Web Based Tools to Improve Medication Continuity in Adolescents With ADHD
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Children's Hospital Medical Center, Cincinnati

Official Title of the study: Web Based Tools to Improve Medication Continuity in Adolescents With 
ADHD   
NCT number: NCT04173000 
Document name: Study Protocol 
Date of the document: 2/21/2021

 
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ABSTRACT:  
Medication is an efficacious treatment strategy for adolescents with attention-
deficit/hyperactivity disorder (ADHD) (Chan et al. 2016), however use significantly declines 
during adolescence when the consequences of ADHD are most severe (e.g. dropping out of 
school, delinquency, etc.) (Visser et al. 2014). The Unified Theory of Behavior Change (UTBC) 
(Fishbein et al. 2001) 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 (Chacko et al. 2010). 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 (Fishbein 
et al. 2001). Indeed, our preliminary data support the relevance of pre-intention factors and 
implementation factors for medication continuity among adolescents with ADHD. For example, 
we found that a significant majority of adolescents intentionally stop taking medicine because 
they question the medicine’s benefits (i.e., Expectations in model). We also found that 
adolescents who intend to take medicine experience a variety of barriers to taking it regularly, 
including deficient organizational and problem solving skills, inconsistent access to timely refills, 
and lack of daily routines to support continuity (Brinkman et al. 2012). For example, an 
adolescent may repeatedly forget to take their medicine. 
Customizable interventions are available to address these factors. For example, 
pediatrician-supervised trials on and off medicine are recommended in ADHD practice 
guidelines (Pliszka 2007; AAP 2011) to shape expectations related to benefit vs. unwanted 
effects of continued medicine use. However, these rarely occur in practice, leaving adolescents 
to conduct impromptu experiments stopping their medicine and often experiencing a negative 
outcome before realizing that medicine is still needed (Brinkman et al. 2012). Forgetting to take 
medicine can be addressed by programming regular text message reminders, which may help 
make medicine taking more automatic. 
Currently, no interventions target medication continuity for adolescents with ADHD. Our 
research team is well positioned to create an intervention that addresses each of the main 
UTBC factors influencing the intention and implementation of regular medicine taking. With NIH 
funding, we have developed web-based interventions that improve the care and outcomes for 
young children with ADHD (Epstein et al. 2011, 2016) and improve adolescent medication 
continuity for other chronic conditions (Hommel et al. 2013). Such an intervention would 
transform care for adolescents with ADHD and help prevent the alarming fall-off in effect size 
from medication efficacy studies to effectiveness in real world practice caused by poor 
adherence. 
 
PURPOSE OF STUDY:  
 
The primary goal of the proposed project 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. Our central hypothesis is that our tailored 
intervention will support ADHD medication continuity, and ultimately improve outcomes for 
adolescents with ADHD.  
 
BACKGROUND: 
 
Statement of the problem 
ADHD is the most common mental health condition of childhood (Perou et al. 2013) 
affecting 6.4 million children aged 4-17 years in the United States (Visser et al. 2014). Children 

 
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with ADHD experience impairments across a wide range of areas of functioning including 
academics, social relationships, and family functioning (Wehmeier et al. 2010). Fortunately, 
efficacious treatments for ADHD exist. Medications, either alone or in combination with behavior 
therapy, reduce ADHD symptoms and some areas of impairment (MTA 1999; Chan et al. 2016) 
and are recommended as a first-line treatment in clinical practice guidelines (Pliszka 2007; 
Wolraich et al. 2011). Medication use is quite common among children with ADHD, but use 
plummets after age 11 even though adolescents continue to demonstrate symptoms and 
impairment (Visser et al. 2014; Howard et al. 2016). Moreover, those who continue to take 
medicine take their medications inconsistently (i.e., only 50% of days covered with medicine; 
Molina et al. 2009). 
 
