Enhancing Reading Skills in 1st Grade Children

July 8, 2019 updated by: Sharon Gutman, Columbia University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10037
        • NYC Elementary Public School (recruitment location)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Enrolled in a NYC elementary school in 1st grade
  • Between 6-7 years old
  • Identified by teachers as reading below 1st grade level

Exclusion Criteria:

  • Children with severe behavioral problems making cooperation with intervention procedures difficult

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group (Reading Program)
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.
Behavioral: 10-week Reading Program
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.
No Intervention: Control Group
First graders who will not take part in the reading program but will continue to receive typical classroom reading instruction.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Post-intervention (10 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Inventory of Reading Occupations (IRO) Score
Time Frame: Post-intervention (10 weeks)
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.
Post-intervention (10 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sharon Gutman, MD, Professor of Rehabilitation and Regenerative Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAR8813

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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