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Early Parenting Intervention Comparison (EPIC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01517867
First Posted: January 25, 2012
Last Update Posted: October 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
University of Iowa
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
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.

Condition Intervention
Behavior Problems, Child Behavioral: Chicago Parent Program Behavioral: Parent-Child Interaction Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Two Parenting Programs for At-Risk Families

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Change in child behavior problems [ Time Frame: baseline, first follow-up (up to 2 years) ]
    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 [ Time Frame: baseline, end of study (up to 2 years) ]
    Combined provider (based on billing records) and parent cost (based on self-report).


Enrollment: 161
Actual Study Start Date: September 2011
Study Completion Date: September 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Chicago Parent Program arm
The Chicago Parent Program is a 12-session group-based parenting skills training program
Behavioral: Chicago Parent Program
The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems
Active Comparator: Parent-Child Interaction Therapy
Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems
Behavioral: Parent-Child Interaction Therapy
Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517867


Locations
United States, Maryland
The Family Center at Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
University of Iowa
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Deborah Gross, DNSc Johns Hopkins University, School of Nursing
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01517867     History of Changes
Other Study ID Numbers: NA_00039328
R01NR012444 ( U.S. NIH Grant/Contract )
First Submitted: January 23, 2012
First Posted: January 25, 2012
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data sharing plan was developed.

Keywords provided by Johns Hopkins University:
preschool children behavior problems
child between 2 and 5 years old

Additional relevant MeSH terms:
Problem Behavior
Behavioral Symptoms