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ADHD Interventions + Stimulant for ADHD

Phase 4
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 end of academic year 1 of enrollment
Awards & highlights

Study Summary

This trial is designed to study the efficacy of interventions for children with ADHD delivered through a Response to Intervention framework.

Who is the study for?
This trial is for children in grades 1-5 diagnosed with ADHD according to DSM-V criteria. It's not suitable for kids who've had successful ADHD treatment with stimulants, those in special education due to behavior issues, have an IQ under 70, psychosis or pervasive developmental disorders, are already part of the study, or are home-schooled.Check my eligibility
What is being tested?
The study tests Tier 1 classroom management and Tier 2 interventions within a Response to Intervention (RTI) framework against typical support strategies. If initial responses fail, it will compare enhanced Tier 2 strategies versus stimulant medication using a SMART design.See study design
What are the potential side effects?
While behavioral interventions may not have side effects like medications do, stimulant medication can cause decreased appetite, trouble sleeping, headaches, stomachaches and increased anxiety or irritability.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of academic year 1 of enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of academic year 1 of enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Observations of Classroom Behavior
Secondary outcome measures
Disruptive Behavior Disorders Rating Scale
Impairment Rating Scale

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Response to Intervention (RTI): Tier 1Experimental Treatment1 Intervention
Two-thirds of participants will be assigned to the RTI Tier 1 Arm. Teachers of students in this arm will receive consultation in RTI Tier 1 Classroom Management strategies.
Group II: RTI: EnhancedExperimental Treatment3 Interventions
Half of students in the RTI DRC Arm who do not respond to the DRC intervention will be randomly assigned to the RTI: Enhanced Arm. Students in this arm will receive a more intensive classroom behavioral intervention directed at individual target behaviors through an enhanced DRC.
Group III: RTI: Daily Report Card (DRC)Experimental Treatment2 Interventions
Students assigned to the RTI Tier 1 Arm, who do not respond to the initial RTI Tier 1 Classroom Management strategies, will move to the RTI DRC Arm of the study. Teachers of students in this arm of the study will receive consultation to implement a daily report card.
Group IV: MedicationExperimental Treatment3 Interventions
Half of students in the RTI DRC Arm who do not respond to the DRC intervention will be randomly assigned to the Medication arm and will receive stimulant medication as an additional intervention.
Group V: Business as Usual (BAU)Active Control1 Intervention
One-third of participants will be assigned to this condition and will receive academic accommodations and interventions as deemed appropriate by their teachers, school personnel, and parents. This condition is intended to mirror current standard procedures for youth with ADHD. Thus, the specific accommodations and interventions are expected to vary across students. Some students' parents and physicians may choose to start stimulant medication with a goal of improving classroom performance.

Find a Location

Who is running the clinical trial?

Florida International UniversityLead Sponsor
100 Previous Clinical Trials
17,255 Total Patients Enrolled
16 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
2,021 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
University at BuffaloOTHER
132 Previous Clinical Trials
98,679 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
60 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
New York
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Florida International University Center for Children and Families
Center for Children and Families, University at Buffalo
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

My ADHD is debilitating and I want to find a way to manage it.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Center for Children and Families, University at Buffalo: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Adaptive Response to Intervention (RTI) for Students With ADHD
2018. "Adaptive Response to Intervention (RTI) for Students With ADHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03511976.
All > Adhd
~8 spots leftby Jun 2024
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