteria:
parent is psychotic or actively abusing substances
child is autistic or severely developmentally delayed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Gross, DNSc
Organizational Affiliation
Johns Hopkins University, School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Family Center at Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No data sharing plan was developed.
Citations:
PubMed Identifier
30768419
Citation
Gross D, Belcher HME, Budhathoki C, Ofonedu ME, Dutrow D, Uveges MK, Slade E. Reducing Preschool Behavior Problems in an Urban Mental Health Clinic: A Pragmatic, Non-Inferiority Trial. J Am Acad Child Adolesc Psychiatry. 2019 Jun;58(6):572-581.e1. doi: 10.1016/j.jaac.2018.08.013. Epub 2018 Nov 12.
Results Reference
derived
PubMed Identifier
24581245
Citation
Gross DA, Belcher HM, Ofonedu ME, Breitenstein S, Frick KD, Chakra B. Study protocol for a comparative effectiveness trial of two parent training programs in a fee-for-service mental health clinic: can we improve mental health services to low-income families? Trials. 2014 Mar 1;15:70. doi: 10.1186/1745-6215-15-70.
Results Reference
derived
Learn more about this trial
Early Parenting Intervention Comparison
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