Developmental influences 
Changes during adolescence likley contribute to the decline in medication continuity. 
Most teenagers expect to have a voice in decisions that concern them. Collaborative decision 
making between parents and children is a part of normative development that precedes full 
decision-making autonomy (White 1996; Wills et al. 1996). Teen involvement in medical 
decisions may positively impact self-efficacy, satisfaction with medical care, adherence, and, 
ultimately, the transition to adult health care (McCabe 1996; White 1996; Wills et al. 1996; 
Walker et al. 2001; Schmidt et al. 2003; Miller et al. 2014). However, many parents are afraid to 
give their teen with ADHD a say in decisions about medicine because they believe it helps and 
worry that teen goals are short sighted (Brinkman et al. 2009; Brinkman et al. 2012). Many 
adolescents desire to stop taking medicine because they don’t believe it helps or they don’t like 
how it makes them feel. Some teens describe feeling ‘zoned out’ or less social, less creative, 
more irritable, or experience other somatic side effects (e.g. headache, etc.) (Knipp 2006; 
Meaux et al. 2006; Singh et al. 2010; Brinkman et al. 2012). Moreover, many teens are given 
the day-to-day responsibility for medication taking, and are increasingly without the safety net of 
parental supervision (Brinkman et al. 2012; Brinkman et al. 2016). 
 
Impact of poor medication continuity 
As a result of these developmental changes, teens with ADHD evidence low rates of 
medication continuity. Unfortunately, at the same time medication continuity declines, the 
outcomes of ADHD become increasingly consequential. For example, adolescents with ADHD 
are more likely than their peers to have fewer friends, drop out of school, use tobacco and illicit 
drugs, interact with the juvenile justice system, be treated for sexually transmitted infections, 
and have teen age pregnancies (Barkley et al. 2006; Molina et al. 2009; Bussing et al. 2010). 
Given that medicine has large effects on adolescent performance across a variety of domains 
(e.g. academic tasks, social skills, etc.) (Smith et al. 1998; Evans et al. 2001; Chan et al. 2016), 
poor medication continuity represents a significant public health problem. Because the vast 
majority of adolescents receive ADHD care from pediatricians in primary care practices (Albert 
et al. 2017), any intervention that will address this problem must be amenable to this setting. An 
intervention that improves medicine continuity during the transition from family- to self-
management of a teen’s mental health condition would transform care and outcomes by closing 
the gap between medication efficacy and effectiveness in real world practice. 
 
Mechanisms supporting medication continuity 
Maintaining continuity of medication treatment among adolescents with ADHD is often 
difficult and influenced by heterogeneous factors. Indeed, different families have different needs 
at different times. A large body of basic behavioral science research has shown that behavioral 
change and maintenance of that change is best accomplished by addressing underlying 
mechanisms of change (i.e., beliefs about the pros and cons of the behavior, social norms and 

