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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Oregon Social Learning Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Katherine C. Pears, Oregon Social Learning Center
ClinicalTrials.gov Identifier:
NCT01593189
First received: May 2, 2012
Last updated: May 7, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
School Readiness
Behavioral: Kids in Transition to School (KITS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Efficacy Trial of the Kids in Transition to School (KITS) Program for Children With Developmental Disabilities and Behavioral Problems

Resource links provided by NLM:


Further study details as provided by Oregon Social Learning Center:

Primary Outcome Measures:
  • Change in caregiver involvement from baseline to kindergarten entry [ Time Frame: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: post-kindergarten (approximately 1 year post-baseline), post 1st grade (approximately 2 years post-baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: post-kindergarten (approximately 1 year post-baseline), post 1st grade (approximately 2 years post-baseline) ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 200
Study Start Date: April 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KITS Behavioral: Kids in Transition to School (KITS)
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
No Intervention: Services as usual

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.

  Eligibility

Ages Eligible for Study:   4 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593189

Locations
United States, Oregon
Oregon Social Learning Center
Eugene, Oregon, United States, 97401
Sponsors and Collaborators
Oregon Social Learning Center
U.S. Department of Education
  More Information

Additional Information:
Publications:
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.

Responsible Party: Katherine C. Pears, Research Scientist, Oregon Social Learning Center
ClinicalTrials.gov Identifier: NCT01593189     History of Changes
Other Study ID Numbers: R324A080026
Study First Received: May 2, 2012
Last Updated: May 7, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Oregon Social Learning Center:
developmental disabilities
school readiness
literacy
social emotional skills
self regulation
caregiver involvement

Additional relevant MeSH terms:
Developmental Disabilities
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on August 18, 2014