Reading Learning DisabilityNCT03991234
Improving the Academic Performance of First-Grade Students With Reading and Math Difficulty
A study testing Reading Intervention, Math Intervention and Coordinated Intervention in people with Reading Learning Disability and Math Learning Disability, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Reading Learning Disability, Math Learning Disability
- What is being tested?
- Reading Intervention, Math Intervention and Coordinated Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2019to 20 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Reading Intervention, Math Intervention, Coordinated Intervention
- Medical subject headings
- Dyslexia, Dyscalculia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reading InterventionBehavioural
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 InterventionBehavioural
Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge \& counting strategies to build arithmetic skill.
Coordinated InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Coordinated Reading and Math Intervention | Experimental | 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. Receives: Behavioral: Coordinated Intervention |
| Reading Intervention | Active comparator | 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. Receives: Behavioral: Reading Intervention |
| Math Intervention | Active comparator | Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill. Receives: Behavioral: Math Intervention |
| Business-as-usual Control | No intervention | Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: an average of 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start11 Nov 2019
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Reading Learning DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doug Fuchs, Vanderbilt University
- Investigators
- Douglas Fuchs, Ph.D., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991234
- Sponsor's protocol ID
- 180633
- Status last verified
- Mar 2026
- First submitted
- 13 Jun 2019
- Last updated
- 23 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Academic Performance of First-Grade Students With Reading and Math Difficulty
- ClinicalTrials.gov ID
- NCT03991234
- Acronym / sponsor ID
- 180633
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Posted 23 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Coordinated Reading and Math Intervention | Experimental | Behavioral: 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 Intervention | Active comparator | Behavioral: 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 Intervention | Active comparator | Behavioral: 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 Control | No intervention | –Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reading 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. | Behavioural | Reading Intervention |
| Math InterventionMath intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge \& counting strategies to build arithmetic skill. | Behavioural | Math Intervention |
| Coordinated 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. | Behavioural | Coordinated Reading and Math Intervention |
Primary outcome
Word Reading Fluency-2 (Zumeta et al., 2012)
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Fuchs, Ph.D. principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reading Intervention, Math Intervention and Coordinated Intervention in people with Reading Learning Disability and Math Learning Disability, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Word Reading Fluency-2 (Zumeta et al., 2012) (time frame: an average of 25 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.