Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT01905332 |
| Other study ID # |
IRB13-00352 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
July 18, 2013 |
| Last updated |
April 30, 2015 |
| Start date |
July 2013 |
| Est. completion date |
September 2014 |
Study information
| Verified date |
April 2015 |
| Source |
Nationwide Children's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
This study's aim is to validate a parent-completed brief literacy screening tool (Early
Literacy Screener) at the 4 year well child check using the Get Ready to Read- Revised
screening tool as a gold standard. Four year old children who fall below the cutoff score
for the GRTR-R will be randomized to either receive current standard of care (control group)
or a referral to receive a 6 month home based literacy promoting program (intervention
group). After 6 months, both groups will be retested using the GRTR-R. The hypothesis is
that the change in raw scores on the GRTR-R in the intervention group after 6 months will be
greater than the change in raw scores in the control group.
Description:
Children's reading success can be predicted from their emergent literacy skills, which begin
to develop during the preschool years. Early identification of delays in the development of
emergent literacy skills offers the opportunity for targeted intervention. The Early
Literacy Screener (ELS) is a 5-item parent questionnaire that was developed for use as a
rapid tool to screen preschool children for early indicators of reading problems. The
verbally administered ELS was previously validated on 4 and 5 year old children using the
Revised Get Ready to Read (GRTR-R) as the gold standard. The investigators are now seeking
to validate the ELS when parents fill it out themselves.
The GRTR-R screener was developed in 2001 by Whitehurst et al at the National Centre for
Learning Disabilities to address the need for a reliable, evidence based screening tool for
use in preschool children. Its reliability and predictive validity have been established in
previous studies carried out in preschools and Head Start programs.
The logical next step after screening for reading problems is to establish literacy
promoting interventions. Different literacy intervention programs aimed at improving school
readiness exist within different communities. The interventions vary widely in intensity and
content, and the efficacy of these programs has not yet been well established.
Currently standard care within the Primary Care Network includes the Reach Out and Read
Program. Reach Out and Read (ROR) is a clinical based pediatric literacy program that
partners with pediatricians who prescribe new books to children 6 months to 5 years of age
during routine well-child visits. By integrating literacy into each well-child visit,
pediatricians promote the acquisition of spoken and written language skills in young
children. Starting at 6 months of age, each child coming in for their well-child visit
receives a new age appropriate book from their pediatrician. Pediatricians use the book to
assess language, motor, and cognitive development while discussing with the parent the value
of reading together at home. In addition, at each 4 year old visit instead of a book the
family will receives a parent take home toolkit. This toolkit will contain kindergarten
readiness activities and a book that will help parents prepare their child for kindergarten.
The Columbus Metropolitan Library (CML) has an early childhood literacy program, known as
Ready to Read. This program reaches out into the community through the Ready to Read Corps
who goes into at-risk communities and works with agencies such as pediatric health centers,
food pantries and benefits offices. It aims to reach parents and caregivers of children
birth to five and share easy literacy-building activities that parents can use at home with
their children. Parents and caregivers receive a kit that includes puppets, board books, and
easy tips for parents to support them in their role as their child's first teacher. Parents
are able to enroll in the Ready to Read home visitation program. Ready to Read Corp members
offer 5-6 home visits at no cost, educating parents on early literacy activities in the
home.
SPARK (Spheres of Proud Achievement in Reading for Kids) is a home-based, family-focused
kindergarten-readiness program that is available in many communities in Ohio. It works
collaboratively with families, schools, and the community. Each month, children receive a
new book, a lesson activity, and educational supplies, and participate in home- or
group-based learning opportunities—all with the goal of increasing the child's success in
school and life.
These community based literacy intervention programs aim to improve Kindergarten literacy
skills and school readiness. The Ohio Department of Education utilizes an assessment tool
known as the KRA-L (Kindergarten Readiness Assessment - Literacy) to identify children in
need of intervention. This test is administered statewide to all children entering
kindergarten in public and community school districts for the first time. The investigators
are using the KRA-L scores as one of the outcome measures in this study. This assessment is
broken down into three bands which guides decisions about further assessment and
instruction.
Band 1 (0-13) assess broadly for intense instruction Band 2 (14-23) assess for targeted
instruction Band 3 (24-29) assess for enriched assessment
By law, it must be administered no sooner than four weeks prior to the start of school but
not later than October 1. It tests the following skills:
1. Answering When and Why Questions - A child who can accurately respond to questions has
a better understanding of what he or she is learning.
2. Repeating Sentences - A child who can repeat back a spoken sentence can remember
information
3. Identifying Rhyming Words - A child who can recognize rhyme patterns in words has a
good understanding of sound in language.
4. Producing Rhyming Words - A child who can play with sounds will be more comfortable
with reading and writing.
5. Recognizing Capital and Lower Case Letters - The ability to name the letters of the
alphabet is a strong predictor of reading success.
Aim: To scientifically validate a system of pediatric office based literacy screening and
assess efficacy of community based literacy interventions.
Objectives:
1. To validate the use of the 5-item Early Literacy Screener questionnaire in screening
preschool children for reading problems
2. To assess the efficacy of referrals by the doctor to various community-based
interventions available to 4-year-old children identified as having a risk of later
reading problems using a randomized controlled trial.
3. To assess the efficacy of the community-based interventions themselves in improving
emergent literacy skills in 4-year-old children identified as having a risk of later
reading problems using a randomized controlled trial.
Inclusion Criteria: All 4 year old children who are typically developing and English
speaking attending well child care at the Main Campus Primary Care Clinic at Nationwide
Children's Hospital.
Exclusion Criteria: Known developmental delays, visual/auditory or cognitive deficits that
preclude child's participation, lack of proficiency in English.
Study Methodology:
Children will be recruited from the Main Campus at Nationwide Children's Hospital. Age
eligible families will be identified at the time of check-in and the research assistants
(RA) will approach them and explain the study to them and obtain informed consent. Parents
will also be asked for permission to obtain KRA-L (Kindergarten Readiness Assessment -
Literacy) scores from the school districts.
Consent for participation in a randomized control trial of interventions will be obtained
from families with 4-year-old children.
Parents will complete the 5-item Early Literacy Screener (ELS) questionnaire and the
children will be screened with the 25-item Get Ready to Read-Revised (GRTR-R) Screener. The
scores for the ELS and GRTR-R will be computed and conveyed to the parents. All children
participating in the study will receive a Literacy Toolkit, with literacy information and
activities and a list of community and library resources.
Children aged 4 years 0 months to 4 years 11 months, who fail the GRTR-R will be eligible to
participate in a randomized control trial to assess the efficacy of available interventions.
Families that consent to participate in this part of the study will be randomized into two
groups. The children in the first group will receive the Literacy Toolkit alone, and will
serve as the control group. The children in the second group will receive information about
Ready to Read Corps and will be offered a referral in addition to the Literacy Toolkit.
Children will be invited for follow up after a period of 6 months, when the GRTR-R
assessment will be repeated. KRA-L scores will be obtained from school districts after the
children are enrolled in Kindergarten. At the 6 month follow-up, if a child within our
intervention group fails the GRTR-R a second time, then they will undergo a detailed
developmental assessment. After this assessment, if a developmental delay is not recognized,
they will receive a referral to SPARK.
