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NCT03991234

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

Completed NA Results posted Last updated 23 March 2026
What this trial tests

NA trial testing Reading Intervention in Reading Learning Disability in 385 participants. Completed in 20 May 2025.

Timeline
11 November 2019
Primary endpoint
20 May 2025
20 May 2025

Quick facts

Lead sponsorVanderbilt University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment385
Start date11 November 2019
Primary completion20 May 2025
Estimated completion20 May 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Vanderbilt University

Who can join

Adults 6 to 8, any sex, with Reading Learning Disability or Math Learning Disability. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Word Reading Fluency-2 (Zumeta et al., 2012) Primary · 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.

GroupValue95% CI
Coordinated Reading and Math Intervention10.216± 8.916
Math Intervention7.068± 7.799
Reading Intervention12.349± 10.158
Business-as-usual Control7.385± 8.178
Sight Word Efficiency (TOWRE2; Wagner et al., 2012) Primary · 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.

GroupValue95% CI
Coordinated Reading and Math Intervention17.567± 11.289
Math Intervention14.405± 10.403
Reading Intervention19.630± 11.402
Business-as-usual Control14.718± 10.588
Woodcock-Johnson IV - Letter Word Identification (Woodcock-Johnson 2014). Primary · 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.

GroupValue95% CI
Coordinated Reading and Math Intervention24.284± 8.026
Math Intervention21.459± 9.036
Reading Intervention26.616± 8.015
Business-as-usual Control21.756± 7.294
Arithmetic Combinations Fluency (Fuchs et al., 2003) Primary · 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.

GroupValue95% CI
Coordinated Reading and Math Intervention11.269± 8.233
Math Intervention15.014± 10.550
Reading Intervention6.849± 6.628
Business-as-usual Control6.269± 5.986
Double-Digit Calculations Fluency (Fuchs et al., 2003) Primary · 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.

GroupValue95% CI
Coordinated Reading and Math Intervention6.284± 6.433
Math Intervention8.649± 7.925
Reading Intervention0.740± 2.517
Business-as-usual Control1.038± 3.077
Woodcock-Johnson IV - Calculations (Woodcock-Johnson 2014) Primary · 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.

GroupValue95% CI
Coordinated Reading and Math Intervention13.090± 4.754
Math Intervention13.811± 4.550
Reading Intervention10.795± 4.595
Business-as-usual Control9.679± 4.697

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing