CClinicalTrials.gg
CompletedNCT03991234Updated Mar 23, 2026Results posted

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

An interventional study of Reading Intervention and Math Intervention in Reading Learning Disability and Math Learning Disability, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 6 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-23.

Sponsored by Vanderbilt University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
385
Allocation
Randomized
Ages
6 Years to 8 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Reading Learning Disability
  • Math Learning Disability

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03

Who can participate

Ages eligible
6 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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 criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
385 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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.

Interventions

  • BehavioralReading 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.

  • BehavioralMath Intervention

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

  • BehavioralCoordinated 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.

05

What researchers measure

Primary outcomes

  1. 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. 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.

    Time frame: an average of 25 weeks

  2. Sight Word Efficiency (TOWRE2; Wagner et al., 2012)

    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.

    Time frame: an average of 25 weeks

  3. Woodcock-Johnson IV - Letter Word Identification (Woodcock-Johnson 2014).

    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.

    Time frame: an average of 25 weeks

  4. Arithmetic Combinations Fluency (Fuchs et al., 2003)

    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.

    Time frame: an average of 25 weeks

  5. Double-Digit Calculations Fluency (Fuchs et al., 2003)

    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.

    Time frame: an average of 25 weeks

  6. Woodcock-Johnson IV - Calculations (Woodcock-Johnson 2014)

    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.

    Time frame: an average of 25 weeks

06

Results

Posted Mar 23, 2026

Participant flow

Initial screening took place in first grade classrooms. All students in the classroom whose parents had consented to the study were administered a math screening test. Students scoring at or below the 25th percentile moved to the individually administered second stage of screening. Students who scored below the 25th percentile on the reading test and who scored at or above the 7th percentile on the test of cognitive performance were eligible for the project.

Participant flow — Overall Study
MilestoneCoordinated Reading and Math InterventionReading InterventionMath InterventionBusiness-as-usual Control
Started96969697
Completed67737478
Not completed29232219
Withdrew: Lost to follow-up29232219

Outcome measures

PrimaryWord 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. 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.

Time frame:
an average of 25 weeks
Reported as:
Mean · words read correctly
Word Reading Fluency-2 (Zumeta et al., 2012)
words read correctlyCoordinated Reading and Math InterventionMath InterventionReading InterventionBusiness-as-usual Control
Word Reading Fluency-2 (Zumeta et al., 2012)10.216 ± 8.9167.068 ± 7.79912.349 ± 10.1587.385 ± 8.178
Statistical analysis
  • Coordinated Reading and Math Intervention vs Business-as-usual Control · Multilevel Model · p = .018 · Mean difference (net): .330 · 95% CI 0.021 to 0.64We fit 3-level multilevel models with students (level-1) nested within classrooms (level-2), within schools (level-3), adjusting for pre-test at level
PrimarySight Word Efficiency (TOWRE2; Wagner et al., 2012)

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.

Time frame:
an average of 25 weeks
Reported as:
Mean · Words read correctly per 45 seconds
Sight Word Efficiency (TOWRE2; Wagner et al., 2012)
Words read correctly per 45 secondsCoordinated Reading and Math InterventionMath InterventionReading InterventionBusiness-as-usual Control
Sight Word Efficiency (TOWRE2; Wagner et al., 2012)17.567 ± 11.28914.405 ± 10.40319.630 ± 11.40214.718 ± 10.588
Statistical analysis
  • Coordinated Reading and Math Intervention vs Business-as-usual Control · Multilevel Model · p = <.001 · Mean difference (net): 0.399 · 95% CI 0.162 to 0.635We fit 3-level multilevel models with students (level-1) nested within classrooms (level-2), within schools (level-3), adjusting for pre-test at level
PrimaryWoodcock-Johnson IV - Letter Word Identification (Woodcock-Johnson 2014).

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.

Time frame:
an average of 25 weeks
Reported as:
Mean · letters and words read aloud correctly
Woodcock-Johnson IV - Letter Word Identification (Woodcock-Johnson 2014).
letters and words read aloud correctlyCoordinated Reading and Math InterventionMath InterventionReading InterventionBusiness-as-usual Control
Woodcock-Johnson IV - Letter Word Identification (Woodcock-Johnson 2014).24.284 ± 8.02621.459 ± 9.03626.616 ± 8.01521.756 ± 7.294
Statistical analysis
  • Coordinated Reading and Math Intervention vs Business-as-usual Control · Multilevel Model · p = <.001 · Mean difference (net): 0.543 · 95% CI 0.259 to 0.826We fit 3-level multilevel models with students (level-1) nested within classrooms (level-2), within schools (level-3), adjusting for pre-test at level
PrimaryArithmetic Combinations Fluency (Fuchs et al., 2003)

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.

Time frame:
an average of 25 weeks
Reported as:
Mean · the number of problems correct
Arithmetic Combinations Fluency (Fuchs et al., 2003)
the number of problems correctCoordinated Reading and Math InterventionMath InterventionReading InterventionBusiness-as-usual Control
Arithmetic Combinations Fluency (Fuchs et al., 2003)11.269 ± 8.23315.014 ± 10.5506.849 ± 6.6286.269 ± 5.986
Statistical analysis
  • Coordinated Reading and Math Intervention vs Business-as-usual Control · Multilevel Model · p = <.001 · Mean difference (net): 0.63 · 95% CI 0.271 to 0.989We fit 3-level multilevel models with students (level-1) nested within classrooms (level-2), within schools (level-3), adjusting for pre-test at level
PrimaryDouble-Digit Calculations Fluency (Fuchs et al., 2003)

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.

