Clinical trial NCT03991234: Improving the Academic Performance of First-Grade Students With Reading and Math Difficulty
Official title: Improving the Academic Performance of First-Grade Students With Reading and Math Difficulty
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Reading Learning Disability
Math Learning Disability
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 334
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Word Reading Fluency-2 (Zumeta et al., 2012)
timeFrame: an average of 25 weeks
measure: Test of Word Reading Efficiency-Sight Word Efficiency
timeFrame: an average of 25 weeks
measure: Arithmetic Combinations Fluency - Addition (Fuchs et al., 2013)
timeFrame: an average of 25 weeks
measure: Arithmetic Combinations Fluency - Subtraction (Fuchs et al., 2013)
timeFrame: an average of 25 weeks
Secondary outcomes:
measure: Wide Range Achievement Test-4-Reading (WRAT4; Wilkinson, & Robertson, 2006)
timeFrame: an average of 25 weeks
measure: WRAT-4-Arithmetic (Wilkinson, & Robertson, 2006)
timeFrame: an average of 25 weeks
Other outcomes:
measure: Comprehensive Test of Phonological Processing (CTOPP; Wagner et al., 2013)-Elision
timeFrame: an average of 25 weeks
measure: CTOPP-Sound Matching
timeFrame: an average of 25 weeks
measure: SWAN Attentive Behavior Rating Scale (J. Swanson, 2004)
timeFrame: an average of 25 weeks
measure: The Grit Scale (Duckworth & Quinn, 2009)-grade 1
timeFrame: an average of 25 weeks
measure: Rating Scale of Effort & Motivation (Malone & Fuchs, 2014)
timeFrame: an average of 25 weeks
measure: Working Memory Test Battery for Children - Nonword List Recall (WMTB-C; Pickering & Gathercole, 2001)
timeFrame: an average of 25 weeks
measure: Test of First-Grade Reading Comprehension (Fuchs, Fuchs, Craddock, & Lehman, 2017).
timeFrame: an average of 25 weeks
measure: Test of First-Grade Math Word Problems (Fuchs, Seethaler, & Craddock, 2009)
timeFrame: an average of 25 weeks
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Douglas Fuchs, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: