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Behavioural Intervention

Behavioral & Language Interventions for ADHD

N/A
Recruiting
Research Sponsored by Florida International University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-treatment (i.e., after completion of the 18-week treatment phase)
Awards & highlights

Summary

This trial will compare language & behavioral interventions to see which is best for students w/ ADHD who are English language learners. Participants will be randomized to a group & receive different interventions. Researchers will compare results at end of program.

Who is the study for?
This trial is for English language learners in kindergarten or 1st grade who show symptoms of ADHD. They must have a teacher and parent willing to participate, and be identified as Level 1-4 English Language Learners by their school.
What is being tested?
The study compares four approaches: usual school experience, an 18-week language intervention, a daily report card behavioral plan, and a combination of both interventions. Participants are randomly assigned to one group to see which method improves language learning and behavior.
What are the potential side effects?
Since this trial involves educational and behavioral interventions rather than medical treatments, traditional side effects are not applicable. However, participants may experience stress or anxiety due to the changes in their routine or the demands of the interventions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-treatment (i.e., after completion of the 18-week treatment phase)
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-treatment (i.e., after completion of the 18-week treatment phase) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Concepts and Following Directions Subtest Score
Expressive One-Word Picture Vocabulary Test 4th Edition (EOWPVT-4) Score
Frequency counts of off-task behavior
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Language InterventionExperimental Treatment1 Intervention
The language intervention will include 18 weeks of 20-25 minutes of intervention approximately 4 days per week. The language intervention is delivered via shared book reading and focuses on English language vocabulary development as well as development of syntax knowledge and expressive language.
Group II: Daily Report CardExperimental Treatment1 Intervention
The Daily Report Card group will receive the Daily Report Card intervention for 18 weeks.
Group III: Combined Language and Daily Report CardExperimental Treatment2 Interventions
Participants in this arm will receive a combination of the language intervention and the behavioral intervention. The interventions will be implemented simultaneously for 18 weeks.
Group IV: School As UsualActive Control1 Intervention
Participants in the School as Usual Arm will receive neither the Behavioral Intervention nor the Language Intervention. There will be no restrictions, however, on interventions or supports that students may receive outside of the study either implemented through standard school protocol or accessed by parents. Thus, the School as Usual Arm provides a real-world practice comparison for the three active treatment groups.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daily Report Card
2019
N/A
~220

Find a Location

Who is running the clinical trial?

Florida International UniversityLead Sponsor
100 Previous Clinical Trials
17,127 Total Patients Enrolled
16 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
2,021 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Florida State UniversityOTHER
213 Previous Clinical Trials
34,196 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
504 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Nova Southeastern UniversityOTHER
95 Previous Clinical Trials
11,437 Total Patients Enrolled

Media Library

Daily Report Card (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05918991 — N/A
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Language Intervention, Daily Report Card, Combined Language and Daily Report Card, School As Usual
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Daily Report Card Highlights & Side Effects. Trial Name: NCT05918991 — N/A
Daily Report Card (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05918991 — N/A
~132 spots leftby Jul 2026
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