ADHD Interventions + Stimulant for ADHD

No longer recruiting at 1 trial location

Overseen By Amy R Altszuler, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Florida International University

Must not be taking: Stimulants

Disqualifiers: Special education, IQ < 70, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best ways to support children with ADHD in schools. It tests various classroom management strategies and, if necessary, adds either enhanced behavioral interventions or stimulant medication (such as Ritalin, Adderall, Concerta, Vyvanse, or Strattera). The goal is to determine which approach most effectively helps children with ADHD manage their symptoms. Children diagnosed with ADHD who are entering grades 1 through 5 may be suitable candidates for this trial. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, providing an opportunity to observe its benefits for more children.

Will I have to stop taking my current medications?

The trial does not specify if participants must stop taking their current medications. However, children with a history of successful treatment with stimulant medication are excluded from the study.

What is the safety track record for these treatments?

Research shows that the treatments being tested for ADHD, including behavior strategies and stimulant medications, are generally safe.

For Tier 1 Classroom Management strategies, studies indicate these are well-established in schools and focus on teaching expected behaviors. This method is safe because it creates supportive learning environments, a common practice in many classrooms.

The Daily Report Card (DRC) intervention has proven effective and safe for students with ADHD. Multiple studies show that DRCs improve social and academic behaviors without any known safety issues.

Enhanced DRC strategies are more focused versions of the regular DRC, targeting specific behaviors more intensely. Research supports their effectiveness, and they are considered safe as they build on the existing DRC framework.

For students who might take stimulant medication, past studies have found these drugs are generally safe for treating ADHD. Some common side effects, like trouble sleeping and dry mouth, can occur, but there's no evidence of increased risk for serious health issues, such as heart problems, in young people. However, there is a slight risk of mood swings or symptoms like hearing voices, though these are rare.

Overall, evidence supports that these treatments, whether behavioral or medicinal, are well-tolerated and safe for treating ADHD in children. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these interventions for ADHD because they explore structured classroom management techniques alongside stimulant medication. Unlike standard treatments, which often rely solely on medication or general accommodations, this study emphasizes a tiered approach. It starts with basic classroom management strategies and progresses to more personalized interventions like a daily report card and enhanced behavioral plans. This method aims to tailor support to each student's unique needs, potentially leading to more effective outcomes. By integrating both behavioral and medicinal strategies, the trial seeks to find a balanced approach that could enhance the academic and behavioral success of students with ADHD.

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

Research has shown that basic classroom management techniques, provided to participants in the RTI Tier 1 Arm of this trial, can improve the behavior and performance of children with ADHD. These methods create a supportive learning environment that helps manage ADHD symptoms.

For participants who do not respond to the initial RTI Tier 1 Classroom Management strategies, the trial includes a Daily Report Card (DRC) Arm. Studies have found that using DRCs, which track and report behavior daily, can significantly reduce ADHD symptoms.

For those needing extra help, the trial offers an Enhanced DRC Arm, providing a more personalized approach that has improved outcomes for students with ADHD. Additionally, the Medication Arm of this trial provides stimulant medications like amphetamines and methylphenidate, which have been proven to reduce key ADHD symptoms and are linked to a better quality of life and fewer hospital visits. These treatments have a strong history of effectively managing ADHD symptoms. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Child meets DSM-V diagnostic criteria for Attention-Deficit/Hyperactivity Disorder

Exclusion Criteria

Child has psychosis or a pervasive developmental disorder

Child is in a classroom that already has a study participant

Child is home-schooled

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tier 1 Intervention

Participants receive Tier 1 classroom-wide management strategies as part of the RTI approach

Throughout the academic year

Regular school visits

Tier 2 Intervention

Participants who do not respond to Tier 1 receive a Daily Report Card (DRC) intervention

Throughout the academic year

Regular school visits

Enhanced RTI or Medication

Participants who do not respond to Tier 2 are randomly assigned to either enhanced RTI strategies or receive stimulant medication

Throughout the academic year

Regular school visits

Follow-up

Participants are monitored for safety and effectiveness after interventions

End of academic year

What Are the Treatments Tested in This Trial?

Interventions

• Daily Report Card (DRC)
• Enhanced DRC (DRC-E)
• Stimulant
• Tier 1 Classroom Management

Trial Overview 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.

How Is the Trial Designed?

Group I: Response to Intervention (RTI): Tier 1 Experimental Treatment 1 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: Enhanced Experimental Treatment 3 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 Treatment 2 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: Medication Experimental Treatment 3 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 Control 1 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.

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

University at Buffalo

Collaborator

Trials

139

Recruited

105,000+

Published Research Related to This Trial

Classroom interventions significantly reduce off-task and disruptive behavior in children with ADHD, with the most effective strategies being consequence-based and self-regulation interventions, showing large effect sizes in both within-subjects and single-subject studies.

These interventions not only help the targeted children but also positively impact the behavioral and academic outcomes of their classmates, indicating a broader benefit in classroom settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Classroom Interventions on Off-Task and Disruptive Classroom Behavior in Children with Symptoms of Attention-Deficit/Hyperactivity Disorder: A Meta-Analytic Review. Gaastra, GF., Groen, Y., Tucha, L., et al.[2019]

Newer stimulant medications for treating attention deficit hyperactivity disorder (ADHD) generally have a safety profile characterized by frequent but mild side effects, indicating they are relatively safe for use in various populations.

The risk of developing long-term substance abuse from ADHD is low, especially when treated properly, suggesting that effective management of ADHD may actually help reduce this risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of stimulant treatment in attention deficit hyperactivity disorder: Part I. Merkel, RL., Kuchibhatla, A.[2013]

A survey of 161 children diagnosed with ADHD revealed that 16% had been approached to sell or trade their prescribed stimulants, indicating a potential risk for misuse among peers.

