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Efficacy Trial of the Kids in Transition to School (KITS) Program for Children With Developmental Disabilities and Behavioral Problems

Primary Purpose

School Readiness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KITS Program
Sponsored by
Oregon Social Learning Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for School Readiness focused on measuring developmental disabilities, school readiness, literacy, social emotional skills, self regulation, caregiver involvement

Eligibility Criteria

4 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Received early childhood special education services
  • Judged to have behavioral problems that would interfere with the transition to kindergarten
  • Entering kindergarten in the fall of the year in which recruited into the study

Exclusion Criteria:

  • Mono-lingual Spanish speaker
  • Severe visual, hearing or physical impairment that would prevent the child from completing the assessment tasks or participating in the intervention

Sites / Locations

  • Oregon Social Learning Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

KITS Program

Services as usual

Arm Description

The KITS intervention consists of: (a) child school readiness play groups to facilitate the development of self-regulatory, social, and early literacy skills (2 times per week in summer, 1 times per week in the fall); and (b) a bi-monthly psychoeducational support group to promote parent involvement in the child's early literacy and schooling and the use of effective parenting techniques

Families continued to receive any services that they had been receiving in the community.

Outcomes

Primary Outcome Measures

Change in caregiver involvement from baseline to kindergarten entry
Caregiver reported involvement in early literacy activities and beliefs about the importance of various literacy skills for kindergarten
Change in early literacy skills from baseline to kindergarten entry
Standardized measures of early literacy skills including letter naming, phonological awareness and understanding of concepts about print
Change in social skills from baseline to kindergarten entry
Standardized direct assessments of the child's responses to social situations as well as parent responses to standardized questionnaires on children's social skills
Change in regulatory skills from baseline to kindergarten entry
Standardized direct assessment of the children's executive function skills as well as parent report on standardized questionnaires used to assess emotion and behavior regulation

Secondary Outcome Measures

Longitudinal academic achievement across grade levels
Standardized direct assessments of child achievement in reading and math as well as parent and teacher report on standardized measures of child achievement.
Longitudinal social competence across grade levels
Standardized direct child assessments of responses to peer situations as well as child report on standardized questionnaires about social functioning at school and parent and teacher reports of child social functioning on standardized questionnaires

Full Information

First Posted
May 2, 2012
Last Updated
October 13, 2015
Sponsor
Oregon Social Learning Center
Collaborators
U.S. Department of Education
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1. Study Identification

Unique Protocol Identification Number
NCT01593189
Brief Title
Efficacy Trial of the Kids in Transition to School (KITS) Program for Children With Developmental Disabilities and Behavioral Problems
Official Title
A Randomized Efficacy Trial of the Kids in Transition to School (KITS) Program for Children With Developmental Disabilities and Behavioral Problems
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Social Learning Center
Collaborators
U.S. Department of Education

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study focuses on children entering kindergarten with co-occurring developmental disabilities and behavior problems, a population especially likely to have low levels of school readiness. Prior research has shown that children with developmental disabilities are at risk for academic difficulties. Behavioral and social problems are likely to interfere with school adjustment. The investigators hypothesize that children who receive the intervention will show better school readiness and school adjustment outcomes.
Detailed Description
Purpose: This project is a randomized efficacy trial of KITS, an intervention to enhance social-emotional and early literacy domains of school readiness in children with co-occurring developmental disabilities and behavior problems who are entering kindergarten. Setting: The setting for the intervention will be playgroups and parent support groups conducted in center-based classrooms during the summer before and the first 2 months of kindergarten. Population: This study involves the recruitment of 200 children with co-occurring developmental disabilities and behavioral problems who are entering kindergarten in the fall (four yearly cohorts of 50 children each). The children will be recruited from the Lane County, Oregon, public agency responsible for early childhood special education services. Intervention: KITS is a short-term, intensive program timed to occur during the transition to kindergarten-a critical developmental milestone with far-reaching effects on school outcomes. The KITS curriculum focuses on the social-emotional and early literacy skills shown to be essential for success in kindergarten and on contextual characteristics (i.e., parent involvement in early literacy and positive parenting) to support and promote these skills. KITS features 24 curriculum-based school readiness playgroups to facilitate the development of self-regulatory, social, and early literacy skills (twice weekly in the summer before kindergarten and once weekly September-October) and 7 psychoeducational parent groups focused on parent involvement in early literacy and positive parenting practices (every 2 weeks June-October). Research Design and Methods: Children will be randomly assigned to the KITS intervention condition or a services-as-usual comparison group and assessed at four intervals: spring prior to kindergarten, immediately prior to kindergarten entry, kindergarten fall, and kindergarten spring. One hundred fifty of the children will also be assessed in the spring of first grade. KITS children will receive the intervention as described above. Control condition: Children in the comparison group will receive any ECSE or other services that they would typically receive. These will be assessed at each data collection point. Key measures: Multimethod, multiagent outcome measures will include the following: direct assessments of the child's social-emotional and early literacy skills prior to kindergarten and social-emotional functioning and literacy skills during kindergarten and first grade; parent and teacher reports on children's characteristics, parent involvement in early literacy and school, and parenting practices; and direct classroom observations of children's academic engaged time and social behaviors during unstructured school time. Data-analytic strategies: Analyses will employ variable-based (e.g., ANOVA and regression) and person-based (e.g., latent growth curve modeling) approaches. SEM will be used to test how changes in hypothesized mediators affect outcomes and how outcomes vary depending on level of hypothesized moderators.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
School Readiness
Keywords
developmental disabilities, school readiness, literacy, social emotional skills, self regulation, caregiver involvement

