Efficacy of a Two-Year Intensive Reading Intervention for Middle School English Learners With Rea… (NCT03695068) | Clinical Trial Compass
UnknownNot Applicable
Efficacy of a Two-Year Intensive Reading Intervention for Middle School English Learners With Reading Difficulties
United States840 participantsStarted 2018-09-01
Plain-language summary
This study investigates the efficacy of a reading comprehension intervention for English learners in Grades 6 and 7 with reading difficulties. Building on previous intervention studies conducted with students in Grades 4 through 8 over the past 10 years, the investigators utilize a longitudinal, double-cohort design utilizing a randomized control trial assigning students to supplemental reading intervention (RISE) or a no intervention "business as usual" (BAU) comparison condition (i.e., Cohort 1 - Years 1 and 2; 205 students in treatment and 205 in control condition; Cohort 2 - Years 3 and 4; 205 students in treatment and 205 in control condition; total 410 in each condition). Students in each cohort will be treated for 2 years (i.e., 6th and 7th grades or 7th and 8th grades). The primary outcome is reading comprehension.
The investigators hypothesize that participants receiving the RISE intervention will outperform those receiving BAU instruction across reading-related elements, including word reading, fluency, and comprehension at end of year two of treatment.
Who can participate
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:
* Participants are enrolled in 6th or 7th grade at a participating school.
* Participants are currently identified as English Learners (designated by school as limited English proficient) or were previously identified as limited English proficient and were redesignated as English proficient within the last 3 years by their school.
* A parent reported that Spanish was spoken at home at initial school entry.
* The participant failed the state level reading comprehension test the previous school year
Exclusion Criteria:
* The potential participant has a sensory disorder that precludes participation int he assessment and intervention protocols.
* The potential participant participates in an alternative curriculum (i.e., life skills course) due to moderate to severe learning disorders.
* The potential participant received a score of Beginner (Level 1) on the Texas English Language Proficiency Assessment System (TELPAS) listening and speaking subtest, indicating limited opportunity to learn English.
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
Change in Reading Comprehension after two years of treatment (Gates MacGinitie Passage Comprehension)
Timeframe: Measured May of year 2 (end of year 2 of treatment)