44% of the children and 37% of schools reported that stimulants were stored unlocked during school hours, highlighting a safety concern regarding the management of these medications in schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulant use and the potential for abuse in Wisconsin as reported by school administrators and longitudinally followed children. Musser, CJ., Ahmann, PA., Theye, FW., et al.[2019]

Stimulants are the primary approved treatment for adults with ADHD in the U.S. and are effective for many patients.

However, due to their potential for misuse, the article recommends a 'universal precautions' approach to ensure safe and appropriate use of these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Universal precautions to reduce stimulant misuse in treating adult ADHD. Modesto-Lowe, V., Chaplin, M., Sinha, S., et al.[2015]

A 3-month intervention program for teachers in a Cologne elementary school highlighted the need for better training and knowledge about ADHD, as many teachers lack understanding of treatment principles and strategies to manage ADHD in the classroom.

The program emphasized the importance of involving teachers in the treatment process and implementing structured behavior therapy techniques, which can improve the educational experience for students with ADHD and foster better cooperation between schools, parents, and therapeutic institutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[General practice of pedagogic management by teachers of hyperkinetic attention deficit disordered children in the classroom]. Frölich, J., Döpfner, M., Biegert, H., et al.[2019]

In a study of 176 students receiving stimulant medication for hyperactivity/inattentiveness, about 75% had pre-treatment ratings indicating moderate to severe symptoms, highlighting the severity of their conditions before treatment.

Over 90% of these students showed at least a 50% improvement in symptoms after starting medication, with 76% maintaining this improvement by the end of the school year, although effectiveness and compliance decreased in middle school.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperactivity and inattentiveness. School assessment of stimulant treatment. Safer, D., Krager, JM.[2017]

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]

Children with ADHD often struggle with behavior, social skills, and academic performance, and while medication can help, it usually isn't enough to fully address their challenges in school.

The article highlights three effective strategies—behavioral, academic, and self-regulation interventions—that can support children with ADHD in the classroom, suggesting a need for more research on these school-based approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-based interventions for elementary school students with ADHD. DuPaul, GJ., Gormley, MJ., Laracy, SD.[2014]

School-wide behavior management systems can enhance both academic performance and behavior in middle schools, particularly benefiting students with ADHD.

The Deployment-Focused Model of Intervention Development emphasizes involving teachers in the creation of these programs, which may improve the feasibility and sustainability of implementing evidence-based behavior management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a school-wide behavior program in a public middle school: an illustration of deployment-focused intervention development, stage 1. Molina, BS., Smith, BH., Pelham, WE.[2015]

Schools have a crucial but underutilized role in the treatment of ADHD, as children spend significant time there and interact with trained professionals who can support their needs.

A multi-modal treatment model is proposed, emphasizing a functional approach that tailors assessments and interventions to individual children's specific challenges and environmental factors affecting their behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of attention deficit hyperactivity disorder: a multi-modal model for schools. Maag, JW., Reid, R.[2005]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29135352/

The Effectiveness of Daily Behavior Report Cards for ... Conclusions: DBRCs effectively reduce the frequency and severity of ADHD symptoms in classroom settings. Additionally, they have a significant effect on co- ...

2. link.springer.com link.springer.com/article/10.1007/s44217-024-00231-6

The effects of the Daily Behavior Report Cards (DBRC) on ... The results showed that DBRCs reduced teacher-rated ADHD symptoms with a moderate effect size (Hedges' g = 0.36). However, two studies that used ...

3. psycnet.apa.org psycnet.apa.org/record/2026-35186-001

A randomized, controlled trial to evaluate the efficacy of a daily ... Objective: Daily report cards (DRC) are an effective approach for improving behavior in children with attention-deficit/hyperactivity disorder (ADHD).

4. charts.intensiveintervention.org charts.intensiveintervention.org/intervention/toolView/?id=3f52df4b74f228df

Daily Report Card Study: Fabiano et al. (2010) The Daily Report Card (DRC) is an evidence-supported intervention for youth with disruptive behavior disorders and school performance challenges.

5. ies.ed.gov ies.ed.gov/use-work/awards/enhancing-ieps-children-adhd-using-daily-report-cards-efficacy-trial

Enhancing IEPs of Children with ADHD Using Daily Report ... Data will be analyzed to determine whether linking a DRC to the IEP results in improved outcomes for students with ADHD and to explore a variety of potential ...

6. files.eric.ed.gov files.eric.ed.gov/fulltext/ED583708.pdf

META-ANALYSIS DRC ADHD Daily Report Card ... - ERIC Overall, the present study supports the use of the DRC with students who have ADHD, and provides guidance for using single-case design studies in meta-analyses ...

7. researchgate.net researchgate.net/publication/316625794_Daily_Report_Cards_A_Recommended_Intervention_in_the_Schools

(PDF) Daily Report Cards: A Recommended Intervention in ... Daily report cards to be an effective intervention for both elementary and middle school students. This was also found across both social and academic ...

8. ccf.fiu.edu ccf.fiu.edu/research/_assets/how_to_establish_a_school_drc.pdf

How to Establish a School-Home Daily Report Card The following steps offer a guide for establishing a successful DRC. Why use a DRC? • Many studies have shown that DRCs are effective in changing ADHD ...

9. dailyreportcardonline.com dailyreportcardonline.com/

Daily Report Card Online | An intuitively designed, web-based ... DRCO is an interactive, web-based tool to support school professionals as they develop and implement the Daily Report Card (DRC) intervention.