Skip to main content
OpenTrials
Completed

NCT Number: NCT01990222

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Augustus Hawkins Mental Health Center, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Stimulant medication adherence

    Time frame: medication follow-up visit 1- visit 3, approx 8 weeks, depending on scheduling of the 3 med visits, usually 1 every 2 weeks

    parent-reported stimulant medication adherence

Secondary outcomes

  1. Parent-provider communication

    Time frame: Once every two weeks for each participant, over approx 8 weeks, depending on scheduling of the 3 med visits, usually 1 every 2 weeks

    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.

  2. Clinic follow-up visit attendance

    Time frame: medication follow-up visit 1-visit 3, approx 8 weeks, depending on scheduling of the 3 med visits, usually 1 every 2 weeks

    attendance of scheduled follow-up clinic visits for medication management

Other outcomes

  1. Parent-centered medication management

    Time frame: 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

    stimulant medication treatment decisions that are responsive to parent- reported symptoms and medication side effects and treatment acceptability ratings

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 21, 2013
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.