ADHD Interventions + Stimulant for ADHD

Recruiting in Palo Alto (17 mi)

+1 other location

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Florida International University

Must not be taking: Stimulants

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

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of this treatment for ADHD?

Research shows that teacher-delivered behavioral classroom interventions can be effective for students with ADHD, and stimulant medications like Ritalin and Adderall have been shown to improve symptoms in over 90% of students initially, with 76% maintaining improvement over a school year. ^{1 2 3 4 5}

Is the combination of ADHD interventions and stimulants safe for humans?

Stimulants used for ADHD, like Ritalin and Adderall, are generally safe but have a potential for misuse and abuse. It's important to monitor their use, especially in school settings, to prevent misuse and ensure they are stored securely. ^{1 2 4 6 7}

How is the Tier 1 Classroom Management treatment for ADHD different from other treatments?

Tier 1 Classroom Management is unique because it involves teachers using specific strategies to manage behavior in the classroom, rather than relying solely on medication. This approach focuses on creating a structured environment and using behavior therapy techniques to help students with ADHD, which can also positively impact their classmates. ^{1 4 8 9 10}

Research Team

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Daily Report Card (DRC) (Behavioural Intervention)
• Enhanced DRC (DRC-E) (Behavioural Intervention)
• Stimulant (Hormone Therapy)
• Tier 1 Classroom Management (Behavioural Intervention)

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.

Participant Groups

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+

Andrés G. Gil

Florida International University

Chief Executive Officer

PhD in Medical Sociology from the University of Miami

Dr. Stuart Hart

Florida International University

Chief Medical Officer

MD from Harvard Medical School

University at Buffalo

Collaborator

Trials

139

Recruited

105,000+

Satish K. Tripathi

University at Buffalo

Chief Executive Officer since 2011

PhD in Computer Science from University of Toronto

Brian M. Parker

University at Buffalo

Chief Medical Officer since 2021

MD from University of Pennsylvania

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

Hyperactivity and inattentiveness. School assessment of stimulant treatment. [2017]

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

School-based interventions for elementary school students with ADHD. [2014]

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

Stimulant use and the potential for abuse in Wisconsin as reported by school administrators and longitudinally followed children. [2019]

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

Treatment of attention deficit hyperactivity disorder: a multi-modal model for schools. [2005]

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

Safety of stimulant treatment in attention deficit hyperactivity disorder: Part I. [2013]

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

Universal precautions to reduce stimulant misuse in treating adult ADHD. [2015]

8. United States 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. [2015]

9. Germany pubmed.ncbi.nlm.nih.gov

[General practice of pedagogic management by teachers of hyperkinetic attention deficit disordered children in the classroom]. [2019]

10. United States 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. [2019]