Classroom-Level Intervention for ADHD

Overseen By Amori Y Mikami, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Pervasive developmental disorder, verbal IQ below 75

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help children with ADHD feel more accepted by their classmates. Teachers will receive training in special classroom practices to enhance peer relationships for these children. The trial will test two approaches: one combines behavioral management (using rewards and consequences to encourage good behavior) with tolerance training (teaching acceptance and understanding of differences), while the other focuses solely on behavioral management. Children aged 6-8 with a primary diagnosis of ADHD might be a good fit. As an unphased trial, this study offers a unique opportunity for children to benefit from innovative strategies designed to improve social acceptance and peer relationships.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that this intervention is safe for children with ADHD?

Research has shown that behavioral contingency management, one of the treatments in this trial, is generally safe and well-tolerated. Studies have found it effective for various groups, particularly in treating substance use disorders. These studies consistently report positive results, indicating that the treatment usually does not cause serious side effects.

The other treatment, tolerance training, lacks direct study for health impacts in clinical settings. However, similar programs, especially those aimed at improving safety and compliance at work, have led to positive behavior changes without harmful effects.

While specific safety data for these treatments in ADHD settings might not be available, both have demonstrated safety and efficacy in other areas. This supports confidence in their safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for ADHD because they focus on changing social dynamics within the classroom. Unlike traditional treatments like medication or individual therapy, these approaches aim to enhance peer acceptance through behavioral contingency management and tolerance training. Behavioral contingency management uses positive reinforcement to encourage kids to support each other, while tolerance training teaches students how to better understand and accept their classmates with ADHD. This could lead to a more inclusive and supportive classroom environment, potentially improving social outcomes for children with ADHD.

What evidence suggests that this trial's treatments could be effective for improving peer relationships in children with ADHD?

Research has shown that behavioral contingency management, which involves rewarding good behavior, is effective in many situations, particularly in reducing substance use. While promising, this method primarily addresses substance use issues rather than social acceptance. Tolerance training, designed to increase patience and reduce problem behaviors, might help children with ADHD interact better with peers. However, direct evidence on how these methods affect peer relationships in children with ADHD remains limited. This trial will compare the effects of behavioral contingency management alone with a combined approach that includes both tolerance training and behavioral management. The goal of combining these strategies is to improve social acceptance, but specific data linking these methods to better peer acceptance in children with ADHD is still being developed. ^{2 3 6 7 8}

Who Is on the Research Team?

Amori Y Mikami, PhD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

Inclusion Criteria

Children ages 6-8

Primary diagnosis of ADHD

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Teachers are trained in classroom practices to reduce peer rejection of students with ADHD in a summer program

2 weeks

Daily sessions in a summer program

Follow-up

Participants are monitored for changes in peer relationships and behavior problems after the summer program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral contingency management
• Tolerance training

How Is the Trial Designed?

Group I: Combined Experimental Treatment 2 Interventions

This represents a combination of the tolerance training and behavioral management interventions together.

Group II: Behavioral management Active Control 1 Intervention

This represents the behavioral contingency management intervention only.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

The study found that there is no formal definition of 'adversity' or guidance on determining the No Observed Adverse Effect Level (NOAEL) in safety pharmacology, indicating a lack of standardized practices in this area.

It was concluded that using NOAEL in safety pharmacology is not recommended, as the diverse functional endpoints measured do not fit into a simple toxic/non-toxic classification, suggesting a need for more nuanced risk assessments in drug development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a role for the no observed adverse effect level in safety pharmacology? Mow, T., Andersen, NK., Dragsted, N., et al.[2021]

Determining whether findings from nonclinical safety studies are adverse can be challenging due to variability in biological responses, leading to subjective interpretations by stakeholders involved in drug development.

The article presents a practical stepwise approach to assess adversity in drug treatment effects, supported by insights from various experts and illustrated through 10 case studies, highlighting the complexities in evaluating safety during pharmaceutical development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Considerations in Determining Adversity and the No-Observed-Adverse-Effect-Level (NOAEL) in Nonclinical Safety Studies: Challenges, Perspectives and Case Studies. Kale, VP., Bebenek, I., Ghantous, H., et al.[2022]

Contingency management procedures have been shown to effectively treat substance use disorders by providing rewards, like vouchers, for drug abstinence, particularly in psychosocial and methadone maintenance settings.

Recent adaptations of these procedures include using lower-cost reinforcers and expanding their application to improve treatment attendance, adherence to goals, and medication compliance, highlighting the versatility of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management for treatment of substance abuse. Stitzer, M., Petry, N.[2019]

Contingency management (CM) effectively uses positive reinforcement to enhance treatment outcomes for substance abusers, particularly in achieving sustained abstinence from drugs.

CM is not only beneficial as a direct therapeutic approach but also serves as a valuable tool in clinical trials for testing new medications and improving patient adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management: utility in the treatment of drug abuse disorders. Stitzer, ML., Vandrey, R.[2019]

In a study involving 333 cocaine-negative patients, both attendance-based and abstinence-based contingency management (CM) were equally effective in enhancing the longest duration of abstinence, with attendance-based CM leading to higher participation and submission of negative samples.

For 109 cocaine-positive patients, a higher magnitude abstinence-based CM ($560Abs) significantly improved abstinence outcomes compared to standard care, indicating that greater rewards can enhance treatment effectiveness for those actively using cocaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial adapting contingency management targets based on initial abstinence status of cocaine-dependent patients. Petry, NM., Barry, D., Alessi, SM., et al.[2021]

In a study of 42 alcohol-dependent veterans, those who received contingency management (CM) alongside standard treatment had a much higher retention rate in treatment (84%) compared to those receiving only standard treatment (22%).

By the end of the 8-week treatment period, 69% of CM participants remained abstinent from alcohol, while 61% of those in standard treatment had relapsed, indicating that CM is an effective strategy for promoting abstinence in alcohol treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Give them prizes, and they will come: contingency management for treatment of alcohol dependence. Petry, NM., Martin, B., Cooney, JL., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

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library.samhsa.gov/sites/default/files/contingency-management-advisory-pep24-06-001.pdf

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Despite the effectiveness of CM on near-term substance use behaviors, the long-term impact on key outcomes such as mortality are unclear. The ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2949875923000279

A systematic review of remotely delivered contingency ...

Remotely delivered contingency management improves substance use outcomes. •. Remotely delivered contingency management increases engagement in health care ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3049167/

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In meta-analyses and reviews (4–6), CM treatments are associated with amongst the largest effect sizes, and they have consistently engendered positive outcomes ...

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Contingency Management Fact Sheet

Moreover, nine meta-analyses performed during the past two decades used the combined data from multiple studies to find positive results from contingency.

8.

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aspe.hhs.gov/reports/contingency-management-treatment-suds

Contingency Management for the Treatment of Substance ...

Contingency management (CM) is an evidence-based psychosocial therapy for the treatment of stimulant use disorder, as well as a variety of other substance use ...