ADHD Classroom Interventions for Attention Deficit Hyperactivity Disorder

Not currently recruiting at 1 trial location

Overseen By Gregory A Fabiano

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Florida International University

Must not be taking: Methylphenidate

Disqualifiers: Autism level 2/3, home schooled, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of different treatments for children with Attention Deficit Hyperactivity Disorder (ADHD) in a classroom setting. Researchers test academic accommodations, behavioral treatments, and medication (Methylphenidate, a common ADHD medication) to assess improvements in focus, quiz scores, and overall school performance. The trial compares these treatments individually and in combination to identify the most effective approach. Children diagnosed with ADHD who have not previously reacted adversely to Methylphenidate may be suitable for this study. As a Phase 4 trial, it involves treatments already FDA-approved and proven effective, aiming to understand how they can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for these treatments?

Research has shown that Methylphenidate ER, a medication for ADHD (Attention Deficit Hyperactivity Disorder), is generally safe for children. Studies have found that using it for up to two years does not raise major safety concerns. However, it has not been proven safe for children under six, so it is usually prescribed to older kids.

Evidence suggests that Positive Behavior Support Classroom interventions can help reduce off-task and disruptive behaviors in children with ADHD. These strategies aim to improve the classroom environment and are safe because they rely on behavioral techniques instead of medication.

Regarding academic accommodations, such as extra time on tests, the evidence is mixed. These accommodations are intended to help students with ADHD perform better in school. They are safe since they do not involve medication, but their effectiveness can vary, and some studies suggest they might not always be very helpful.

Overall, both the behavioral and educational interventions, along with Methylphenidate ER, have been shown to be safe for children with ADHD, making them viable options for managing symptoms. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these ADHD classroom interventions because they explore unique approaches to managing the condition beyond typical medication. The Positive Behavior Support Classroom method stands out as it emphasizes modifying classroom dynamics to encourage positive behavior and improve focus, rather than relying solely on medication. Academic accommodations are another highlight, as they tailor learning environments to fit individual student needs during tasks like seat work and quizzes, potentially enhancing academic performance without pharmacological intervention. These techniques offer promising alternatives or complements to standard ADHD treatments, which usually involve stimulant medications like methylphenidate, by addressing behavioral and educational aspects of the disorder.

What evidence suggests that this trial's treatments could be effective for ADHD?

Research shows that Methylphenidate ER, which participants in this trial may receive, can help manage ADHD symptoms in children by reducing hyperactivity and impulsivity and improving focus. In studies where some children took a placebo (a pill with no medicine), Methylphenidate proved moderately effective in treating key ADHD symptoms.

The Positive Behavior Support Classroom is another approach tested in this trial. Evidence suggests it can enhance the learning environment for students with ADHD, as managing behavior in the classroom has been shown to help children perform better in school.

Academic accommodations, also evaluated in this trial, have shown mixed results in research regarding their effectiveness specifically for students with ADHD. Some accommodations may not offer more benefits than those experienced by students without ADHD. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

IQ >= 70

ADHD Diagnosis

Exclusion Criteria

Prior adverse reaction to methylphenidate

Autism Spectrum disorder level 2/3

Child is home schooled

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and combined academic accommodation, behavioral treatment, and medication treatment

8 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Academic Accommodations
• Behavioral classroom
• General Classroom
• Methylphenidate Hydrochloride ER
• Placebo

Trial Overview

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.

How Is the Trial Designed?

Group I: Positive Behavior Support Classroom Experimental Treatment 3 Interventions

Positive Behavior Support Classroom procedures

Group II: Methylphenidate ER (.3 mg/kg dose) Experimental Treatment 3 Interventions

Methylphenidate ER (.3 mg/kg dose)administered in the morning

Group III: Academic accommodations Experimental Treatment 4 Interventions

Academic accommodations are used during seat work and quiz

Group IV: General Classroom Active Control 3 Interventions

General classroom procedures

Group V: Placebo Placebo Group 3 Interventions

Placebo capsule administered in the morning

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

Published Research Related to This Trial

Both methylphenidate (a medication) and teacher consultation (a behavioral intervention) significantly improved on-task behavior in hyperkinetic boys, with no notable difference in effectiveness between the two treatments.

