- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00688129
KITS: School Readiness in Foster Care Efficacy Trial (KITS)
September 18, 2017 updated by: Katherine C. Pears, Oregon Social Learning Center
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
192
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oregon
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Eugene, Oregon, United States, 97401
- Oregon Social Learning Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 6 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Services as usual
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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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Early literacy skills
Time Frame: pre-intervention, pre-kindergarten, end of kindergarten
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pre-intervention, pre-kindergarten, end of kindergarten
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Social skills
Time Frame: pre-intervention, pre-kindergarten, end of kindergarten
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pre-intervention, pre-kindergarten, end of kindergarten
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Regulatory skills
Time Frame: pre-intervention, pre-kindergarten, end of kindergarten
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pre-intervention, pre-kindergarten, end of kindergarten
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Caregiver involvement
Time Frame: pre-intervention, pre-kindergarten, end of kindergarten
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pre-intervention, pre-kindergarten, end of kindergarten
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Academic achievement
Time Frame: post-kindergarten, post 1st grade, post 2nd grade
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post-kindergarten, post 1st grade, post 2nd grade
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Peer relations
Time Frame: post 1st grade, post 2nd grade
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post 1st grade, post 2nd grade
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Katherine C Pears, PhD, Oregon Social Learning Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pears KC, Kim HK, Fisher PA. Effects of a School Readiness Intervention for Children in Foster Care on Oppositional and Aggressive Behaviors in Kindergarten. Child Youth Serv Rev. 2012 Dec;34(12):2361-2366. doi: 10.1016/j.childyouth.2012.08.015. No abstract available.
- Pears KC, Fisher PA, Bronz KD. An Intervention to Promote Social Emotional School Readiness in Foster Children: Preliminary Outcomes From a Pilot Study. School Psych Rev. 2007;36(4):665-673.
- Pears KC, Fisher PA, Kim HK, Bruce J, Healey CV, Yoerger K. Immediate Effects of a School Readiness Intervention for Children in Foster Care. Early Educ Dev. 2013 Aug;24(6):771-791. doi: 10.1080/10409289.2013.736037.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
May 28, 2008
First Submitted That Met QC Criteria
May 28, 2008
First Posted (Estimate)
June 2, 2008
Study Record Updates
Last Update Posted (Actual)
September 19, 2017
Last Update Submitted That Met QC Criteria
September 18, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R01DA021424 (U.S. NIH Grant/Contract)
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