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Attention Deficit Hyperactivity DisorderNCT04386096

Web Based Tools to Improve Medication Continuity in Adolescents With ADHD

A study testing Mehealth for ADHD software with medication continuity tools and Mehealth for ADHD software with no medication continuity tools in people with Attention Deficit Hyperactivity Disorder and Adherence, Medication, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Medication is an efficacious treatment strategy for adolescents with attention-deficit/hyperactivity disorder (ADHD), however use significantly declines during adolescence when the consequences of ADHD are most severe (e.g. dropping out of school, delinquency, etc.). Read more about this study

Who is it for?
Ages 11 to 15 years
What is being tested?
Mehealth for ADHD software with medication continuity tools and Mehealth for ADHD software with no medication continuity tools
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
1 Jun 2020to 24 May 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 11 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • First prescribed ADHD medicine more than one year prior to enrollment
  • Treated by pediatrician at practice participating in study
  • Filled at least one prescription for a stimulant medication in the past year

Who cannot join

  • More than 80% of days covered with medicine over past one year
  • Poor understanding level: The participant and parent cannot understand or follow instructions given in the study.
  • Do not have reliable access to the internet at their home or another location.
  • Parent will not permit their child to access the internet for study related activities
  • Are not able or willing to send or receive text messages for study related activities

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3039

Other trials in United States

About this study

Official title: Randomized Controlled Trial of Web Based Tools to Improve Medication Continuity in Adolescents With ADHD

Medication is an efficacious treatment strategy for adolescents with attention-deficit/hyperactivity disorder (ADHD), however use significantly declines during adolescence when the consequences of ADHD are most severe (e.g. dropping out of school, delinquency, etc.). The Unified Theory of Behavior Change (UTBC) has been proposed as a conceptual model to explain the mechanism underlying ADHD medication adherence and to guide the development of interventions to improve the continuity of treatment. The UTBC is a well-established and empirically tested model that identifies factors that influence an individual's intention to perform a behavior as well as factors that influence whether a behavior is actually carried out. Indeed, the research team's preliminary data support the relevance of pre-intention factors and implementation factors for medication continuity among adolescents with ADHD. Currently, no evidence-based interventions target medication continuity for adolescents with ADHD. The objective of this study is to test a multi-component intervention that systematically identifies and targets aspects of the UTBC model most relevant for each adolescent with poor ADHD medication continuity. The central hypothesis is that the tailored intervention will support ADHD medication continuity. The study will objectively test the central hypothesis by conducting a randomized controlled trial among adolescents with poor medication continuity to test whether the intervention engages the mechanism underlying medication continuity and improves outcomes.

Being tested
Mehealth for ADHD software with medication continuity tools, Mehealth for ADHD software with no medication continuity tools
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mehealth for ADHD software with medication continuity toolsOther

    Medication continuity tools integrated within the mehealth for ADHD software will assess factors influencing medication continuity for each adolescent and recommend tools to address relevant factors. Tools include 1) a system to track outcomes and resolve uncertainty about the need for and/or benefit from medicine, 2) a module to address stigma, 3) a module to help manage side effects, and 4) reminders to take medicine and/or request refills.

  • Mehealth for ADHD software with no medication continuity toolsOther

    The mehealth for ADHD software has multiple functionalities including 1) online training regarding the American Academy of Pediatrics (AAP) ADHD guidelines; 2) an ADHD workflow wizard that guides pediatricians through the creation of an efficient office workflow to deliver quality ADHD care; 3) online collection of parent- and teacher-report ADHD rating scales for the assessment of ADHD as well as monitoring response to medication treatment; 4) integrated algorithms that automatically score rating scales in real time and provide pediatricians with assessment and treatment reports as well as immediate warnings; 5) an online pediatrician "report card"; and 6) a Plan-Do-Study-Act wizard that allows pediatricians to select a practice behavior to improve based on their report card and guides them through the creation of small tests of change to improve their office systems.

