Attention Deficit Disorder With HyperactivityNCT01990222
Leveraging Mobile Health Technology to Optimize Early Stimulant Medication Treatment: A Feasibility Pilot
An observational study of Attention Deficit Disorder With Hyperactivity, run by University of California, Los Angeles at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2014to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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)
Who cannot join
- any chronic medical condition that requires on-going medication management
- prescription of combined psychotropic medication
- moderate-severe developmental delays, mental retardation or autism
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Augustus Hawkins Mental Health Center
Los Angeles, California, 90059
UCLA Children's Health Center
Los Angeles, California, 90095
Child and Family Guidance Center
Northridge, California, 91325
About this study
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.
Read the 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.
- Keywords
- ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulant medication adherence
parent-reported stimulant medication adherence
Measured: 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 (2)
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.
Measured: 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
Measured: medication follow-up visit 1-visit 3, approx 8 weeks, depending on scheduling of the 3 med visits, usually 1 every 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bonnie Zima, MD MPH, University of California, Los Angeles
- Investigators
- Bonnie Zima, MD, MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990222
- Sponsor's protocol ID
- UL1TR000124
- Other IDs
- IRB#12-001879
- Status last verified
- Feb 2020
- First submitted
- 1 Jul 2013
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Mobile Health Technology to Optimize Early Stimulant Medication Treatment: A Feasibility Pilot
- ClinicalTrials.gov ID
- NCT01990222
- Acronym / sponsor ID
- UL1TR000124
- Keywords
- ADHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- any chronic medical condition that requires on-going medication management
- prescription of combined psychotropic medication
- moderate-severe developmental delays, mental retardation or autism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonnie Zima, MD, MPH principal investigator
University of California, Los Angeles
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Disorder With Hyperactivity, run by University of California, Los Angeles at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.