Web Based Tools to Improve Medication Continuity in Adolescents With ADHD

Not Applicable

Completed

Conditions: Attention Deficit Hyperactivity Disorder
Adherence, Medication

Interventions: Other: Mehealth for ADHD software with no medication continuity tools
Other: Mehealth for ADHD software with medication continuity tools

Registration Number: NCT04386096

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mehealth for ADHD software with no medication continuity tools	Mehealth for ADHD software with no medication continuity tools	-
Mehealth for ADHD software with medication continuity tools	Mehealth for ADHD software with medication continuity tools	-

Primary Outcome Measures

Name	Time	Method
Proportion of Days Covered With Medicine	An average of 4 months	This will be calculated based pharmacy dispensing records

Secondary Outcome Measures

Name	Time	Method
Change in Intention to Take/Give ADHD Medicine Regularly	At baseline and approximately 4 months later	Adolescent and parent self-report on a 1-7-point scale. Items were re-scaled to a 1 (signifying less intention) to 5 (signifying stronger intention) scale. Items were coded so that higher scores aligned with stronger intention to take ADHD medicine every school day, weekend day, and during school vacations. We calculated the average score of the 3 items. Range of change score is (-4) to (+4).
Fidelity to Intended Use of Intervention Components	An average of 4 months	Proportion of intervention components completed relative to the components that were recommended by the portal based on adolescent/parent responses to the assessment battery.
Change in Pre-intention Factors of Unified Theory of Behavior Change	At baseline and approximately 4 months later	Adolescent and parent self-report on a 1-5 or 1-7-point scale, depending on the item. Items were re-scaled to a 1 (signifying less belief) to 5 (signifying stronger belief) scale. Individual items measure specific attitudes, subjective norms, and perceived behavioral control. Items were coded so that higher scores aligned with increased perceived advantages of performing the behavior and behavioral control around taking ADHD medicine. We calculated the average score of the total items (Adolescent report = 19 items; Parent report = 17 items). Range of change score is (-4) to (+4).
Change in Medication Diversion	At baseline and approximately 4 months later	Adolescent self-report of the number of occasions of giving away, trading, or selling ADHD medicine to someone for whom it was not prescribed.
Change in Adolescent-report of Medication Barriers	At baseline and approximately 4 months later	Adolescent self-report on Adolescent Medication Barriers Scale using a 1-5-point Likert Scale. 1 indicates strong agreement and 5 indicates strong disagreement, with higher scores indicating less barriers. Items were coded so that higher scores aligned with increased organizational skills, salience of behavior, and routine around taking ADHD medicine. We calculated the average score of the 8 items. Range of change score is (-4) to (+4).
Change in Parent-report of Medication Barriers	At baseline and approximately 4 months later	Parent self-report on Parent Medication Barriers Scale using a 1-5-point Likert Scale. 1 indicates strong agreement and 5 indicates strong disagreement, with higher scores indicating less barriers. Items were coded so that higher scores aligned with increased adolescent organizational skills, salience of behavior, and routine around taking ADHD medicine. We calculated the average score of the 9 items. Range of change score is (-4) to (+4).
Change in Decision Making Involvement Scale	At baseline and approximately 4 months later	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.