A Pilot Study of a Remote Attention-Deficit/Hyperactivity Disorder Monitoring Program (RAMP) for Children in Rural Areas
IDeA States Pediatric Clinical Trials Network
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.
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 hy…
Eligibility
- Age range
- 5–11 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- OtherRAMP 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.
- OtherDigital 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.
Locations (2)
- University of Mississippi Medical CenterJackson, Mississippi
- Medical University of South CarolinaCharleston, South Carolina