The behavioral intervention not only helped the hyperkinetic boys but also positively affected their overactive classmates, suggesting that behavioral strategies can have broader benefits in classroom settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing psychological and pharmacological treatments for hyperkinetic boys and their classmates. Loney, J., Weissenburger, FE., Woolson, RF., et al.[2019]

In a phase 3 study involving 90 children aged 6-12 with ADHD, methylphenidate hydrochloride extended-release chewable tablets (MPH ERCT) significantly reduced ADHD symptoms compared to placebo, with effects observed from 2 to 8 hours postdose.

The treatment was generally safe and well tolerated, with common side effects including decreased appetite and irritability, but no reports of suicidal ideation, indicating a favorable safety profile similar to other methylphenidate formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of a Chewable Methylphenidate Extended-Release Tablet in Children with Attention-Deficit/Hyperactivity Disorder. Wigal, SB., Childress, A., Berry, SA., et al.[2018]

A psychosocial program designed for individualized treatment in the classroom significantly improved behavior in children with ADHD, as reported by both parents and teachers.

Factors such as inhibitory control deficits, anxiety, disobedience, isolation, and social inadaptation were identified as variables that could influence the effectiveness of the treatment program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Factors modulating the efficacy of psychosocial treatment in children with attention deficit hyperactivity disorder]. Miranda, A., García, R., Presentación, MJ.[2009]

The study will pilot test a resource package called Positive Behavior Management Implementation Resources (PBMIR) to help teachers effectively implement behavioral classroom management strategies for students with ADHD symptoms, using a randomized controlled trial design with two groups.

Outcomes will be measured for both teachers and students over an 8-week period, focusing on the fidelity of intervention implementation and improvements in ADHD-related symptoms and academic performance, which could lead to larger-scale evaluations if successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation resources to support teachers' use of behavioral classroom interventions: protocol of a randomized pilot trial. Lawson, GM., Owens, JS., Mandell, DS., et al.[2023]

In a study involving 20 hyperactive children aged 6 to 9, Ritalin (0.3 mg/kg) significantly reduced hyperactive behaviors such as inappropriate vocalizing and peer interactions during group activities, while behavior modification alone did not show significant effects during individual tasks.

The combination of medication and behavior modification did not interact to enhance outcomes, indicating that while Ritalin effectively reduced certain hyperactive behaviors, behavior modification was necessary for improving academic performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of methylphenidate alone and in combination with behavior modification procedures on the behavior and academic performance of hyperactive children. Wolraich, M., Drummond, T., Salomon, MK., et al.[2020]

Methylphenidate (MPH) was found to have varying effects on disruptive and off-task behaviors in children with ADHD, depending on the classroom conditions, indicating that the environment can influence medication efficacy.

Time-out strategies were particularly effective, leading to minimal disruptive and off-task behaviors in 3 out of 4 participants, regardless of whether they were on MPH or placebo, suggesting that behavioral interventions can complement medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Further analysis of the separate and interactive effects of methylphenidate and common classroom contingencies. Northup, J., Fusilier, I., Swanson, V., et al.[2018]

In a study involving 24 boys with ADHD, both methylphenidate (MPH) and behavior modification techniques significantly improved classroom behavior, but only MPH enhanced academic productivity and accuracy.

The combination of behavior therapy with a lower dose of MPH (0.3 mg/kg) achieved similar behavioral improvements to a higher dose (0.6 mg/kg) MPH alone, suggesting that lower doses combined with behavioral strategies can be effective in managing ADHD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single and combined effects of methylphenidate and behavior therapy on the classroom performance of children with attention-deficit hyperactivity disorder. Carlson, CL., Pelham, WE., Milich, R., et al.[2019]

In an 8-year-old boy with ADHD, the presence of methylphenidate significantly reduced disruptive behavior that was otherwise maintained by peer attention when the medication was not taken.