 
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influences, self-efficacy beliefs, and the degree to which any individual actually intends to adopt 
a behavior) (Armitage et al. 2000). Hundreds of studies have demonstrated that interventions 
must address these underlying mechanisms in order to reliably change behavior (Ajzen 1991; 
Jaccard et al. 1999; Fishbein et al. 2001; Rhodes et al. 2013). The UTBC (Fishbein et al. 2001) 
has been proposed as a conceptual model to explain the mechanism underlying ADHD 
medication continuity and guide the development of interventions to improve it (Chacko et al. 
2010). 
The UTBC identifies two processes in behavioral change (see Figure 1). The first process 
focuses on 5 determinants of an individual's willingness, intention, or decision to perform a 
critical behavior (see pre-intention factors on left of Figure 1): 1) Expectations (also called 
expected-values) refers to an individual's perceived advantages and disadvantages of 
performing the behavior. For example, in the case of taking a medication, an adolescent might 
believe with varying degrees of certainty that a medication will help her/him pay attention at 
school, but s/he may also believe that these benefits may be outweighed by other negative 
consequences (e.g., side effects). 2) Social Norms include two components, a) the adolescent’s 
perceptions about what their parents think s/he should do with respect to the behavior (i.e. 
taking medicine), and b) the adolescent’s perceptions about whether his/her peers would also 
approve of and/or perform the behavior. Thus, the more stigma an individual feels about taking 
medicine for ADHD (Pescosolido et al. 2007), the less likely it is that s/he will decide to do so. 3) 
Self-concept and image considerations refer to an individual’s concept of one’s self and whether 
performing the behavior is 
consistent with or contradicts 
one’s self-image, rendering 
the behavior more or less 
attractive. An individual who 
strongly feels that ADHD is a 
biomedical condition that 
requires biomedical treatment 
and s/he is the type of person 
who always takes action to 
improve their health will be 
more likely to take medicine 
for ADHD than one who does 
not (Leslie et al. 2007); 4) 
Affect and emotions refers to 
an individual’s affective and 
emotional reactions to 
behavioral performance: 
individuals who have a strong 
negative emotional reaction to taking medicine because they equate it to a battle for control with 
their parents will be less inclined to regularly take medicine than if one feels like their parent 
involves them in decisions that impact them. Adolescent-parent conflict often flows from 
differences of opinion about the benefit of medicine with parents worrying that adolescents are 
short sighted in their goals and overestimate their competence compared to objective criteria 
(Owens et al. 2007; Brinkman et al. 2009). Conversely, adolescent involvement in decision 
making (e.g. sharing opinions, negotiating with parent) has been related to higher levels of 
treatment regimen adherence in chronic conditions like diabetes (Miller et al. 2014). 5) Self-
efficacy refers to one's beliefs that s/he can perform the behavior, and how easy/difficult it is to 
perform the behavior. Thus, an adolescent who believes that s/he can easily take medicine 
regularly within their daily routines will be more willing to do so (i.e., higher self-efficacy beliefs 

 
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will result in stronger behavioral intentions). Each of these five factors predicts variation in 
behavioral intentions or the decisions whether to perform specific behaviors. 
The second set of four factors affect whether strong behavioral intentions are actually 
carried out (see implementation factors on right side of Figure 1). One variable pertains to the 
requisite knowledge and skills for behavioral performance - one may intend to take ADHD 
medicine regularly, but may subsequently find that s/he does not have the skills needed to take 
medicine every day. For example, some adolescents struggle to swallow pills. Adolescents may 
also lack the organizational and/or problem-solving skills needed to take medicine reliably. 
Another variable is the environmental constraints that may render behavioral performance 
difficult or impossible. For example, adolescents taking ADHD medicine are often dependent on 
their parent(s) to obtain medicine refills. This is often relevant because parents of adolescents 
with ADHD are more likely to have ADHD and/or depression (Chronis et al. 2003) which may 
interfere with their ability to support medication continuity by obtaining timely refills. Third, 
salience of the behavior is important so that the person does not forget to enact it. Even when 
salience is present, forgetting can be a challenge for adolescents with ADHD. Finally, habit and 
automatic processes may influence behavior. For example, by force of habit, a person who has 
developed a routine to help them to remember to obtain and take their medicine regularly will be 
more likely to sustain this behavior when competing intentions are activated and distractions are 
present. 
We acknowledge that adolescent medication continuity is a complex phenomena and that 
no model can capture all of the factors and directionality that lead to medication continuity. 
Indeed, self-efficacy is likely influenced by past experiences managing pre-intention and 
implementation factors. In addition, Figure 1 fails to capture the important roles that parents and 
pediatricians play in supporting medication continuity. Regardless of these limitations, the UTBC 
conceptual model helps explain the mechanism underlying ADHD medication continuity and will 
help guide efforts to develop and test interventions (Chacko et al. 2010). 
 
