A Pilot Study of a Remote ADHD Monitoring Program (RAMP)

April 27, 2026 updated by: IDeA States Pediatric Clinical Trials Network

A Pilot Study of a Remote Attention-Deficit/Hyperactivity Disorder Monitoring Program (RAMP) for Children in Rural Areas

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The RAMP study is designed to examine the use of an attention-Deficit/Hyperactivity Disorder (ADHD) Monitoring Program during the early stages of treating ADHD in children living in rural settings. It is a multi-site pilot study conducted across two Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN) sites in conjunction with four practices with high rural and/or underserved populations.

The Remote ADHD Monitoring Program (RAMP) will include provider ADHD Best Practice education, caregiver and teacher prompts for frequent RAMP Reports of inattention and hyperactivity symptoms and a provider dashboard with enrolled children. The RAMP Report includes the publicly available Vanderbilt Rating Scales (henceforth shortened to Vanderbilt Assessment), which is a commonly used, guideline-recommended tool for both diagnosis and management of ADHD for use by parents and teachers.

Families will be approached until 36 caregiver/child dyads are enrolled. Those enrolled will be randomized 1:1 to either the intervention group or control group. The intervention group will be enrolled in the RAMP, with prompts to provide frequent reports including ADHD symptoms. The control group will provide ADHD symptom reports through paper forms (usual care), on a provider determined schedule.

The intervention group will be enrolled in the RAMP platform and will receive text-based requests for reports with embedded links to fill out the RAMP questionnaires weekly for 4 weeks, then monthly for 2 months. The control group will receive digital education handouts about age-appropriate pediatric health topics weekly for 4 weeks, then monthly for 2 months.

For the intervention group, the child's teacher can voluntarily return the RAMP questionnaires as well, but will not have direct contact with the study team. The child's provider will also be a participant for the intervention group, and will receive requests to review the submitted RAMP reports.

The primary endpoint for this study is to evaluate the number of clinical assessments per participant that are completed by caregivers and teacher and returned to providers for ADHD management.

The secondary endpoint for this study is to evaluate the proportion of all submitted RAMP reports that are reviewed by providers.

The results of this pilot will be used to design a full-scale efficacy trial in additional rural sites to expand diversity and assess generalizability.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Kripa Patel, BDS, MPH
  • Phone Number: (501) 686-5547
  • Email: kpatel@uams.edu

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Contact:
          • Hannah Ford, PhD
          • Phone Number: 601-815-8413
          • Email: hford@umc.edu
        • Contact:
        • Principal Investigator:
          • Hannah Ford, PhD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claire MacGeorge, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

The child must

  • be under the care of a participating provider
  • be aged 5-11 at enrollment
  • have a diagnosis of ADHD
  • be initiating stimulant medication for treatment for the first time or have not received stimulant medication for the last 6 months
  • be attending in-person elementary school

The Primary caregiver must

  • be willing and legally able to give consent
  • have access to a smartphone
  • be English-speaking
  • reside with the child at least 3 days per week
  • complete an initial symptom assessment prior to starting stimulant treatment and be willing to provide a copy to the study team

The provider must

  • manage ADHD care in patients age 5-11 years
  • provide informed consent
  • agree to use the RAMP platform if they care for patients randomized to use it
  • agree to provide information to potential participants about the study and contact the research coordinator if interested

Exclusion Criteria:

Child:

  • has serious mental health comorbidities (Children with depression, anxiety, oppositional defiant disorder will be permitted to participate. Children with schizophrenia, bipolar disorder, conduct disorder and those who have been hospitalized for any mental health condition will be excluded from the study.)
  • has severe neurodevelopment disorders (Children with well-controlled seizure disorders will be permitted to participate.)
  • is currently receiving, or previously received, atypical antipsychotic medication treatment
  • is or becomes pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RAMP Reports
Submit RAMP reports weekly for 4 weeks and then monthly for 2 months.
Other: RAMP Reports
Participants will receive text-based requests for reports with embedded links to select radio button questionnaires directly on their mobile device. Questions include current inattention/hyperactivity symptoms, school performance, and any engagement in behavioral therapy. Inattention/hyperactivity symptom questions and scoring is taken directly from the publicly available Vanderbilt Rating Scales, which is a commonly used, guideline-recommended tool for both diagnosis and management of ADHD for use by parents and teachers.
Other Names:
  • Remote ADHD Monitoring Program
Active Comparator: Digital Education Handouts
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.
Other: Digital Education Handouts
The digital education handouts will be sent via email to the control group and will serve as an attention control. They will consist of information regarding a general pediatric health topic and will be emailed at intervals matching the RAMP requests in the intervention group.
Other Names:
  • Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate completion of clinical assessments by caregivers and teachers.
Time Frame: 6 Months
The number of clinical assessments (paper assessments in control and RAMP Reports in intervention) per participant that are completed by caregivers and teachers and returned to providers for ADHD management.
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate provider acceptability of the RAMP through utilization measures.
Time Frame: 6 Months
The proportion of all submitted RAMP Reports that are reviewed by providers.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IDeA States Pediatric Clinical Trials Network

Collaborators

Medical University of South Carolina
National Institutes of Health (NIH)
University of Mississippi Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2025

Primary Completion (Actual)

March 26, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

December 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 276280

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Investigators will conduct this trial following the publication and data-sharing policies and regulations listed below:

NIH Public Access Policy requires scientists to submit final peer-reviewed journal manuscripts arising from NIH funds to the digital archive PubMed Central upon acceptance for publication.

Environmental Influences on Child Health Outcomes (ECHO) IDeA States Pediatric Clinical Trials Network (ISPCTN) Publications and Presentations Policy ensures the accurate, responsible, and efficient communication of findings from ECHO ISPCTN clinical trials.

NIH Data Sharing Policy and the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Resulting Information Submission Rule. Other researchers may request data from this trial by contacting Song Ounpraseuth, Ph.D., at the ISPCTN Data Coordinating and Operations Center (DCOC).

IPD Sharing Time Frame

Per data sharing polices of NIH and the ISPCTN

IPD Sharing Supporting Information Type

  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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