N/A
N=40
Web Based Tools to Improve Medication Continuity in Adolescents With ADHD
Attention Deficit Hyperactivity Disorder · Adherence, Medication
Bottom Line
View on ClinicalTrials.gov: NCT04386096 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Proportion of Days Covered With Medicine — 0.24; 0 proportion of days covered with medicine — p=0.08
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mehealth for ADHD software with medication continuity tools (Other); Mehealth for ADHD software with no medication continuity tools (Other)
- Age
- Pediatric · 11+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Days Covered With Medicine |
0.24; 0 | 0.08 |
| SECONDARY Fidelity to Intended Use of Intervention Components |
0.07 | — |
| SECONDARY Change in Pre-intention Factors of Unified Theory of Behavior Change |
-0.08; 0.14; -0.24; -0.18 | 0.30 |
| SECONDARY Change in Intention to Take/Give ADHD Medicine Regularly |
-0.51; -0.01; 0.03; -0.42 | 0.29 |
| SECONDARY Change in Adolescent-report of Medication Barriers |
0.08; 0.19 | 0.64 |
| SECONDARY Change in Parent-report of Medication Barriers |
-0.11; -0.07 | 0.81 |
| SECONDARY Change in Medication Diversion |
0; 0 | — |
| SECONDARY Change in Decision Making Involvement Scale |
-0.02; -0.02; 0; 0.24; 0.16; 0.10 | 0.10 |
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
Data sourced from ClinicalTrials.gov (NCT04386096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.