Pre-intention factors influencing ADHD medication continuity 
We analyzed data from the Multimodal Treatment Study of Children with ADHD (MTA) to 
determine the prevalence of factors that impact adolescents’ intentions to take medicine 
regularly (Brinkman et al. 2016). Twelve years after enrolling in the MTA, patients completed a 
survey reporting their age when they last stopped taking medicine for a month or more and their 
reasons for stopping. 94% of the sample (350/372) reported stopping, with a mean (SD) age of 
14.2 (3.5) years when they last stopped taking medicine for ADHD. The most commonly 
endorsed reasons for stopping medicine related to questioning whether medicine was still 
needed or helped. Reasons related to side effect concerns were endorsed by a significant 
minority of adolescents (33-46%). The most commonly endorsed adolescent reasons for re-
starting medicine related to recognition that medicine was helping at school or work (86%), with 
45% of adolescents coming to realize that medicine was still needed after they had stopped 
taking it. For both stopping and restarting, the proportion endorsing some reasons differed by 
age range, with the overall pattern suggesting that parental involvement in stopping and 
restarting medications decreased with age. 98% of participants continued to have functional 
impairment after stopping medicine.  
 
Implementation factors influencing ADHD medication continuity  
We conducted focus groups with adolescents with ADHD (n=44) and parents (n=52) 
(Brinkman et al. 2009, 2012). Using an inductive approach to code transcripts and identify 
saturated themes, we elucidated a variety of barriers to medication continuity when adolescents 
intended to take medicine regularly. Some adolescents struggle with swallowing pills. Parental 
involvement in medication taking ranged from providing direct supervision, to reminders, to 
providing no supervision. Adolescent responsibility for medication taking increased with age and 

 
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maturity. However, many adolescents acknowledged that forgetting to take their medication was 
still an issue. Indeed, the organizational difficulties experienced by many adolescents with 
ADHD and their parents, who are at higher risk for ADHD themselves (Chronis et al. 2003), are 
a significant barrier to reliably obtaining refills before medicine runs out and taking medicine 
regularly. Moreover, parents often benefit from training on how to set goals, use behavioral 
contracts and rewards/consequences to encourage desired behaviors from their children with 
ADHD (Chronis et al. 2006), though these approaches have not been applied to ADHD 
medication continuity. 
 
Intervention development requires adolescent, parent, and pediatrician participation to 
ensure all needs are met 
We have a strong record of success conducting ADHD research in partnership with primary 
care practices. 10 studies conducted by Drs. Brinkman and Epstein have involved 180 
practices, 616 pediatricians, and 3011 families (Epstein et al. 2007; Epstein et al. 2008; 
Brinkman et al. 2009; Epstein et al. 2010; Brinkman et al. 2011; Epstein et al. 2011; Brinkman et 
al. 2012; Brinkman et al. 2013; Brinkman et al. 2016; Brinkman et al. 2016; Epstein et al. 2016). 
Dr. Brinkman developed and is testing an intervention to improve adherence among 118 
children with ADHD ages 6-10 years cared for by 43 pediatricians. By engaging parents in the 
intervention development process for this study, we learned that the Vanderbilt ADHD Rating 
Scales (used by pediatricians around the country to monitor response to treatment) lack 
salience. Parents voiced a need to be able to track specific behaviors that were important for 
their child. As a result, we developed this capability in the intervention. In focus groups we’ve 
conducted in preparation for the proposed project, adolescents have voiced a similar need. 
Teens would like to be able to track outcomes that matter most to them and depend on their 
report. For example, parents and teachers have a perspective on how teens get along with 
peers, but only the teen can say whether they feel accepted by their peers or experience 
stigma. Teens we met with are eager to have their voice more fully integrated in the process of 
treatment monitoring. 
 
