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Improving the Academic Performance of First-Grade Students With Reading and Math Difficulty

Primary Purpose

Reading Learning Disability, Math Learning Disability

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reading Intervention
Math Intervention
Coordinated Intervention
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reading Learning Disability

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Attends a participating school in the Metropolitan-Nashville Public Schools
  • Is a member of a first-grade classroom whose teacher has agreed to let his/her students participate
  • Has the available school schedule to participate
  • Has adequate English proficiency to be reliably assessed in English on study entry screening measures
  • Scores at or below the 25th percentile on the study's screening math test
  • Scores at or below the 25th percentile on the study's screening reading test
  • Scores at or above the 7th percentile on at least one of the study's two measures of cognitive performance

Exclusion Criterion:

  • Does not attend a participating school in the Metropolitan-Nashville Public Schools
  • Is not a member of a first-grade classroom whose teacher has agreed to let his/her students participate
  • Does not have the available school schedule to participate
  • Does not have adequate English proficiency to be reliably assessed in English on study entry screening measures
  • Scores above the 25th percentile on the study's screening math test
  • Scores above the 25th percentile on the study's screening reading test
  • Scores below the 7th percentile on both of the study's two measures of cognitive performance

Sites / Locations

  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

No Intervention

Arm Label

Coordinated Reading and Math Intervention

Reading Intervention

Math Intervention

Business-as-usual Control

Arm Description

Coordinated intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction addressing similar skills as those addressed in the reading intervention arm & similar skills as the math intervention arm.

Reading intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction designed to build skill on letter-sound associations, decoding, sight words, & contextualized reading.

Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill.

Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program.

Outcomes

Primary Outcome Measures

Word Reading Fluency-2 (Zumeta et al., 2012)
Students have 1 min to read 60 words randomly sampled/presented in bands of 5 words from most frequent words; then from next-most frequent words; etc.). If students finish before 1 min, the score is prorated. Two alternate forms are administered.
Test of Word Reading Efficiency-Sight Word Efficiency
The tester shows a word list ordered in increasing difficulty; children read as many words as they can in 45 seconds.
Arithmetic Combinations Fluency - Addition (Fuchs et al., 2013)
Students have 1 minute to write answers to 25 addition items (sums 5-12).
Arithmetic Combinations Fluency - Subtraction (Fuchs et al., 2013)
Students have 1 minute to write answers to 25 subtraction items (minuends 5-12).

Secondary Outcome Measures

Wide Range Achievement Test-4-Reading (WRAT4; Wilkinson, & Robertson, 2006)
Students read words ordered in difficulty (no time limit; testing ends after 10 consecutive errors).
WRAT-4-Arithmetic (Wilkinson, & Robertson, 2006)
Children complete calculation problems of increasing difficulty (10 minutes).

