LiteracyNCT03644914
Enhancing Reading Skills in 1st Grade Children
A study testing 10-week Reading Program in people with Literacy, run by Columbia University at 1 site in United States.
Trial summary
The purpose of the present study is to assess a reading intervention for first graders who are identified by their teachers as reading below grade level. The intervention addresses reading skills through a variety of techniques including games, play, movement exercises, music, and breaks to enhance literacy skills and… Read more about this study
- Who is it for?
- Ages 6 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Literacy
- What is being tested?
- 10-week Reading Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2019to 30 Jun 2019
- 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 6 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Enrolled in a NYC elementary school in 1st grade
- Between 6-7 years old
- Identified by teachers as reading below 1st grade level
Who cannot join
- Children with severe behavioral problems making cooperation with intervention procedures difficult
Trial locations and contacts
1 site in 1 country.
United States1 site
NYC Elementary Public School (recruitment location)
New York, New York, 10037
About this study
Official title: Enhancing Reading Skills in 1st Grade Children Identified as Reading Below Grade Level
The purpose of the present study is to assess a reading intervention for first graders who are identified by their teachers as reading below grade level. The intervention addresses reading skills through a variety of techniques including games, play, movement exercises, music, and breaks to enhance literacy skills and reduce frustration commonly accompanying sight word recognition and phonemic decoding.
Over half of elementary school students in the United States are reading below grade level compared to their same age peers. Children with poor reading skills are more likely to experience academic and behavioral problems. When students are not reading at grade level by 4th grade, they are more likely to experience future academic failure, school dropout, juvenile delinquency, teenage pregnancy, and under- or unemployment in adulthood. Traditional methods of classroom large group instruction require children to sit quietly and concentrate on small print for extended periods of time. Many children experience frustration and agitation in response to such reading demands.
Read the detailed description
The National Assessment of Educational Progress estimates that only 35% of fourth graders in the United States are able to read at or above grade level. Children's future academic success is accurately predicted by performance in the first three years of school. A student is four times more likely to drop out of high school if he or she is not reading proficiently by the end of third grade. High school dropouts are three times more likely to be unemployed than college graduates per US Bureau of Labor Statistics in 2018, and those who are employed earn an average of 61% less over the course of their lifetimes compared to their college-educated peers per US Census Bureau in 2012. Eighty-five percent of juveniles facing trial in the court system are functionally illiterate per National Criminal Justice Reference Service in 2003, and adolescent girls with low literacy skills are five times more likely to become pregnant than teenagers who can read at or above grade level.
Despite the preponderance of data expounding a literacy crisis in the US, the status quo of reading instruction in US elementary schools has not been effective in remediating functional illiteracy. In classrooms averaging 21.6 students, teachers are unable to provide the individualized instruction that is necessary to meet the learning needs of at-risk students. Reading specialists who work with children one-on-one and in small groups employ methods similar to those of classroom teachers, requiring children to sit quietly and sustain their attention on small print. These demands are difficult for children experiencing challenges with self-regulation, and school environments requiring these behaviors for several hours each day may inculcate feelings of frustration and failure in the children who most need to develop a sense of self-efficacy as readers with full membership in the world of print. In this study, twenty-four first graders will be assigned by chance to a reading or no-reading group.
- Conditions
- Literacy
- Being tested
- 10-week Reading Program
- Keywords
- Reading, 1st grade, Literacy
- Medical subject headings
- Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10-week Reading ProgramBehavioural
Intervention sessions will be carried out during the school day in a private school room. In each session, the investigator will work with the child individually to help him or her read better. Intervention will incorporate word recognition and phonetic decoding of words established as meeting 1st grade essential literacy standards. Learning techniques will involve games, play, movement, music, and breaks (i.e., the child is able to move about and associate words with color, video, and music. Three 5-minute breaks will be integrated into each 1-hour session to allow the child time to rest and process learned material). Intervention will also use each child's personal interests as a context around which sight words will be learned.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Reading Program) | Experimental | First graders who will receive the 10-week reading program (a total of 20 hours), twice weekly in 1-hour sessions, and will continue to receive typical classroom reading instruction. Receives: Behavioral: 10-week Reading Program |
| Control Group | No intervention | First graders who will not take part in the reading program but will continue to receive typical classroom reading instruction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Test of Word Reading Efficiency (TOWRE) Score
The TOWRE is a measure of reading fluency and accuracy for both children and adults. The instrument consists of two subtests: sight word efficiency (108 word items) and phonemic decoding efficiency (66 word items). The subtests can be scored separately or aggregately for a total score. Scores are calculated based on the number of total words read correctly in a 45 second period. Administration requires approximately 10 minutes.
