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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01806987
Other study ID # R305A120391
Secondary ID R305A120391
Status Completed
Phase N/A
First received March 1, 2013
Last updated September 18, 2017
Start date March 2013
Est. completion date January 31, 2017

Study information

Verified date September 2017
Source Oregon Social Learning Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this project to determine whether the KITS Program, an intervention to improve early literacy, prosocial and emotion and behavior regulation domains of school readiness, improves school readiness and school outcomes in children from socioeconomically disadvantaged neighborhoods.


Description:

PURPOSE: This project is a randomized efficacy trial of the KITS Program, an intervention to improve early literacy, prosocial and emotion and behavior regulation domains of school readiness, with children from socioeconomically disadvantaged neighborhoods. The project will extend the evidence on the efficacy of the intervention from two previous randomized efficacy trials of the KITS Program with special needs populations to examine the impacts of the intervention on the broader population of children from disadvantaged backgrounds in general education.

SETTING: The intervention will be conducted in elementary school classrooms in high-poverty, high-crime neighborhoods in a medium-sized metropolitan area of the Pacific Northwest during the summer before and the first 2 months of kindergarten.

POPULATION: This study involves the recruitment of 240 children who will be entering kindergarten in the fall and their families in three yearly cohorts (n = 80). The children will be recruited from neighborhoods that have been selected as some of the most disadvantaged in the state in terms of income and school readiness indicators.

INTERVENTION: The KITS Program is a high-intensity, short-term program timed to occur during the transition to kindergarten—a critical developmental milestone with far-reaching effects on school outcomes. The curriculum focuses on the early literacy, social, and self-regulation skills critical for success in kindergarten and on contextual characteristics (i.e., parent involvement in early literacy and positive parenting). KITS features 24 curriculum-based therapeutic playgroups focused on early literacy, social, and self-regulatory skills and 12 psychoeducational parent workshops focused on parent involvement in early literacy and positive parenting practices.

CONTROL CONDITION: The children in the services-as-usual condition will receive any early childhood learning services that they would typically receive prior to school entry. Services received will be assessed at each data time point.

RESEARCH DESIGN AND METHODS: The children will be randomly assigned to the KITS condition or a services-as-usual condition and assessed at four time points: spring prior to kindergarten, immediately prior to kindergarten entry, kindergarten fall, and kindergarten spring; 160 of the children will also be assessed in first grade spring.

MEASURES AND KEY OUTCOMES: Our multimethod, multi-informant outcome measures will include the following: direct assessments of early literacy and social-emotional skills prior to kindergarten and literacy skills and social-emotional functioning during kindergarten and first grade; parent and teacher reports on child skills and behaviors, parent involvement in early literacy and school, and parenting practices; direct classroom observations of child academic engaged time and social behaviors; and school records data on grades, office discipline referrals, special education services received, and attendance.

DATA-ANALYTIC STRATEGIES: Analyses will employ variable-centered (e.g., ANOVA and regression) and person-centered (e.g., latent growth curve modeling) approaches. Multilevel latent variable modeling will be used to test how changes in hypothesized mediators affect longer-term outcomes and how outcomes vary depending on level of hypothesized moderators.


Recruitment information / eligibility

Status Completed
Enrollment 265
Est. completion date January 31, 2017
Est. primary completion date January 31, 2017
Accepts healthy volunteers No
Gender All
Age group 4 Years to 6 Years
Eligibility Inclusion Criteria:

- Child is entering kindergarten in a disadvantaged neighborhood

- Child is a bilingual or monolingual English speaker

Exclusion Criteria:

- Child has a hearing or vision impairment that would limit participation in the intervention activities or assessment protocol

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
KITS Program
The KITS Program is a 4-month psychosocial intervention for children at high risk for school difficulties and their caregivers. The intervention begins in the summer before kindergarten and continues across the first two months of 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 time per week in the fall); and (b) a 12 session psychoeducational workshop to promote parent involvement in the child's early literacy and schooling and the use of effective parenting techniques (once per week in summer, bi-weekly in the fall).

