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Medication is an efficacious treatment strategy for adolescents with attention-deficit/hyperactivity disorder (ADHD), however use significantly declines during adolescence when the consequences of ADHD are most severe (e.g. dropping out of school, delinquency, etc.). The Unified Theory of Behavior Change (UTBC) has been proposed as a conceptual model to explain the mechanism underlying ADHD medication adherence and to guide the development of interventions to improve the continuity of treatment. The UTBC is a well-established and empirically tested model that identifies factors that influence an individual's intention to perform a behavior as well as factors that influence whether a behavior is actually carried out. Indeed, the research team's preliminary data support the relevance of pre-intention factors and implementation factors for medication continuity among adolescents with ADHD. Currently, no evidence-based interventions target medication continuity for adolescents with ADHD. The objective of this study is to test a multi-component intervention that systematically identifies and targets aspects of the UTBC model most relevant for each adolescent with poor ADHD medication continuity. The central hypothesis is that the tailored intervention will support ADHD medication continuity. The study will conduct an open label trial among adolescents with poor medication continuity to test whether the intervention engages the mechanism underlying medication continuity and improves outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | All adolescent/parent dyads enrolled at each practice will have access to the meHealth for ADHD software without medication continuity tools prior to being given access to the medication continuity tools. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mehealth for ADHD software with medication continuity tools | Other | Medication continuity tools integrated within the mehealth for ADHD software will assess factors influencing medication continuity for each adolescent and recommends tools to address relevant factors. Tools include 1) a system to track outcomes and resolve uncertainty about the need for and/or benefit from medicine, 2) a module to address stigma, 3) a module to help manage side effects, and 4) reminders to take medicine and/or request refills. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Days Covered With Medicine | This will be calculated based pharmacy dispensing records | An average of 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fidelity to Intended Use of Intervention Components | Proportion of intervention components completed relative to the components that were recommended by the portal based on adolescent/parent responses to the assessment battery. | An average of 4 months |
| Change in Pre-intention Factors of Unified Theory of Behavior Change Influencing Medication Continuity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Brinkman, MD | Cincinnati Children's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | All parent/adolescent dyads enrolled at each practice will have access to the meHealth for ADHD software without medication continuity tools prior to being given access to the medication continuity tools. Mehealth for ADHD software with medication continuity tools: Medication continuity tools integrated within the mehealth for ADHD software will assess factors influencing medication continuity for each adolescent and recommends tools to address relevant factors. Tools include 1) a system to track outcomes and resolve uncertainty about the need for and/or benefit from medicine, 2) a module to address stigma, 3) a module to help manage side effects, and 4) reminders to take medicine and/or request refills. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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8 adolescent-parent dyads included a total of 16 participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | All parent/adolescent dyads enrolled at each practice will have access to the meHealth for ADHD software without medication continuity tools prior to being given access to the medication continuity tools. Mehealth for ADHD software with medication continuity tools: Medication continuity tools integrated within the mehealth for ADHD software will assess factors influencing medication continuity for each adolescent and recommends tools to address relevant factors. Tools include 1) a system to track outcomes and resolve uncertainty about the need for and/or benefit from medicine, 2) a module to address stigma, 3) a module to help manage side effects, and 4) reminders to take medicine and/or request refills. |
| 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 | Mean |
| 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 | Proportion of Days Covered With Medicine | This will be calculated based pharmacy dispensing records | Missing data for 1 adolescent | Posted | Mean | Full Range | Proportion of days covered with medicine | An average of 4 months |
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4 months