Measured: Post-intervention (10 weeks)
Secondary outcomes (1)
Change in Inventory of Reading Occupations (IRO) Score
The IRO is an 85-item assessment that measures a child's level of reading participation in 17 categories (storybooks, school books, school worksheets, chalk and white boards, posters, comic books, magazines, computers, e-readers, smart phones, television shows, game consoles, board games, labels, community signs and symbols, bulletin boards, and notebooks). Using a 5-item Likert scale, the 17 categories are measured with regard to (1) five separate reading dimensions (preference, mastery, frequency, contexts an environments, social support, and available resources), (2) three physical contexts (home, school, and community), and (3) five social contexts (reading with parents, other family members, friends, classmates, and teachers). Administration requires approximately 15 minutes.
Measured: Post-intervention (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start15 Feb 2019
- Primary completion21 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LiteracyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention will take place in a New York City (NYC) elementary school. 24 first graders, identified by their teachers as reading below grade level, will be randomized to an intervention or control group. The 12 participants randomized to the intervention group will receive the 10-week reading program, twice weekly in 1-hour sessions. The Co-I and child will work together in individual sessions on sight recognition and phonetic decoding of words established as meeting 1st grade essential literacy standards. Intervention will incorporate word recognition and phonetic decoding within the context of games and play in which the child is able to move about and associate words with color, video, and music. Intervention will also use each child's personal interests as a context around which sight words will be learned. Control group participants will not receive intervention. Both the intervention and control group participants will continue to receive typical classroom reading instruction.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Gutman, Columbia University
- Investigators
- Sharon Gutman, MD, Principal investigator, Professor of Rehabilitation and Regenerative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644914
- Sponsor's protocol ID
- AAAR8813
- Status last verified
- Jul 2019
- First submitted
- 21 Aug 2018
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bennett IM, Frasso R, Bellamy SL, Wortham S, Gross KS. Pre-teen literacy and subsequent teenage childbearing in a US population. Contraception. 2013 Apr;87(4):459-64. doi: 10.1016/j.contraception.2012.08.020. Epub 2012 Dec 11.
PubMed 23245352
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Reading Skills in 1st Grade Children Identified as Reading Below Grade Level
- ClinicalTrials.gov ID
- NCT03644914
- Acronym / sponsor ID
- AAAR8813
- Conditions
- Literacy
- Keywords
- Reading, 1st grade, Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 23 Aug 2018 (actual)
- 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.
The purpose of the present study is to assess a reading intervention for first graders who are identified by their teachers as reading below grade level. The intervention addresses reading skills through a variety of techniques including games, play, movement exercises, music, and breaks to enhance literacy skills and reduce frustration commonly accompanying sight word recognition and phonemic decoding.
Over half of elementary school students in the United States are reading below grade level compared to their same age peers. Children with poor reading skills are more likely to experience academic and behavioral problems. When students are not reading at grade level by 4th grade, they are more likely to experience future academic failure, school dropout, juvenile delinquency, teenage pregnancy, and under- or unemployment in adulthood. Traditional methods of classroom large group instruction require children to sit quietly and concentrate on small print for extended periods of time. Many children experience frustration and agitation in response to such reading demands.
Detailed description
The National Assessment of Educational Progress estimates that only 35% of fourth graders in the United States are able to read at or above grade level. Children's future academic success is accurately predicted by performance in the first three years of school. A student is four times more likely to drop out of high school if he or she is not reading proficiently by the end of third grade. High school dropouts are three times more likely to be unemployed than college graduates per US Bureau of Labor Statistics in 2018, and those who are employed earn an average of 61% less over the course of their lifetimes compared to their college-educated peers per US Census Bureau in 2012. Eighty-five percent of juveniles facing trial in the court system are functionally illiterate per National Criminal Justice Reference Service in 2003, and adolescent girls with low literacy skills are five times more likely to become pregnant than teenagers who can read at or above grade level.
