An interventional study of Reading Intervention and Math Intervention in Reading Learning Disability and Math Learning Disability, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 6 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Vanderbilt University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criterion:
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.
Behavioral: Coordinated 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.
Behavioral: Reading Intervention
Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill.
Behavioral: Math Intervention
Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program.
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 provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge \& counting strategies to build arithmetic skill.
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.
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. 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.
Time frame: an average of 25 weeks
Sight Word Efficiency (TOWRE2; Wagner et al., 2012)
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.
Time frame: an average of 25 weeks
Woodcock-Johnson IV - Letter Word Identification (Woodcock-Johnson 2014).
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.
Time frame: an average of 25 weeks
Arithmetic Combinations Fluency (Fuchs et al., 2003)
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.
Time frame: an average of 25 weeks
Double-Digit Calculations Fluency (Fuchs et al., 2003)
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.
Time frame: an average of 25 weeks
Woodcock-Johnson IV - Calculations (Woodcock-Johnson 2014)
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.
Time frame: an average of 25 weeks
Initial screening took place in first grade classrooms. All students in the classroom whose parents had consented to the study were administered a math screening test. Students scoring at or below the 25th percentile moved to the individually administered second stage of screening. Students who scored below the 25th percentile on the reading test and who scored at or above the 7th percentile on the test of cognitive performance were eligible for the project.
| Milestone | Coordinated Reading and Math Intervention | Reading Intervention | Math Intervention | Business-as-usual Control |
|---|---|---|---|---|
| Started | 96 | 96 | 96 | 97 |
| Completed | 67 | 73 | 74 | 78 |
| Not completed | 29 | 23 | 22 | 19 |
| Withdrew: Lost to follow-up | 29 | 23 | 22 | 19 |
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.
| words read correctly | Coordinated Reading and Math Intervention | Math Intervention | Reading Intervention | Business-as-usual Control |
|---|---|---|---|---|
| Word Reading Fluency-2 (Zumeta et al., 2012) | 10.216 ± 8.916 | 7.068 ± 7.799 | 12.349 ± 10.158 | 7.385 ± 8.178 |
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.
| Words read correctly per 45 seconds | Coordinated Reading and Math Intervention | Math Intervention | Reading Intervention | Business-as-usual Control |
|---|---|---|---|---|
| Sight Word Efficiency (TOWRE2; Wagner et al., 2012) | 17.567 ± 11.289 | 14.405 ± 10.403 | 19.630 ± 11.402 | 14.718 ± 10.588 |
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.
| letters and words read aloud correctly | Coordinated Reading and Math Intervention | Math Intervention | Reading Intervention | Business-as-usual Control |
|---|---|---|---|---|
| Woodcock-Johnson IV - Letter Word Identification (Woodcock-Johnson 2014). | 24.284 ± 8.026 | 21.459 ± 9.036 | 26.616 ± 8.015 | 21.756 ± 7.294 |
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.
| the number of problems correct | Coordinated Reading and Math Intervention | Math Intervention | Reading Intervention | Business-as-usual Control |
|---|---|---|---|---|
| Arithmetic Combinations Fluency (Fuchs et al., 2003) | 11.269 ± 8.233 | 15.014 ± 10.550 | 6.849 ± 6.628 | 6.269 ± 5.986 |
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.
| number of problems correct | Coordinated Reading and Math Intervention | Math Intervention | Reading Intervention | Business-as-usual Control |
|---|---|---|---|---|
| Double-Digit Calculations Fluency (Fuchs et al., 2003) | 6.284 ± 6.433 | 8.649 ± 7.925 | 0.740 ± 2.517 | 1.038 ± 3.077 |
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.