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 (5)

Pears KC, Fisher PA, Bronz KD. An Intervention to Promote Social Emotional School Readiness in Foster Children: Preliminary Outcomes From a Pilot Study. School Psych Rev. 2007;36(4):665-673. — View Citation

Pears KC, Fisher PA, Kim HK, Bruce J, Healey CV, Yoerger K. Immediate Effects of a School Readiness Intervention for Children in Foster Care. Early Educ Dev. 2013 Aug;24(6):771-791. — View Citation

Pears KC, Healey CV, Fisher PA, Braun D, Gill C, Conte HM, Newman J, Ticer S. Immediate Effects of a Program to Promote School Readiness in Low-Income Children: Results of a Pilot Study. Educ Treat Children. 2014 Aug;37(3):431-460. — View Citation

Pears KC, Kim HK, Fisher PA. Decreasing Risk Factors for Later Alcohol Use and Antisocial Behaviors in Children in Foster Care by Increasing Early Promotive Factors. Child Youth Serv Rev. 2016 May;65:156-165. — View Citation

Pears KC, Kim HK, Fisher PA. Effects of a School Readiness Intervention for Children in Foster Care on Oppositional and Aggressive Behaviors in Kindergarten. Child Youth Serv Rev. 2012 Dec;34(12):2361-2366. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in early literacy skills from baseline to kindergarten fall Standardized measures of early literacy skills including letter naming, phonological awareness and understanding of concepts about print pre-intervention (baseline), pre-kindergarten (average of 2-3 months post baseline), kindergarten fall (average of 4-5 months post-baseline)
Primary Change in prosocial skills from baseline to kindergarten fall Standardized direct assessments of the child's responses to social situations as well as parent and teacher responses to standardized questionnaires on children's social skills pre-intervention (baseline), pre-kindergarten (average of 2-3 months post baseline), kindergarten fall (average of 4-5 months post-baseline)
Primary Change in emotion and behavior regulation skills from baseline to kindergarten fall Standardized direct assessment of the children's executive function skills as well as parent and teacher report on standardized questionnaires used to assess emotion and behavior regulation pre-intervention (baseline), pre-kindergarten (average of 2-3 months post baseline), kindergarten fall (average of 4-5 months post-baseline)
Primary Change in parenting behavior (parent involvement and positive parenting practices) from baseline to kindergarten fall Caregiver reported involvement in early literacy activities and beliefs about the importance of various literacy skills for kindergarten as well as parenting practices pre-intervention (baseline), pre-kindergarten (average of 2-3 months post baseline), kindergarten fall (average of 4-5 months post-baseline)
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 (average of 12 months post-baseline), post-first grade (average of 24 months post-baseline)
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 (average of 12 months post-baseline), post-first grade (average of 24 months post-baseline)
Secondary Longitudinal parenting behaviors (parental involvement and positive parenting) Caregiver and teacher reports on parental involvement in school as well as positive parenting practices post-kindergarten (average of 12 months post-baseline), post-first grade (average of 24 months post-baseline)
See also
  Status Clinical Trial Phase
Completed NCT02945384 - Broader Implementation of a Successful Dual-Generation Intervention in Partnership With Head Start of Lane County N/A
Completed NCT00688129 - KITS: School Readiness in Foster Care Efficacy Trial N/A
Recruiting NCT06390215 - Clinic-Based School Readiness Coaching N/A
Active, not recruiting NCT05736159 - Scientific Justification of Assessment Criteria and Improvement of the Methodology for Assessing School Maturity
Active, not recruiting NCT00701194 - Early Intervention Foster Care: A Prevention Trial N/A
Active, not recruiting NCT03081624 - Evaluation of Neurological Status and School Readiness in Preterm Preschoolers N/A
Recruiting NCT06083220 - School Readiness in Preschool-Aged Children With Cerebral Palsy N/A
Completed NCT05140460 - Cultural Pride Reinforcement for Early School Readiness N/A
Completed NCT01593189 - Efficacy Trial of the Kids in Transition to School (KITS) Program for Children With Developmental Disabilities and Behavioral Problems N/A

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