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Early Parenting Intervention Comparison (EPIC)

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ClinicalTrials.gov Identifier: NCT01517867
Recruitment Status : Completed
First Posted : January 25, 2012
Results First Posted : April 2, 2018
Last Update Posted : April 2, 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 Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Behavior Problems, Child
Interventions: Behavioral: Chicago Parent Program
Behavioral: Parent-Child Interaction Therapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intervention Chicago Parent Program Arm

The Chicago Parent Program is a 12-session group-based parenting skills training program

Chicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems

Parent-Child Interaction Therapy

Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems

Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems


Participant Flow:   Overall Study
    Intervention Chicago Parent Program Arm   Parent-Child Interaction Therapy
STARTED   81   80 
COMPLETED   18   15 
NOT COMPLETED   63   65 
never started treatment                29                32 
Withdrawal by Subject                34                30 
Still in treatment at study end                0                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intervention Chicago Parent Program Arm

The Chicago Parent Program is a 12-session group-based parenting skills training program

Chicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems

Parent-Child Interaction Therapy

Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems

Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems

Total Total of all reporting groups

Baseline Measures
   Intervention Chicago Parent Program Arm   Parent-Child Interaction Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 81   80   161 
Age 
[Units: Years]
Mean (Full Range)
 33.0 
 (22 to 69) 
 34.5 
 (22 to 71) 
 33.76 
 (22 to 71) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      73  90.1%      75  93.8%      148  91.9% 
Male      8   9.9%      5   6.3%      13   8.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      5   6.2%      2   2.5%      7   4.3% 
Not Hispanic or Latino      76  93.8%      78  97.5%      154  95.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   1.2%      0   0.0%      1   0.6% 
Asian      0   0.0%      1   1.3%      1   0.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      55  67.9%      59  73.8%      114  70.8% 
White      16  19.8%      18  22.5%      34  21.1% 
More than one race      9  11.1%      2   2.5%      11   6.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   81   80   161 


  Outcome Measures

1.  Primary:   Change in Child Behavior Problems   [ Time Frame: baseline, first follow-up (up to 2 years) ]

2.  Secondary:   Aggregate Cost   [ Time Frame: through end of study (up to 2 years) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Deborah Gross
Organization: Johns Hopkins University
phone: 410-614-5311
e-mail: debgross@jhu.edu


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
Results First Submitted: February 27, 2018
Results First Posted: April 2, 2018
Last Update Posted: April 2, 2018