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KITS Program
Arm Type
Experimental
Arm Description
The KITS intervention consists of: (a) child school readiness play groups to facilitate the development of self-regulatory, social, and early literacy skills (2 times per week in summer, 1 times per week in the fall); and (b) a bi-monthly psychoeducational support group to promote parent involvement in the child's early literacy and schooling and the use of effective parenting techniques
Arm Title
Services as usual
Arm Type
No Intervention
Arm Description
Families continued to receive any services that they had been receiving in the community.
Intervention Type
Behavioral
Intervention Name(s)
KITS Program
Other Intervention Name(s)
Kids in Transition to School (KITS) Program
Intervention Description
This is a 4-month psychosocial intervention for children with developmental disabilities and behavior problems who are entering kindergarten and their caregivers. The intervention begins in the summer before kindergarten. The KITS intervention consists of: (a) child school readiness play groups to facilitate the development of self-regulatory, social, and early literacy skills (2 times per week in summer, 1 times per week in the fall); and (b) a bi-monthly psychoeducational support group to promote parent involvement in the child's early literacy and schooling and the use of effective parenting techniques
Primary Outcome Measure Information:
Title
Change in caregiver involvement from baseline to kindergarten entry
Description
Caregiver reported involvement in early literacy activities and beliefs about the importance of various literacy skills for kindergarten
Time Frame
pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
Title
Change in early literacy skills from baseline to kindergarten entry
Description
Standardized measures of early literacy skills including letter naming, phonological awareness and understanding of concepts about print
Time Frame
pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
Title
Change in social skills from baseline to kindergarten entry
Description
Standardized direct assessments of the child's responses to social situations as well as parent responses to standardized questionnaires on children's social skills
Time Frame
pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
Title
Change in regulatory skills from baseline to kindergarten entry
Description
Standardized direct assessment of the children's executive function skills as well as parent report on standardized questionnaires used to assess emotion and behavior regulation
Time Frame
pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
Secondary Outcome Measure Information:
Title
Longitudinal academic achievement across grade levels
Description
Standardized direct assessments of child achievement in reading and math as well as parent and teacher report on standardized measures of child achievement.
Time Frame
post-kindergarten (approximately 1 year post-baseline), post 1st grade (approximately 2 years post-baseline)
Title
Longitudinal social competence across grade levels
Description
Standardized direct child assessments of responses to peer situations as well as child report on standardized questionnaires about social functioning at school and parent and teacher reports of child social functioning on standardized questionnaires
Time Frame
post-kindergarten (approximately 1 year post-baseline), post 1st grade (approximately 2 years post-baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Received early childhood special education services Judged to have behavioral problems that would interfere with the transition to kindergarten Entering kindergarten in the fall of the year in which recruited into the study Exclusion Criteria: Mono-lingual Spanish speaker Severe visual, hearing or physical impairment that would prevent the child from completing the assessment tasks or participating in the intervention
Facility Information:
Facility Name
Oregon Social Learning Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Pears KC, Fisher PA, Heywood CV, Bronz KD. Promoting school readiness in foster children. In: Saracho ON, Spodek B, eds. Contemporary Perspectives on Social Learning in Early Childhood Education Greenwich, CT: Information Age Publishing; 2007:173-198.
Results Reference
background
PubMed Identifier
24676874
Citation
Pears KC, Kim HK, Healey CV, Yoerger K, Fisher PA. Improving child self-regulation and parenting in families of pre-kindergarten children with developmental disabilities and behavioral difficulties. Prev Sci. 2015 Feb;16(2):222-32. doi: 10.1007/s11121-014-0482-2.
Results Reference
background
Links:
URL
http://www.oslc.org
Description
Oregon Social Learning Center web site

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Efficacy Trial of the Kids in Transition to School (KITS) Program for Children With Developmental Disabilities and Behavioral Problems

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