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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00688129
Other study ID # R01DA021424
Secondary ID R01DA021424
Status Completed
Phase N/A
First received May 28, 2008
Last updated September 18, 2017
Start date September 2005
Est. completion date December 31, 2016

Study information

Verified date September 2017
Source Oregon Social Learning Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 192
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 4 Years to 6 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Oregon Social Learning Center Eugene Oregon

Sponsors (3)

Lead Sponsor Collaborator
Oregon Social Learning Center Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Early literacy skills pre-intervention, pre-kindergarten, end of kindergarten
Primary Social skills pre-intervention, pre-kindergarten, end of kindergarten
Primary Regulatory skills pre-intervention, pre-kindergarten, end of kindergarten
Primary Caregiver involvement pre-intervention, pre-kindergarten, end of kindergarten
Secondary Academic achievement post-kindergarten, post 1st grade, post 2nd grade
Secondary Peer relations post 1st grade, post 2nd grade
See also
  Status Clinical Trial Phase
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Recruiting NCT06390215 - Clinic-Based School Readiness Coaching N/A
Active, not recruiting NCT05736159 - Scientific Justification of Assessment Criteria and Improvement of the Methodology for Assessing School Maturity
Completed NCT01806987 - A Test of the Kids in Transition to School (KITS) Program in Disadvantaged Neighborhoods N/A
Active, not recruiting NCT00701194 - Early Intervention Foster Care: A Prevention Trial N/A
Active, not recruiting NCT03081624 - Evaluation of Neurological Status and School Readiness in Preterm Preschoolers N/A
Recruiting NCT06083220 - School Readiness in Preschool-Aged Children With Cerebral Palsy N/A
Completed NCT05140460 - Cultural Pride Reinforcement for Early School Readiness N/A
Completed NCT01593189 - Efficacy Trial of the Kids in Transition to School (KITS) Program for Children With Developmental Disabilities and Behavioral Problems N/A