Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | an average of 25 weeks |
| Woodcock-Johnson IV - Calculations (Woodcock-Johnson 2014) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criterion:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Douglas Fuchs, Ph.D. | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University | Nashville | Tennessee | 37203 | United States |
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.
The de-identified (stripped) primary outcome data set will become available no later than acceptance for publication of the main findings from the final data set and remain accessible for 3 years following the closeout of this grant. This time frame for data accessibility will be reviewed at the proposed project's completion and revised as needed.
If all Investigators leave or become unavailable, the last remaining Investigator will assume responsibility for identifying a Vanderbilt faculty member to undertake these responsibilities.
The user submits a request describing variables of interest, research aims, & quantitative methods and signs a user agreement form (see Plan Description).
Not provided
Students who met the eligibility criteria were pretested. After pretesting, the number of students needed for enrollment were randomly selected from the group of students with complete pretest data. Those students were subsequently randomly assigned to the four treatment groups.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Coordinated Reading and Math Intervention | 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. |
| FG001 | Reading 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. |
| FG002 | Math Intervention | Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill. |
| FG003 | Business-as-usual Control | Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The 93 students who were lost to follow-up were not included in the analysis because they did not have follow-up data.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Coordinated Reading and Math Intervention | 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. |
| BG001 | Reading Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | words read correctly | an average of 25 weeks |
|
From enrollment until the student exited the study, up to approximately 25 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Coordinated Reading and Math Intervention | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Douglas Fuchs | Vanderbilt University | (615)343-4782 | doug.fuchs@vanderbilt.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2025 | Mar 1, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Parent Consent (English) | Oct 26, 2023 | Feb 6, 2026 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Student Assent for Testing | Oct 26, 2023 | Feb 6, 2026 | ICF_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: Student Assent for Tutoring | Oct 26, 2023 | Feb 6, 2026 | ICF_004.pdf |
| ICF | No | No | Yes | Informed Consent Form: Teacher Consent | Oct 26, 2023 | Feb 6, 2026 | ICF_005.pdf |
Not provided
| ID | Term |
|---|---|
| D004410 | Dyslexia |
| D060705 | Dyscalculia |
| ID | Term |
|---|---|
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
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. |
| an average of 25 weeks |
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. |
| BG002 | Math Intervention | Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill. |
| BG003 | Business-as-usual Control | Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| 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. | Mean | Standard Deviation | Words read correctly |
|
| 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. | Mean | Standard Deviation | Words read correctly |
|
| 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. | Mean | Standard Deviation | Number of correct responses |
|
| 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. | Mean | Standard Deviation | Number of correct answers |
|
| 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. | Mean | Standard Deviation | Number of correct answers |
|
| 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. | Mean | Standard Deviation | Number of correct responses |
|
Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill.
| OG002 | Reading 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. |
| OG003 | Business-as-usual Control | Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Words read correctly per 45 seconds | an average of 25 weeks |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | letters and words read aloud correctly | an average of 25 weeks |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | the number of problems correct | an average of 25 weeks |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | number of problems correct | an average of 25 weeks |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | The number of problems correct | an average of 25 weeks |
|
|
|
|
| 0 |
| 96 |
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | Reading 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. | 0 | 96 | 0 | 96 | 0 | 96 |
| EG002 | Math Intervention | Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill. | 0 | 96 | 0 | 96 | 0 | 96 |
| EG003 | Business-as-usual Control | Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program. | 0 | 97 | 0 | 97 | 0 | 97 |
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D000067559 | Specific Learning Disorder |
| D007859 | Learning Disabilities |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |