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

October 13, 2015 updated by: Katherine C. Pears, Oregon Social Learning Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

209

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

    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oregon Social Learning Center

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:

  • 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

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KITS Program
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
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
Other Names:
  • Kids in Transition to School (KITS) Program
No Intervention: Services as usual
Families continued to receive any services that they had been receiving in the community.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in caregiver involvement from baseline to kindergarten entry
Time Frame: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
Caregiver reported involvement in early literacy activities and beliefs about the importance of various literacy skills for kindergarten
pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
Change in early literacy skills from baseline to kindergarten entry
Time Frame: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
Standardized measures of early literacy skills including letter naming, phonological awareness and understanding of concepts about print
pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
Change in social skills from baseline to kindergarten entry
Time Frame: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
Standardized direct assessments of the child's responses to social situations as well as parent responses to standardized questionnaires on children's social skills
pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
Change in regulatory skills from baseline to kindergarten entry
Time Frame: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
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
pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Longitudinal academic achievement across grade levels
Time Frame: post-kindergarten (approximately 1 year post-baseline), post 1st grade (approximately 2 years post-baseline)
Standardized direct assessments of child achievement in reading and math as well as parent and teacher report on standardized measures of child achievement.
post-kindergarten (approximately 1 year post-baseline), post 1st grade (approximately 2 years post-baseline)
Longitudinal social competence across grade levels
Time Frame: post-kindergarten (approximately 1 year post-baseline), post 1st grade (approximately 2 years post-baseline)
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
post-kindergarten (approximately 1 year post-baseline), post 1st grade (approximately 2 years post-baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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

April 1, 2008

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

May 2, 2012

First Submitted That Met QC Criteria

May 7, 2012

First Posted (Estimate)

May 8, 2012

Study Record Updates

Last Update Posted (Estimate)

October 15, 2015

Last Update Submitted That Met QC Criteria

October 13, 2015

Last Verified

October 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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