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Completed

NCT Number: NCT03991234

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.

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Key information

Conditions

Reading Learning Disability Communication Disorders Dyscalculia Dyslexia Language Disorders Learning Disabilities Math Learning Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Specific Learning Disorder

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University

Nashville, Tennessee, 37203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reading Intervention

Behavioral

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.

Math Intervention

Behavioral

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

Coordinated Intervention

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jun 19, 2019
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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