[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04878757":3,"trial-entities:NCT04878757":88,"trial-summary:NCT04878757":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":33,"secondary_outcomes":44,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":69,"locations":71,"central_contacts":81,"overall_officials":82,"references":86,"see_also_links":87},"NCT04878757","191312","Implementing Inclusive Fraction Intervention Classwide","ENROLLING_BY_INVITATION","2027-08-31","2025-11","2025-11-10","2021-09-24","Vanderbilt University","OTHER",false,"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.","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.\n\nEach 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.\n\nThe 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.",[18],"Math Learning Difficulty",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},2210,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"BEHAVIORAL","CFI - Classwide Fraction Intervention","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.",[30],[34,38,41],{"measure":35,"description":36,"timeFrame":37},"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.","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.",{"measure":39,"description":40,"timeFrame":37},"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.",{"measure":42,"description":43,"timeFrame":37},"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.",[45,48,52,55],{"measure":46,"description":47,"timeFrame":37},"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.",{"measure":49,"description":50,"timeFrame":51},"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.","Measurement will take place within three weeks after the end of intervention",{"measure":53,"description":54,"timeFrame":37},"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.",{"measure":56,"description":57,"timeFrame":58},"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.","Within six weeks of intervention completion","ALL","8 Years","11 Years",true,{"inclusion":64,"exclusion":66,"raw_text":68},[65],"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\u002Fher school to participate and participate in a fourth-grade classroom whose teacher has agreed to let her\u002Fhis students participate.",[67],"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.","Inclusion Criteria:\n\n* 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\u002Fher school to participate and participate in a fourth-grade classroom whose teacher has agreed to let her\u002Fhis students participate.\n\nExclusion Criteria:\n\n* 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.",[70],"CHILD",[72],{"facility":73,"city":74,"state":75,"zip":76,"country":77,"geoPoint":78},"Metropolitan Nashville Public Schools","Nashville","Tennessee","37204","United States",{"lat":79,"lon":80},36.16589,-86.78444,[],[83],{"name":84,"affiliation":12,"role":85},"Lynn Fuchs, Ph.D.","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":89,"biomarkers":90},[18],[],{"nct_id":4,"found":62,"summary":92,"prompt_version":102},{"design":93,"status":94,"heading":95,"summary":96,"follow_up":97,"word_count":98,"commitments":99,"compensation":100,"drugs_mentioned":101},"This interventional study involves teachers being randomly assigned to either use the Classwide Fraction Intervention (CFI) in their classroom or continue with their standard math program. It aims to enroll 2210 students.","completed","Classwide Fraction Intervention for 4th Graders with Math Learning Difficulties","This study, called \"Implementing Inclusive Fraction Intervention Classwide,\" is looking at how a special teaching method called Classwide Fraction Intervention (CFI) affects the understanding of fractions in fourth-grade students. CFI is a behavioral intervention, meaning it's a way of teaching, not a medicine. It involves 40 sessions, twice a week for about 25-31 minutes each, focusing on understanding fraction size and how to do calculations with fractions. The study aims to see if CFI helps students with and without math learning difficulties. You might be eligible if you are a 8-11 year old student in a participating Metropolitan-Nashville Public School. Success in this study means students show improvement in their ability to order fractions, estimate fractions on a number line, and perform fraction calculations. The study is currently unclear on its recruitment status and plans to enroll 2210 students.","Students are tested within three weeks before the intervention starts and within three weeks after it ends.",139,"If you participate, your child will complete tests before and after the intervention. Teachers will also report scores from school-collected measures and be observed during CFI implementation.","Not stated in the trial record.",[],"v2"]