Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Parenting Intervention Comparison (EPIC)

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.
 
ClinicalTrials.gov Identifier: NCT01517867
Recruitment Status : Completed
First Posted : January 25, 2012
Results First Posted : April 2, 2018
Last Update Posted : May 3, 2018
Sponsor:
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Behavior Problems, Child Behavioral: Chicago Parent Program Behavioral: Parent-Child Interaction Therapy Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Two Parenting Programs for At-Risk Families
Actual Study Start Date : September 2011
Actual Primary Completion Date : February 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. Aggregate Cost [ Time Frame: through end of study (up to 2 years) ]
    Combined provider (based on billing records) and parent cost (based on self-report).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Deborah Gross, DNSc Johns Hopkins University, School of Nursing
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
Study Protocol and Statistical Analysis Plan  [PDF] January 30, 2012

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01517867    
Other Study ID Numbers: NA_00039328
R01NR012444 ( U.S. NIH Grant/Contract )
First Posted: January 25, 2012    Key Record Dates
Results First Posted: April 2, 2018
Last Update Posted: May 3, 2018
Last Verified: April 2018
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:
Layout table for MeSH terms
Problem Behavior
Behavioral Symptoms