Open-Label Trial of Personalized Medication Experiments to Inform Decisions About Future Attention-Deficit/Hyperactivity Disorder (ADHD) Medication Use
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Decision Making Involvement Scale [Parent Seek] - Reported by Child
Study Overview
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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
None (open-label)
Eligibility Criteria
- Ages
- 11 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Intervention
All will choose one of five medication experiment options to complete.
Intervention: Personalized ADHD Medication Experiment (Other)
Outcomes
Primary Outcomes
Decision Making Involvement Scale [Parent Seek] - Reported by Child
Time Frame: 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.
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.
Decision Making Involvement Scale [Parent Seek] - Parent Report
Time Frame: 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.
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.
Decision Making Involvement Scale [Child Express] - Child Report
Time Frame: 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.
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.
Decision Making Involvement Scale [Child Express] - Parent Report
Time Frame: 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.
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.
Decisional Conflict - Parent Report
Time Frame: The DCS was collected at the first study visit, and then again after the medication experiment was completed (between 4 and 12 weeks later)
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.
Decisional Conflict - Child Report
Time Frame: The DCS was collected at the first study visit, and then again after the medication experiment was completed (between 4 and 12 weeks later)
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.
Decision Making Involvement Scale - Joint/Options
Time Frame: 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.
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.
Decision Making Involvement Scale - Child Express
Time Frame: 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.
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.
Secondary Outcomes
- Difference in Intention to Give/Take Medication on School Days(Collected at study visit 1 and 4-12 weeks later at study visit 2.)
- Difference in Intention to Give/Take Medication on Weekend Days(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(Collected at study visit 1 and 4-12 weeks later at study visit 2.)
- System Usability Scale Total Score(Collected at study visit 2 (which is 4-12 weeks after study visit 1).)
- Implementation of Decision(3 months after study visit 2 (which is 4-12 weeks after study visit 1).)