Early Parenting Intervention Comparison (EPIC)
This study is currently recruiting participants.
Verified January 2012 by Johns Hopkins University
Sponsor:
Johns Hopkins University
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
| Tracking Information | |||||
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| First Received Date ICMJE | January 23, 2012 | ||||
| Last Updated Date | January 24, 2012 | ||||
| Start Date ICMJE | September 2011 | ||||
| Estimated Primary Completion Date | October 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
change in child behavior [ Time Frame: 4 months to 8 months ] [ Designated as safety issue: No ] parent-report measure called The Child Behavior Checklist |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01517867 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Early Parenting Intervention Comparison | ||||
| Official Title ICMJE | Comparing Two Parenting Programs for At-Risk Families | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Behavior Problems, Child | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 264 | ||||
| Estimated Completion Date | June 2016 | ||||
| Estimated Primary Completion Date | October 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 2 Years to 5 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01517867 | ||||
| Other Study ID Numbers ICMJE | R01NR012444 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Deborah Gross, Johns Hopkins University | ||||
| Study Sponsor ICMJE | Johns Hopkins University | ||||
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Johns Hopkins University | ||||
| Verification Date | January 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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