Trial Outcomes & Findings for Personalized Attention-Deficit/Hyperactivity Disorder (ADHD) Medication Experiment Study (NCT NCT06305078)
NCT ID: NCT06305078
Last Updated: 2026-05-05
Results Overview
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.
COMPLETED
NA
31 participants
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.
2026-05-05
Participant Flow
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.
One consented dyad withdrew before the first study visit and did not begin study procedures, resulting in 30 dyads who started the study.
Participant milestones
| Measure |
Intervention
All will choose one of five medication experiment options to complete.
Personalized ADHD Medication Experiment: All parent/adolescent dyads will select and complete a medication experiment.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only children analyzed
Baseline characteristics by cohort
| Measure |
Intervention
n=60 Participants
All will choose one of five medication experiment options to complete.
|
|---|---|
|
Age, Continuous
|
13.1 Years
STANDARD_DEVIATION 1.3 • n=30 Participants • Only children analyzed
|
|
Sex: Female, Male
Female
|
11 Participants
n=30 Participants • Only child cohort analyzed
|
|
Sex: Female, Male
Male
|
19 Participants
n=30 Participants • Only child cohort analyzed
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants • Only child cohort analyzed
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants • Only child cohort analyzed
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants • Only child cohort analyzed
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=30 Participants • Only child cohort analyzed
|
|
Race (NIH/OMB)
White
|
26 Participants
n=30 Participants • Only child cohort analyzed
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=30 Participants • Only child cohort analyzed
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants • Only child cohort analyzed
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=30 Participants • Only child cohort analyzed
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=30 Participants • Only child cohort analyzed
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=30 Participants • Only child cohort analyzed
|
|
Region of Enrollment
United States
|
60 Participants
n=60 Participants
|
|
Adolescent Digital Health Care Literacy Scale - Child Report
|
9.0 Scores on a scale
STANDARD_DEVIATION 2.3 • n=30 Participants • Only child cohort analyzed
|
|
Adolescent ADHD Self Report Scale
|
25.2 Scores on a scale
STANDARD_DEVIATION 9.4 • n=30 Participants • Only child cohort analyzed
|
|
Vanderbilt ADHD Parent Rating Scale
|
20.7 Scores on a scale
STANDARD_DEVIATION 9.3 • n=30 Participants • Only parent cohort analyzed
|
|
Oppositional-Defiant Disorder Symptom Score
|
7.2 Scores on a scale
STANDARD_DEVIATION 5.8 • n=30 Participants • Only parent cohort analyzed
|
|
Conduct Disorder Symptom Score
|
1.2 Scores on a scale
STANDARD_DEVIATION 1.4 • n=30 Participants • Only parent cohort analyzed
|
|
Anxiety Symptom Score
|
2.4 Scores on a scale
STANDARD_DEVIATION 1.9 • n=30 Participants • Only parent cohort analyzed
|
|
Depression Symptom Score
|
2.4 Scores on a scale
STANDARD_DEVIATION 1.7 • n=30 Participants • Only parent cohort analyzed
|
|
Columbia Impairment Scale (Self-reported by child)
|
15.3 Scores on a scale
STANDARD_DEVIATION 7.9 • n=30 Participants • Only child cohort analyzed
|
|
Columbia Impairment Scale (Child impairment as reported by parent)
|
12.4 Scores on a scale
STANDARD_DEVIATION 8.7 • n=30 Participants • Only parent cohort analyzed
|
|
Pittsburgh Side Effect Rating Scale (Self-reported by child)
|
2.0 Units on a Scale
STANDARD_DEVIATION 1.9 • n=30 Participants • Only child cohort analyzed
|
|
Pittsburgh Side Effect Rating Scale (Child side effects as reported by parent)
|
1.4 Units on a Scale
STANDARD_DEVIATION 1.5 • n=30 Participants • Only parent cohort analyzed
|
|
Baseline medication continuity
|
59.1 Percentage of Days
STANDARD_DEVIATION 25.8 • n=30 Participants • Only child cohort analyzed
|
|
Conflict Behavior Questionnaire (reported by child)
|
3.1 Scores on a scale
STANDARD_DEVIATION 3.3 • n=30 Participants • Only child cohort analyzed
|
|
Conflict Behavior Questionnaire (reported by parent)
|
5.2 Scores on a scale
STANDARD_DEVIATION 5.1 • n=30 Participants • Only parent cohort analyzed
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention
n=30 Participants
All will choose one of five medication experiment options to complete.
|
|---|---|
|
Decision Making Involvement Scale [Parent Seek] - Reported by Child
Pre
|
2.6 Scores on a Scale
Standard Deviation 0.8
|
|
Decision Making Involvement Scale [Parent Seek] - Reported by Child
Post
|
2.9 Scores on a Scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention
n=30 Participants
All will choose one of five medication experiment options to complete.
|
|---|---|
|
Decision Making Involvement Scale [Parent Seek] - Parent Report
Pre
|
2.6 Scores on a Scale
Standard Deviation 0.7
|
|
Decision Making Involvement Scale [Parent Seek] - Parent Report
Post
|
2.6 Scores on a Scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention
n=30 Participants
All will choose one of five medication experiment options to complete.
|
|---|---|
|
Decision Making Involvement Scale [Child Express] - Child Report
Pre
|
2.4 Scores on a Scale
Standard Deviation 0.7
|
|
Decision Making Involvement Scale [Child Express] - Child Report
Post
|
2.5 Scores on a Scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention
n=30 Participants
All will choose one of five medication experiment options to complete.
