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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
RAMP Reports
Other interventionParticipants 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.
Digital Education Handouts
Other interventionThe 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.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: RAMP ReportsExperimental treatment 1 intervention
Group B: Digital Education HandoutsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate completion of clinical assessments by caregivers and teachers.
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.
Time frame
6 MonthsSecondary outcomes
1
Evaluate provider acceptability of the RAMP through utilization measures.
The proportion of all submitted RAMP Reports that are reviewed by providers.
Time frame
6 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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