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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | All will choose one of five medication experiment options to complete. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized ADHD Medication Experiment | Other | All parent/adolescent dyads will select and complete a medication experiment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria: Participants for the study must meet all of the following criteria:
Exclusion Criteria: Exclusion Criteria: Participants will be excluded from the study if they meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Brinkman, MD, MEd, MSc | Cincinnati Children's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45220 | United States |
One consented dyad withdrew before the first study visit and did not begin study procedures, resulting in 30 dyads who started the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline characteristics were collected from children and parents participating together as child-parent dyads. The unit of enrollment and analysis was the dyad. Baseline characteristics are reported by cohort (children or parents), as appropriate for each measure; not all baseline measures were collected from both members of the dyad.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | All will choose one of five medication experiment options to complete. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Child Age | Only children analyzed |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Scores on a Scale | 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. |
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From enrollment to end of follow up period (3 months after study visit 2)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention: Parents | 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. No Adverse Events occurred. |
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Small sample size with multiple comparisons
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alyssa Banister - Clinical Research Coordinator | Cincinnati Children's Hospital Medical Center | 5138031931 | alyssa.banister@cchmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2023 | Jan 26, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 26, 2023 | Jan 26, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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Open Label Trial
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None (open-label)
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| 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. | 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. | 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. | 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. | 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. | 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. |
| 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. | 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. | 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. | 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. | 3 months after study visit 2 (which is 4-12 weeks after study visit 1). |
| Mean |
| Standard Deviation |
| Years |
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| Sex: Female, Male | Child Sex | Only child cohort analyzed | Count of Participants | Participants |
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| Race (NIH/OMB) | Child Race | Only child cohort analyzed | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Child Ethnicity | Only child cohort analyzed | Count of Participants | Participants |
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| Region of Enrollment | Dyad regional of enrollment | Number | Participants |
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| Adolescent Digital Health Care Literacy Scale - Child Report | Parents and children self-reported demographic information and a 3-item Digital Health Care Literacy measure with 5-point Likert scale of "strongly disagree" to "strongly agree" to characterize their confidence in using applications on various devices and solve basic technical problems. The total score range is 0-12, with higher scores indicating higher literacy. | Only child cohort analyzed | Mean | Standard Deviation | Scores on a scale |
|
| Adolescent ADHD Self Report Scale | Participating children completed the ADHD self report scale, an 18-item measure of symptom frequency with response options of "Never"=0, "Occasionally"=1, "Often"=2, or "Very Often"=3. The total score range is 0-54. Higher scores indicate more frequent symptoms. | Only child cohort analyzed | Mean | Standard Deviation | Scores on a scale |
|
| Vanderbilt ADHD Parent Rating Scale | Parents completed a 18-item measure of ADHD and other comorbid symptom frequency with response options of "Never"=0, "Occasionally"=1, "Often"=2, or "Very Often"=3. The total score range is 0-54. Higher scores indicate more frequent symptoms. | Only parent cohort analyzed | Mean | Standard Deviation | Scores on a scale |
|
| Oppositional-Defiant Disorder Symptom Score | Co-existing Symptoms: We calculated a sum score to characterize oppositional defiant disorder, conduct disorder, anxiety, and depression symptoms using the Vanderbilt ADHD Diagnostic Parent Rating Scale. [range 0-24] Higher scores are considered to be a worse outcome. *reported by parents | Only parent cohort analyzed | Mean | Standard Deviation | Scores on a scale |
|
| Conduct Disorder Symptom Score | Co-existing Symptoms: We calculated a sum score to characterize oppositional defiant disorder, conduct disorder, anxiety, and depression symptoms using the Vanderbilt ADHD Diagnostic Parent Rating Scale. [range 0-42] Higher scores are considered to be a worse outcome. *reported by parents | Only parent cohort analyzed | Mean | Standard Deviation | Scores on a scale |
|
| Anxiety Symptom Score | Co-existing Symptoms: We calculated a sum score to characterize oppositional defiant disorder, conduct disorder, anxiety, and depression symptoms using the Vanderbilt ADHD Diagnostic Parent Rating Scale. [range 0-9] Higher scores are considered to be a worse outcome. *reported by parents | Only parent cohort analyzed | Mean | Standard Deviation | Scores on a scale |
|
| Depression Symptom Score | Co-existing Symptoms: We calculated a sum score to characterize oppositional defiant disorder, conduct disorder, anxiety, and depression symptoms using the Vanderbilt ADHD Diagnostic Parent Rating Scale. [range 0-12] Higher scores are considered to be a worse outcome. *reported by parents | Only parent cohort analyzed | Mean | Standard Deviation | Scores on a scale |
