What side effects are associated with this type of intervention?

Common treatments for ADHD include academic accommodations, behavioral treatments, and medications. Academic accommodations typically have no direct side effects but may require changes in teaching methods. Behavioral treatments like cognitive-behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT) are generally safe but can sometimes cause temporary increases in anxiety or emotional discomfort. Medications, including stimulants (e.g., methylphenidate, amphetamines) and non-stimulants (e.g., atomoxetine), are effective but can have side effects such as insomnia, decreased appetite, weight loss, increased heart rate, and potential for substance misuse. Non-stimulant medications may also cause gastrointestinal issues and mood swings.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of ADHD, including stimulants like methylphenidate (e.g., Concerta, Ritalin) and non-stimulants like atomoxetine (Strattera), guanfacine (Intuniv), and clonidine (Kapvay). These medications have been shown to improve core symptoms of ADHD such as inattention, hyperactivity, and impulsivity. Studies have also explored the combined effects of these medications with behavioral treatments and academic accommodations, demonstrating improvements in on-task behavior, quiz scores, and academic productivity in children with ADHD.

What other types of research exist?

Promising novel alternatives for ADHD treatment in 2024 include dietary and lifestyle changes, deep brain stimulation, transcranial magnetic stimulation, and transcranial direct current stimulation (tDCS).

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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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, a maximum of eight weeks for reporting.

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

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

Do I qualify?Apply below to find out

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.

Find a Location

Who is running the clinical trial?

Florida International UniversityLead Sponsor

100 Previous Clinical Trials

17,139 Total Patients Enrolled

16 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)

2,033 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Media Library

Behavioral classroom Clinical Trial Eligibility Overview. Trial Name: NCT05469386 — Phase 4

Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Placebo, Methylphenidate ER (.3 mg/kg dose), General Classroom, Positive Behavior Support Classroom, Academic accommodations

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Behavioral classroom Highlights & Side Effects. Trial Name: NCT05469386 — Phase 4

Behavioral classroom 2023 Treatment Timeline for Medical Study. Trial Name: NCT05469386 — Phase 4

Attention Deficit Hyperactivity Disorder (ADHD) Patient Testimony for trial: Trial Name: NCT05469386 — Phase 4

~83 spots leftby Aug 2025

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