- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04173000
Tools to Improve Medication Continuity in Adolescents With ADHD
January 5, 2022 updated by: Children's Hospital Medical Center, Cincinnati
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 conduct an open label trial among adolescents with poor medication continuity to test whether the intervention engages the mechanism underlying medication continuity and improves outcomes.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- First prescribed ADHD medicine more than one year prior to enrollment
- Registered on myADHDportal.com at practice participating in study
- Filled at least one prescription for a stimulant medication in the past year
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
All adolescent/parent dyads enrolled at each practice will have access to the meHealth for ADHD software without medication continuity tools prior to being given access to the medication continuity tools.
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Medication continuity tools integrated within the mehealth for ADHD software will assess factors influencing medication continuity for each adolescent and recommends 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.
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) a communication feature that allows parents, teachers, and pediatricians to communicate with each other; 6) an online pediatrician "report card"; and 7) 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of days covered with medicine
Time Frame: An average of 4 months
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This will be calculated based pharmacy dispensing records
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An average of 4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fidelity to intended use of intervention components
Time Frame: An average of 4 months
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Proportion of intervention components completed relative to the components that were recommended by the portal based on adolescent/parent responses to the assessment battery.
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An average of 4 months
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Change in pre-intention factors of Unified Theory of Behavior Change influencing medication continuity
Time Frame: At baseline and 4 months later
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Adolescent and parent self-report on a 7 point scale.
Individual items measure specific attitudes, subjective norms, and perceived behavioral control.
Higher scores indicate a stronger intention to perform the behavior
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At baseline and 4 months later
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Change in intention to take/give ADHD medicine regularly
Time Frame: At baseline and 4 months later
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Adolescent and parent self-report on 7 point scale.
Higher scores indicate a stronger intention.
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At baseline and 4 months later
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Change in adolescent report of medication barriers
Time Frame: At baseline and 4 months later
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Adolescent self-report on the 17 item Adolescent Medication Barriers Scale using 5 point Likert scale.
Minimum score = 17, Maximum score = 85.
Higher score means more barriers.
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At baseline and 4 months later
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Change in parent report of medication barriers
Time Frame: At baseline and 4 months later
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Parent self-report on the 16 item Parent Medication Barriers Scale using 5 point Likert scale.
Minimum score = 16, Maximum score = 80.
Higher score means more barriers.
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At baseline and 4 months later
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Change in medication diversion
Time Frame: At baseline and 4 months later
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Adolescent self-report of the number of occasions of giving away, trading, or selling ADHD medicine to someone for whom it was not prescribed.
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At baseline and 4 months later
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Change in Decision Making Involvement Scale
Time Frame: At baseline and 4 months later
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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.
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At baseline and 4 months later
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: William Brinkman, MD, Cincinnati Children's
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 2, 2019
Primary Completion (Actual)
February 16, 2021
Study Completion (Actual)
May 24, 2021
Study Registration Dates
First Submitted
November 5, 2019
First Submitted That Met QC Criteria
November 19, 2019
First Posted (Actual)
November 21, 2019
Study Record Updates
Last Update Posted (Actual)
January 20, 2022
Last Update Submitted That Met QC Criteria
January 5, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-0172
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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