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A Pilot Study of a Remote Attention-Deficit/Hyperactivity Disorder Monitoring Program (RAMP Trial)
N/A
Waitlist Available
Research Sponsored by IDeA States Pediatric Clinical Trials Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The child must
* be under the care of a participating provider
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- ADHD
- Attention Deficit Hyperactivity Disorder (ADHD)
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate completion of clinical assessments by caregivers and teachers.
Secondary study objectives
Evaluate provider acceptability of the RAMP through utilization measures.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RAMP ReportsExperimental Treatment1 Intervention
Submit RAMP reports weekly for 4 weeks and then monthly for 2 months.
Group II: Digital Education HandoutsActive Control1 Intervention
Standard of care determined by the treating healthcare provider and digital education handouts (attention controls) distributed by the study team weekly for 4 weeks and then monthly for 2 months.
Find a Location
Who is running the clinical trial?
IDeA States Pediatric Clinical Trials NetworkLead Sponsor
7 Previous Clinical Trials
1,257 Total Patients Enrolled
Medical University of South CarolinaOTHER
979 Previous Clinical Trials
7,400,929 Total Patients Enrolled
University of Mississippi Medical CenterOTHER
182 Previous Clinical Trials
197,068 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,839 Previous Clinical Trials
8,171,948 Total Patients Enrolled