Improving the Academic Performance of First-Grade Students With Reading and Math Difficulty (NCT03991234) | Clinical Trial Compass
CompletedNot Applicable
Improving the Academic Performance of First-Grade Students With Reading and Math Difficulty
United States385 participantsStarted 2019-11-11
Plain-language 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. 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.
Who can participate
Age range
6 Years – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criterion:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Word Reading Fluency-2 (Zumeta et al., 2012)
Timeframe: an average of 25 weeks
2
Sight Word Efficiency (TOWRE2; Wagner et al., 2012)
Timeframe: an average of 25 weeks
3
Woodcock-Johnson IV - Letter Word Identification (Woodcock-Johnson 2014).
Timeframe: an average of 25 weeks
4
Arithmetic Combinations Fluency (Fuchs et al., 2003)
Timeframe: an average of 25 weeks
5
Double-Digit Calculations Fluency (Fuchs et al., 2003)
Timeframe: an average of 25 weeks
6
Woodcock-Johnson IV - Calculations (Woodcock-Johnson 2014)