KITS: School Readiness in Foster Care Efficacy Trial
| Tracking Information | |||||
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| First Received Date ICMJE | May 28, 2008 | ||||
| Last Updated Date | May 1, 2012 | ||||
| Start Date ICMJE | September 2005 | ||||
| Estimated Primary Completion Date | July 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00688129 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 | KITS: School Readiness in Foster Care Efficacy Trial | ||||
| Official Title ICMJE | KITS: School Readiness in Foster Care Efficacy Trial | ||||
| Brief Summary | The KITS project is a 5-year randomized trial to evaluate a program designed to enhance academic and social-emotional aspects of school readiness for foster preschoolers. |
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| Detailed Description | The overarching goal of this research project is to conduct a randomized efficacy trial of a preventive intervention—the Kids in Transition to School (KITS) program—to enhance socioemotional and academic school readiness among preschool-aged foster children. Foster children are at great risk for poor social and academic school outcomes. Because of their experiences of early adversity, these children may have particular vulnerabilities that decrease the likelihood of a successful transition to school. Extensive prior research has shown that chronic early adversity is associated with alterations in the functioning of key neural systems (specifically, prefrontal cortex function and hypothalamic-pituitary-adrenal axis activity) related to self-regulation and stress reactivity. Alterations in these systems may interfere with children's abilities to relate to peers, to maintain focused attention, to follow directions, and to learn academic skills. Additionally, because these children are likely to have experienced multiple living transitions, they may be at a disadvantage in terms of caregiver involvement in school, a critical aspect of early school success. Foster children are recruited in the spring before they enter kindergarten and randomly assigned to the intervention and comparison conditions. The KITS intervention includes three components: (a) child therapeutic play groups to facilitate the development of self-regulatory, social, and emergent literacy skills; (b) a psychoeducational support group to promote caregiver involvement in the child's emergent literacy and schooling and the use of effective parenting techniques; (c) home- and school-based behavioral consultation. The intervention coincides with the transition into kindergarten. Multi-method, multi-agent assessments of the children's socioemotional readiness and literacy skills are conducted at baseline, kindergarten entry, and postkindergarten. We will examine the direct effects of the intervention on school readiness and kindergarten outcomes. We will also assess whether intervention effects are mediated through mechanisms of stress reactivity and regulation and caregiver variables. Finally, we will test for moderator effects of child and contextual characteristics including early adversity (prenatal/neonatal health, maltreatment history and placement history), child cognitive functioning, and placement transitions during the course of the study. An additional exploratory aim of the study is to examine intervention effects on first and second grade outcomes for subsamples of children. Group comparisons and longitudinal growth modeling will allow for evaluation of hypotheses. |
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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: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic |
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| Condition ICMJE | School Readiness | ||||
| Intervention ICMJE | Behavioral: Kids in Transition to School (KITS)
This is a 4-month psychosocial intervention for foster children entering kindergarten and their caregivers beginning the summer before kindergarten. The KITS intervention consists of: (a) child therapeutic play groups to facilitate the development of self-regulatory, social, and emergent literacy skills (2 times per week in summer, 1 times per week in the fall); (b) a bi-monthly psychoeducational support group to promote caregiver involvement in the child's emergent literacy and schooling and the use of effective parenting techniques; (c) home- and school-based behavioral consultation on an as needed basis. |
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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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | July 2015 | ||||
| Estimated Primary Completion Date | July 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 4 Years to 6 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 | NCT00688129 | ||||
| Other Study ID Numbers ICMJE | R01-DA021424 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Katherine C. Pears, Oregon Social Learning Center | ||||
| Study Sponsor ICMJE | Oregon Social Learning Center | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Oregon Social Learning Center | ||||
| Verification Date | May 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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