Attention Deficit Hyperactivity DisorderNCT06305078
Personalized Attention-Deficit/Hyperactivity Disorder (ADHD) Medication Experiment Study
A study testing Personalized ADHD Medication Experiment in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 15 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Personalized ADHD Medication Experiment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2023to 1 Nov 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 15 years
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria: Participants for the study must meet all of the following criteria:
- Consent: A parent or legal guardian must provide written informed consent
- Assent: Adolescents must provide written assent to participate in the study
- Ages 11-15
- Treated for ADHD by pediatrician
- First prescribed ADHD medicine more than one year prior to enrollment
- Filled at least one prescription for a stimulant medication in the past year
- Uncertainty about continued ADHD medication use
- 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:
- Do not have reliable access to the internet at their home or another location.
- Will not permit their child to access the internet for study related activities.
- Are not able or willing to send or receive text messages.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45220
About this study
Official title: Open-Label Trial of Personalized Medication Experiments to Inform Decisions About Future Attention-Deficit/Hyperactivity Disorder (ADHD) Medication Use
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.
Read the 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.
- Make no changes. Track current state: continue to take medication as it is currently prescribed.
- 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.
- 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.
- 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.
- 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
- Being tested
- Personalized ADHD Medication Experiment
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized ADHD Medication ExperimentOther
All parent/adolescent dyads will select and complete a medication experiment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All will choose one of five medication experiment options to complete. Receives: Other: Personalized ADHD Medication Experiment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision Making Involvement Scale [Parent Seek] - Reported by Child
A 30-item scale to measure adolescent involvement in a decision. The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child). Each subscale has a range of 1-4, with higher scores indicating higher involvement. Subscales are scored by calculating the average of pertinent questions.
Measured: The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
Decision Making Involvement Scale [Parent Seek] - Parent Report
A 30-item scale to measure adolescent involvement in a decision. The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child). Each subscale has a range of 1-4, with higher scores indicating higher involvement. Subscales are scored by calculating the average of pertinent questions.
Measured: The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
Decision Making Involvement Scale [Child Express] - Child Report
A 30-item scale to measure adolescent involvement in a decision. The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child). Each subscale has a range of 1-4, with higher scores indicating higher involvement. Subscales are scored by calculating the average of pertinent questions.
Measured: The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
Decision Making Involvement Scale [Child Express] - Parent Report
A 30-item scale to measure adolescent involvement in a decision. The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child). Each subscale has a range of 1-4, with higher scores indicating higher involvement. Subscales are scored by calculating the average of pertinent questions.
Measured: The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
Decisional Conflict - Parent Report
The Decisional Conflict Scale (DCS) has an initial question to ascertain the option that has been selected. Options presented will be: continue [medication regimen from experiment], resume previous medication/dosage, conduct another experiment, return to pediatrician to adjust dosage or change medication, other [write in]. The DCS then has 16 questions that are divided into five subscales: informed subscale, values clarity subscale, support subscale, uncertainty subscale, and an effective decision subscale. The total DCS scores are calculated by summing item scores and then converting the scores to a 0-100 scale, where 0 implies no decisional conflict and 100 implies extremely high decisional conflict.
Measured: The DCS was collected at the first study visit, and then again after the medication experiment was completed (between 4 and 12 weeks later)
Decisional Conflict - Child Report
The Decisional Conflict Scale (DCS) has an initial question to ascertain the option that has been selected. Options presented will be: continue [medication regimen from experiment], resume previous medication/dosage, conduct another experiment, return to pediatrician to adjust dosage or change medication, other [write in]. The DCS then has 16 questions that are divided into five subscales: informed subscale, values clarity subscale, support subscale, uncertainty subscale, and an effective decision subscale. The total DCS scores are calculated by summing item scores and then converting the scores to a 0-100 scale, where 0 implies no decisional conflict and 100 implies extremely high decisional conflict.
Measured: The DCS was collected at the first study visit, and then again after the medication experiment was completed (between 4 and 12 weeks later)
Decision Making Involvement Scale - Joint/Options
A 30-item scale to measure adolescent involvement in a decision. The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child). Each subscale has a range of 1-4, with higher scores indicating higher involvement. Subscales are scored by calculating the average of pertinent questions.
Measured: The investigators will reference the Decision-Making Involvement interview guide to collect this measure at study visit 2 (post), which is 4-12 weeks after study visit 1.
Decision Making Involvement Scale - Child Express
A 30-item scale to measure adolescent involvement in a decision. The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child). Each subscale has a range of 1-4, with higher scores indicating higher involvement. Subscales are scored by calculating the average of pertinent questions.
Measured: The investigators will reference the Decision-Making Involvement Scale and Control Preferences Scale collected at Study Visit 2, which is 4-12 weeks after study visit 1.
Secondary outcomes (5)
Difference in Intention to Give/Take Medication on School Days
This measure will capture the difference between the child and parent report of their intention to give/take ADHD medication on school days. This was assessed using a scale question from the Unified Theory of Behavior Change. Responses are on a 7-point scale from strongly agree (+3) to strongly disagree (-3) that assess intention to take medicine for ADHD on weekdays, weekends, and school vacations - this particular measure examined responses when asked their intentions regarding school days.
Measured: Collected at study visit 1 and 4-12 weeks later at study visit 2.
Difference in Intention to Give/Take Medication on Weekend Days
This measure will capture the difference between the child and parent report of their intention to give/take ADHD medication on weekend days. This was assessed using a scale question from the Unified Theory of Behavior Change. Responses are on a 7-point scale from strongly agree (+3) to strongly disagree (-3) that assess intention to take medicine for ADHD on weekdays, weekends, and school vacations - this particular measure examined responses when asked their intentions regarding weekend days.
Measured: Collected at study visit 1 and 4-12 weeks later at study visit 2.
Difference in Intention to Give/Take Medication on School Vacation Days
This measure will capture the difference between the child and parent report of their intention to give/take ADHD medication on school vacation days. This was assessed using a scale question from the Unified Theory of Behavior Change. Responses are on a 7-point scale from strongly agree (+3) to strongly disagree (-3) that assess intention to take medicine for ADHD on weekdays, weekends, and school vacations - this particular measure examined responses when asked their intentions regarding school vacation days.
Measured: Collected at study visit 1 and 4-12 weeks later at study visit 2.
System Usability Scale Total Score
Parents and children completed the System Usability Scale (SUS) to assess the usability of the mehealth platform for completing a personalized medication experiment. The SUS is a 10-item questionnaire with items rated on a 5-point agreement scale. Item scores are converted and summed using standard scoring procedures to produce a total score ranging from 0 to 100, with higher scores indicating better usability/better outcome.
Measured: Collected at study visit 2 (which is 4-12 weeks after study visit 1).
Implementation of Decision
We obtained pharmacy dispensing records to confirm eligibility and to assess decision implementation within 90 days post-study, identifying cases where pharmacy records contradicted the dyad's decision about their future ADHD treatment.
Measured: 3 months after study visit 2 (which is 4-12 weeks after study visit 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start10 Nov 2023
- Primary completion1 May 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label Trial
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Brinkman, MD, MEd, MSc, Principal investigator, Cincinnati Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305078
- Sponsor's protocol ID
- 2023-0528
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2024
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No