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Interventions for English Language Learners At-Risk for ADHD

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jul 30, 2026 → Jul 30, 2027
See other at-risk trials from Florida International University

Record History

  1. Primary and study completion pushed from Jul 30, 2026 to Jul 30, 2027
    • Enrollment closed, study ongoing
    • Site details revised
    v4
  2. 2 versions Re-verified since Jul 30, 2024, no change to tracked fieldsv2-v3
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to compare the effect of language and behavioral interventions for students who are English language learners and who have symptoms of attention-deficit/hyperactivity disorder (ADHD). The main question it aims to answer is: \- Which intervention is better for the students: the behavioral intervention, the language intervention, or a combination of the behavioral and language interventions? Participants will be asked to do the following: * Participants' parents and teachers will be asked to complete questionnaires about their behavior. * Participants will be asked to complete tests assessing language, cognitive, and academic abilities. * Members of the research team will complete classroom observations for the participating students. * Participants will be randomly assigned to one of four groups: a school as usual group, a language group, a daily report card group, and a combined daily report card and language group. * If assigned to the language group, participants will receive an 18-week language intervention. * If assigned to the daily report card group, a behavioral consultant will work with participants' parents and teachers to set up a home-school behavior plan called a daily report card. * If assigned to the combined daily report card and language group, participants will receive both the language intervention and the daily report card. * If assigned to the school as usual group, participants will no study interventions. Researchers will compare the language group, the daily report card group, the combined language and daily report card group, and the school as usual group to see which group has the best language learning and classroom behavior at the end of the program.
Trial Details
NCT Number NCT05918991
Lead Sponsor Florida International University
Collaborators: Florida State University, Nova Southeastern University, University of South Florida
Conditions
(from sponsor)		 Attention Deficit Hyperactivity Disorder
Related terms Attention Deficit Disorder with Hyperactivity
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov