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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593189
• Other study ID #: R324A080026
• Status: Completed
• Phase: N/A
• First received: May 2, 2012
• Last updated: October 13, 2015
• Start date: April 2008
• Est. completion date: March 2013

Study information

• Verified date: October 2015
• Source: Oregon Social Learning Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 6 Years

Eligibility

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 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

Intervention

Behavioral:
• KITS Program
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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Social Learning Center	U.S. Department of Education

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)	No
Primary	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	pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)	No
Primary	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	pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)	No
Primary	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	pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)	No
Secondary	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.	post-kindergarten (approximately 1 year post-baseline), post 1st grade (approximately 2 years post-baseline)	No
Secondary	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	post-kindergarten (approximately 1 year post-baseline), post 1st grade (approximately 2 years post-baseline)	No

External Links

•   Oregon Social Learning Center web site