Time frame:
an average of 25 weeks
Reported as:
Mean · number of problems correct
Double-Digit Calculations Fluency (Fuchs et al., 2003)
number of problems correctCoordinated Reading and Math InterventionMath InterventionReading InterventionBusiness-as-usual Control
Double-Digit Calculations Fluency (Fuchs et al., 2003)6.284 ± 6.4338.649 ± 7.9250.740 ± 2.5171.038 ± 3.077
Statistical analysis
  • Coordinated Reading and Math Intervention vs Business-as-usual Control · Multilevel Model · p = <.001 · Mean difference (net): 0.914 · 95% CI 0.564 to 1.263We fit 3-level multilevel models with students (level-1) nested within classrooms (level-2), within schools (level-3), adjusting for pre-test at level
PrimaryWoodcock-Johnson IV - Calculations (Woodcock-Johnson 2014)

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.

Time frame:
an average of 25 weeks
Reported as:
Mean · The number of problems correct
Woodcock-Johnson IV - Calculations (Woodcock-Johnson 2014)
The number of problems correctCoordinated Reading and Math InterventionMath InterventionReading InterventionBusiness-as-usual Control
Woodcock-Johnson IV - Calculations (Woodcock-Johnson 2014)13.090 ± 4.75413.811 ± 4.55010.795 ± 4.5959.679 ± 4.697
Statistical analysis
  • Coordinated Reading and Math Intervention vs Business-as-usual Control · Multilevel Model · p = <.001 · Mean difference (net): 0.805 · 95% CI 0.478 to 1.133We fit 3-level multilevel models with students (level-1) nested within classrooms (level-2), within schools (level-3), adjusting for pre-test at level

Adverse events

Collected over From enrollment until the student exited the study, up to approximately 25 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Coordinated Reading and Math Intervention0/96 (0%)0/96 (0%)0/96 (0%)
Reading Intervention0/96 (0%)0/96 (0%)0/96 (0%)
Math Intervention0/96 (0%)0/96 (0%)0/96 (0%)
Business-as-usual Control0/97 (0%)0/97 (0%)0/97 (0%)

Baseline characteristics

The 93 students who were lost to follow-up were not included in the analysis because they did not have follow-up data.

Age, Continuous
Age, Continuous(Years)Coordinated Reading and Math InterventionReading InterventionMath InterventionBusiness-as-usual ControlTotal
Mean6.49 ± .336.57 ± .386.49 ± .366.56 ± .376.53 ± .36
Sex: Female, Male
Sex: Female, Male(Participants)Coordinated Reading and Math InterventionReading InterventionMath InterventionBusiness-as-usual ControlTotal
Female43404339165
Male24333139127
Sex: Female, Male
Sex: Female, Male(Participants)Coordinated Reading and Math InterventionReading InterventionMath InterventionBusiness-as-usual ControlTotal
Female43404339165
Male24333139127
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Coordinated Reading and Math InterventionReading InterventionMath InterventionBusiness-as-usual ControlTotal
American Indian or Alaska Native00000
Asian00011
Native Hawaiian or Other Pacific Islander00000
Black or African American22312029102
White43394644172
More than one race138315
Unknown or Not Reported10012
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Coordinated Reading and Math InterventionReading InterventionMath InterventionBusiness-as-usual ControlTotal
American Indian or Alaska Native00000
Asian00011
Native Hawaiian or Other Pacific Islander00000
Black or African American22312029102
White43384542168
More than one race138315
Unknown or Not Reported11136
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Coordinated Reading and Math InterventionReading InterventionMath InterventionBusiness-as-usual ControlTotal
Hispanic or Latino23273229111
Not Hispanic or Latino44464249181
Unknown or Not Reported00000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Coordinated Reading and Math InterventionReading InterventionMath InterventionBusiness-as-usual ControlTotal
Hispanic or Latino23273229111
Not Hispanic or Latino44464249181
Unknown or Not Reported00000
Word Reading Fluency-2 (Zumeta et al., 2012)
Word Reading Fluency-2 (Zumeta et al., 2012)(Words read correctly)Coordinated Reading and Math InterventionReading InterventionMath InterventionBusiness-as-usual ControlTotal
Mean2.41 ± 2.552.27 ± 2.492.47 ± 2.482.02 ± 2.132.29 ± 2.40

5 further baseline measures are reported on the registry.

07

Study locations

1 site
  • Vanderbilt University
    Nashville, Tennessee 37203, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 27, 2025
  • Informed consent form · Oct 26, 2023
  • Informed consent form · Oct 26, 2023
  • Informed consent form · Oct 26, 2023
  • Informed consent form · Oct 26, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap

09

Registry details

Key details

Study ID
NCT03991234
Lead sponsor
Vanderbilt University
Responsible party
Doug Fuchs (Professor, Vanderbilt University) — Principal investigator
First posted
Jun 19, 2019
Start date
Nov 11, 2019
Primary completion
May 20, 2025
Completion
May 20, 2025
Results posted
Mar 23, 2026
Last update
Mar 23, 2026

Study contacts

Douglas Fuchs, Ph.D.
principal investigator · Vanderbilt University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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