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

School Readiness Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Developmental Disabilities
• School Readiness

• NCT number: NCT01593189
• Study type: Interventional
• Source: Oregon Social Learning Center
• Status: Completed
• Phase: N/A
• Start date: April 2008
• Completion date: March 2013