Attention Deficit Hyperactivity Disorder
Conditions
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.
Interventions
OTHERPersonalized ADHD Medication Experiment
All parent/adolescent dyads will select and complete a medication experiment.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
None (open-label)
Intervention model description
Open Label Trial
Eligibility
Sex/Gender
ALL
Age
11 Years to 15 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decision Making Involvement Scale [Child Express] - Parent Report | 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 - Child Report | 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 | 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 | 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. |
| Decision Making Involvement Scale [Parent Seek] - Reported by Child | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Difference in Intention to Give/Take Medication on School Days | Collected at study visit 1 and 4-12 weeks later at study visit 2. | 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. |
| Difference in Intention to Give/Take Medication on Weekend Days | Collected at study visit 1 and 4-12 weeks later at study visit 2. | 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. |
| System Usability Scale Total Score | Collected at study visit 2 (which is 4-12 weeks after study visit 1). | 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. |
| Implementation of Decision | 3 months after study visit 2 (which is 4-12 weeks after study visit 1). | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWilliam Brinkman, MD, MEd, MSc
Cincinnati Children's
Participant flow
Recruitment details
We advertised the study to employees at our children's hospital. 5 emails with study recruitment flyer sent to Children's Hospital Employees (n ≈ 24,000). 92 parents reached out expressing interest in the study. In about 6 months, we recruited 31 child-parent dyads.
Pre-assignment details
One consented dyad withdrew before the first study visit and did not begin study procedures, resulting in 30 dyads who started the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Adolescent ADHD Self Report Scale | 25.2 Scores on a scale STANDARD_DEVIATION 9.4 |
| Adolescent Digital Health Care Literacy Scale - Child Report | 9.0 Scores on a scale STANDARD_DEVIATION 2.3 |
| Age, Continuous | 13.1 Years STANDARD_DEVIATION 1.3 |
| Anxiety Symptom Score | 2.4 Scores on a scale STANDARD_DEVIATION 1.9 |
| Baseline medication continuity | 59.1 Percentage of Days STANDARD_DEVIATION 25.8 |
| Columbia Impairment Scale (Child impairment as reported by parent) | 12.4 Scores on a scale STANDARD_DEVIATION 8.7 |
| Columbia Impairment Scale (Self-reported by child) | 15.3 Scores on a scale STANDARD_DEVIATION 7.9 |
| Conduct Disorder Symptom Score | 1.2 Scores on a scale STANDARD_DEVIATION 1.4 |
| Conflict Behavior Questionnaire (reported by child) | 3.1 Scores on a scale STANDARD_DEVIATION 3.3 |
| Conflict Behavior Questionnaire (reported by parent) | 5.2 Scores on a scale STANDARD_DEVIATION 5.1 |
| Depression Symptom Score | 2.4 Scores on a scale STANDARD_DEVIATION 1.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Oppositional-Defiant Disorder Symptom Score | 7.2 Scores on a scale STANDARD_DEVIATION 5.8 |
| Pittsburgh Side Effect Rating Scale (Child side effects as reported by parent) | 1.4 Units on a Scale STANDARD_DEVIATION 1.5 |
| Pittsburgh Side Effect Rating Scale (Self-reported by child) | 2.0 Units on a Scale STANDARD_DEVIATION 1.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Region of Enrollment United States | 60 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 19 Participants |
| Vanderbilt ADHD Parent Rating Scale | 20.7 Scores on a scale STANDARD_DEVIATION 9.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
None listed