Math Learning DifficultyNCT04878757
Implementing Inclusive Fraction Intervention Classwide
A study testing CFI - Classwide Fraction Intervention in people with Math Learning Difficulty, run by Vanderbilt University at 1 site in United States.
Trial summary
The main purpose of this study is to assess effects of a previously validated fraction intervention when it is conducted classwide on the fraction knowledge of fourth-grade students with and without math learning difficulties (MLD). The study population is 4th-grade students with MLD and without MLD. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Math Learning Difficulty
- What is being tested?
- CFI - Classwide Fraction Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,210 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2021to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- To enter the study, students must meet the following criteria. They must attend a Metropolitan-Nashville Public School whose principal has given permission for his/her school to participate and participate in a fourth-grade classroom whose teacher has agreed to let her/his students participate.
Who cannot join
- We exclude students with identified intellectual disability from study data collection because CFI is not designed to meet the needs of this population. There are no other exclusions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Metropolitan Nashville Public Schools
Nashville, Tennessee, 37204
About this study
The main purpose of this study is to assess effects of a previously validated fraction intervention when it is conducted classwide on the fraction knowledge of fourth-grade students with and without math learning difficulties (MLD). The study population is 4th-grade students with MLD and without MLD. Teachers agree to be randomly assigned to two conditions. In one condition, teachers include classwide fraction intervention (CFI) in their standard math program. In the other condition, teachers conduct their standard math program without CFI. CFI is implemented 2 times per week for 20 weeks for about 30 minutes each time. Students in both conditions are tested before and after CFI ends.
Read the detailed description
The study is conducted in the Metropolitan-Nashville Public Schools. Teachers decide if they want to participate. Parents of students in their classrooms decide if they want their children to participate in the study; participation means students complete the study's pretesting and posttesting, and teachers report their test scores on a school-collected measure. Students decide if they want to participate. Teachers complete a survey, report student scores on the school-collected measure, and are observed during CFI implementation.
Each CFI session comprises 3 segments. In Segment 1 (10-12 minutes), teachers conduct that day's CFI lesson. In Segment 2 (10-12 minutes), students work in pairs, taking turns being "coach" and "player" as they explain their thinking and solution strategies taught in that day's Segment 1. Students use CFI help cards to provide constructive feedback to each other. Segment 3 (5-7 minutes) is independent practice.
The primary end-points are students' posttest fraction ordering, fraction number line estimate, fraction calculations. Secondary end-points are students' performance on more distal fraction measures. Other measures are a teacher survey describing fractions instruction and reliance on CFI procedures and their perceptions of CFI's effectiveness and feasibility, as well as CFI adherence from audio recordings and live observations of teachers implementing CFI.
- Conditions
- Math Learning Difficulty
- Being tested
- CFI - Classwide Fraction Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CFI - Classwide Fraction InterventionBehavioural
40 sessions (2 sessions per week; 25-31 minutes per session) of explicit fraction intervention designed to improve students understanding of fraction magnitude and fraction operations.
| Study group | Role | What they receive |
|---|---|---|
| CFI - Classwide Fraction Intervention | Experimental | 40 sessions (2 sessions per week; 25-31 minutes per session) of explicit fraction intervention designed to improve students understanding of fraction magnitude and fraction operations. Receives: Behavioral: CFI - Classwide Fraction Intervention |
| Control - Business-As-Usual | No intervention | Involves participation in the schools' typical math program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fraction Ordering Score
In Fraction Ordering, students order 11 strings of 3 fractions to be ordered from least to greatest. The student's score is the change from pre-intervention to post-intervention in the number of correctly ordered strings.
Measured: Pre-intervention measurement will take place within three weeks prior to beginning of intervention; post-intervention measurement will take place within three weeks after completion of intervention.
Change in Fraction Number Line Estimation Score
In Fraction Number Line Estimation, students place fractions on a 0-2 number line, presented via computer with labeled endpoints. Accuracy for each of the 20 items is the absolute value of the difference between actual and correct answer multiplied by 100. The student's score is the change from pre-intervention to post-intervention in average accuracy across all 20 items.
Measured: Pre-intervention measurement will take place within three weeks prior to beginning of intervention; post-intervention measurement will take place within three weeks after completion of intervention.
