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

Not Applicable

• Conditions: Reading Learning Disability; Math Learning Disability
• Interventions: Behavioral: Coordinated Intervention; Behavioral: Reading Intervention; Behavioral: Math Intervention

• Registration Number: NCT03991234
• Lead Sponsor: Vanderbilt University

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.

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 Timeline

• Study First Submitted: 2019-06-13
• Study First Submitted QC: 2019-06-17
• Study First Posted: 2019-06-19
• Study Start: 2019-11-11
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-26
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 334

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coordinated Reading and Math Intervention	Coordinated 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.
Reading Intervention	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.
Math Intervention	Math Intervention	Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill.

Primary Outcome Measures

Name	Time	Method
Test of Word Reading Efficiency-Sight Word Efficiency	an average of 25 weeks	The tester shows a word list ordered in increasing difficulty; children read as many words as they can in 45 seconds.
Word Reading Fluency-2 (Zumeta et al., 2012)	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.). If students finish before 1 min, the score is prorated. Two alternate forms are administered.
Arithmetic Combinations Fluency - Addition (Fuchs et al., 2013)	an average of 25 weeks	Students have 1 minute to write answers to 25 addition items (sums 5-12).
Arithmetic Combinations Fluency - Subtraction (Fuchs et al., 2013)	an average of 25 weeks	Students have 1 minute to write answers to 25 subtraction items (minuends 5-12).

Secondary Outcome Measures

Name	Time	Method
WRAT-4-Arithmetic (Wilkinson, & Robertson, 2006)	an average of 25 weeks	Children complete calculation problems of increasing difficulty (10 minutes).
Wide Range Achievement Test-4-Reading (WRAT4; Wilkinson, & Robertson, 2006)	an average of 25 weeks	Students read words ordered in difficulty (no time limit; testing ends after 10 consecutive errors).

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States