|
|---|---|
|
Decision Making Involvement Scale [Child Express] - Parent Report
Pre
|
2.5 Scores on a Scale
Standard Deviation 0.8
|
|
Decision Making Involvement Scale [Child Express] - Parent Report
Post
|
2.3 Scores on a Scale
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention
n=30 Participants
All will choose one of five medication experiment options to complete.
|
|---|---|
|
Decisional Conflict - Parent Report
Post-Parent
|
9.3 Scores on a Scale
Standard Deviation 10.0
|
|
Decisional Conflict - Parent Report
Pre-Parent
|
15.9 Scores on a Scale
Standard Deviation 13.7
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention
n=30 Participants
All will choose one of five medication experiment options to complete.
|
|---|---|
|
Decisional Conflict - Child Report
Child Post
|
22.5 Scores on a Scale
Standard Deviation 13.1
|
|
Decisional Conflict - Child Report
Child Pre
|
26.3 Scores on a Scale
Standard Deviation 11.6
|
PRIMARY outcome
Timeframe: 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.Population: Following the experiment, individuals indicated their preference for how to proceed, with 17 of parents and children agreeing initially (concordant). The rest (n=13) came to agreement after discussion (discordant). These two were analyzed separately. Scores on the decision making involvement scale subscore "Joint/Options" are reported below as reported by parent and child. Joint/Options subscale has a range of 1-4, with higher score indicating higher collaborative decision making.
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.
Outcome measures
| Measure |
Intervention
n=60 Participants
All will choose one of five medication experiment options to complete.
|
|---|---|
|
Decision Making Involvement Scale - Joint/Options
Joint/Options Score - Reported by Discordant Parents
|
2.4 Scores on a Scale
Standard Deviation 0.5
|
|
Decision Making Involvement Scale - Joint/Options
Joint/Options Score - Reported by Concordant Parents
|
2.0 Scores on a Scale
Standard Deviation 0.6
|
|
Decision Making Involvement Scale - Joint/Options
Joint/Options Score - Reported by Discordant Children
|
2.5 Scores on a Scale
Standard Deviation .7
|
|
Decision Making Involvement Scale - Joint/Options
Joint/Options Score - Reported by Concordant Children
|
2.5 Scores on a Scale
Standard Deviation .6
|
PRIMARY outcome
Timeframe: 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.Population: At the second study visit, dyads completed the Control Preferences Scale, which assesses whether the respondent would like the child to make medical treatment decisions on their own, the parent and child to work together to make decisions, or for the parent to make the decision for the child. We compared children who prefer to make the decision by themselves to those who prefer to share the decision or have a parent make the decision to look at differences in the "Child Express" DMIS subscale.
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.
Outcome measures
| Measure |
Intervention
n=30 Participants
All will choose one of five medication experiment options to complete.
|
|---|---|
|
Decision Making Involvement Scale - Child Express
Children who preferred making decisions on their own
|
3.0 Scores on a Scale
Standard Deviation 0.8
|
|
Decision Making Involvement Scale - Child Express
Children who preferred joint or parent decision making
|
2.3 Scores on a Scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention
n=60 Participants
All will choose one of five medication experiment options to complete.
|
|---|---|
|
Difference in Intention to Give/Take Medication on School Days
Visit 1 Difference (Between parent and child)
|
1 Scores on a Scale
Interval 0.0 to 2.0
|
|
Difference in Intention to Give/Take Medication on School Days
Visit 2 Difference (Between parent and child)
|
0 Scores on a Scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention
n=60 Participants
All will choose one of five medication experiment options to complete.
|
|---|---|
|
Difference in Intention to Give/Take Medication on Weekend Days
Visit 1 Difference (Parent-Child)
|
1 Points
Interval 1.0 to 2.0
|
|
Difference in Intention to Give/Take Medication on Weekend Days
Visit 2 Difference (Parent-Child)
|
1 Points
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention
n=60 Participants
All will choose one of five medication experiment options to complete.
|
|---|---|
|
Difference in Intention to Give/Take Medication on School Vacation Days
Visit 2 Difference (Parent-Child)
|
1 Points
Interval 0.0 to 2.0
|
|
Difference in Intention to Give/Take Medication on School Vacation Days
Visit 1 Difference (Parent-Child)
|
1 Points
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Collected at study visit 2 (which is 4-12 weeks after study visit 1).Population: The overall number of participants analyzed includes both children and parents who completed the System Usability Scale. Results are presented separately by cohort; therefore, the number analyzed in each row represents only children (n=30) or parents (n=30), which is less than the overall number analyzed (n=60)
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.
Outcome measures
| Measure |
Intervention
n=60 Participants
All will choose one of five medication experiment options to complete.
|
|---|---|
|
System Usability Scale Total Score
Child Report
|
69.4 Points
Standard Deviation 12.3
|
|
System Usability Scale Total Score
Parent Report
|
84.2 Points
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention
n=30 Participants
All will choose one of five medication experiment options to complete.
|
|---|---|
|
Implementation of Decision
# that had pharmacy records consistent with the option they chose at study visit 2
|
25 Participants
|
|
Implementation of Decision
# that had pharmacy records inconsistent with their final decision
|
5 Participants
|
Adverse Events
Intervention: Parents
Intervention: Children
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alyssa Banister - Clinical Research Coordinator
Cincinnati Children's Hospital Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place