Community Implementation of KEEP
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 18, 2009 | ||||||||
| Last Updated Date | March 7, 2011 | ||||||||
| Start Date ICMJE | September 2009 | ||||||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Reduction in child behavior problems as assessed by the Parent Daily Report (PDR) [ Time Frame: Baseline, 6-months, 12-months, 18-months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00980512 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Placement Disruptions from Foster Placement [ Time Frame: 6-month, 12-month, 18-month ] [ Designated as safety issue: No ] | ||||||||
| 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 | Community Implementation of KEEP | ||||||||
| Official Title ICMJE | Community Implementation of KEEP: Fidelity and Generalization of Parenting | ||||||||
| Brief Summary | The primary goal of this study is to examine the fidelity and generalization of parenting effects of the KEEP foster parent training intervention as it is being delivered within a child welfare system of care by a community mental health provider. |
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| Detailed Description | The primary goal of this study is to utilize this opportunity as a real-world platform for addressing three key questions that need to be answered prior to wide-scale implementation of the KEEP intervention. First, do the effects of the KEEP parent training generalize (concurrently) to other children currently in foster and kin intervention homes and lead to reductions in overall levels of behavior problems? Second, does the KEEP intervention continue to have effects after the completion of the intervention and generalize (temporally) to new children who enter the homes of these families at a later point in time? Finally, as the KEEP intervention is being implemented by a community agency in a real-world system of care, can the intervention be delivered and maintained in a manner that preserves the goals and quality of the intervention? Children in foster care, between the ages of 5 and 12, will be randomly assigned to one of two conditions - the KEEP intervention or a "services as usual" condition. In the KEEP intervention condition, foster and kin caregivers will participate in 16 weekly group meetings. Outcomes to be assessed include child problem behavior (of the focal child and other children in the household), child functioning, parental stress, family functioning, use of mental health services, child placement changes (e.g., reunification with biological parents, move to another foster home), and foster parent retention rates. In addition, for a year following the completion of the intervention, new children entering the home of foster/kin caregiver will be included in the assessments, along with the impact of these additional children on parental stress and family functioning. Finally, several dimensions of intervention fidelity (e.g., facilitator adherence and group engagement) will be assessed and examined in relation to child, family, and system outcomes. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Parenting Training
16 weeks of parent training led by trained group facilitator
Other Name: Parent Management Training |
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| Study Arm (s) | Experimental: Parent training
16 weeks of parent training in group context with 5 to 10 relative and non-relative foster caregivers.
Intervention: Behavioral: Parenting Training |
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 354 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 5 Years to 12 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00980512 | ||||||||
| Other Study ID Numbers ICMJE | RMH060195B, 2R01MH060195-06A1, DSIR 84-CTP | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dr. Joseph M. Price, Professor, San Diego State University | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | Oregon Social Learning Center | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 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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