NCT01806987

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

3.9 years

First QC Date

March 1, 2013

Last Update Submit

September 18, 2017

Conditions

School Readiness

Keywords

school readinessliteracysocial emotional skillsself regulationcaregiver involvementsocioeconomic disadvantage

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (3)

  • Longitudinal academic achievement across grade levels

    post-kindergarten (average of 12 months post-baseline), post-first grade (average of 24 months post-baseline)

  • Longitudinal social competence across grade levels

    post-kindergarten (average of 12 months post-baseline), post-first grade (average of 24 months post-baseline)

  • Longitudinal parenting behaviors (parental involvement and positive parenting)

    post-kindergarten (average of 12 months post-baseline), post-first grade (average of 24 months post-baseline)

Study Arms (2)

KITS Program

EXPERIMENTAL

The KITS Program 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).

Behavioral: KITS Program

Services as usual

NO INTERVENTION

These include any services that the child and family might already be receiving in the community.

Interventions

KITS ProgramBEHAVIORAL

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).

Also known as: Kids in Transition to School Program
KITS Program

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Child is entering kindergarten in a disadvantaged neighborhood
  • Child is a bilingual or monolingual English speaker

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Social Learning Center

Eugene, Oregon, 97405, United States

Location

Related Publications (5)

  • 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.

    PMID: 23710106BACKGROUND

  • 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.

    PMID: 19057655BACKGROUND

  • 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.

    PMID: 25382932BACKGROUND

  • 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.

    PMID: 24015056RESULT

  • 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.

    PMID: 27158175RESULT

Related Links

MeSH Terms

Conditions

LiteracySelf-Control

Condition Hierarchy (Ancestors)

CommunicationBehaviorSocial Behavior

Study Officials

  • Katherine C Pears, Ph.D.

    Oregon Social Learning Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

March 1, 2013

First Posted

March 8, 2013

Study Start

March 1, 2013

Primary Completion

January 31, 2017

Study Completion

January 31, 2017

Last Updated

September 19, 2017

Record last verified: 2017-09

Locations

US(1)