A Pilot Study of a Remote ADHD Monitoring Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-11
SponsorIDeA States Pediatric Clinical Trials Network
About 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- RAMP Reports
- Digital Education Handouts
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
IDeA States Pediatric Clinical Trials Network
Lead sponsor
Medical University of South Carolina
Collaborator
University of Mississippi Medical Center
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov