IDeA States Pediatric Clinical Trials Network
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.
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 hy…
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…
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.
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.
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