Despite the preponderance of data expounding a literacy crisis in the US, the status quo of reading instruction in US elementary schools has not been effective in remediating functional illiteracy. In classrooms averaging 21.6 students, teachers are unable to provide the individualized instruction that is necessary to meet the learning needs of at-risk students. Reading specialists who work with children one-on-one and in small groups employ methods similar to those of classroom teachers, requiring children to sit quietly and sustain their attention on small print. These demands are difficult for children experiencing challenges with self-regulation, and school environments requiring these behaviors for several hours each day may inculcate feelings of frustration and failure in the children who most need to develop a sense of self-efficacy as readers with full membership in the world of print. In this study, twenty-four first graders will be assigned by chance to a reading or no-reading group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention will take place in a New York City (NYC) elementary school. 24 first graders, identified by their teachers as reading below grade level, will be randomized to an intervention or control group. The 12 participants randomized to the intervention group will receive the 10-week reading program, twice weekly in 1-hour sessions. The Co-I and child will work together in individual sessions on sight recognition and phonetic decoding of words established as meeting 1st grade essential literacy standards. Intervention will incorporate word recognition and phonetic decoding within the context of games and play in which the child is able to move about and associate words with color, video, and music. Intervention will also use each child's personal interests as a context around which sight words will be learned. Control group participants will not receive intervention. Both the intervention and control group participants will continue to receive typical classroom reading instruction.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Reading Program) | Experimental | Behavioral: 10-week Reading ProgramFirst graders who will receive the 10-week reading program (a total of 20 hours), twice weekly in 1-hour sessions, and will continue to receive typical classroom reading instruction. |
| Control Group | No intervention | –First graders who will not take part in the reading program but will continue to receive typical classroom reading instruction. |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Enrolled in a NYC elementary school in 1st grade
- Between 6-7 years old
- Identified by teachers as reading below 1st grade level
Key exclusion criteria (1 listed)
- Children with severe behavioral problems making cooperation with intervention procedures difficult
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 |
|---|---|---|
| 10-week Reading ProgramIntervention sessions will be carried out during the school day in a private school room. In each session, the investigator will work with the child individually to help him or her read better. Intervention will incorporate word recognition and phonetic decoding of words established as meeting 1st grade essential literacy standards. Learning techniques will involve games, play, movement, music, and breaks (i.e., the child is able to move about and associate words with color, video, and music. Three 5-minute breaks will be integrated into each 1-hour session to allow the child time to rest and process learned material). Intervention will also use each child's personal interests as a context around which sight words will be learned. | Behavioural | Intervention Group (Reading Program) |
Primary outcome
Change in Test of Word Reading Efficiency (TOWRE) Score
Time frame: Post-intervention (10 weeks)
The TOWRE is a measure of reading fluency and accuracy for both children and adults. The instrument consists of two subtests: sight word efficiency (108 word items) and phonemic decoding efficiency (66 word items). The subtests can be scored separately or aggregately for a total score. Scores are calculated based on the number of total words read correctly in a 45 second period. Administration requires approximately 10 minutes.
1 secondary outcome
Change in Inventory of Reading Occupations (IRO) Score
Time frame: Post-intervention (10 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Background: PubMed 23245352Bennett IM, Frasso R, Bellamy SL, Wortham S, Gross KS. Pre-teen literacy and subsequent teenage childbearing in a US population. Contraception. 2013 Apr;87(4):459-64. doi: 10.1016/j.contraception.2012.08.020. Epub 2012 Dec 11.
- Hernandez, D. J. (2012). Double jeopardy: How third-grade reading skills and poverty influence high school graduation.Link provided by the sponsor.
- National Center for Educational Statistics. (2012). Schools and staffing survey.Link provided by the sponsor.
- Nation's Report Card. (2017). Data tools: State performance compared to the nation.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Sharon Gutman, MD principal investigator
Professor of Rehabilitation and Regenerative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10-week Reading Program in people with Literacy, run by Columbia University 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 3 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: finished, as of the sponsor's last update on 9 Jul 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Test of Word Reading Efficiency (TOWRE) Score (time frame: Post-intervention (10 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03644914, which also lists 1 linked publication.
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 9 Jul 2019.