Leveraging a web-based intervention used by parents and pediatricians to efficiently 
conduct the proposed research and facilitate future dissemination 
Dr. Epstein developed a web-based intervention (mehealth for ADHD) which enables 
community-based pediatricians to deliver higher quality ADHD care (Epstein et al. 2011) leading 
to children with significantly fewer ADHD symptoms (Epstein et al. 2016). Subsequently, 
partnerships with the American Academy of Pediatrics and American Board of Pediatrics helped 
spread use of the portal beyond practices that participated in research and now includes 17,412 
patients cared for by 890 pediatricians in 659 practices across the US. These practices use the 
portal as a registry to manage their entire ADHD patient population. With pediatricians 
continuing to enroll patients on the portal as part of routine clinical care, opportunity exists to 
leverage this infrastucture to efficiently develop and test new interventions. The proposed 
research would fill a sizable gap as the current portal is focused exclusively on young school 
age children with ADHD and medication adherence has not been targeted nor improved. 
Specifically, while a randomized controlled trial testing the efficacy of the mehealth for ADHD 
web intervention demonstrated significant effects on children’s treatment outcomes, there was 
not a significant intervention effect on medication adherence (i.e., 59% of days covered by 
children in the mehealth for ADHD portal group vs. 54% in the control group) (Epstein et al. 
2016). Moreover, the portal is devoid of features for adolescents. In focus groups, pediatricians, 
parents, and adolescents have repeatedly requested such features. 
 

 
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STUDY DESIGN: 
We will conduct a 4-month open label trial among adolescents with poor medication 
continuity (see Figure 2) to test whether the intervention engages the mechanism underlying 
medication continuity and improves outcomes. We will recruit 24 pediatricians from ~8 
practices. Currently, 890 pediatricians are using the ADHD portal software nationwide to 
manage the care of 17,412 patients with ADHD. Therefore, there is a large group of eligible 
pediatricians from 
which to recruit. At 
the start of the 
school year, the 
enrolled families 
from each practice 
will receive access to 
the new features on 
their mehealth for 
ADHD account. We 
will recruit 20 
adolescents with 
ADHD with poor 
medication continuity who receive care from one of these 24 pediatricians prior to the start of 
the open label trial. Because the medication experiment feature is not clinically relevant for 
adolescents taking a non-stimulant ADHD medication, and this is a key portion of the 
intervention, those who are taking non-stimulant medications will not be included. At the time of 
enrollment, families will complete consent and assent forms electronically via REDCap, and be 
sent baseline surveys to complete electronically. Before the intervention begins, we will verify 
the number of days covered with medicine based on dispensing data. Because medication use 
varies widely during the summer months and school holidays, the intervention will begin at the 
beginning of the school year to reduce variation in medication continuity based on time of year. 
The trial will end 4 months later. At that time, families will complete end of study measures, and 
pharmacy dispensing records will be obtained. End of study measures will also be completed 
electronically. 
DURATION: 
This IRB protocol covers the second phase of the study during which we will test the 
medication continuity tools developed in collaboration with our stakeholders during the first 
phase of the study. Families will be enrolled in the study for approximately 10 months.  
PROCEDURES: 
Research Participant Recruitment and Obtaining Informed Consent 
We will enroll 18 pediatricians from 14 practices who currently use the mehealth for 
ADHD portal to participate in the trial. The PI, Dr. Brinkman, or a co-investigator will visit with 
each of the practices and pediatricians prior to starting the research activities. At this meeting, 
the intervention components and requirements for pediatrician participation will be described in 
detail. Given that not all practices will be located in the Greater Cincinnati region, these 
meetings may take place over the phone or video conference. Pediatricians will be provided 
with a written description of what participation will entail, and will be asked to document their 

