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KITS: School Readiness in Foster Care Efficacy Trial (KITS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00688129
First Posted: June 2, 2008
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute on Drug Abuse (NIDA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Katherine C. Pears, Oregon Social Learning Center
  Purpose
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.

Condition Intervention
School Readiness Behavioral: KITS Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: KITS: School Readiness in Foster Care Efficacy Trial

Further study details as provided by Katherine C. Pears, Oregon Social Learning Center:

Primary Outcome Measures:
  • Early literacy skills [ Time Frame: pre-intervention, pre-kindergarten, end of kindergarten ]
  • Social skills [ Time Frame: pre-intervention, pre-kindergarten, end of kindergarten ]
  • Regulatory skills [ Time Frame: pre-intervention, pre-kindergarten, end of kindergarten ]
  • Caregiver involvement [ Time Frame: pre-intervention, pre-kindergarten, end of kindergarten ]

Secondary Outcome Measures:
  • Academic achievement [ Time Frame: post-kindergarten, post 1st grade, post 2nd grade ]
  • Peer relations [ Time Frame: post 1st grade, post 2nd grade ]

Enrollment: 192
Study Start Date: September 2005
Study Completion Date: December 31, 2016
Primary Completion Date: December 31, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KITS Program
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.
Behavioral: KITS Program
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.
Other Name: Kids in Transition to School (KITS) Program
No Intervention: Services as usual

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a child currently in foster care
  • living in Lane or Marion County, Oregon
  • eligible to enter Kindergarten in fall of assessment year (age 5 by September 1 of assessment year)

Exclusion Criteria:

  • medical or developmental condition which would prevent the child from completing the assessment tasks
  • current or previous involvement in Oregon Social Learning Center treatment programs
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688129


Locations
United States, Oregon
Oregon Social Learning Center
Eugene, Oregon, United States, 97401
Sponsors and Collaborators
Oregon Social Learning Center
National Institute on Drug Abuse (NIDA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Katherine C Pears, PhD Oregon Social Learning Center
  More Information

Additional Information:
Publications:
Responsible Party: Katherine C. Pears, Research Scientist, Oregon Social Learning Center
ClinicalTrials.gov Identifier: NCT00688129     History of Changes
Other Study ID Numbers: R01DA021424 ( U.S. NIH Grant/Contract )
First Submitted: May 28, 2008
First Posted: June 2, 2008
Last Update Posted: September 19, 2017
Last Verified: September 2017

Keywords provided by Katherine C. Pears, Oregon Social Learning Center:
school readiness
foster care
maltreatment
literacy
social emotional skills
self regulation
caregiver involvement