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

March 1, 2026 updated by: Doug Fuchs, Vanderbilt University
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

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

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

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.
385

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

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 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

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: Single

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: 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

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
Word Reading Fluency-2 (Zumeta et al., 2012)
Time Frame: an average of 25 weeks
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. Student's score is the number of words read correctly. Two forms are given, and student's final score is the average score on the two forms.
an average of 25 weeks
Sight Word Efficiency (TOWRE2; Wagner et al., 2012)
Time Frame: an average of 25 weeks
Students have 45 seconds to read a list of words beginning with very simple words followed by words of increasing difficulty. Student's score is the number of words read correctly.
an average of 25 weeks
Woodcock-Johnson IV - Letter Word Identification (Woodcock-Johnson 2014).
Time Frame: an average of 25 weeks
Students read aloud letters followed by simple words followed by words of increasing difficulty. Test ends when after six incorrect responses. Student's score is the number of correct responses.
an average of 25 weeks
Arithmetic Combinations Fluency (Fuchs et al., 2003)
Time Frame: an average of 25 weeks
Students have 1 minute to write answers for 25 addition items; same for 25 subtraction items (sums & minuends 5-12). Student's score is number correct across all 50 items.
an average of 25 weeks
Double-Digit Calculations Fluency (Fuchs et al., 2003)
Time Frame: an average of 25 weeks
Students have 10 min to write answers to 20 addition problems with 2-digit addends without regrouping and 20 subtraction problems with double-digit minuends and subtrahends without regrouping. The score is number correct across all 40 items.
an average of 25 weeks
Woodcock-Johnson IV - Calculations (Woodcock-Johnson 2014)
Time Frame: an average of 25 weeks
Students solve mathematical computation problems beginning with simple basic facts followed by problems of increasing difficulty. Test ends when the student misses 6 consecutive problems. Student's score is the number of correct responses.
an average of 25 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
Wide Range Achievement Test-4-Reading (WRAT4; Wilkinson, & Robertson, 2006)
Time Frame: an average of 25 weeks
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)
Time Frame: an average of 25 weeks
Children complete calculation problems of increasing difficulty (10 minutes).
an average of 25 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comprehensive Test of Phonological Processing (CTOPP; Wagner et al., 2013)-Elision
Time Frame: an average of 25 weeks
Students say words with a constituent part removed from the words.
an average of 25 weeks
CTOPP-Sound Matching
Time Frame: an average of 25 weeks
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)
Time Frame: an average of 25 weeks
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
Time Frame: an average of 25 weeks
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)
Time Frame: an average of 25 weeks
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)
Time Frame: an average of 25 weeks
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).
Time Frame: an average of 25 weeks
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)
Time Frame: an average of 25 weeks
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

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.
Vanderbilt 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: Douglas Fuchs, Ph.D., Vanderbilt University

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.
November 11, 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.
May 20, 2025

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.
May 20, 2025

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).
June 13, 2019

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.
June 17, 2019

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.
June 19, 2019

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.
March 23, 2026

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.
March 1, 2026

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.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 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

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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