Clinical trial NCT04386096: Web Based Tools to Improve Medication Continuity in Adolescents With ADHD
Official title: Randomized Controlled Trial of Web Based Tools to Improve Medication Continuity in Adolescents With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Adherence, Medication
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-05-13
Enrollment: 40
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* 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

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.
* 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

Primary outcomes:
measure: Proportion of Days Covered With Medicine
timeFrame: An average of 4 months
Secondary outcomes:
measure: Fidelity to Intended Use of Intervention Components
timeFrame: An average of 4 months
measure: Change in Pre-intention Factors of Unified Theory of Behavior Change
timeFrame: At baseline and approximately 4 months later
measure: Change in Intention to Take/Give ADHD Medicine Regularly
timeFrame: At baseline and approximately 4 months later
measure: Change in Adolescent-report of Medication Barriers
timeFrame: At baseline and approximately 4 months later
measure: Change in Parent-report of Medication Barriers
timeFrame: At baseline and approximately 4 months later
measure: Change in Medication Diversion
timeFrame: At baseline and approximately 4 months later
measure: Change in Decision Making Involvement Scale
timeFrame: At baseline and approximately 4 months later
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References: