Tools to Improve Medication Continuity in Adolescents With ADHD

Web Based Tools to Improve Medication Continuity in Adolescents With ADHD

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04173000

Enrollment

Registered

2019-11-21

Start date

2019-07-02

Completion date

2021-05-24

Last updated

2024-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder

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 conduct an open label trial among adolescents with poor medication continuity to test whether the intervention engages the mechanism underlying medication continuity and improves outcomes.

Interventions

OTHERMehealth for ADHD software with medication continuity tools

Medication continuity tools integrated within the mehealth for ADHD software will assess factors influencing medication continuity for each adolescent and recommends 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.

OTHERMehealth for ADHD software without medication continuity tools

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) a communication feature that allows parents, teachers, and pediatricians to communicate with each other; 6) an online pediatrician report card; and 7) 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Intervention model description

Open Label Trial

Eligibility

Sex/Gender

ALL

Age

11 Years to 15 Years

Healthy volunteers

Inclusion criteria

* First prescribed ADHD medicine more than one year prior to enrollment * Registered on myADHDportal.com 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.

Design outcomes

Primary

Measure	Time frame	Description
Proportion of Days Covered With Medicine	An average of 4 months	This will be calculated based pharmacy dispensing records

Secondary

Measure	Time frame	Description
Change in Pre-intention Factors of Unified Theory of Behavior Change Influencing Medication Continuity	At baseline and 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 Intention to Take/Give ADHD Medicine Regularly	At baseline and 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).
Change in Adolescent Report of Medication Barriers	At baseline and 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).
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 Medication Diversion	At baseline and 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 Decision Making Involvement Scale	At baseline and 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.
Change in Parent Report of Medication Barriers	At baseline and 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).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Intervention All parent/adolescent dyads enrolled at each practice will have access to the meHealth for ADHD software without medication continuity tools prior to being given access to the medication continuity tools. Mehealth for ADHD software with medication continuity tools: Medication continuity tools integrated within the mehealth for ADHD software will assess factors influencing medication continuity for each adolescent and recommends 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.	8
Total	8

Arm

Count

Intervention

All parent/adolescent dyads enrolled at each practice will have access to the meHealth for ADHD software without medication continuity tools prior to being given access to the medication continuity tools. Mehealth for ADHD software with medication continuity tools: Medication continuity tools integrated within the mehealth for ADHD software will assess factors influencing medication continuity for each adolescent and recommends 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.

Total

Baseline characteristics

Characteristic	Intervention
Age, Continuous Adolescent	13.60 years STANDARD_DEVIATION 1.7
Age, Continuous Parent	44.62 years STANDARD_DEVIATION 6.81
Ethnicity (NIH/OMB) Adolescent Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Adolescent Not Hispanic or Latino	8 Participants
Ethnicity (NIH/OMB) Adolescent Unknown or Not Reported	0 Participants
Ethnicity (NIH/OMB) Parent Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Parent Not Hispanic or Latino	8 Participants
Ethnicity (NIH/OMB) Parent Unknown or Not Reported	0 Participants
Race (NIH/OMB) Adolescent American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Adolescent Asian	0 Participants
Race (NIH/OMB) Adolescent Black or African American	0 Participants
Race (NIH/OMB) Adolescent More than one race	3 Participants
Race (NIH/OMB) Adolescent Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Adolescent Unknown or Not Reported	0 Participants
Race (NIH/OMB) Adolescent White	5 Participants
Race (NIH/OMB) Parent American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Parent Asian	0 Participants
Race (NIH/OMB) Parent Black or African American	1 Participants
Race (NIH/OMB) Parent More than one race	0 Participants
Race (NIH/OMB) Parent Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Parent Unknown or Not Reported	0 Participants
Race (NIH/OMB) Parent White	7 Participants
Sex: Female, Male Adolescent Female	3 Participants
Sex: Female, Male Adolescent Male	5 Participants
Sex: Female, Male Parent Female	8 Participants
Sex: Female, Male Parent Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 16
other Total, other adverse events	0 / 16
serious Total, serious adverse events	0 / 16

Outcome results

Primary

Proportion of Days Covered With Medicine

This will be calculated based pharmacy dispensing records

Time frame: An average of 4 months

Population: Missing data for 1 adolescent

Arm	Measure	Value (MEAN)
Intervention	Proportion of Days Covered With Medicine	0.69 Proportion of days covered with medicine

Secondary

Change in Adolescent Report of Medication Barriers

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).