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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Math Learning Disability; Reading Learning Disability
• Intervention / Treatment: Behavioral: Coordinated Intervention; Behavioral: Reading Intervention; Behavioral: Math Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 334
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coordinated Reading and Math Intervention; 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.	Behavioral: Coordinated Intervention; 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.
Active Comparator: Reading Intervention; 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.	Behavioral: Reading Intervention; 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.
Active Comparator: Math Intervention; Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill.	Behavioral: Math Intervention; Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge & counting strategies to build arithmetic skill.
No Intervention: Business-as-usual Control; Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	an average of 25 weeks
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.	an average of 25 weeks
Arithmetic Combinations Fluency - Addition (Fuchs et al., 2013)	Students have 1 minute to write answers to 25 addition items (sums 5-12).	an average of 25 weeks
Arithmetic Combinations Fluency - Subtraction (Fuchs et al., 2013)	Students have 1 minute to write answers to 25 subtraction items (minuends 5-12).	an average of 25 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	an average of 25 weeks
WRAT-4-Arithmetic (Wilkinson, & Robertson, 2006)	Children complete calculation problems of increasing difficulty (10 minutes).	an average of 25 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comprehensive Test of Phonological Processing (CTOPP; Wagner et al., 2013)-Elision	Students say words with a constituent part removed from the words.	an average of 25 weeks
CTOPP-Sound Matching	Children see words and for each say which of 3 words (shown as pictures) start/end with the same sound.	an average of 25 weeks
SWAN Attentive Behavior Rating Scale (J. Swanson, 2004)	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.	an average of 25 weeks
The Grit Scale (Duckworth & Quinn, 2009)-grade 1	Students rate their own beliefs concerning perseverance in learning. The grade 1 adaptation simplifies language and situates questions entirely in terms of reading & math.	an average of 25 weeks
Rating Scale of Effort & Motivation (Malone & Fuchs, 2014)	Teachers rate items assessing students' effort and motivation.	an average of 25 weeks
Working Memory Test Battery for Children - Nonword List Recall (WMTB-C; Pickering & Gathercole, 2001)	Children repeat stimuli spoken by the tester in the same order. Trials correct is the score.	an average of 25 weeks
Test of First-Grade Reading Comprehension (Fuchs, Fuchs, Craddock, & Lehman, 2017).	Children read short passages aloud and answer open-ended literal and inferential questions. Number correct is the score.	an average of 25 weeks
Test of First-Grade Math Word Problems (Fuchs, Seethaler, & Craddock, 2009)	Children listen words problem read aloud to them, while they see the text, and find solutions.Number correct is the score.	an average of 25 weeks

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Douglas Fuchs, Ph.D., Vanderbilt University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2019
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: June 13, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Specific Learning Disorder; Learning Disabilities; Dyscalculia
• Other Study ID Numbers: 180633

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No