Change in Fraction Calculations Score
In Fractions Calculations, students complete 25 fraction calculation problems with like and unlike denominators, with and without whole or mixed numbers. The student's score is the change from pre-intervention to post-intervention in the number of correct answers.
Measured: Pre-intervention measurement will take place within three weeks prior to beginning of intervention; post-intervention measurement will take place within three weeks after completion of intervention.
Secondary outcomes (4)
Change in Fraction Arithmetic Number Line Estimation Score
In Fraction Arithmetic Number Line Estimation, students estimate placement of the total or difference of 16 fraction addition and subtraction problems on number lines. Accuracy for each of the items is the absolute value of the difference between actual and correct answer multiplied by 100. The student's score is the change from pre-intervention to post-intervention in the average accuracy across all items.
Measured: Pre-intervention measurement will take place within three weeks prior to beginning of intervention; post-intervention measurement will take place within three weeks after completion of intervention.
National Assessment of Educational Progress (NAEP) Released Fraction Items - Updated
Students complete 12 items from the 4th-grade assessment and 8th-grade assessment, tapping fractions magnitude understanding, part-whole understanding, and fractions calculations. The student's score is the number of correct answers.
Measured: Measurement will take place within three weeks after the end of intervention
Change in Fraction Magnitude & Calculations in Context Score
In Fraction Magnitude and Calculations in Context, students complete 14 word problems: 3 involving ordering, 3 involving making units into fractions, and 8 involving additional and subtraction to reflect a change in quantity over time. The student's score is the change from pre-intervention to post-intervention in the number of problems answered correctly.
Measured: Pre-intervention measurement will take place within three weeks prior to beginning of intervention; post-intervention measurement will take place within three weeks after completion of intervention.
Measures of Academic Progress (MAP)
These scores are students' scores on the school district's Northwest Evaluation Association Measures of Academic Progress (NWEA MAP) testing for Numbers and Operations as reported by classroom teachers. Percentile scores range from 0 to 99. The Rasch Unit (RIT) scores range from 100-300. For both measures, higher scores indicate a better outcome.
Measured: Within six weeks of intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start24 Sep 2021
- Primary completion31 May 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Math Learning DifficultyStudies 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
- None (open label)
- Enrolment
- 2,210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doug Fuchs, Vanderbilt University
- Investigators
- Lynn Fuchs, Ph.D., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878757
- Sponsor's protocol ID
- 191312
- Status last verified
- Oct 2026
- First submitted
- 23 Apr 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make de-identified datasets electronically available to external users under a signed data-sharing agreement (see Access Criteria). The outside user submits a request describing the variables of interest and the research design. If approved, a Data Use Agreement Form will be sent to the user to complete. If approved, the relevant dataset data will be extracted and provided with relevant portions of the data dictionary. If not, written communication will be provided explaining the basis for this decision. If we are unclear, a written request for clarifications will be provided, with up to two rounds of clarifications.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Inclusive Fraction Intervention Classwide
- ClinicalTrials.gov ID
- NCT04878757
- Acronym / sponsor ID
- 191312
- Conditions
- Math Learning Difficulty
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,210 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
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 study is to assess effects of a previously validated fraction intervention when it is conducted classwide on the fraction knowledge of fourth-grade students with and without math learning difficulties (MLD). The study population is 4th-grade students with MLD and without MLD. Teachers agree to be randomly assigned to two conditions. In one condition, teachers include classwide fraction intervention (CFI) in their standard math program. In the other condition, teachers conduct their standard math program without CFI. CFI is implemented 2 times per week for 20 weeks for about 30 minutes each time. Students in both conditions are tested before and after CFI ends.
Detailed description
The study is conducted in the Metropolitan-Nashville Public Schools. Teachers decide if they want to participate. Parents of students in their classrooms decide if they want their children to participate in the study; participation means students complete the study's pretesting and posttesting, and teachers report their test scores on a school-collected measure. Students decide if they want to participate. Teachers complete a survey, report student scores on the school-collected measure, and are observed during CFI implementation.
Each CFI session comprises 3 segments. In Segment 1 (10-12 minutes), teachers conduct that day's CFI lesson. In Segment 2 (10-12 minutes), students work in pairs, taking turns being "coach" and "player" as they explain their thinking and solution strategies taught in that day's Segment 1. Students use CFI help cards to provide constructive feedback to each other. Segment 3 (5-7 minutes) is independent practice.
