NCT06743425

A Pilot Study of a Remote ADHD Monitoring Program

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: IDeA States Pediatric Clinical Trials Network · Network
• Sex: All
• Age: 5 Years – 11 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Attention-deficit/Hyperactivity Disorder
• ADHD

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2025-02-04
• Primary completion: 2026-02-23
• Completion: 2026-07-01
• First posted: 2024-12-19
• Last updated: 2025-06-24

Locations

2 sites across 1 country: United States