Clinical trial NCT01990222: Leveraging Mobile Health Technology to Optimize Early Stimulant Medication Treatment: A Feasibility Pilot
Official title: Leveraging Mobile Health Technology to Optimize Early Stimulant Medication Treatment: A Feasibility Pilot
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 26
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents taking their children to Augustus Hawkins Mental Health Center for treatment of ADHD who were prescribed stimulant medication for the first time. The attending physicians will work at the clinic.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Stimulant medication adherence
timeFrame: medication follow-up visit 1- visit 3, approx 8 weeks, depending on scheduling of the 3 med visits, usually 1 every 2 weeks
Secondary outcomes:
measure: Parent-provider communication
timeFrame: Once every two weeks for each participant, over approx 8 weeks, depending on scheduling of the 3 med visits, usually 1 every 2 weeks
measure: Clinic follow-up visit attendance
timeFrame: medication follow-up visit 1-visit 3, approx 8 weeks, depending on scheduling of the 3 med visits, usually 1 every 2 weeks
Other outcomes:
measure: Parent-centered medication management
timeFrame: between medication follow-up visit 1- visit 3, over approx 8 weeks, depending on scheduling of the 3 med visits, usually 1 every 2 weeks
Locations:
city: Los Angeles
country: United States
facility: Augustus Hawkins Mental Health Center
state: California
city: Los Angeles
country: United States
facility: UCLA Children's Health Center
state: California
city: Northridge
country: United States
facility: Child and Family Guidance Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Bonnie Zima, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: