What side effects are associated with this type of intervention?

Behavioral interventions for ADHD generally have minimal side effects but require significant time and effort from children and caregivers. Stimulant medications, such as methylphenidate and amphetamines, are effective but can cause decreased appetite, insomnia, increased heart rate, and potential for misuse or dependency. Nonstimulant medications like atomoxetine may also be used and can cause gastrointestinal issues, fatigue, and mood swings.

What prior FDA approvals exist?

The FDA has approved several stimulant medications for the treatment of ADHD, including methylphenidate (e.g., Ritalin, Concerta) and amphetamines (e.g., Adderall, Vyvanse). These medications are known for their efficacy in improving core symptoms of ADHD by modulating neurochemical pathways. Additionally, non-stimulant medications like atomoxetine (Strattera) and alpha-2 adrenergic agonists such as guanfacine (Intuniv) and clonidine (Kapvay) have also been approved. Behavioral interventions, although not requiring FDA approval, are a critical component of ADHD management and are often recommended in conjunction with medication to address behavioral and psychosocial aspects of the disorder.

What other types of research exist?

Promising novel alternatives for ADHD treatment in 2024 include non-stimulant medications such as extended-release formulations, cognitive training programs like Cogmed Working Memory Training, and noninvasive cerebral stimulation techniques such as transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS). These alternatives offer different mechanisms of action and may be suitable for patients who do not respond well to traditional behavioral interventions or stimulant medications.

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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

Must not have

Child has an IQ less than 70

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of academic year 1 of enrollment

Awards & highlights

No Placebo-Only Group

Pivotal Trial

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Drug Has Already Been Approved

Summary

This trial tests different ways to help children with ADHD behave better in school. It starts with general classroom techniques, adds more focused help if needed, and uses advanced methods or medication if necessary. The study targets young children with ADHD who are not in special education or on medication. Medication has been extensively studied and shown to improve ADHD symptoms in children.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My child's IQ is below 70.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of academic year 1 of enrollment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Observations of Classroom Behavior

Secondary study objectives

Disruptive Behavior Disorders Rating Scale

Impairment Rating Scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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.

0 / 1Eligibility criteria met

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

Behavioral interventions for ADHD focus on modifying the environment and teaching skills to manage symptoms, using strategies like organization, behavior analysis, and stress management. These interventions help patients develop coping mechanisms and improve daily functioning. Stimulant medications, such as methylphenidate and amphetamines, increase levels of neurotransmitters like dopamine and norepinephrine in the brain, enhancing attention, focus, and impulse control. Understanding these mechanisms is crucial for selecting appropriate treatment strategies tailored to individual needs, thereby improving the overall management of ADHD symptoms.