Full Information

First Posted
June 13, 2019
Last Updated
October 10, 2023
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT03991234
Brief Title
Improving the Academic Performance of First-Grade Students With Reading and Math Difficulty
Official Title
Improving the Academic Performance of First-Grade Students With Reading and Math Difficulty
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 11, 2019 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of this clinical trials is to explore short-term effects of coordinated intervention versus the business-as-usual school program on the primary endpoints of post-intervention word-reading fluency and arithmetic fluency. The study population is students who begin 1st grade with delays in word reading and calculations. Students who meet entry criteria are randomly assigned to coordinated intervention across reading and math, reading intervention, math intervention, and a business-as-usual control group (schools' typical program). The 3 researcher-delivered interventions last 15 weeks (3 sessions per week; 30 minutes per session). Students in all 4 conditions are tested before researcher-delivered intervention begins and after it ends.
Detailed Description
First-grade students who meet study entry criteria are identified near the start of the school year using a 3-stage screening process. Students who enter the study complete the pretest battery. Then, students are randomly assigned at the individual level to coordinated intervention, reading intervention, math intervention, or a business-as-usual control group (the schools' typical classroom instruction with supplemental intervention schools choose to provide). Research staff deliver intervention in the coordinated intervention condition, in the reading intervention condition, and in the math intervention condition 1:1 for 15 weeks (three 30-min sessions per week, scheduled in line with teacher input to avoid students missing important content). Adherence to the researcher-delivered interventions is monitored via audio recordings and live observations. The content of each researcher-delivered intervention is aligned with the school district's 1st-grade foundational reading & math learning standards; relies on explicit instruction; and incorporates fluency-building activities word reading and/or arithmetic problems; incorporates procedures designed to build engagement and perseverance. Reading intervention is designed to build skill in letter-sound associations, decoding, sight words, and contextualized reading. Math intervention provides is designed to build number knowledge, counting strategies, and arithmetic skill. Coordinated intervention addresses the same instructional objectives as reading intervention & math intervention. When researcher-delivered intervention ends, students in all four conditions complete the posttest assessment battery. Testers are blind to students' study conditions. Adherence to testing protocols is monitored via audio recordings. The primary endpoints are posttest word-reading fluency and arithmetic fluency.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reading Learning Disability, Math Learning Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
334 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coordinated Reading and Math Intervention
Arm Type
Experimental
Arm Description
Coordinated intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction addressing similar skills as those addressed in the reading intervention arm & similar skills as the math intervention arm.
Arm Title
Reading Intervention
Arm Type
Active Comparator
Arm Description
Reading intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction designed to build skill on letter-sound associations, decoding, sight words, & contextualized reading.
Arm Title
Math Intervention
Arm Type
Active Comparator
Arm Description
Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill.
Arm Title
Business-as-usual Control
Arm Type
No Intervention
Arm Description
Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program.
Intervention Type
Behavioral
Intervention Name(s)
Reading Intervention
Intervention Description
Reading intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction to build skill on letter-sound associations, decoding, sight words, & contextualized reading.
Intervention Type
Behavioral
Intervention Name(s)
Math Intervention
Intervention Description
Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge & counting strategies to build arithmetic skill.
Intervention Type
Behavioral
Intervention Name(s)
Coordinated Intervention
Intervention Description
Coordinated intervention provides 15 weeks (30-minute sessions per week) of explicit instruction addressing the similar skills as in the reading intervention arm & similar objectives as the math intervention arm.
Primary Outcome Measure Information:
Title
Word Reading Fluency-2 (Zumeta et al., 2012)
Description
Students have 1 min to read 60 words randomly sampled/presented in bands of 5 words from most frequent words; then from next-most frequent words; etc.). If students finish before 1 min, the score is prorated. Two alternate forms are administered.
Time Frame
an average of 25 weeks
Title
Test of Word Reading Efficiency-Sight Word Efficiency
Description
The tester shows a word list ordered in increasing difficulty; children read as many words as they can in 45 seconds.
Time Frame
an average of 25 weeks
Title
Arithmetic Combinations Fluency - Addition (Fuchs et al., 2013)
Description
Students have 1 minute to write answers to 25 addition items (sums 5-12).
Time Frame
an average of 25 weeks
Title
