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Early Childhood LiteracyNCT01905332

Preschool Literacy Screening: Validating a 5 Question Survey Using the GRTR-R and the Efficacy of Literacy-promoting Interventions

A study testing Literacy promoting home based program and Literacy Toolkit in people with Early Childhood Literacy, run by Nationwide Children's Hospital at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 4 to 5 yearsHealthy volunteers can take part
Conditions the study is for
Early Childhood Literacy
What is being tested?
Literacy promoting home based program and Literacy Toolkit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jul 2013to Sep 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 5 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • Known developmental delays, visual/auditory or cognitive deficits that preclude child's participation, lack of proficiency in English.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Nationwide Children's Hospital Main Campus Primary Care Centers

    Columbus, Ohio

Other trials in United States

About this study

Official title: Preschool Literacy Screening: Validating a 5 Question Survey Using the GRTR-R and Evaluation of the Efficacy of Literacy-promoting Interventions.

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.

Read the detailed 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.

Being tested
Literacy promoting home based program, Literacy Toolkit

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Literacy promoting home based programOther

    The Columbus Metropolitan Library (CML) has an early childhood literacy program, known as Ready to Read. 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. Ready to Read Corp members offer 5-6 home visits at no cost, educating parents on early literacy activities in the home.

  • Literacy ToolkitOther

    Package of books, games, and multi-sensory toys to facilitate the development of emergent literacy skills.

Study groups in NCT01905332
Study groupRoleWhat they receive
Literacy promoting home based programExperimentalThose 4 year old children who fall below the cutoff score on the literacy screening will be randomized to either receive standard of care (literacy toolkit) or will be given a referral to a home -based literacy promoting program through the Columbus Metropolitan Library.
Receives: Other: Literacy promoting home based program
Literacy ToolkitActive comparatorChildren who fall below the cut off score on the GRTR-R will be randomized to either receive a literacy toolkit (current standard of care) or a referral to a home based literacy promoting program. The toolkit will contain age-appropriate books and games.
Receives: Other: Literacy Toolkit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Get Ready To Read- Revised score

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionSep 2014 (estimated)
  4. Study completionSep 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01905332
Sponsor's protocol ID
IRB13-00352
Status last verified
Apr 2015
First submitted
18 Jul 2013
Last updated
4 May 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Literacy promoting home based program and Literacy Toolkit in people with Early Childhood Literacy, run by Nationwide Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Get Ready To Read- Revised score (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.

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