Clinical trial NCT01806987: A Test of the Kids in Transition to School (KITS) Program in Disadvantaged Neighborhoods
Official title: A Randomized Efficacy Trial of the Kids in Transition to School (KITS) Program to Improve School Readiness of Children in Disadvantaged Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: School Readiness
Keywords: school readiness
literacy
social emotional skills
self regulation
caregiver involvement
socioeconomic disadvantage
Lead sponsor: Oregon Social Learning Center
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2013-03-08
Enrollment: 265
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in early literacy skills from baseline to kindergarten fall
timeFrame: pre-intervention (baseline), pre-kindergarten (average of 2-3 months post baseline), kindergarten fall (average of 4-5 months post-baseline)
measure: Change in prosocial skills from baseline to kindergarten fall
timeFrame: pre-intervention (baseline), pre-kindergarten (average of 2-3 months post baseline), kindergarten fall (average of 4-5 months post-baseline)
measure: Change in emotion and behavior regulation skills from baseline to kindergarten fall
timeFrame: pre-intervention (baseline), pre-kindergarten (average of 2-3 months post baseline), kindergarten fall (average of 4-5 months post-baseline)
measure: Change in parenting behavior (parent involvement and positive parenting practices) from baseline to kindergarten fall
timeFrame: pre-intervention (baseline), pre-kindergarten (average of 2-3 months post baseline), kindergarten fall (average of 4-5 months post-baseline)
Secondary outcomes:
measure: Longitudinal academic achievement across grade levels
timeFrame: post-kindergarten (average of 12 months post-baseline), post-first grade (average of 24 months post-baseline)
measure: Longitudinal social competence across grade levels
timeFrame: post-kindergarten (average of 12 months post-baseline), post-first grade (average of 24 months post-baseline)
measure: Longitudinal parenting behaviors (parental involvement and positive parenting)
timeFrame: post-kindergarten (average of 12 months post-baseline), post-first grade (average of 24 months post-baseline)
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Social Learning Center
state: Oregon
Study officials:
affiliation: Oregon Social Learning Center
name: Katherine C Pears, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.childyouth.2012.08.015. No abstract available.
citation: 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.
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. doi: 10.1353/etc.2014.0021.
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. doi: 10.1080/10409289.2013.736037.
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. doi: 10.1016/j.childyouth.2016.04.005.