Classroom-Level Intervention to Promote Peers' Acceptance of Children With Attention Deficit Hyperactivity Disorder (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

102 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to help children with ADHD make friends by training teachers to highlight their positive behaviors. The goal is to reduce peer rejection by changing how classmates perceive these children. The intervention will be tested in a program similar to a regular classroom.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Behavioral contingency management, Tolerance training?

Research shows that contingency management, which uses rewards to encourage positive behaviors, is effective in treating substance use disorders. It helps people stay in treatment longer and reduces drug use by providing incentives for meeting treatment goals. ^{1 2 3 4 5}

Is the treatment known as Behavioral contingency management or Tolerance training generally safe for humans?

The research articles provided do not contain specific safety data for Behavioral contingency management or Tolerance training in humans. ^{6 7 8 9 10}

How does the treatment Behavioral contingency management, Tolerance training differ from other treatments for this condition?

This treatment is unique because it focuses on using reinforcement (rewards) to help individuals develop tolerance to certain effects, such as those from alcohol, by learning to associate positive outcomes with unimpaired behavior. Unlike other treatments that might focus solely on physiological changes, this approach emphasizes behavioral learning and reinforcement to manage tolerance. ^{11 12 13 14 15}

Research Team

Amori Y Mikami, PhD

Principal Investigator

University of Virginia

Eligibility Criteria

Inclusion Criteria

Children ages 6-8

Primary diagnosis of ADHD

Timeline

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

Treatment Details

Interventions

• Behavioral contingency management
• Tolerance training

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

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

Challenges to Conducting Contingency Management Treatment for Substance Use Disorders: Practice Recommendations for Clinicians. [2022]

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

Contingency management: utility in the treatment of drug abuse disorders. [2019]

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

A randomized trial adapting contingency management targets based on initial abstinence status of cocaine-dependent patients. [2021]

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

Contingency management for treatment of substance abuse. [2019]

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

Give them prizes, and they will come: contingency management for treatment of alcohol dependence. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Statistical analysis of behavioral toxicology data and studies. [2019]

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

Repeated measurements of motor activity in rats in long-term toxicity studies. [2014]

8. United States 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. [2022]

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

Toxicity testing in the 21st century: using the new toxicity testing paradigm to create a taxonomy of adverse effects. [2021]

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

Is there a role for the no observed adverse effect level in safety pharmacology? [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

Control of alcohol tolerance by reinforcement in nonalcoholics. [2019]

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

Is behavioral tolerance learned? [2019]

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

Characterizing tolerance to trichloroethylene (TCE): effects of repeated inhalation of TCE on performance of a signal detection task in rats. [2019]

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

Stimulus-reinforcer relations established during training determine resistance to extinction and relapse via reinstatement. [2019]

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

Conditioned suppression and variable ratio reinforcement. [2019]