New Technologies to Help Manage ADHD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Developing New Technologies to Improve ADHD Medication Continuity

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Other: enhanced myADHDportal.com
* Other: treatment as usual standard portal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents of children are eligible to participate if their child receives ADHD care at one of the pediatric primary care practices that is partnering to conduct this trial child being registered on myADHDportal.com to initiate child assessment of ADHD child age 6-10 years child must not have been previously treated with ADHD medication child prescribed ADHD medication within 12 months of enrolling in the study Exclusion Criteria: Unable to read and speak English

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: enhanced myADHDportal.com<br>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 | Other: enhanced myADHDportal.com<br>* 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<br>|
| Active Comparator: treatment as usual standard portal<br>Standard version of myADHDportal.com web software | Other: treatment as usual standard portal<br>* Standard version of myADHDportal.com web software<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |