A Pilot Study of a Remote ADHD Monitoring Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RAMP Reports, Digital Education Handouts.
- Who it may be relevant to
- Registry conditions: Attention-deficit/Hyperactivity Disorder, ADHD. Basic parameters: 5 years — 11 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Study of a Remote Attention-Deficit/Hyperactivity Disorder Monitoring Program (RAMP) for Children in Rural Areas
Overview
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.
Detailed 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 hyperactivity symptoms and a provider dashboard with enrolled children. The RAMP Report includes the publicly available Vanderbilt Rating Scales (henceforth shortened to Vanderbilt Assessment), which is a commonly used, guideline-recommended tool for both diagnosis and management of ADHD for use by parents and teachers.
Families will be approached until 36 caregiver/child dyads are enrolled. Those enrolled will be randomized 1:1 to either the intervention group or control group. The intervention group will be enrolled in the RAMP, with prompts to provide frequent reports including ADHD symptoms. The control group will provide ADHD symptom reports through paper forms (usual care), on a provider determined schedule.
The intervention group will be enrolled in the RAMP platform and will receive text-based requests for reports with embedded links to fill out the RAMP questionnaires weekly for 4 weeks, then monthly for 2 months. The control group will receive digital education handouts about age-appropriate pediatric health topics weekly for 4 weeks, then monthly for 2 months.
For the intervention group, the child's teacher can voluntarily return the RAMP questionnaires as well, but will not have direct contact with the study team. The child's provider will also be a participant for the intervention group, and will receive requests to review the submitted RAMP reports.
The primary endpoint for this study is to evaluate the number of clinical assessments per participant that are completed by caregivers and teacher and returned to providers for ADHD management.
The secondary endpoint for this study is to evaluate the proportion of all submitted RAMP reports that are reviewed by providers.
The results of this pilot will be used to design a full-scale efficacy trial in additional rural sites to expand diversity and assess generalizability.
Interventions
- Other RAMP 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 - Other Digital 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.
Primary outcome measures
- Evaluate completion of clinical assessments by caregivers and teachers. [Time frame: 6 Months]
Secondary outcome measures (1)
- Evaluate provider acceptability of the RAMP through utilization measures. [Time frame: 6 Months]
Eligibility criteria
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 copy to the study team
The provider must
- manage ADHD care in patients age 5-11 years
- provide informed consent
- agree to use the RAMP platform if they care for patients randomized to use it
- agree to provide information to potential participants about the study and contact the research coordinator if interested
Exclusion criteria
Child:
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- University of Mississippi Medical Center — Jackson
- Medical University of South Carolina — Charleston
Publications
- MacGeorge CA, Henry M, Ford HA, Malloch L, Fratesi E, Cabaniss S, Baldner J, Greer M, Gaffney K, Bimali M, Abraham P, Fu LY, Ounpraseuth PS, Turley CB. Study protocol for a pilot study for Remote ADHD Monitoring Program (RAMP) for children in rural areas. PLoS One. 2025 Dec 2;20(12):e0337802. doi: 10.1371/journal.pone.0337802. eCollection 2025. PMID 41329787
Identifiers
NCT: NCT06743425 · 276280