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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 | All adolescent/parent dyads enrolled at each practice will have access to the meHealth for ADHD software without medication continuity tools prior to being given access to the medication continuity tools. Mehealth for ADHD software with medication continuity tools: Medication continuity tools integrated within the mehealth for ADHD software will assess factors influencing medication continuity for each adolescent and recommends tools to address relevant factors. Tools include 1) a system to track outcomes and resolve uncertainty about the need for and/or benefit from medicine, 2) a module to address stigma, 3) a module to help manage side effects, and 4) reminders to take medicine and/or request refills. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William B. Brinkman | Cincinnati Children's | 513-636-2576 | bill.brinkman@cchmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 21, 2021 | May 31, 2022 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 19, 2022 | May 31, 2022 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 29, 2020 | Jan 4, 2022 | ICF_000.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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| Mehealth for ADHD software without medication continuity tools | Other | The mehealth for ADHD software has multiple functionalities including 1) online training regarding the American Academy of Pediatrics (AAP) ADHD guidelines; 2) an ADHD workflow wizard that guides pediatricians through the creation of an efficient office workflow to deliver quality ADHD care; 3) online collection of parent- and teacher-report ADHD rating scales for the assessment of ADHD as well as monitoring response to medication treatment; 4) integrated algorithms that automatically score rating scales in real time and provide pediatricians with assessment and treatment reports as well as immediate warnings; 5) a communication feature that allows parents, teachers, and pediatricians to communicate with each other; 6) an online pediatrician "report card"; and 7) a Plan-Do-Study-Act wizard that allows pediatricians to select a practice behavior to improve based on their report card and guides them through the creation of small tests of change to improve their office systems. |
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Adolescent and parent self-report on a 1-5 or 1-7-point scale, depending on the item. Items were re-scaled to a 1 (signifying less belief) to 5 (signifying stronger belief) scale. Individual items measure specific attitudes, subjective norms, and perceived behavioral control. Items were coded so that higher scores aligned with increased perceived advantages of performing the behavior and behavioral control around taking ADHD medicine. We calculated the average score of the total items (Adolescent report = 19 items; Parent report = 17 items). Range of change score is (-4) to (+4). |
| At baseline and 4 months later |
| Change in Intention to Take/Give ADHD Medicine Regularly | Adolescent and parent self-report on a 1-7-point scale. Items were re-scaled to a 1 (signifying less intention) to 5 (signifying stronger intention) scale. Items were coded so that higher scores aligned with stronger intention to take ADHD medicine every school day, weekend day, and during school vacations. We calculated the average score of the 3 items. Range of change score is (-4) to (+4). | At baseline and 4 months later |
| Change in Adolescent Report of Medication Barriers | Adolescent self-report on Adolescent Medication Barriers Scale using a 1-5-point Likert Scale. 1 indicates strong agreement and 5 indicates strong disagreement, with higher scores indicating less barriers. Items were coded so that higher scores aligned with increased organizational skills, salience of behavior, and routine around taking ADHD medicine. We calculated the average score of the 8 items. Range of change score is (-4) to (+4). | At baseline and 4 months later |
| Change in Parent Report of Medication Barriers | Parent self-report on Parent Medication Barriers Scale using a 1-5-point Likert Scale. 1 indicates strong agreement and 5 indicates strong disagreement, with higher scores indicating less barriers. Items were coded so that higher scores aligned with increased adolescent organizational skills, salience of behavior, and routine around taking ADHD medicine. We calculated the average score of the 9 items. Range of change score is (-4) to (+4). | At baseline and 4 months later |
| Change in Medication Diversion | Adolescent self-report of the number of occasions of giving away, trading, or selling ADHD medicine to someone for whom it was not prescribed. | At baseline and 4 months later |
| Change in Decision Making Involvement Scale | Adolescent and Parent self-report. The scale contains the following subscales: "Child Seek" (e.g. child asks for an opinion or information from the parent), "Child Express" (e.g. child expresses an opinion or information to the parent), "Parent Seek" (e.g. parent asks for an opinion or information from child), "Parent Express" (e.g. parent expresses advice, an opinion, or information to the child), and "Joint/Options" (e.g. negotiation and brainstorming between child and parent). Each subscale produces a score which ranges from 1 to 4 with higher scores indicating more of that behavior. | At baseline and 4 months later |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Fidelity to Intended Use of Intervention Components | Proportion of intervention components completed relative to the components that were recommended by the portal based on adolescent/parent responses to the assessment battery. | Posted | Mean | Full Range | Proportion of intervention components | An average of 4 months |