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| Columbia Impairment Scale (Self-reported by child) | [range: 0-52] Columbia Impairment Scale parent and child versions: Dyads completed this 13-item scale to characterize child impairment of behavioral, emotional, interpersonal, and task-related functioning, on a scale of 0 to 4 (0=no problem to 4=a very bad problem). The total score range is 0-52, with higher scores indicating more impairment. | Only child cohort analyzed | Mean | Standard Deviation | Scores on a scale |
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| Columbia Impairment Scale (Child impairment as reported by parent) | [range: 0-52] Columbia Impairment Scale parent and child versions: Dyads completed this 13-item scale to characterize child impairment of behavioral, emotional, interpersonal, and task-related functioning, on a scale of 0 to 4 (0=no problem to 4=a very bad problem). The total score range is 0-52, with higher scores indicating more impairment. | Only parent cohort analyzed | Mean | Standard Deviation | Scores on a scale |
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| Pittsburgh Side Effect Rating Scale (Self-reported by child) | Pittsburgh Side Effects Rating Scale: Dyads completed this 13-item measure to rate ADHD medicine side effects as none, mild, moderate, or severe. We counted the number of side effects that the parent/child endorsed as moderate or severe. [Number of Moderate/Severe Symptoms range: 0-13] | Only child cohort analyzed | Mean | Standard Deviation | Units on a Scale |
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| Pittsburgh Side Effect Rating Scale (Child side effects as reported by parent) | Pittsburgh Side Effects Rating Scale: Dyads completed this 13-item measure to rate ADHD medicine side effects as none, mild, moderate, or severe. We counted the number of side effects that the parent/child endorsed as moderate or severe. [Number of Moderate/Severe Symptoms range: 0-13] | Only parent cohort analyzed | Mean | Standard Deviation | Units on a Scale |
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| Baseline medication continuity | Percentage of days covered by medication in the past year | Only child cohort analyzed | Mean | Standard Deviation | Percentage of Days |
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| Conflict Behavior Questionnaire (reported by child) | Conflict Behavior Questionnaire (CBQ), parent and child versions: Dyads completed the CBQ to report conflict in their everyday communication. Each evaluated the other's behavior on a 20-item true/false scale. The total score range is 0-20, with higher scores reflecting more conflict. | Only child cohort analyzed | Mean | Standard Deviation | Scores on a scale |
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| Conflict Behavior Questionnaire (reported by parent) | Conflict Behavior Questionnaire (CBQ), parent and child versions: Dyads completed the CBQ to report conflict in their everyday communication. Each evaluated the other's behavior on a 20-item true/false scale. The total score range is 0-20, with higher scores reflecting more conflict. | Only parent cohort analyzed | Mean | Standard Deviation | Scores on a scale |
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| Primary | 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. | Posted | Mean | Standard Deviation | Scores on a Scale | 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. |
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| Primary | 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. | Posted | Mean | Standard Deviation | Scores on a Scale | 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. |
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| Primary | 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. | Posted | Mean | Standard Deviation | Scores on a Scale | 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. |
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| Primary | 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. | Posted | Mean | Standard Deviation | Scores on a Scale | The DCS was collected at the first study visit, and then again after the medication experiment was completed (between 4 and 12 weeks later) |
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| Primary | 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. | Posted | Mean | Standard Deviation | Scores on a Scale | The DCS was collected at the first study visit, and then again after the medication experiment was completed (between 4 and 12 weeks later) |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Scores on a Scale | 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. |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | Scores on a Scale | Collected at study visit 1 and 4-12 weeks later at study visit 2. |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | Points | Collected at study visit 1 and 4-12 weeks later at study visit 2. |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | Points | Collected at study visit 1 and 4-12 weeks later at study visit 2. |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Scores on a Scale | 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. |
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| Secondary | 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. | 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) | Posted | Mean | Standard Deviation | Points | Collected at study visit 2 (which is 4-12 weeks after study visit 1). |
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| Secondary | 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. | Posted | Count of Participants | Participants | 3 months after study visit 2 (which is 4-12 weeks after study visit 1). |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Intervention: Children | This study enrolled child-parent dyads. Adverse events were monitored separately for children and parents throughout the study. No serious or other adverse events occurred among either children or parents. This arm represents the children. | 0 | 30 | 0 | 30 | 0 | 30 |
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| Joint/Options Score - Reported by Discordant Children |
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| Joint/Options Score - Reported by Concordant Children |
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| <0.04 |
| Other |
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