RECRUITING

A Pilot Study of a Remote ADHD Monitoring Program

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Pilot Study of a Remote Attention-Deficit/Hyperactivity Disorder Monitoring Program (RAMP) for Children in Rural Areas

Quick Facts

Study Start:2025-02-04
Study Completion:2025-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06743425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 11 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * be under the care of a participating provider
  2. * be aged 5-11 at enrollment
  3. * have a diagnosis of ADHD
  4. * be initiating stimulant medication for treatment for the first time or have not received stimulant medication for the last 6 months
  5. * be attending in-person elementary school
  6. * be willing and legally able to give consent
  7. * have access to a smartphone
  8. * be English-speaking
  9. * reside with the child at least 3 days per week
  10. * complete an initial symptom assessment prior to starting stimulant treatment and be willing to provide a copy to the study team
  11. * manage ADHD care in patients age 5-11 years
  12. * provide informed consent
  13. * agree to use the RAMP platform if they care for patients randomized to use it
  14. * agree to provide information to potential participants about the study and contact the research coordinator if interested
  1. * 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.)
  2. * has severe neurodevelopment disorders (Children with well-controlled seizure disorders will be permitted to participate.)
  3. * is currently receiving, or previously received, atypical antipsychotic medication treatment
  4. * is or becomes pregnant

Contacts and Locations

Study Contact

Song Ounpraseuth, PhD
CONTACT
501-686-7233
STOunpraseuth@uams.edu
Matthew Henry, MSc
CONTACT
(501) 686-5547
mhenry3@uams.edu

Study Locations (Sites)

University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: IDeA States Pediatric Clinical Trials Network

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-04
Study Completion Date2025-10-30

Study Record Updates

Study Start Date2025-02-04
Study Completion Date2025-10-30

Terms related to this study

Keywords Provided by Researchers

  • Rural health
  • Vanderbilt
  • Text-based Symptom Reporting

Additional Relevant MeSH Terms

  • Attention-deficit/Hyperactivity Disorder
  • ADHD