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.
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
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:
- Answering When and Why Questions - A child who can accurately respond to questions has a better understanding of what he or she is learning.
- Repeating Sentences - A child who can repeat back a spoken sentence can remember information
- Identifying Rhyming Words - A child who can recognize rhyme patterns in words has a good understanding of sound in language.
- Producing Rhyming Words - A child who can play with sounds will be more comfortable with reading and writing.
- 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:
- To validate the use of the 5-item Early Literacy Screener questionnaire in screening preschool children for reading problems
- 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.
- 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.
- Conditions
- Early Childhood Literacy
- 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 group | Role | What they receive |
|---|---|---|
| Literacy promoting home based program | Experimental | Those 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 Toolkit | Active comparator | Children 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.
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.
- First posted23 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Caldwell, Nationwide Children's Hospital
- Investigators
- Nicole V Caldwell, MD, Principal investigator, Nationwide Children's HospitalClaudia Barrett, Principal investigator, Nationwide Children's Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preschool Literacy Screening: Validating a 5 Question Survey Using the GRTR-R and Evaluation of the Efficacy of Literacy-promoting Interventions.
- ClinicalTrials.gov ID
- NCT01905332
- Acronym / sponsor ID
- IRB13-00352
- Conditions
- Early Childhood Literacy
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Answering When and Why Questions - A child who can accurately respond to questions has a better understanding of what he or she is learning.
- Repeating Sentences - A child who can repeat back a spoken sentence can remember information
- Identifying Rhyming Words - A child who can recognize rhyme patterns in words has a good understanding of sound in language.
- Producing Rhyming Words - A child who can play with sounds will be more comfortable with reading and writing.
- 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:
- To validate the use of the 5-item Early Literacy Screener questionnaire in screening preschool children for reading problems
- 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.
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Literacy promoting home based program | Experimental | Other: Literacy promoting home based programThose 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. |
| Literacy Toolkit | Active comparator | Other: Literacy ToolkitChildren 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. |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Known developmental delays, visual/auditory or cognitive deficits that preclude child's participation, lack of proficiency in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Literacy promoting home based programThe 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. | Other | Literacy promoting home based program |
| Literacy ToolkitPackage of books, games, and multi-sensory toys to facilitate the development of emergent literacy skills. | Other | Literacy Toolkit |
Primary outcome
Get Ready To Read- Revised score
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
Related trials for Early Childhood Literacy
Not yet recruiting
Self-Concept Reinforcement for Early School Readiness
Child Behavior, Child Behavior Problem
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole V Caldwell, MD principal investigator
Nationwide Children's Hospital
Claudia Barrett principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
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.