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Early Parenting Intervention Comparison (EPIC)

This study is currently recruiting participants.
Verified January 2012 by Johns Hopkins University
Sponsor:
Collaborators:
The Family Center at Kennedy Krieger Institute
University of Iowa
Information provided by (Responsible Party):
Deborah Gross, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01517867
First received: January 23, 2012
Last updated: January 24, 2012
Last verified: January 2012
History of Changes
  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 Phase
Behavior Problems, Child
 Behavioral: Chicago Parent Program
Behavioral: Parent-Child Interaction Therapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparing Two Parenting Programs for At-Risk Families

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • change in child behavior [ Time Frame: 4 months to 8 months ] [ Designated as safety issue: No ]
    parent-report measure called The Child Behavior Checklist


Estimated Enrollment: 264
Study Start Date: September 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: October 2015 (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

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517867

Contacts
Contact: Deborah Gross, DNSc 410-614-5311 debgross@jhu.edu

Locations
United States, Maryland
The Family Center at Kennedy Krieger Institute Recruiting
Baltimore, Maryland, United States, 21205
Contact: Mirian Ofonedu, PhD     443-923-5900     ofonedu@kennedykrieger.org    
Contact: Harolyn Belcher, MD     443-923-5875     belcher@kennedykrieger.org    
Principal Investigator: Harolyn Belcher, MD            
Sponsors and Collaborators
Johns Hopkins University
The Family Center at Kennedy Krieger Institute
University of Iowa
  More Information

No publications provided

Responsible Party: Deborah Gross, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01517867     History of Changes
Other Study ID Numbers: R01NR012444
Study First Received: January 23, 2012
Last Updated: January 24, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013