A Pilot Study of a Remote ADHD Monitoring Program

Part of paid clinical trials in Jackson, Mississippi.

Sponsor
IDeA States Pediatric Clinical Trials Network
Study ID
NCT06743425
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 11 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 4, 2025
Status verified
Apr 2026
Primary completion
Mar 26, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Mississippi Medical CenterJacksonMississippi39216
Hannah Ford, PhD
[email protected]
601-815-8413
Lacy Malloch, BS
[email protected]
601-815-4517
Hannah Ford, PhD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Claire MacGeorge, MD
[email protected]
843-876-8512
Shannon Cabaniss, BA
[email protected]
843-732-1839
Claire MacGeorge, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jackson, MS

By condition
ADHD
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Mississippi Medical Center· Jackson, MSMedical University of South Carolina· Charleston, SC

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