Study protocol for a pilot study for Remote ADHD Monitoring Program (RAMP) for children in rural areas.
Claire A MacGeorge, Matthew Henry, Hannah A Ford...
https://pubmed.ncbi.nlm.nih.gov/41329787Actively Recruiting
Phase Not Applicable
Age: 5Years - 11Years
All Genders
Healthy Volunteers
ID06743425
A Pilot Study of a Remote Attention-Deficit/Hyperactivity Disorder Monitoring Program (RAMP) for Children in Rural Areas
Led by IDeA States Pediatric Clinical Trials Network · Updated on 2026-04-28
36
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
Sponsors
I
IDeA States Pediatric Clinical Trials Network
Lead Sponsor
M
Medical University of South Carolina
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a Remote Attention-Deficit/Hyperactivity Disorder (ADHD) Monitoring Program called RAMP for children aged 5 to 11 living in rural areas. This pilot study involves 36 caregiver/child pairs and aims to assess how feasible it is to use RAMP during the early stages of ADHD treatment rather than focusing on clinical outcomes. The study is conducted across two sites with rural and underserved populations and will help design a larger future trial. Participants will be randomly assigned to one of two groups. The intervention group will receive weekly text-based requests for RAMP reports on ADHD symptoms for 4 weeks, then monthly for 2 months. These reports use the Vanderbilt Rating Scales, a tool for parents and teachers to assess inattention and hyperactivity. The control group will receive digital education handouts on general pediatric health topics on the same schedule. Teachers may optionally return RAMP questionnaires, and providers will review submitted reports in the intervention group. During the 10-month study period, caregivers and teachers will submit clinical assessments to providers, and researchers will track how often these assessments are completed and reviewed. The study includes enrollment, intervention, and data analysis phases. The main outcomes are the number of completed clinical assessments and provider use of RAMP reports. This pilot will inform the design of a full-scale trial to expand diversity and assess generalizability in rural settings.
CONDITIONS
Brief Title
A Pilot Study of a Remote ADHD Monitoring Program
Who Can Participate
Age: 5Years - 11Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Child is aged 5 to 11 years at enrollment
- Child has a diagnosis of ADHD
- Child is initiating stimulant medication for treatment for the first time or has not received stimulant medication in the last 6 months
- Child attends in-person elementary school
- Child is under the care of a participating provider
- Primary caregiver is willing and legally able to give consent
- Primary caregiver has access to a smartphone
- Primary caregiver is English-speaking
- Primary caregiver resides with the child at least 3 days per week
- Primary caregiver completes an initial symptom assessment before starting stimulant treatment and agrees to provide a copy to the study team
- Provider manages ADHD care for patients aged 5 to 11 years
- Provider provides informed consent
- Provider agrees to use the RAMP platform for patients randomized to it
- Provider agrees to inform potential participants about the study and refer them to the research coordinator if interested
You will not qualify if you...
- Child has serious mental health conditions such as schizophrenia, bipolar disorder, conduct disorder, or has been hospitalized for any mental health condition
- Child has severe neurodevelopmental disorders
- Child is currently receiving or has previously received atypical antipsychotic medication treatment
- Child is or becomes pregnant
- Children with depression, anxiety, or oppositional defiant disorder are allowed
- Children with well-controlled seizure disorders are allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Monitoring
Duration - 6 months
Participants will submit reports on ADHD symptoms through either the RAMP platform or paper forms according to their group assignment.
Weekly reports for 4 weeks, then monthly reports for 2 months
Trial Site Locations
Total: 2 locations
1
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
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Research Team
S
Song Ounpraseuth, PhD
K
Kripa Patel, BDS, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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