Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2025-02-04
2026-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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RAMP Reports
Submit RAMP reports weekly for 4 weeks and then monthly for 2 months.
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 use by parents and teachers.
Digital Education Handouts
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.
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.
Interventions
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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 use by parents and teachers.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
5 Years
11 Years
ALL
Yes
Sponsors
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Medical University of South Carolina
OTHER
University of Mississippi Medical Center
OTHER
National Institutes of Health (NIH)
NIH
IDeA States Pediatric Clinical Trials Network
NETWORK
Responsible Party
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Locations
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University of Mississippi Medical Center
Jackson, Mississippi, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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276280
Identifier Type: -
Identifier Source: org_study_id
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