ADHD Monitoring Program for ADHD

(RAMP Trial)

Recruiting at 1 trial location

Overseen By Matthew Henry, MSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: IDeA States Pediatric Clinical Trials Network

Must be taking: Stimulants

Must not be taking: Atypical antipsychotics

Disqualifiers: Schizophrenia, Bipolar, Conduct disorder, others

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

Compensation: Varies

Number of Visits: 4

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new ADHD Monitoring Program (RAMP) to help manage ADHD symptoms in children living in rural areas. The study aims to determine if RAMP reports, a type of monitoring tool, are feasible and beneficial during the early stages of ADHD treatment compared to digital education handouts. Children aged 5-11 with a new ADHD diagnosis who are starting stimulant medication and attending elementary school may be suitable for this trial. The trial will compare two groups: one using RAMP reports and one receiving digital handouts. The main focus is on the practicality of implementing these tools, not on clinical outcomes. As an unphased trial, this study offers a unique opportunity to contribute to innovative ADHD management strategies in underserved communities.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that children should not have received stimulant medication for the last 6 months. If your child is on other medications, it's best to discuss with the trial team.

What prior data suggests that this ADHD Monitoring Program is safe for children?

A previous study tested the Remote ADHD Monitoring Program (RAMP) to evaluate its effectiveness in tracking ADHD (Attention-Deficit/Hyperactivity Disorder) symptoms in children. The study primarily assessed the program's ease of use, rather than the children's health. As RAMP is a monitoring tool, not a medication or medical device, no reports of side effects or safety issues have been associated with the program itself.

This trial is in the "Not Applicable" phase, indicating it is in the early stages of testing and focuses on the program's practicality, not health outcomes. This suggests it is unlikely to pose any direct safety risks, as it observes symptoms rather than treats them. RAMP aims to enhance understanding of ADHD symptoms, not alter them, ensuring safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique approach to monitoring ADHD using RAMP Reports. Unlike traditional treatments for ADHD that often focus on medication or therapy, RAMP Reports involve submitting regular reports to track symptoms and progress over time. This method could potentially provide a more dynamic and personalized understanding of ADHD management. By offering real-time insights and adjustments, it aims to complement existing treatment strategies, offering a new layer of support for individuals with ADHD.

What evidence suggests that this ADHD Monitoring Program is effective for ADHD?

Research has shown that programs like RAMP, available to participants in this trial, regularly monitor a child's ADHD symptoms and can manage these symptoms more effectively. Studies have found that tracking progress can lead to better treatment adjustments, potentially improving outcomes for children with ADHD. The RAMP method involves submitting reports that monitor symptoms and treatment effectiveness over time, aiding doctors in creating more precise treatment plans. While specific data on RAMP's effectiveness is limited, regular monitoring is well-supported in managing ADHD. Overall, early signs suggest that RAMP reports could be a useful tool for tracking and managing ADHD symptoms. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for caregivers with infants showing early signs of hyperactivity, specifically ADHD. It's designed for those in rural areas and involves 36 pairs across two sites. Participants must be willing to use a monitoring program or receive digital handouts.

Inclusion Criteria

Child must be under the care of a participating provider

Child must have a diagnosis of ADHD

My child is between 5 and 11 years old.

Exclusion Criteria

My child has been treated with atypical antipsychotic medication.

Child has severe neurodevelopment disorders (Children with well-controlled seizure disorders will be permitted to participate.)

Child is or becomes pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention group submit RAMP reports weekly for 4 weeks and then monthly for 2 months. Control group receives digital education handouts on the same schedule.

3 months

Weekly for 4 weeks, then monthly for 2 months (remote)

Follow-up

Participants are monitored for the completion and review of RAMP reports and clinical assessments.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Digital Education Handouts
• RAMP Reports

Trial Overview

The study tests an ADHD Monitoring Program (RAMP) against standard digital educational materials. Caregivers and infants are randomly assigned to either get regular RAMP reports or just the educational handouts over a period of 10 months.

How Is the Trial Designed?

Group I: RAMP Reports Experimental Treatment 1 Intervention

Submit RAMP reports weekly for 4 weeks and then monthly for 2 months.

Group II: Digital Education Handouts Active Control 1 Intervention

Standard of care determined by the treating healthcare provider and digital education handouts (attention controls) distributed by the study team weekly for 4 weeks and then monthly for 2 months.

Who Is Running the Clinical Trial?

IDeA States Pediatric Clinical Trials Network

Lead Sponsor

Trials

8

Recruited

2,500+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

University of Mississippi Medical Center

Collaborator

Trials

185

Recruited

200,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

The prevalence of diagnosed ADHD in Canada increased significantly from 1999 to 2012 across all provinces, with boys being diagnosed approximately three times more often than girls, particularly in the 10- to 14-year age group.

While the incidence of ADHD diagnoses rose in Manitoba, Quebec, and Nova Scotia during the same period, it remained stable in Ontario, indicating regional differences in ADHD diagnosis trends.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal Trends in the Prevalence and Incidence of Diagnosed ADHD in Children and Young Adults between 1999 and 2012 in Canada: A Data Linkage Study. Vasiliadis, HM., Diallo, FB., Rochette, L., et al.[2018]

An algorithm-based treatment program for ADHD was successfully implemented in a Texas community mental health center, involving 50 child and adolescent patients over a 4-month period.

While psychiatrists generally adhered to the main aspects of the algorithm, there was less compliance with specific tactics, such as the fixed titration of stimulant medications, indicating areas for improvement in treatment consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study of the children's medication algorithm project (CMAP) algorithm for the treatment of ADHD. Pliszka, SR., Lopez, M., Crismon, ML., et al.[2015]

The clinical practice guideline emphasizes that primary care clinicians should evaluate school-aged children (6 to 12 years old) for ADHD if they exhibit symptoms like inattention, hyperactivity, or behavior problems, based on a systematic review of evidence.

Diagnosis of ADHD requires meeting specific criteria from the Diagnostic and Statistical Manual of Mental Disorders, and assessments should include input from parents and teachers about the child's symptoms and functional impairment, while also considering coexisting conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical practice guideline: diagnosis and evaluation of the child with attention-deficit/hyperactivity disorder. American Academy of Pediatrics. [2022]

The SANDAP protocol, implemented in seven primary care offices, was found to be feasible and acceptable for evaluating ADHD in children, with 159 children enrolled, but only 44% met the strict criteria for ADHD based on both parent and teacher assessments.

Significant barriers to implementing ADHD diagnostic guidelines were identified, including the need for better education for families, limited information in the guidelines about specific rating scales, and challenges related to mental health care access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing the American Academy of Pediatrics attention-deficit/hyperactivity disorder diagnostic guidelines in primary care settings. Leslie, LK., Weckerly, J., Plemmons, D., et al.[2022]

The implementation of an ADHD evaluation program significantly improved provider documentation, with 100% of DSM-5 criteria met after the program compared to only 50% before, indicating enhanced diagnostic accuracy.

The program also reduced the use of the unspecified ADHD ICD-10 code, allowing for more tailored and effective care plans for children aged 5 to 18 diagnosed with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A program to improve the assessment of a child for attention deficit hyperactivity disorder. Lukomski, M., Caruso, D., Thompson, K., et al.[2022]

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A listing of 27 ADHD clinical trials actively recruiting volunteers for paid trials and research studies in various therapeutic areas.