 
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informed consent. Consent will be recorded via RedCap using a study-specific consent form 
modeled after the eConsent demo on the RedCap Resource Center.  
Each pediatrician will identify families who are using the ADHD web portal to care for a 
child (aged 11 to 15) to participate in the trial. Permission for research staff to contact families of 
children meeting eligibility criteria will be sought by members of the pediatrician’s office by 1) 
sending a secure message to parents from their child’s pediatrician on mehealth for ADHD, 
and/or 2) making a phone call to parents from a member of the pediatrician’s staff (e.g., nurse) 
who will act as a research liaison and will use a script to describe the purpose of the study and 
ask parents if they would like to be contacted by a research team member with more information 
about the study.  We will enroll a total of 22 parents and 22 children to participate in the 
intervention.   
If a parent consents to be contacted about the study, the research liaison or CCHMC 
contact reference will provide the research team with patient contact information.  Once the 
research team has received a parent’s consent to be contacted, a research assistant will 
contact parents via phone to provide information and answer questions. Those who express 
interest will complete screening questions needed to assess eligibility criteria and to collect 
Medicaid status, race/ethnicity information, and medication continuity information that will be 
used to ensure a representative sample. If they are eligible, the research assistant will send 
interested parents a consent form and a link to the RedCap consent form via email, review the 
form with the parent, and complete a full informed consent for the study. If the parent does not 
have enough time to review the consent form and complete the consenting process, the 
research assistant will schedule a time to call back and do so. The consent form will include 
permission to access the child’s pharmacy dispensing records in order to confirm eligibility. We 
will also explain the study to children (in language appropriate to them; see below) on these 
phone calls.  We will review the content of consent form with the parent over the phone and the 
parent will record their consent and the child will record their assent on RedCap using a study-
specific consent form modeled after the eConsent demo on the RedCap Resource Center. If 
child is not available at the time of the consent call with parent, their contact information and 
availability will be collected and assent will be collected later during a follow-up call at their 
convenience.  
Inclusion/Exclusion Criteria 
Inclusion Criteria: Participants for the study must meet all of the following criteria:  
a. Consent: The family must provide informed consent by parents or legal guardians 
b. Assent: Children must provide assent to participate in the study  
c. Ages 11-15 
d. Treated for ADHD by pediatrician 
e. First prescribed ADHD medicine more than one year prior to enrollment 
f. Have < 80% of days covered by ADHD medicine in the past year of treatment (based on 
pharmacy dispensing records) 
g. Filled at least one prescription for a stimulant medication in the past year 
Exclusion Criteria: Participants will be excluded from the study if they meet any of the following 
criteria: 
a. Poor understanding level: The participant and parent cannot understand or follow 
instructions given in the study. 
b. Have > 80% of days covered by ADHD medicine in the past year of treatment (based on 
pharmacy dispensing records) 

