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

Trial Summary

What is the purpose of this trial?

RAMP is a pilot study examining the use of an Attention-Deficit/Hyperactivity Disorder (ADHD) Monitoring Program during the early stages of treating ADHD in children living in rural settings. This trial will enroll 36 caregiver/infant dyads across 2 sites and will evaluate feasibility endpoints rather than clinical outcomes. Enrolled participants will be randomized 1:1 to the intervention group (RAMP reports) or control group (digital education handouts). The study duration is 10 months, including start-up, enrollment and intervention, and data analysis and manuscript submission.

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.

How is the RAMP Reports treatment for ADHD different from other treatments?

The RAMP Reports treatment for ADHD is unique because it focuses on monitoring and evaluating the condition rather than directly treating symptoms with medication. This approach aims to improve the assessment process, ensuring that children are accurately diagnosed and monitored, which can lead to more personalized and effective management of ADHD. ^{1 2 3 4 5}

Eligibility Criteria

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

Primary caregiver must reside with the child at least 3 days per week

Child must be under the care of a participating provider

Primary caregiver must complete an initial symptom assessment prior to starting stimulant treatment and be willing to provide a copy to the study team

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

References

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

A program to improve the assessment of a child for attention deficit hyperactivity disorder. [2022]

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

A feasibility study of the children's medication algorithm project (CMAP) algorithm for the treatment of ADHD. [2015]

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

Implementing the American Academy of Pediatrics attention-deficit/hyperactivity disorder diagnostic guidelines in primary care settings. [2022]

4. United States 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. [2018]

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

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