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Completed

NCT Number: NCT01593189

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.

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Key information

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Social Learning Center

Eugene, Oregon, 97401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KITS Program

Behavioral

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Oregon Social Learning Center

Other

Collaborators

  • U.S. Department of Education

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
May 8, 2012
Registry last updated
Oct 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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