Clinical trial NCT06305078: Personalized Attention-Deficit/Hyperactivity Disorder (ADHD) Medication Experiment Study
Official title: Open-Label Trial of Personalized Medication Experiments to Inform Decisions About Future Attention-Deficit/Hyperactivity Disorder (ADHD) Medication Use
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Label Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria: Participants for the study must meet all of the following criteria:

1. Consent: A parent or legal guardian must provide written informed consent
2. Assent: Adolescents must provide written assent to participate in the study
3. Ages 11-15
4. Treated for ADHD by pediatrician
5. First prescribed ADHD medicine more than one year prior to enrollment
6. Filled at least one prescription for a stimulant medication in the past year
7. Uncertainty about continued ADHD medication use
8. Only one child per household can participate in the study. For families who have more than one child who is potentially eligible, they may decide which of their children would be the best fit for the study.

Exclusion Criteria: Exclusion Criteria: Participants will be excluded from the study if they meet any of the following criteria:

1. Do not have reliable access to the internet at their home or another location.
2. Will not permit their child to access the internet for study related activities.
3. Are not able or willing to send or receive text messages.

Primary outcomes:
measure: Decision-Making Involvement Scale
timeFrame: The investigators will reference the Decision-Making Involvement interview guide to collect this measure at study visit 1 and the stand-alone version 4-12 weeks later at study visit 2.
measure: Decisional Conflict Scale (DCS)
timeFrame: Collected at study visit 1 and 4-12 weeks later at study visit 2.
measure: Behavioral Intention Questions
timeFrame: Collected at study visit 1 and 4-12 weeks later at study visit 2.
measure: System Usability Scale
timeFrame: Collected at study visit 2 (which is 4-12 weeks after study visit 1).
measure: Implementation of Decision
timeFrame: 3 months after study visit 2 (which is 4-12 weeks after study visit 1).
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Children's
name: William Brinkman, MD, MEd, MSc
role: PRINCIPAL_INVESTIGATOR
References: