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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Disorder With Hyperactivity

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.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Children's Health Center
    • Los Angeles, California, United States, 90059
      • Augustus Hawkins Mental Health Center
    • Northridge, California, United States, 91325
      • Child and Family Guidance Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent-centered medication management	stimulant medication treatment decisions that are responsive to parent- reported symptoms and medication side effects and treatment acceptability ratings	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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Bonnie Zima, MD, MPH, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: July 1, 2013
• First Submitted That Met QC Criteria: November 14, 2013
• First Posted (Estimate): November 21, 2013

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: ADHD
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: UL1TR000124 (U.S. NIH Grant/Contract); IRB#12-001879 (Other Identifier: University of California at Los Angeles (UCLA) IRB)