Clinical Trials Directory

Trials / Completed

CompletedNCT03991234

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
385 (actual)
Sponsor
Vanderbilt University · Academic / Other
Sex
All
Age
6 Years – 8 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALReading InterventionReading 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.
BEHAVIORALMath InterventionMath intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge \& counting strategies to build arithmetic skill.
BEHAVIORALCoordinated InterventionCoordinated 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.

Timeline

Start date
2019-11-11
Primary completion
2025-05-20
Completion
2025-05-20
First posted
2019-06-19
Last updated
2026-03-23
Results posted
2026-03-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03991234. Inclusion in this directory is not an endorsement.