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

NCT03991234 | Completed Results

• 1 other identifier: 180633
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Reading Learning Disability; Math Learning Disability

Outcome Measures

Primary Outcomes (6)

• 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.

  an average of 25 weeks

• 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.

  an average of 25 weeks

• 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.

  an average of 25 weeks

• 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.

  an average of 25 weeks

• 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.

  an average of 25 weeks

• 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.

  an average of 25 weeks

Study Arms (4)

Coordinated Reading and Math Intervention

EXPERIMENTAL

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

Reading Intervention

ACTIVE COMPARATOR

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

Math Intervention

ACTIVE COMPARATOR

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

Business-as-usual Control

NO INTERVENTION

Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program.

Interventions

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.

Reading Intervention

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.

Math Intervention

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.

Coordinated Reading and Math Intervention

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Dyslexia; Dyscalculia

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Douglas Fuchs
• Organization: Vanderbilt University

doug.fuchs@vanderbilt.edu

(615)343-4782

Study Officials

• Douglas Fuchs, Ph.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 19, 2019
• Study Start: November 11, 2019
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: March 23, 2026
• Results First Posted: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• Access Criteria: The user submits a request describing variables of interest, research aims, \& quantitative methods and signs a user agreement form (see Plan Description).

Locations

US (1)