Recruiting

ADHD Monitoring

Sponsor:

IDeA States Pediatric Clinical Trials Network

Code:

NCT06743425

Conditions

Attention-deficit/Hyperactivity Disorder

ADHD

Eligibility Criteria

Sex: All

Age: 5 - 11

Healthy Volunteers: Accepted

Interventions

RAMP Reports

Digital Education Handouts

Study Details

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

Study ID

NCT06743425

Start date

Feb 4, 2025

Status verified date

Apr, 2026

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Mar 26, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 11

Healthy Volunteers: Accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: RAMP Reports

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

active comparator: 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.

Interventions

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.

Primary outcome measure

  • Evaluate completion of clinical assessments by caregivers and teachers. [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Song Ounpraseuth, PhD

501-686-7233STOunpraseuth@uams.edu

Kripa Patel, BDS, MPH

(501) 686-5547kpatel@uams.edu

Locations

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Hannah Ford, PhD

601-815-8413hford@umc.edu

Lacy Malloch, BS

601-815-4517lmalloch@umc.edu

Principal Investigator:

Hannah Ford, PhD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Claire MacGeorge, MD

843-876-8512macgeorg@musc.edu

Shannon Cabaniss, BA

843-732-1839smw207@musc.edu

Principal Investigator:

Claire MacGeorge, MD

More Information

Sponsor

IDeA States Pediatric Clinical Trials Network

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

  • Rural health
  • Vanderbilt
  • Text-based Symptom Reporting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by IDeA States Pediatric Clinical Trials Network on 2026-04-28.