TrialReader


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

NCT03991234 — Not applicable, Completed, 385 participants, Vanderbilt University

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT03991234
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment385 (Actual)
SponsorVanderbilt University (Other)
ConditionsReading Learning Disability, Math Learning Disability
InterventionsReading Intervention, Math Intervention, Coordinated Intervention (Behavioral)
Datesstart 2019-11-11, primary completion 2025-05-20, completion 2025-05-20, first posted 2019-06-19, last updated 2026-03-23
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Reading Learning Disability All trials for Math Learning Disability All trials of Reading Intervention All trials of Math Intervention

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
Coordinated Reading and Math InterventionExperimentalBehavioral: Coordinated InterventionCoordinated 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 InterventionActive comparatorBehavioral: Reading InterventionReading 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 InterventionActive comparatorBehavioral: Math InterventionMath intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill.
Business-as-usual ControlNo interventionParticipation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program.
  • Reading Intervention (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 (Behavioral): 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 (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.

+Outcome measures

Primary outcomes

  • 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. Student's score is the number of words read correctly. Two forms are given, and student's final score is the average score on the two forms.
  • Sight Word Efficiency (TOWRE2; Wagner et al., 2012) [an average of 25 weeks]: Students have 45 seconds to read a list of words beginning with very simple words followed by words of increasing difficulty. Student's score is the number of words read correctly.
  • Woodcock-Johnson IV - Letter Word Identification (Woodcock-Johnson 2014). [an average of 25 weeks]: Students read aloud letters followed by simple words followed by words of increasing difficulty. Test ends when after six incorrect responses. Student's score is the number of correct responses.
  • Arithmetic Combinations Fluency (Fuchs et al., 2003) [an average of 25 weeks]: Students have 1 minute to write answers for 25 addition items; same for 25 subtraction items (sums \& minuends 5-12). Student's score is number correct across all 50 items.
  • Double-Digit Calculations Fluency (Fuchs et al., 2003) [an average of 25 weeks]: Students have 10 min to write answers to 20 addition problems with 2-digit addends without regrouping and 20 subtraction problems with double-digit minuends and subtrahends without regrouping. The score is number correct across all 40 items.
  • Woodcock-Johnson IV - Calculations (Woodcock-Johnson 2014) [an average of 25 weeks]: Students solve mathematical computation problems beginning with simple basic facts followed by problems of increasing difficulty. Test ends when the student misses 6 consecutive problems. Student's score is the number of correct responses.

+Eligibility

Sex: All, ages: 6 Years to 8 Years, accepts healthy volunteers

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

+Posted results

Participant flow

MilestoneCoordinated Reading and Math InterventionReading InterventionMath InterventionBusiness-as-usual Control
Started96969697
Completed67737478
Not completed29232219

Outcome results

  • Word Reading Fluency-2 (Zumeta et al., 2012) (Primary), Mean, words read correctly: Coordinated Reading and Math Intervention 10.216 +/- 8.916; Math Intervention 7.068 +/- 7.799; Reading Intervention 12.349 +/- 10.158; Business-as-usual Control 7.385 +/- 8.178 (p .018)
  • Sight Word Efficiency (TOWRE2; Wagner et al., 2012) (Primary), Mean, Words read correctly per 45 seconds: Coordinated Reading and Math Intervention 17.567 +/- 11.289; Math Intervention 14.405 +/- 10.403; Reading Intervention 19.630 +/- 11.402; Business-as-usual Control 14.718 +/- 10.588 (p <.001)
  • Woodcock-Johnson IV - Letter Word Identification (Woodcock-Johnson 2014). (Primary), Mean, letters and words read aloud correctly: Coordinated Reading and Math Intervention 24.284 +/- 8.026; Math Intervention 21.459 +/- 9.036; Reading Intervention 26.616 +/- 8.015; Business-as-usual Control 21.756 +/- 7.294 (p <.001)
  • Arithmetic Combinations Fluency (Fuchs et al., 2003) (Primary), Mean, the number of problems correct: Coordinated Reading and Math Intervention 11.269 +/- 8.233; Math Intervention 15.014 +/- 10.550; Reading Intervention 6.849 +/- 6.628; Business-as-usual Control 6.269 +/- 5.986 (p <.001)
  • Double-Digit Calculations Fluency (Fuchs et al., 2003) (Primary), Mean, number of problems correct: Coordinated Reading and Math Intervention 6.284 +/- 6.433; Math Intervention 8.649 +/- 7.925; Reading Intervention 0.740 +/- 2.517; Business-as-usual Control 1.038 +/- 3.077 (p <.001)
  • Woodcock-Johnson IV - Calculations (Woodcock-Johnson 2014) (Primary), Mean, The number of problems correct: Coordinated Reading and Math Intervention 13.090 +/- 4.754; Math Intervention 13.811 +/- 4.550; Reading Intervention 10.795 +/- 4.595; Business-as-usual Control 9.679 +/- 4.697 (p <.001)

Adverse events

Time frame: From enrollment until the student exited the study, up to approximately 25 weeks

ArmDeathsSerious adverse eventsOther adverse events
Coordinated Reading and Math Intervention0/96 (0.0%)0/96 (0.0%)0/96 (0.0%)
Reading Intervention0/96 (0.0%)0/96 (0.0%)0/96 (0.0%)
Math Intervention0/96 (0.0%)0/96 (0.0%)0/96 (0.0%)
Business-as-usual Control0/97 (0.0%)0/97 (0.0%)0/97 (0.0%)

+Locations (1)

FacilityCityCountryStatus
Vanderbilt UniversityNashville, TennesseeUnited States

+Study documents

+Investigators

My Notes