Early Parenting Intervention Comparison (EPIC)

April 3, 2018 updated by: Johns Hopkins University

Comparing Two Parenting Programs for At-Risk Families

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • The Family Center at Kennedy Krieger Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, first follow-up (up to 2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
through end of study (up to 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute of Nursing Research (NINR)
University of Iowa
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Investigators

  • Principal Investigator: Deborah Gross, DNSc, Johns Hopkins university, School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2011

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

January 23, 2012

First Submitted That Met QC Criteria

January 24, 2012

First Posted (Estimate)

January 25, 2012

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00039328
  • R01NR012444 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No data sharing plan was developed.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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