Study groups in NCT04386096
Study groupRoleWhat they receive
Mehealth for ADHD software with medication continuity toolsExperimentalNot described
Receives: Other: Mehealth for ADHD software with medication continuity tools
Mehealth for ADHD software with no medication continuity toolsActive comparatorNot described
Receives: Other: Mehealth for ADHD software with no medication continuity tools

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Days Covered With Medicine

    This will be calculated based pharmacy dispensing records

    Measured: An average of 4 months

Secondary outcomes (7)

  1. Fidelity to Intended Use of Intervention Components

    Proportion of intervention components completed relative to the components that were recommended by the portal based on adolescent/parent responses to the assessment battery.

    Measured: An average of 4 months

  2. Change in Pre-intention Factors of Unified Theory of Behavior Change

    Adolescent and parent self-report on a 1-5 or 1-7-point scale, depending on the item. Items were re-scaled to a 1 (signifying less belief) to 5 (signifying stronger belief) scale. Individual items measure specific attitudes, subjective norms, and perceived behavioral control. Items were coded so that higher scores aligned with increased perceived advantages of performing the behavior and behavioral control around taking ADHD medicine. We calculated the average score of the total items (Adolescent report = 19 items; Parent report = 17 items). Range of change score is (-4) to (+4).

    Measured: At baseline and approximately 4 months later

  3. Change in Intention to Take/Give ADHD Medicine Regularly

    Adolescent and parent self-report on a 1-7-point scale. Items were re-scaled to a 1 (signifying less intention) to 5 (signifying stronger intention) scale. Items were coded so that higher scores aligned with stronger intention to take ADHD medicine every school day, weekend day, and during school vacations. We calculated the average score of the 3 items. Range of change score is (-4) to (+4).

    Measured: At baseline and approximately 4 months later

  4. Change in Adolescent-report of Medication Barriers

    Adolescent self-report on Adolescent Medication Barriers Scale using a 1-5-point Likert Scale. 1 indicates strong agreement and 5 indicates strong disagreement, with higher scores indicating less barriers. Items were coded so that higher scores aligned with increased organizational skills, salience of behavior, and routine around taking ADHD medicine. We calculated the average score of the 8 items. Range of change score is (-4) to (+4).

    Measured: At baseline and approximately 4 months later

  5. Change in Parent-report of Medication Barriers

    Parent self-report on Parent Medication Barriers Scale using a 1-5-point Likert Scale. 1 indicates strong agreement and 5 indicates strong disagreement, with higher scores indicating less barriers. Items were coded so that higher scores aligned with increased adolescent organizational skills, salience of behavior, and routine around taking ADHD medicine. We calculated the average score of the 9 items. Range of change score is (-4) to (+4).

    Measured: At baseline and approximately 4 months later

  6. Change in Medication Diversion

    Adolescent self-report of the number of occasions of giving away, trading, or selling ADHD medicine to someone for whom it was not prescribed.

    Measured: At baseline and approximately 4 months later

  7. Change in Decision Making Involvement Scale

    Adolescent and Parent self-report. The scale contains the following subscales: "Child Seek" (e.g. child asks for an opinion or information from the parent), "Child Express" (e.g. child expresses an opinion or information to the parent), "Parent Seek" (e.g. parent asks for an opinion or information from child), "Parent Express" (e.g. parent expresses advice, an opinion, or information to the child), and "Joint/Options" (e.g. negotiation and brainstorming between child and parent). Each subscale produces a score which ranges from 1 to 4 with higher scores indicating more of that behavior.

    Measured: At baseline and approximately 4 months later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2020
  2. Study start1 Jun 2020
  3. Primary completion16 Feb 2021
  4. Study completion24 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04386096
Sponsor's protocol ID
2020-0236
Other IDs
R34MH112648
Status last verified
Feb 2022
First submitted
5 May 2020
Last updated
21 Mar 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Mehealth for ADHD software with medication continuity tools and Mehealth for ADHD software with no medication continuity tools in people with Attention Deficit Hyperactivity Disorder and Adherence, Medication, run by Children's Hospital Medical Center, Cincinnati at 1 site 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 3 inclusion and 5 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 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 21 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Days Covered With Medicine (time frame: An average of 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04386096.

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 21 Mar 2022.

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Clinical Trial NCT04386096 | AzTrials