A Pilot Study of a Remote ADHD Monitoring Program
Recruiting · NCT06743425 · Interventional (participants receive a specific treatment) · Lead sponsor: IDeA States Pediatric Clinical Trials Network
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
2 locations listed across 2 US states.
- University of Mississippi Medical Center - Jackson, Mississippi, United States
- Medical University of South Carolina - Charleston, South Carolina, United States