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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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Though the most effective treatment for children with Attention Deficit Hyperactivity Disorder (ADHD) consists of combined medication and behavioral strategies, the vast majority of children with ADHD are treated with medication only. One reason for the low rates of behavioral treatment is that primary care pediatricians, not mental health professionals, are responsible for treating the vast majority of children with ADHD. The investigators have developed, tested, and are beginning to disseminate web-based software (mehealth for ADHD) that has been shown in randomized clinical trials to improve the quality of ADHD medication care delivered by pediatricians. The goal of the proposed study is to develop and test the integration of behavioral tools into the evidence-based myadhdportal.com software in order to improve access to behavioral treatment strategies, and ultimately improve outcomes for children with ADHD. The automated algorithms and decision rules the investigators have developed for creating and monitoring the behavioral tools ensure that behavioral treatments like daily report cards and token economies are delivered in a manner that is consistent with the evidence-base. The investigators are conducting a cluster randomized controlled trial in community pediatric settings to test whether integration of the behavioral tools into the myADHDportal.com software (1) increases rates of behavioral treatment; (2) facilitates better integrity of behavioral interventions when implemented; (3) improves functional impairment in children with ADHD; and (4) generates higher satisfaction with ADHD care. By continuing to expand the functionality of the myADHDportal.com software, the investigators are increasing patients' access to evidence-based care. This is especially critical for rural and underserved communities who have no or limited access to evidence-based mental health services. Moreover, by putting these behavioral tools in the hands of parents, teachers, and pediatricians, the investigators are making it more likely that children will receive a high quality of care that includes both medication management and behavioral strategies, thereby improving the overall treatment outcomes of children with ADHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mehealth portal with integrated behavioral tools | Experimental | Patients in this arm will continue to use the mehealth for ADHD web-based software for ADHD care but will also have access to a module that allows parents and teachers to develop and implement behavioral interventions such as daily report cards online. |
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| mehealth portal with no integrated behavioral tools | Other | Patients in this arm will continue to use the mehealth for ADHD web-based software for ADHD care but will wait one year before getting access to the behavioral intervention features. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral tools integrated within mehealth for ADHD software | Other | Integrated functionality within the mehealth for ADHD software allows parents and teachers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts. Automated wizards lead parents and teachers through the process of selecting target behaviors and setting up reward schedules. Baseline data is gathered online and algorithms derive a set of behavioral goals for the child. Thereafter, parents or teachers record the child's performance directly into the software. Once behavioral monitoring begins, parents and teachers receive daily email or text communications from mehealth for ADHD alerting them to the daily rewards earned by their child. Finally, online algorithms exist that detect how a child is doing in meeting behavioral goals and prompt users to modify goals accordingly. |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Behavioral Treatment | Parent-report of implementation of behavioral interventions on the Services Use in Children and Adolescents Parent Interview | 12 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Parent Rating of School Performance on Impairment Rating Scale | Parent rating of child's impairment on School Performance on the Impairment Rating Scale. Items rated on a Likert scale ranging from 0 (no impairment) to 6 (extreme impairment). | 6 months after randomization |
| Teacher Rating of Academic Performance on Impairment Rating Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3026 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mehealth Portal With Integrated Behavioral Tools | Patients in this arm will have access to online behavioral interventions such as daily report cards online integrated within mehealth for attention deficit hyperactivity disorder (ADHD) software that allows parents and teachers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts. |
| FG001 | Mehealth Portal With no Integrated Behavioral Tools | Patients in this arm will wait one year before getting access to the behavioral intervention features. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mehealth Portal With Integrated Behavioral Tools | Patients in this arm will have access to online behavioral interventions such as daily report cards online integrated within mehealth for ADHD software that allows parents and teachers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts |
| 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, Categorical | Count of Participants |
| 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 | Rates of Behavioral Treatment | Parent-report of implementation of behavioral interventions on the Services Use in Children and Adolescents Parent Interview | Posted | Count of Participants | Participants | 12 months after randomization |
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1 year
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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 | Mehealth Portal With Integrated Behavioral Tools | Patients in this arm will have access to online behavioral interventions such as daily report cards online integrated within mehealth for ADHD software that allows parents and teachers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeff Epstein | Cincinnati Children's Hospital Medical Center | 15136368296 | jeff.epstein@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 | Mar 6, 2020 | Dec 8, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 11, 2019 | Dec 8, 2021 | 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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| mehealth for ADHD | 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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Teacher rating of child's impairment on Academic Performance on the Impairment Rating Scale. Items rated on a Likert scale ranging from 0 (no impairment) to 6 (extreme impairment). |
| 6 months after randomization |
| Teacher Rating of Classroom Performance on Impairment Rating Scale | Teacher rating of child's impairment on Classroom Performance on the Impairment Rating Scale. Items rated on a Likert scale ranging from 0 (no impairment) to 6 (extreme impairment). | 6 months after randomization |
| BG001 |
| Mehealth Portal With no Integrated Behavioral Tools |
Patients in this arm will wait one year before getting access to the behavioral intervention features. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | 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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| Region of Enrollment | Number | participants |
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| Parent-report of child receiving behavioral treatment at home or school | Collected via parent-report using Services Use in Children and Adolescents Parent Interview | Number | participants |
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| Parent rating of School Performance on Impairment Rating Scale | Parent rating of child's impairment on School Performance on the Impairment Rating Scale. Items rated on a Likert scale ranging from 0 (no impairment) to 6 (extreme impairment). | Mean | Standard Deviation | units on a scale |
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| Teacher rating of Academic Performance on Impairment Rating Scale | Mean | Standard Deviation | units on a scale |
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| Teacher rating of Classroom Performance on Impairment Rating Scale | Mean | Standard Deviation | units on a scale |
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| Secondary | Parent Rating of School Performance on Impairment Rating Scale | Parent rating of child's impairment on School Performance on the Impairment Rating Scale. Items rated on a Likert scale ranging from 0 (no impairment) to 6 (extreme impairment). | Posted | Mean | Standard Deviation | units on a scale | 6 months after randomization |
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| Secondary | Teacher Rating of Academic Performance on Impairment Rating Scale | Teacher rating of child's impairment on Academic Performance on the Impairment Rating Scale. Items rated on a Likert scale ranging from 0 (no impairment) to 6 (extreme impairment). | Posted | Mean | Standard Deviation | units on a scale | 6 months after randomization |
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| Secondary | Teacher Rating of Classroom Performance on Impairment Rating Scale | Teacher rating of child's impairment on Classroom Performance on the Impairment Rating Scale. Items rated on a Likert scale ranging from 0 (no impairment) to 6 (extreme impairment). | Posted | Mean | Standard Deviation | units on a scale | 6 months after randomization |
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| 0 |
| 85 |
| 0 |
| 85 |
| 0 |
| 85 |
| EG001 | Mehealth Portal With no Integrated Behavioral Tools | Patients in this arm will wait one year before getting access to the behavioral intervention features. | 0 | 84 | 0 | 84 | 0 | 84 |
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