ADHD Classroom Interventions for Attention Deficit Hyperactivity Disorder

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

288 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the drug methylphenidate for ADHD classroom interventions?

Research shows that methylphenidate significantly improves classroom behavior and academic performance in children with ADHD. It enhances the effectiveness of classroom reinforcers and, when combined with behavior therapy, leads to maximal improvements in behavior. ^{1 2 3 4 5}

Is the treatment safe for humans?

The safety of methylphenidate (a common medication for ADHD) has been studied, and it generally shows no significant adverse effects in children when used as directed. Behavioral classroom interventions are also considered safe, as they involve non-drug strategies to manage behavior. ^{6 7 8 9 10}

How does the treatment for ADHD using behavioral classroom interventions and methylphenidate differ from other treatments?

This treatment is unique because it combines behavioral classroom interventions, which help teachers manage ADHD symptoms in students, with methylphenidate, a medication that can improve focus and reduce disruptive behavior. The combination of these approaches may enhance both academic performance and classroom behavior more effectively than using either method alone. ^{4 6 8 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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 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 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]

References

1. United States 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. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Attention deficit disorder and methylphenidate: normalization rates, clinical effectiveness, and response prediction in 76 children. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

An evaluation of methylphenidate as a potential establishing operation for some common classroom reinforcers. [2019]

4. Spain pubmed.ncbi.nlm.nih.gov

[Factors modulating the efficacy of psychosocial treatment in children with attention deficit hyperactivity disorder]. [2009]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy and duration of effect of extended-release dexmethylphenidate versus placebo in schoolchildren with attention-deficit/hyperactivity disorder. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Implementation resources to support teachers' use of behavioral classroom interventions: protocol of a randomized pilot trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Comparing psychological and pharmacological treatments for hyperkinetic boys and their classmates. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of a Chewable Methylphenidate Extended-Release Tablet in Children with Attention-Deficit/Hyperactivity Disorder. [2018]

9. United States 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. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Further analysis of the separate and interactive effects of methylphenidate and common classroom contingencies. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

A preliminary analysis of interactive effects between common classroom contingencies and methylphenidate. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Methylphenidate and children with attention deficit disorder. Dose effects on classroom academic and social behavior. [2019]