Leveraging Mobile Health Technology to Optimize Early Stimulant Medication Treatment: A Feasibility Pilot

Study Overview
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Brief Summary
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The goal of this study is to develop and test a mobile web application to optimize early stimulant medication treatment for children receiving care for Attention/Deficit Hyperactivity Disorder (ADHD) in a publicly-funded mental health clinic.

Detailed Description
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In other words, the study will find out whether it is feasible and acceptable for parents to receive reminders for clinic visits and ADHD medication and enter daily ratings of their child's ADHD symptoms and medication side effects into a smart phone. It will also examine whether it is feasible and acceptable for doctors to use this information summarized on a tablet (iPad) screen during a medication follow-up visit. If the parent consents, the study will also examine whether it is feasible and acceptable for the child's teacher to enter their ratings of ADHD symptoms twice a week using a link on their email. This information will also be included in the doctor's iPad screen. If this technology is found to be promising, then a larger study will be done to examine if medication treatment is safer, more consistent, and more effective using this technology compared to usual care. This is important because the technology may remove the burden on parents and teachers to report ADHD symptoms and medication side effects using paper forms, and for doctors to record this information in the medical record. In total, there will be 12 parent/ child dyads, 6 clinicians and up to 12 teachers enrolled. Each parent/child dyad will be videotaped for up to 3 visits with the clinician (n=36 videotaped sessions). The study time period is from the first visit that ADHD medication is prescribed to the time of the third follow-up medication visit. We anticipate that the follow-up visits will be every 1-2 weeks during this early phase of stimulant medication treatment. Thus, the study time period for each parent/child dyad will be between 4-8 weeks. We anticipate that data collection will occur between August 19, 2013 and June 31, 2014.

Official Title
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Leveraging Mobile Health Technology to Optimize Early Stimulant Medication Treatment: A Feasibility Pilot

Conditions
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Attention Deficit Disorder With Hyperactivity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: parent's and child's primary language is English or Spanish child is between 5-11 years child received a clinical diagnosis of ADHD child is receiving stimulant medication for the first time child does not take any other medication on a regular basis (like every day) Exclusion Criteria: any chronic medical condition that requires on-going medication management prescription of combined psychotropic medication moderate-severe developmental delays, mental retardation or autism

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stimulant medication adherence | parent-reported stimulant medication adherence | medication follow-up visit 1- visit 3, approx 8 weeks, depending on scheduling of the 3 med visits, usually 1 every 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent-provider communication | Each parent/child dyad, if consented, will have their first three medication visits with their doctor videotaped. These visits are typically once every two weeks for each dyad. | Once every two weeks for each participant, over approx 8 weeks, depending on scheduling of the 3 med visits, usually 1 every 2 weeks | 
| Clinic follow-up visit attendance | attendance of scheduled follow-up clinic visits for medication management | medication follow-up visit 1-visit 3, approx 8 weeks, depending on scheduling of the 3 med visits, usually 1 every 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD