CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Mehealth for ADHD software with medication continuity tools +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04386096
NCT04386096N/ACompleted

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

Children's Hospital Medical Center, Cincinnati·interventional·Posted May 13, 2020·Updated Mar 21, 2022

In Brief

A clinical study evaluating Mehealth for ADHD software with medication continuity tools and Mehealth for ADHD software with no medication continuity tools for Attention Deficit Hyperactivity Disorder and Adherence, Medication. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 13, 2020
Enrollment StartJun 1, 2020
Primary CompletionFeb 16, 2021
Study CompletionMay 24, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 6.1 years ago

Interventions

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.