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| Secondary | Change in Pre-intention Factors of Unified Theory of Behavior Change Influencing Medication Continuity | Adolescent and parent self-report on a 1-5 or 1-7-point scale, depending on the item. Items were re-scaled to a 1 (signifying less belief) to 5 (signifying stronger belief) scale. Individual items measure specific attitudes, subjective norms, and perceived behavioral control. Items were coded so that higher scores aligned with increased perceived advantages of performing the behavior and behavioral control around taking ADHD medicine. We calculated the average score of the total items (Adolescent report = 19 items; Parent report = 17 items). Range of change score is (-4) to (+4). | Missing data for 1 parent/adolescent dyad and 1 adolescent | Posted | Mean | Standard Deviation | score on a scale | At baseline and 4 months later |
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| Secondary | Change in Intention to Take/Give ADHD Medicine Regularly | Adolescent and parent self-report on a 1-7-point scale. Items were re-scaled to a 1 (signifying less intention) to 5 (signifying stronger intention) scale. Items were coded so that higher scores aligned with stronger intention to take ADHD medicine every school day, weekend day, and during school vacations. We calculated the average score of the 3 items. Range of change score is (-4) to (+4). | Missing data for 1 parent/adolescent dyad and 1 adolescent | Posted | Mean | Standard Deviation | score on a scale | At baseline and 4 months later |
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| Secondary | Change in Adolescent Report of Medication Barriers | Adolescent self-report on Adolescent Medication Barriers Scale using a 1-5-point Likert Scale. 1 indicates strong agreement and 5 indicates strong disagreement, with higher scores indicating less barriers. Items were coded so that higher scores aligned with increased organizational skills, salience of behavior, and routine around taking ADHD medicine. We calculated the average score of the 8 items. Range of change score is (-4) to (+4). | Missing data for 2 adolescents | Posted | Mean | Standard Deviation | score on a scale | At baseline and 4 months later |
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| Secondary | Change in Parent Report of Medication Barriers | Parent self-report on Parent Medication Barriers Scale using a 1-5-point Likert Scale. 1 indicates strong agreement and 5 indicates strong disagreement, with higher scores indicating less barriers. Items were coded so that higher scores aligned with increased adolescent organizational skills, salience of behavior, and routine around taking ADHD medicine. We calculated the average score of the 9 items. Range of change score is (-4) to (+4). | Missing data for 1 parent | Posted | Mean | Standard Deviation | score on a scale | At baseline and 4 months later |
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| Secondary | Change in Medication Diversion | Adolescent self-report of the number of occasions of giving away, trading, or selling ADHD medicine to someone for whom it was not prescribed. | Missing data for 2 adolescents | Posted | Mean | Standard Deviation | Events | At baseline and 4 months later |
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| Secondary | Change in Decision Making Involvement Scale | Adolescent and Parent self-report. The scale contains the following subscales: "Child Seek" (e.g. child asks for an opinion or information from the parent), "Child Express" (e.g. child expresses an opinion or information to the parent), "Parent Seek" (e.g. parent asks for an opinion or information from child), "Parent Express" (e.g. parent expresses advice, an opinion, or information to the child), and "Joint/Options" (e.g. negotiation and brainstorming between child and parent). Each subscale produces a score which ranges from 1 to 4 with higher scores indicating more of that behavior. | Missing data for 1 parent/adolescent dyad and 1 adolescent | Posted | Mean | Standard Deviation | score on a scale | At baseline and 4 months later |
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| 16 |
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| 16 |
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| 16 |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Adolescent: Parent Seek |
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| Adolescent: Parent Express |
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| Adolescent: Joint/Options |
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| Parent: Child Seek |
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| Parent: Child Express |
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| Parent: Parent Seek |
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| Parent: Parent Express |
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| Parent: Joint/Options |
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