The primary end-points are students' posttest fraction ordering, fraction number line estimate, fraction calculations. Secondary end-points are students' performance on more distal fraction measures. Other measures are a teacher survey describing fractions instruction and reliance on CFI procedures and their perceptions of CFI's effectiveness and feasibility, as well as CFI adherence from audio recordings and live observations of teachers implementing CFI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CFI - Classwide Fraction Intervention | Experimental | Behavioral: CFI - Classwide Fraction Intervention40 sessions (2 sessions per week; 25-31 minutes per session) of explicit fraction intervention designed to improve students understanding of fraction magnitude and fraction operations. |
| Control - Business-As-Usual | No intervention | –Involves participation in the schools' typical math program |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- To enter the study, students must meet the following criteria. They must attend a Metropolitan-Nashville Public School whose principal has given permission for his/her school to participate and participate in a fourth-grade classroom whose teacher has agreed to let her/his students participate.
Key exclusion criteria (1 listed)
- We exclude students with identified intellectual disability from study data collection because CFI is not designed to meet the needs of this population. There are no other exclusions.
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 |
|---|---|---|
| CFI - Classwide Fraction Intervention40 sessions (2 sessions per week; 25-31 minutes per session) of explicit fraction intervention designed to improve students understanding of fraction magnitude and fraction operations. | Behavioural | CFI - Classwide Fraction Intervention |
Primary outcome
Change in Fraction Ordering Score
Time frame: Pre-intervention measurement will take place within three weeks prior to beginning of intervention; post-intervention measurement will take place within three weeks after completion of intervention.
In Fraction Ordering, students order 11 strings of 3 fractions to be ordered from least to greatest. The student's score is the change from pre-intervention to post-intervention in the number of correctly ordered strings.
Change in Fraction Number Line Estimation Score
Time frame: Pre-intervention measurement will take place within three weeks prior to beginning of intervention; post-intervention measurement will take place within three weeks after completion of intervention.
In Fraction Number Line Estimation, students place fractions on a 0-2 number line, presented via computer with labeled endpoints. Accuracy for each of the 20 items is the absolute value of the difference between actual and correct answer multiplied by 100. The student's score is the change from pre-intervention to post-intervention in average accuracy across all 20 items.
Change in Fraction Calculations Score
Time frame: Pre-intervention measurement will take place within three weeks prior to beginning of intervention; post-intervention measurement will take place within three weeks after completion of intervention.
In Fractions Calculations, students complete 25 fraction calculation problems with like and unlike denominators, with and without whole or mixed numbers. The student's score is the change from pre-intervention to post-intervention in the number of correct answers.
4 secondary outcomes
Change in Fraction Arithmetic Number Line Estimation Score
Time frame: Pre-intervention measurement will take place within three weeks prior to beginning of intervention; post-intervention measurement will take place within three weeks after completion of intervention.
National Assessment of Educational Progress (NAEP) Released Fraction Items - Updated
Time frame: Measurement will take place within three weeks after the end of intervention
Change in Fraction Magnitude & Calculations in Context Score
Time frame: Pre-intervention measurement will take place within three weeks prior to beginning of intervention; post-intervention measurement will take place within three weeks after completion of intervention.
Measures of Academic Progress (MAP)
Time frame: Within six weeks of intervention completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. We will make de-identified datasets electronically available to external users under a signed data-sharing agreement (see Access Criteria). The outside user submits a request describing the variables of interest and the research design. If approved, a Data Use Agreement Form will be sent to the user to complete. If approved, the relevant dataset data will be extracted and provided with relevant portions of the data dictionary. If not, written communication will be provided explaining the basis for this decision. If we are unclear, a written request for clarifications will be provided, with up to two rounds of clarifications.
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.
Lynn 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 CFI - Classwide Fraction Intervention in people with Math Learning Difficulty, 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 13 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Fraction Ordering Score (time frame: Pre-intervention measurement will take place within three weeks prior to beginning of intervention; post-intervention measurement will take place within three weeks after completion of intervention.). The study lists 3 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 13 Oct 2026.