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ADHD Classroom Interventions for Attention Deficit Hyperactivity Disorder
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, a maximum of eight weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial looks at how school adjustments, behavior techniques, and medicine help kids with ADHD do better in school. It focuses on children who have trouble paying attention and performing well academically. The treatments work by making school easier, encouraging good behavior, and helping kids focus better.
Who is the study for?
This trial is for children with ADHD who have an IQ of 70 or above and attend a regular school. It's not suitable for kids with severe autism, those who've had bad reactions to the drug Methylphenidate, or are homeschooled.
What is being tested?
The study tests how well different treatments work alone or together in managing ADHD in school settings. Treatments include a long-acting stimulant medication (Methylphenidate ER), behavior strategies in class, academic help, and placebo.
What are the potential side effects?
Possible side effects from Methylphenidate may include nervousness, trouble sleeping, loss of appetite, weight loss, dizziness, nausea, vomiting or headaches.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, a maximum of eight weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, a maximum of eight weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Behavioral frequency count of rule violations
Quiz Scores
Seatwork completion
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Positive Behavior Support ClassroomExperimental Treatment3 Interventions
Positive Behavior Support Classroom procedures
Group II: Methylphenidate ER (.3 mg/kg dose)Experimental Treatment3 Interventions
Methylphenidate ER (.3 mg/kg dose)administered in the morning
Group III: Academic accommodationsExperimental Treatment4 Interventions
Academic accommodations are used during seat work and quiz
Group IV: General ClassroomActive Control3 Interventions
General classroom procedures
Group V: PlaceboPlacebo Group3 Interventions
Placebo capsule administered in the morning
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for ADHD include medication, behavioral therapy, and academic accommodations. Medications, such as stimulants (e.g., methylphenidate and amphetamines), work by increasing the levels of neurotransmitters like dopamine and norepinephrine in the brain, which helps improve attention and reduce hyperactive and impulsive behaviors.
Behavioral therapy focuses on modifying the patient's environment and using reinforcement strategies to encourage desirable behaviors and reduce problematic ones. Academic accommodations, such as extended time on tests and a structured learning environment, help mitigate the impact of ADHD symptoms on academic performance.
These treatments are crucial for ADHD patients as they address both the neurological and behavioral aspects of the disorder, leading to improved daily functioning and quality of life.
Psychosocial treatments for adults with attention-deficit/hyperactivity disorder.
Psychosocial treatments for adults with attention-deficit/hyperactivity disorder.
Find a Location
Who is running the clinical trial?
Florida International UniversityLead Sponsor
106 Previous Clinical Trials
18,652 Total Patients Enrolled
17 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
2,153 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Methylphenidate ER (.3 mg/kg dose)
- Group 3: General Classroom
- Group 4: Positive Behavior Support Classroom
- Group 5: Academic accommodations
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Attention Deficit Hyperactivity Disorder (ADHD) Patient Testimony for trial: Trial Name: NCT05469386 — Phase 4
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