NCT06305078

Personalized Attention-Deficit/Hyperactivity Disorder (ADHD) Medication Experiment Study

Open-Label Trial of Personalized Medication Experiments to Inform Decisions About Future Attention-Deficit/Hyperactivity Disorder (ADHD) Medication Use

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 11 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

The primary goal of the project is to test personalized medication experiments to inform decisions about future medication use. Our central hypothesis is that our intervention will lead to within subject increases in adolescent involvement in decision making and decreases in uncertainty about future medication use. The investigators view this open label trial as a pilot study to test the feasibility, acceptability, and preliminary efficacy of the medication experiment intervention and therefore warrants further testing in a future larger trial.

Detailed description

The investigators will conduct a pilot, single-arm, open-label trial of the medication experiment intervention among 30 adolescents and parents experiencing uncertainty about continued medicine use. Because the medication experiment intervention is not clinically relevant for adolescents taking a non-stimulant ADHD medication, they will be excluded. At the time of enrollment, families will complete baseline measures electronically and schedule an in-person visit. The investigators will verify the medication prescribed and the number of days covered with medicine in the past year using dispensing data. During the visit, parents and adolescents will choose one of five medication experiments to complete together and track the effects for the desired amount of time. 1. Make no changes. Track current state: continue to take medication as it is currently prescribed. 2. Take medication on non-school days. Track effects: If not currently taking medication on non-school days, start taking medication on those days and track the effects. 3. Stop taking medication on non-school days. Track effects. If currently taking medication on non-school days, stop taking medication on those days and track the effects. 4. Do a formal trial off of medication. Take current medication as currently prescribed for 2 weeks while tracking, then stop taking medication for 2-4 weeks while continuing to track. 5. Change dose or change medication. Consider a different medication or different dose of current medication in consultation with study doctor. Track the effects. Once dyads have completed the medication experiment, they will complete a follow-up study visit to review the results from the experiment, discuss feasibility of the software, and complete end of study measures.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
OTHER	Personalized ADHD Medication Experiment	All parent/adolescent dyads will select and complete a medication experiment.

Timeline

• Start date: 2023-11-10
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-03-12
• Last updated: 2025-01-08

Locations

1 site across 1 country: United States