NCT03644914

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

February 15, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2019

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

July 9, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

August 21, 2018

Last Update Submit

July 8, 2019

Conditions

Keywords

Reading1st gradeLiteracy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Post-intervention (10 weeks)

Secondary Outcomes (1)

  • Change in Inventory of Reading Occupations (IRO) Score

    Post-intervention (10 weeks)

Study Arms (2)

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.

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.

Interventions

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.

Intervention Group (Reading Program)

Eligibility Criteria

Age6 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYC Elementary Public School (recruitment location)

New York, New York, 10037, United States

Location

Related Publications (1)

  • 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.

    PMID: 23245352BACKGROUND

Related Links

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Sharon Gutman, MD

    Professor of Rehabilitation and Regenerative Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 23, 2018

Study Start

February 15, 2019

Primary Completion

June 21, 2019

Study Completion

June 30, 2019

Last Updated

July 9, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations