- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01593189
Efficacy Trial of the Kids in Transition to School (KITS) Program for Children With Developmental Disabilities and Behavioral Problems
A Randomized Efficacy Trial of the Kids in Transition to School (KITS) Program for Children With Developmental Disabilities and Behavioral Problems
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oregon
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Eugene, Oregon, United States, 97401
- Oregon Social Learning Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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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
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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:
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No Intervention: Services as usual
Families continued to receive any services that they had been receiving in the community.
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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)
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Caregiver reported involvement in early literacy activities and beliefs about the importance of various literacy skills for kindergarten
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pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
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Change in early literacy skills from baseline to kindergarten entry
Time Frame: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
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Standardized measures of early literacy skills including letter naming, phonological awareness and understanding of concepts about print
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pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
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Change in social skills from baseline to kindergarten entry
Time Frame: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
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Standardized direct assessments of the child's responses to social situations as well as parent responses to standardized questionnaires on children's social skills
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pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
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Change in regulatory skills from baseline to kindergarten entry
Time Frame: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
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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
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pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
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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)
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Standardized direct assessments of child achievement in reading and math as well as parent and teacher report on standardized measures of child achievement.
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post-kindergarten (approximately 1 year post-baseline), post 1st grade (approximately 2 years post-baseline)
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Longitudinal social competence across grade levels
Time Frame: post-kindergarten (approximately 1 year post-baseline), post 1st grade (approximately 2 years post-baseline)
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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
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post-kindergarten (approximately 1 year post-baseline), post 1st grade (approximately 2 years post-baseline)
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R324A080026
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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