Effectiveness Trial for Project SafeCare for Child Neglect
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| First Received Date ICMJE | June 29, 2011 | ||||
| Last Updated Date | July 8, 2011 | ||||
| Start Date ICMJE | October 2003 | ||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Child welfare system recidivism [ Time Frame: Up to 2766 days ] [ Designated as safety issue: No ] Follow-up for recidivism reports to child welfare, captured from administrative data maintained by the state child welfare system |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01391754 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness Trial for Project SafeCare for Child Neglect | ||||
| Official Title ICMJE | Effectiveness Trial for Project SafeCare for Child Neglect | ||||
| Brief Summary | The study is a field trial comparing the SafeCare family preservation model to a comparable usual care model for parents in child welfare. The study also compares two levels of service quality control. |
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| Detailed Description | The study is a cluster-randomized field trial of the SafeCare(SC) home-based family preservation model for families in the child welfare system. The trial is conducted in collaboration with the state child welfare agency and their contracted in-home service system. The service system is regionalized and provides in home services to families referred by child welfare. Regions of the state are assigned by the study to either the SC model or to services as usual. Provider teams, nested within regions, are assigned to either a monitored or unmonitored model implementation quality control condition. The aims of the project are to test client level child welfare reentry outcomes between SC and standard conditions, across the two implementation and quality control conditions. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Child Neglect | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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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 | Completed | ||||
| Enrollment ICMJE | 2175 | ||||
| Completion Date | September 2007 | ||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 14 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01391754 | ||||
| Other Study ID Numbers ICMJE | 5R01MH065667 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Mark Chaffin, PhD - Principal Investigator, University of Oklahoma Health Sciences Center | ||||
| Study Sponsor ICMJE | University of Oklahoma | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Oklahoma | ||||
| Verification Date | July 2011 | ||||
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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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