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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH101155 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Cluster randomized controlled trial to evaluate the general effectiveness of intervention compared to control on medication continuity as measured by prescriptions written and other more proximal outcomes during the first six months of treatment.
This cluster randomized controlled trial will evaluate the general effectiveness of the intervention (e.g. enhanced myADHDportal.com), compared to control (e.g. treatment as usual standard portal), on medication continuity as measured by prescriptions written and other more proximal outcomes during the first six months of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enhanced myADHDportal.com | Experimental | Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child |
|
| treatment as usual standard portal | Active Comparator | Standard version of myADHDportal.com web software |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enhanced myADHDportal.com | Other | Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Continuity: The Number of Days Covered With Medicine | the number of days covered with medicine will be calculated from audit of prescriptions written | first 6 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Parent-reported Necessity to Concerns Differential (Beliefs About Medication Scale) | Necessity to concerns differential score, range -4 to 4, positive scores mean necessity outweighs concerns, negative scores mean that concerns outweigh beliefs about necessity | 6 months after starting treatment |
| Parent-reported Decisional Conflict (Decisional Conflict Scale) |
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Inclusion Criteria:
Parents of children are eligible to participate if
Exclusion 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 |
|---|---|---|---|---|---|---|
| William B Brinkman | Cincinnati | Ohio | 45237 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced myADHDportal.Com | Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child enhanced myADHDportal.com: Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child |
| FG001 | Treatment as Usual Standard Portal | Standard version of myADHDportal.com web software treatment as usual standard portal: Standard version of myADHDportal.com web software |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced myADHDportal.Com | Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child enhanced myADHDportal.com: Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Medication Continuity: The Number of Days Covered With Medicine | the number of days covered with medicine will be calculated from audit of prescriptions written | Posted | Mean | Standard Deviation | Days | first 6 months of treatment |
|
6 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 | Enhanced myADHDportal.Com | Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child enhanced myADHDportal.com: Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child |
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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 | Jun 19, 2017 | Aug 23, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 1, 2017 | Aug 23, 2018 | SAP_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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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| treatment as usual standard portal | Other | Standard version of myADHDportal.com web software |
|
Total score calculated from parent-report on the Decisional Conflict Scale, range 0 to 100; higher scores are worse |
| 6 months after starting treatment |
| Parent Trust in Provider (Trust in Provider Scale) | Total score calculated from parent-report on the Trust in Provider Scale, range 10 to 50 with higher scores better (more trust) | 6 months after starting treatment |
| Working Alliance Inventory | range 12-60, higher scores better (more alliance) | 6 months after starting treatment |
| Parent Perceived Social Support (Perceived Social Support Scale) | Total score calculated from parent-report on the Perceived Social Support Scale, range 12-84, higher score better (more social support) | 6 months after starting treatment |
| Parent Distress (Parenting Stress Index - Short Form) | Parental distress subscale score calculated from the Parenting Stress Index - Short Form; range 36-180, higher scores is worse (more stress) | 6 months after starting treatment |
| Number of Participants With Side Effects Rated by Parents as Moderate or Severe on the Pittsburgh Side Effects Rating Scale | Number of Participants with side effects rated by parents as moderate or severe on the Pittsburgh Side Effects Rating Scale | 6 months after starting treatment |
| Total Number of myADHDportal.Com Log-ins by Parent | 6 months after starting treatment |
| Total Number of Measures Completed by Parents to Track Child Response to Treatment | 6 months after starting treatment |
| BG001 | Treatment as Usual Standard Portal | Standard version of myADHDportal.com web software treatment as usual standard portal: Standard version of myADHDportal.com web software |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Standard version of myADHDportal.com web software
treatment as usual standard portal: Standard version of myADHDportal.com web software
|
|
|
| Secondary | Parent-reported Necessity to Concerns Differential (Beliefs About Medication Scale) | Necessity to concerns differential score, range -4 to 4, positive scores mean necessity outweighs concerns, negative scores mean that concerns outweigh beliefs about necessity | population who completed this outcome assessment | Posted | Median | Inter-Quartile Range | score on a scale | 6 months after starting treatment |
|
|
|
|
| Secondary | Parent-reported Decisional Conflict (Decisional Conflict Scale) | Total score calculated from parent-report on the Decisional Conflict Scale, range 0 to 100; higher scores are worse | population who completed this outcome assessment | Posted | Median | Inter-Quartile Range | score on a scale | 6 months after starting treatment |
|
|
|
|
| Secondary | Parent Trust in Provider (Trust in Provider Scale) | Total score calculated from parent-report on the Trust in Provider Scale, range 10 to 50 with higher scores better (more trust) | population who completed this outcome assessment | Posted | Median | Inter-Quartile Range | score on a scale | 6 months after starting treatment |
|
|
|
|
| Secondary | Working Alliance Inventory | range 12-60, higher scores better (more alliance) | population who completed this outcome assessment | Posted | Median | Inter-Quartile Range | score on a scale | 6 months after starting treatment |
|
|
|
|
| Secondary | Parent Perceived Social Support (Perceived Social Support Scale) | Total score calculated from parent-report on the Perceived Social Support Scale, range 12-84, higher score better (more social support) | population who completed this outcome assessment | Posted | Median | Inter-Quartile Range | score on a scale | 6 months after starting treatment |
|
|
|
|
| Secondary | Parent Distress (Parenting Stress Index - Short Form) | Parental distress subscale score calculated from the Parenting Stress Index - Short Form; range 36-180, higher scores is worse (more stress) | population who completed this outcome assessment | Posted | Median | Inter-Quartile Range | score on a scale | 6 months after starting treatment |
|
|
|
|
| Secondary | Number of Participants With Side Effects Rated by Parents as Moderate or Severe on the Pittsburgh Side Effects Rating Scale | Number of Participants with side effects rated by parents as moderate or severe on the Pittsburgh Side Effects Rating Scale | population who completed this outcome assessment | Posted | Count of Participants | Participants | 6 months after starting treatment |
|
|
|
|
| Secondary | Total Number of myADHDportal.Com Log-ins by Parent | Posted | Mean | Standard Deviation | logins | 6 months after starting treatment |
|
|
|
|
| Secondary | Total Number of Measures Completed by Parents to Track Child Response to Treatment | Posted | Mean | Standard Deviation | measures | 6 months after starting treatment |
|
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Treatment as Usual Standard Portal | Standard version of myADHDportal.com web software treatment as usual standard portal: Standard version of myADHDportal.com web software | 0 | 45 | 0 | 45 | 0 | 45 |
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