Web Based Tools to Improve Medication Continuity in Adolescents With ADHD
Randomized Controlled Trial of Web Based Tools to Improve Medication Continuity in Adolescents With ADHD
2 other identifiers
interventional
40
1 country
1
Brief 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.). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2020
CompletedFirst Posted
Study publicly available on registry
May 13, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2021
CompletedResults Posted
Study results publicly available
March 21, 2022
CompletedMarch 21, 2022
February 1, 2022
9 months
May 5, 2020
October 7, 2021
February 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Days Covered With Medicine
This will be calculated based pharmacy dispensing records
An average of 4 months
Secondary Outcomes (7)
Fidelity to Intended Use of Intervention Components
An average of 4 months
Change in Pre-intention Factors of Unified Theory of Behavior Change
At baseline and approximately 4 months later
Change in Intention to Take/Give ADHD Medicine Regularly
At baseline and approximately 4 months later
Change in Adolescent-report of Medication Barriers
At baseline and approximately 4 months later
Change in Parent-report of Medication Barriers
At baseline and approximately 4 months later
- +2 more secondary outcomes
Study Arms (2)
Mehealth for ADHD software with medication continuity tools
EXPERIMENTALMehealth for ADHD software with no medication continuity tools
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. William B. Brinkman
- Organization
- Cincinnati Children's
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2020
First Posted
May 13, 2020
Study Start
June 1, 2020
Primary Completion
February 16, 2021
Study Completion
May 24, 2021
Last Updated
March 21, 2022
Results First Posted
March 21, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share