Arithmetic Combinations Fluency - Subtraction (Fuchs et al., 2013)
Description
Students have 1 minute to write answers to 25 subtraction items (minuends 5-12).
Time Frame
an average of 25 weeks
Secondary Outcome Measure Information:
Title
Wide Range Achievement Test-4-Reading (WRAT4; Wilkinson, & Robertson, 2006)
Description
Students read words ordered in difficulty (no time limit; testing ends after 10 consecutive errors).
Time Frame
an average of 25 weeks
Title
WRAT-4-Arithmetic (Wilkinson, & Robertson, 2006)
Description
Children complete calculation problems of increasing difficulty (10 minutes).
Time Frame
an average of 25 weeks
Other Pre-specified Outcome Measures:
Title
Comprehensive Test of Phonological Processing (CTOPP; Wagner et al., 2013)-Elision
Description
Students say words with a constituent part removed from the words.
Time Frame
an average of 25 weeks
Title
CTOPP-Sound Matching
Description
Children see words and for each say which of 3 words (shown as pictures) start/end with the same sound.
Time Frame
an average of 25 weeks
Title
SWAN Attentive Behavior Rating Scale (J. Swanson, 2004)
Description
Teachers rate 9 items from the DSM criteria for Attention Deficit Hyperactivity Disorder for inattention, each on a 7-point scale. The score is the sum of the 9 ratings.
Time Frame
an average of 25 weeks
Title
The Grit Scale (Duckworth & Quinn, 2009)-grade 1
Description
Students rate their own beliefs concerning perseverance in learning. The grade 1 adaptation simplifies language and situates questions entirely in terms of reading & math.
Time Frame
an average of 25 weeks
Title
Rating Scale of Effort & Motivation (Malone & Fuchs, 2014)
Description
Teachers rate items assessing students' effort and motivation.
Time Frame
an average of 25 weeks
Title
Working Memory Test Battery for Children - Nonword List Recall (WMTB-C; Pickering & Gathercole, 2001)
Description
Children repeat stimuli spoken by the tester in the same order. Trials correct is the score.
Time Frame
an average of 25 weeks
Title
Test of First-Grade Reading Comprehension (Fuchs, Fuchs, Craddock, & Lehman, 2017).
Description
Children read short passages aloud and answer open-ended literal and inferential questions. Number correct is the score.
Time Frame
an average of 25 weeks
Title
Test of First-Grade Math Word Problems (Fuchs, Seethaler, & Craddock, 2009)
Description
Children listen words problem read aloud to them, while they see the text, and find solutions.Number correct is the score.
Time Frame
an average of 25 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Attends a participating school in the Metropolitan-Nashville Public Schools Is a member of a first-grade classroom whose teacher has agreed to let his/her students participate Has the available school schedule to participate Has adequate English proficiency to be reliably assessed in English on study entry screening measures Scores at or below the 25th percentile on the study's screening math test Scores at or below the 25th percentile on the study's screening reading test Scores at or above the 7th percentile on at least one of the study's two measures of cognitive performance Exclusion Criterion: Does not attend a participating school in the Metropolitan-Nashville Public Schools Is not a member of a first-grade classroom whose teacher has agreed to let his/her students participate Does not have the available school schedule to participate Does not have adequate English proficiency to be reliably assessed in English on study entry screening measures Scores above the 25th percentile on the study's screening math test Scores above the 25th percentile on the study's screening reading test Scores below the 7th percentile on both of the study's two measures of cognitive performance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Fuchs, Ph.D.
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Research staff will make de-identified data sets electronically available to external users under a data-sharing agreement providing the user's commitment to use data for the research purposes described in the user's request; assurance that no research participant will be identified for any purpose; a commitment to securing the data; a commitment to not transferring data to other users & destroying the data after analyses are complete; & guarantees publications are credited to grant/agency and entered in PubMed. Once the user signs and returns the Agreement Form, a database with the variables of interest and codebook are provided, and staff provide relevant, de-identified data and segments of the code book with variable names/values, notes clarifying scoring/data-reduction methods not otherwise available, and a technical report describing the sample, study, and procedures.
IPD Sharing Time Frame
The de-identified (stripped) primary outcome data set will become available no later than acceptance for publication of the main findings from the final data set and remain accessible for 3 years following the closeout of this grant. This time frame for data accessibility will be reviewed at the proposed project's completion and revised as needed. If all Investigators leave or become unavailable, the last remaining Investigator will assume responsibility for identifying a Vanderbilt faculty member to undertake these responsibilities.
IPD Sharing Access Criteria
The user submits a request describing variables of interest, research aims, & quantitative methods and signs a user agreement form (see Plan Description).

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Improving the Academic Performance of First-Grade Students With Reading and Math Difficulty

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