Attention-deficit/Hyperactivity DisorderRAMPNCT06743425
A Pilot Study of a Remote ADHD Monitoring Program
A study testing RAMP Reports and Digital Education Handouts in people with Attention-deficit/Hyperactivity Disorder and ADHD, run by IDeA States Pediatric Clinical Trials Network at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention-deficit/Hyperactivity Disorder, ADHD
- What is being tested?
- RAMP Reports and Digital Education Handouts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Feb 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Claire MacGeorge, MD, 843-876-8512, macgeorg@musc.edu
Shannon Cabaniss, BA, 843-732-1839, smw207@musc.edu
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Hannah Ford, PhD, 601-815-8413, hford@umc.edu
Lacy Malloch, BS, 601-815-4517, lmalloch@umc.edu
About this study
Official title: A Pilot Study of a Remote Attention-Deficit/Hyperactivity Disorder Monitoring Program (RAMP) for Children in Rural Areas
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.
Read the 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.
- Conditions
- Attention-deficit/Hyperactivity Disorder, ADHD
- Being tested
- RAMP Reports, Digital Education Handouts
- Keywords
- Rural health, Vanderbilt, Text-based Symptom Reporting
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAMP ReportsOther
Also called Remote ADHD Monitoring Program
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 HandoutsOther
Also called Standard of Care
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.
| Study group | Role | What they receive |
|---|---|---|
| RAMP Reports | Experimental | Submit RAMP reports weekly for 4 weeks and then monthly for 2 months. Receives: Other: RAMP Reports |
| Digital Education Handouts | Active comparator | 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. Receives: Other: Digital Education Handouts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Secondary outcomes (1)
Evaluate provider acceptability of the RAMP through utilization measures.
The proportion of all submitted RAMP Reports that are reviewed by providers.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start4 Feb 2025
- Primary completion26 Mar 2026
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention-deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multi-center, parallel, unblinded, randomized controlled clinical trial.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IDeA States Pediatric Clinical Trials Network
- Sponsor type
- Research network
- Collaborators
- Medical University of South Carolina, University of Mississippi Medical Center, National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743425
- Sponsor's protocol ID
- 276280
- Acronym
- RAMP
- Status last verified
- Apr 2026
- First submitted
- 11 Dec 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will conduct this trial following the publication and data-sharing policies and regulations listed below: NIH Public Access Policy requires scientists to submit final peer-reviewed journal manuscripts arising from NIH funds to the digital archive PubMed Central upon acceptance for publication. Environmental Influences on Child Health Outcomes (ECHO) IDeA States Pediatric Clinical Trials Network (ISPCTN) Publications and Presentations Policy ensures the accurate, responsible, and efficient communication of findings from ECHO ISPCTN clinical trials. NIH Data Sharing Policy and the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Resulting Information Submission Rule. Other researchers may request data from this trial by contacting Song Ounpraseuth, Ph.D., at the ISPCTN Data Coordinating and Operations Center (DCOC).
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.
PubMed 41329787
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Remote Attention-Deficit/Hyperactivity Disorder Monitoring Program (RAMP) for Children in Rural Areas
- ClinicalTrials.gov ID
- NCT06743425
- Acronym / sponsor ID
- RAMP / 276280
- Conditions
- Attention-deficit/Hyperactivity Disorder, ADHD
- Keywords
- Rural health, Vanderbilt, Text-based Symptom Reporting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- IDeA States Pediatric Clinical Trials NetworkResearch network
- Collaborators
- Medical University of South Carolina, University of Mississippi Medical Center, National Institutes of Health (NIH)
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 26 Mar 2026 (actual)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multi-center, parallel, unblinded, randomized controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| RAMP Reports | Experimental | Other: RAMP ReportsSubmit RAMP reports weekly for 4 weeks and then monthly for 2 months. |
| Digital Education Handouts | Active comparator | Other: Digital Education HandoutsStandard 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. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAMP ReportsAlso: Remote ADHD Monitoring ProgramParticipants 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. | Other | RAMP Reports |
| Digital Education HandoutsAlso: Standard of CareThe 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 | Digital Education Handouts |
Primary outcome
Evaluate completion of clinical assessments by caregivers and teachers.
Time frame: 6 Months
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.
1 secondary outcome
Evaluate provider acceptability of the RAMP through utilization measures.
Time frame: 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Derived from this study: PubMed 41329787MacGeorge 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.
- Individual participant dataSharing planned: Yes. Investigators will conduct this trial following the publication and data-sharing policies and regulations listed below: NIH Public Access Policy requires scientists to submit final peer-reviewed journal manuscripts arising from NIH funds to the digital archive PubMed Central upon acceptance for publication. Environmental Influences on Child Health Outcomes (ECHO) IDeA States Pediatric Clinical Trials Network (ISPCTN) Publications and Presentations Policy ensures the accurate, responsible, and efficient communication of findings from ECHO ISPCTN clinical trials. NIH Data Sharing Policy and the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Resulting Information Submission Rule. Other researchers may request data from this trial by contacting Song Ounpraseuth, Ph.D., at the ISPCTN Data Coordinating and Operations Center (DCOC).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAMP Reports and Digital Education Handouts in people with Attention-deficit/Hyperactivity Disorder and ADHD, run by IDeA States Pediatric Clinical Trials Network at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Song Ounpraseuth, PhD (501-686-7233, STOunpraseuth@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate completion of clinical assessments by caregivers and teachers. (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06743425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.