NCT01593189

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

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

Study Start

First participant enrolled

April 1, 2008

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 8, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

October 15, 2015

Status Verified

October 1, 2015

Enrollment Period

4.9 years

First QC Date

May 2, 2012

Last Update Submit

October 13, 2015

Conditions

Keywords

developmental disabilitiesschool readinessliteracysocial emotional skillsself regulationcaregiver involvement

Outcome Measures

Primary Outcomes (4)

  • Change in caregiver involvement from baseline to kindergarten entry

    Caregiver reported involvement in early literacy activities and beliefs about the importance of various literacy skills for kindergarten

    pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)

  • Change in early literacy skills from baseline to kindergarten entry

    Standardized measures of early literacy skills including letter naming, phonological awareness and understanding of concepts about print

    pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)

  • Change in social skills from baseline to kindergarten entry

    Standardized direct assessments of the child's responses to social situations as well as parent responses to standardized questionnaires on children's social skills

    pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)

  • Change in regulatory skills from baseline to kindergarten entry

    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

    pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)

Secondary Outcomes (2)

  • Longitudinal academic achievement across grade levels

    post-kindergarten (approximately 1 year post-baseline), post 1st grade (approximately 2 years post-baseline)

  • Longitudinal social competence across grade levels

    post-kindergarten (approximately 1 year post-baseline), post 1st grade (approximately 2 years post-baseline)

Study Arms (2)

KITS Program

EXPERIMENTAL

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

Behavioral: KITS Program

Services as usual

NO INTERVENTION

Families continued to receive any services that they had been receiving in the community.

Interventions

KITS ProgramBEHAVIORAL

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

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

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Social Learning Center

Eugene, Oregon, 97401, United States

Location

Related Publications (2)

  • 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.

    BACKGROUND
  • 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.

    PMID: 24676874BACKGROUND

Related Links

MeSH Terms

Conditions

Developmental DisabilitiesLiteracySelf-Control

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersCommunicationBehaviorSocial Behavior

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
Research Scientist

Study Record Dates

First Submitted

May 2, 2012

First Posted

May 8, 2012

Study Start

April 1, 2008

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

October 15, 2015

Record last verified: 2015-10

Locations