A Pilot Study of a Remote ADHD Monitoring Program

NCT06743425 | Recruiting DMC

• 1 other identifier: 276280
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Attention-deficit/Hyperactivity Disorder; ADHD

Keywords

Rural health; Vanderbilt; Text-based Symptom Reporting

Outcome Measures

Primary Outcomes (1)

• 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.

  6 Months

Secondary Outcomes (1)

• Evaluate provider acceptability of the RAMP through utilization measures.

  6 Months

Study Arms (2)

RAMP Reports

EXPERIMENTAL

Submit RAMP reports weekly for 4 weeks and then monthly for 2 months.

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.

Other: Digital Education Handouts

Interventions

RAMP Reports OTHER

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.

Also known as: Remote ADHD Monitoring Program

RAMP Reports

Digital Education Handouts OTHER

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.

Also known as: Standard of Care

Digital Education Handouts

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IDeA States Pediatric Clinical Trials Network: lead
• Medical University of South Carolina: collaborator
• University of Mississippi Medical Center: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Song Ounpraseuth, PhD

CONTACT

501-686-7233; STOunpraseuth@uams.edu

Kripa Patel, BDS, MPH

CONTACT

(501) 686-5547; kpatel@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This is a multi-center, parallel, unblinded, randomized controlled clinical trial.

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 19, 2024
• Study Start: February 4, 2025
• Primary Completion: March 26, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: Per data sharing polices of NIH and the ISPCTN

Locations

US (2)