The study highlights the importance of both classroom environment and medication in managing ADHD symptoms, suggesting that methylphenidate can effectively mitigate the influence of peer interactions on behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary analysis of interactive effects between common classroom contingencies and methylphenidate. Northup, J., Jones, K., Broussard, C., et al.[2018]

In a study involving 3 boys with ADHD, the use of methylphenidate significantly changed how effective certain classroom rewards were compared to when they received a placebo.

The findings suggest that methylphenidate may enhance the effectiveness of common reinforcers used in behavioral treatment programs, indicating its potential role in improving classroom behavior management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of methylphenidate as a potential establishing operation for some common classroom reinforcers. Northup, J., Fusilier, I., Swanson, V., et al.[2019]

Methylphenidate (MPH) significantly improves classroom behavior and attention in a majority of the 76 children with attention deficit disorder/hyperactivity (ADDH) studied, with effects observed across multiple doses (5 mg to 20 mg).

Despite improvements in behavior, many children did not show corresponding gains in academic performance, indicating that additional support may be necessary for those who do not respond to MPH alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention deficit disorder and methylphenidate: normalization rates, clinical effectiveness, and response prediction in 76 children. Rapport, MD., Denney, C., DuPaul, GJ., et al.[2022]

In a study involving 54 children aged 6-12, extended-release dexmethylphenidate (d-MPH-ER) significantly improved ADHD symptoms compared to placebo, showing effectiveness as early as 1 hour postdose and maintaining superiority for up to 12 hours.

D-MPH-ER was well tolerated with no severe adverse events reported, indicating it is a safe option for improving attention and performance in children with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and duration of effect of extended-release dexmethylphenidate versus placebo in schoolchildren with attention-deficit/hyperactivity disorder. Silva, RR., Muniz, R., Pestreich, L., et al.[2015]

In a study involving 29 children with attention deficit disorder, methylphenidate hydrochloride showed beneficial effects on academic performance and classroom behavior, with improvements observed across various tasks such as reading comprehension and arithmetic.

The research demonstrated a linear dose-response relationship, indicating that higher doses of methylphenidate (up to 0.6 mg/kg) were associated with greater improvements in both academic output and on-task behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methylphenidate and children with attention deficit disorder. Dose effects on classroom academic and social behavior. Pelham, WE., Bender, ME., Caddell, J., et al.[2019]

Citations

1.

files.eric.ed.gov

files.eric.ed.gov/fulltext/EJ1435041.pdf

Academic Accommodations and Functioning in College ...

Studies investigating outcomes of academic accommodation use among college students with. ADHD currently present mixed findings. College stu- dents with ADHD ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5424262/

Academic Testing Accommodations for ADHD: Do They Help?

Results indicated that typically developing students outperformed students with ADHD under both standard administration and extended time conditions, and ...

3.

tandfonline.com

tandfonline.com/doi/full/10.1080/02602938.2025.2547053

Give me a break: assessing the effectiveness of test- ...

This study examined the effectiveness of combined test-break and small-group testing accommodations in high-stakes standardized assessments for ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9027028/

University students with attention deficit hyperactivity disorder ...

This consensus aims to provide an informed understanding of the impact of ADHD on the educational (or academic) outcomes of university students.

5.

jaacap.org

jaacap.org/article/S0890-8567%2820%2931333-2/fulltext

Systematic Review: Educational Accommodations for ...

However, most accommodations fail to show evidence of benefits that are specific to students with ADHD, and many of the more common ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2920775/

Update on standards and diagnostic concerns - PMC

Students with ADHD require comprehensive documentation of their disabilities to obtain accommodations at the postsecondary level.

7.

udallas.edu

udallas.edu/offices-services/americans-with-disabilities-act/adhd.php

Student Disability Services ADHD

Documenting Attention-Deficit/Hyperactivity Disorder. A PDF version of these guidelines is available here. In addition, the corresponding verification form ...

8.

jcimcr.org

jcimcr.org/pdfs/JCIMCR-v6-3528.pdf

Adolescents with ADHD in the school environment

Additionally, the review will explore inter- ventions and educational accommodations designed to support students with ADHD, ranging from ...