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

NCT ID: NCT03991234

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 383 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-11
• Study Completion Date: 2025-05-20

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.

Conditions

Reading Learning Disability; Math Learning Disability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Coordinated Reading and Math 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.

Group Type: EXPERIMENTAL

Coordinated Intervention

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Reading Intervention

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Math Intervention

Intervention Type: BEHAVIORAL

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

Business-as-usual Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Doug Fuchs

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Douglas Fuchs, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

180633

Identifier Type: -

Identifier Source: org_study_id