| The number of problems correct | Coordinated Reading and Math Intervention | Math Intervention | Reading Intervention | Business-as-usual Control |
|---|---|---|---|---|
| Woodcock-Johnson IV - Calculations (Woodcock-Johnson 2014) | 13.090 ± 4.754 | 13.811 ± 4.550 | 10.795 ± 4.595 | 9.679 ± 4.697 |
Collected over From enrollment until the student exited the study, up to approximately 25 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Coordinated Reading and Math Intervention | 0/96 (0%) | 0/96 (0%) | 0/96 (0%) |
| Reading Intervention | 0/96 (0%) | 0/96 (0%) | 0/96 (0%) |
| Math Intervention | 0/96 (0%) | 0/96 (0%) | 0/96 (0%) |
| Business-as-usual Control | 0/97 (0%) | 0/97 (0%) | 0/97 (0%) |
The 93 students who were lost to follow-up were not included in the analysis because they did not have follow-up data.
| Age, Continuous(Years) | Coordinated Reading and Math Intervention | Reading Intervention | Math Intervention | Business-as-usual Control | Total |
|---|---|---|---|---|---|
| Mean | 6.49 ± .33 | 6.57 ± .38 | 6.49 ± .36 | 6.56 ± .37 | 6.53 ± .36 |
| Sex: Female, Male(Participants) | Coordinated Reading and Math Intervention | Reading Intervention | Math Intervention | Business-as-usual Control | Total |
|---|---|---|---|---|---|
| Female | 43 | 40 | 43 | 39 | 165 |
| Male | 24 | 33 | 31 | 39 | 127 |
| Sex: Female, Male(Participants) | Coordinated Reading and Math Intervention | Reading Intervention | Math Intervention | Business-as-usual Control | Total |
|---|---|---|---|---|---|
| Female | 43 | 40 | 43 | 39 | 165 |
| Male | 24 | 33 | 31 | 39 | 127 |
| Race (NIH/OMB)(Participants) | Coordinated Reading and Math Intervention | Reading Intervention | Math Intervention | Business-as-usual Control | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 22 | 31 | 20 | 29 | 102 |
| White | 43 | 39 | 46 | 44 | 172 |
| More than one race | 1 | 3 | 8 | 3 | 15 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Coordinated Reading and Math Intervention | Reading Intervention | Math Intervention | Business-as-usual Control | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 22 | 31 | 20 | 29 | 102 |
| White | 43 | 38 | 45 | 42 | 168 |
| More than one race | 1 | 3 | 8 | 3 | 15 |
| Unknown or Not Reported | 1 | 1 | 1 | 3 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Coordinated Reading and Math Intervention | Reading Intervention | Math Intervention | Business-as-usual Control | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 23 | 27 | 32 | 29 | 111 |
| Not Hispanic or Latino | 44 | 46 | 42 | 49 | 181 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Coordinated Reading and Math Intervention | Reading Intervention | Math Intervention | Business-as-usual Control | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 23 | 27 | 32 | 29 | 111 |
| Not Hispanic or Latino | 44 | 46 | 42 | 49 | 181 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Word Reading Fluency-2 (Zumeta et al., 2012)(Words read correctly) | Coordinated Reading and Math Intervention | Reading Intervention | Math Intervention | Business-as-usual Control | Total |
|---|---|---|---|---|---|
| Mean | 2.41 ± 2.55 | 2.27 ± 2.49 | 2.47 ± 2.48 | 2.02 ± 2.13 | 2.29 ± 2.40 |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Research staff will make de-identified data sets electronically available to external users under a data-sharing agreement providing the user's commitment to use data for the research purposes described in the user's request; assurance that no research participant will be identified for any purpose; a commitment to securing the data; a commitment to not transferring data to other users \& destroying the data after analyses are complete; \& guarantees publications are credited to grant/agency and entered in PubMed. Once the user signs and returns the Agreement Form, a database with the variables of interest and codebook are provided, and staff provide relevant, de-identified data and segments of the code book with variable names/values, notes clarifying scoring/data-reduction methods not otherwise available, and a technical report describing the sample, study, and procedures.
Supporting information: Study protocol, Sap
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Vanderbilt University