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

Math Learning Disability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03991234
• Other study ID #: 180633
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: October 31, 2025

Study information

• Verified date: March 2024
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 334
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyscalculia
• Learning Disabilities
• Math Learning Disability
• Reading Learning Disability

Intervention

Behavioral:
• Reading 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.
• Math Intervention
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
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.

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comprehensive Test of Phonological Processing (CTOPP; Wagner et al., 2013)-Elision	Students say words with a constituent part removed from the words.	an average of 25 weeks
Other	CTOPP-Sound Matching	Children see words and for each say which of 3 words (shown as pictures) start/end with the same sound.	an average of 25 weeks
Other	SWAN Attentive Behavior Rating Scale (J. Swanson, 2004)	Teachers rate 9 items from the DSM criteria for Attention Deficit Hyperactivity Disorder for inattention, each on a 7-point scale. The score is the sum of the 9 ratings.	an average of 25 weeks
Other	The Grit Scale (Duckworth & Quinn, 2009)-grade 1	Students rate their own beliefs concerning perseverance in learning. The grade 1 adaptation simplifies language and situates questions entirely in terms of reading & math.	an average of 25 weeks
Other	Rating Scale of Effort & Motivation (Malone & Fuchs, 2014)	Teachers rate items assessing students' effort and motivation.	an average of 25 weeks
Other	Working Memory Test Battery for Children - Nonword List Recall (WMTB-C; Pickering & Gathercole, 2001)	Children repeat stimuli spoken by the tester in the same order. Trials correct is the score.	an average of 25 weeks
Other	Test of First-Grade Reading Comprehension (Fuchs, Fuchs, Craddock, & Lehman, 2017).	Children read short passages aloud and answer open-ended literal and inferential questions. Number correct is the score.	an average of 25 weeks
Other	Test of First-Grade Math Word Problems (Fuchs, Seethaler, & Craddock, 2009)	Children listen words problem read aloud to them, while they see the text, and find solutions.Number correct is the score.	an average of 25 weeks
Primary	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.). If students finish before 1 min, the score is prorated. Two alternate forms are administered.	an average of 25 weeks
Primary	Test of Word Reading Efficiency-Sight Word Efficiency	The tester shows a word list ordered in increasing difficulty; children read as many words as they can in 45 seconds.	an average of 25 weeks
Primary	Arithmetic Combinations Fluency - Addition (Fuchs et al., 2013)	Students have 1 minute to write answers to 25 addition items (sums 5-12).	an average of 25 weeks
Primary	Arithmetic Combinations Fluency - Subtraction (Fuchs et al., 2013)	Students have 1 minute to write answers to 25 subtraction items (minuends 5-12).	an average of 25 weeks
Secondary	Wide Range Achievement Test-4-Reading (WRAT4; Wilkinson, & Robertson, 2006)	Students read words ordered in difficulty (no time limit; testing ends after 10 consecutive errors).	an average of 25 weeks
Secondary	WRAT-4-Arithmetic (Wilkinson, & Robertson, 2006)	Children complete calculation problems of increasing difficulty (10 minutes).	an average of 25 weeks