 
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Intervention components targeting UTBC pre-intention factors 
1. Education (Targeting adolescent and parent expectations, self-concept, affect and 
emotions) 
The intervention delivers education about relevant topics (e.g. the etiology of ADHD; how 
medicine works; the importance of medication titration, how to mitigate side effects and 
minimize dosing regimen complexity, and how adolescents, parents, and doctors can work 
together to titrate medicine, conduct a trial on/off, and discourage diversion). 
2. Pediatrician supervised medication management (Targeting adolescent and parent 
expectations, self-concept, affect and emotions). 
Overview: Pediatricians can play a critical role supporting medication management and 
continuity of treatment, if they have the right information and teens and parents are actively 
engaged in the process. When teen and parent responses to the assessment battery suggest 
that the teen may benefit from additional titration or a trial on/off medication, the teen and parent 
will all be alerted to the recommendation. Adolescents and parents will be guided through a 
series of customized steps using program routines, called wizards. A software wizard is a user 
interface type that presents a sequence of dialog boxes that lead the user through a series of 
steps towards goal completion. Wizards will prompt patients and parents to identify, prioritize, 
and discuss behavioral targets to monitor during titration or trial on/off medicine.  
Medication titration: Dosage adjustment and/or titration of a medicine with a different 
chemical ingredient will be recommended to optimize effectiveness when a teen/parent indicate 
they are interested in trying a new medication or dose. Parents and adolescents who express 
interest in changing medicine or dose will be directed to make an appointment with their 
pediatrician to discuss what the best option is for the family. Videos that describe different 
medication/treatment options will also be available for the parents and adolescents.  
Pediatrician supervised trial on/off optimal dosage: A structured trial on/off medicine will be 
recommended when teen/parent responses to the assessment battery indicate uncertainty 
about whether medicine is still needed because the teen appears to be thriving. The intervention 
delivers training on how to conduct a high quality trial on/off medicine will include the ADHD 
clinical practice guideline recommendations (Pliszka 2007; AAP 2011) that differentiate these 
trials from the common clinical practice of stopping medication during summer or holiday breaks 
from school (e.g., best when there are few transitions or demands [mid school year], avoid at 
beginning of any school year, especially at the start of junior/senior high school, discontinue 
medication for 2-4 weeks, monitor target outcomes). The trial on/off medicine is designed to 
reduce ambivalence about medicine (i.e. document improvement among teens that still benefit) 
which may motivate self-directed changes to support medication continuity. Of note, trials on/off 
non-stimulant medication have limited utility given that atomoxetine and guanfacine take 4-6 
weeks before maximal response is achieved and guanfacine can’t be abruptly stopped due to 
risk of rebound hypertension (Froehlich et al. 2013). Accordingly, pediatricians will advise each 
family regarding the value of conducting an on/off trial in each situation. 
Symptom & side effect monitoring: The mehealth for ADHD intervention enables the tracking 
of ADHD symptoms, medicine side effects, and other outcomes that are important to 
adolescents and parents. In addition, adolescents and parents can construct their own 
measures using a structured approach with examples to ensure that adolescents and parents 
can translate what matters most to them into a measure that can be tracked over time. For 
example, an adolescent could decide to record the presence of a relevant side effect (e.g. 
irritability) on a daily basis. A parent could decide to track the time spent completing homework 
every night. Adolescents and parents can report on their chosen outcomes via an internet 
survey that has been optimized for completion on a mobile screen. The system provides 
reminders to adolescents and parents to rate targeted outcomes by cell phone text messages. 
At the conclusion each titration or trial on/off medicine, the pediatrician, adolescent and parents 

 
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will regroup to discuss what was learned using a report generated by mehealth for ADHD to 
visualize the outcome data that was collected. The intervention also includes a tool that will 
enable parents and/or adolescents to indicate side effect(s) that are problematic for them. The 
tool will guide them through solutions that may mitigate the side effect(s) they are experiencing 
from their ADHD medication.  
3. Stigma (Targeting adolescent and parent social norms) 
Videos normalizing ADHD and medication taking: There are hundreds of videos available on 
YouTube related to ADHD (Kang et al. 2016). Some videos share information about successful 
people with ADHD. Other videos feature celebrities talking about how medication helps them 
manage ADHD. Yet other videos, like TED talks, feature adolescents and adults discussing how 
they have made sense of ADHD and have been successful managing ADHD symptoms. Other 
videos discourage diversion of ADHD medicine. The intervention includes links to videos that 
may help adolescents normalize ADHD and medication taking and discourage diversion. 
 
Intervention components targeting UTBC implementation factors 
4. Organizational interventions: Refill reminders; visual cues, pill taking 
reminders (Targeting adolescent and parent habits and automatic processing, and 
environmental constraints) 
The portal enables parents and/or adolescents to schedule reminders for when to request a 
refill from the pediatrician’s office. Adolescents and parents will also be oriented to strategies 
such as use of visual cues embedded within their daily routine to take medicine (e.g. putting pill 
bottle next to toothbrush, etc.). Adolescents will be able to schedule daily text message 
reminders to take medicine. 
5. Monitoring medication taking (Targeting adolescent, parent, and pediatrician 
salience) 
After receiving their text message reminders to take their medication, adolescents will be 
sent a second text message asking if the dosage was taken with response options of Yes/No. 
This will enable tracking of medication to inform a feedback loop for self-monitoring. Tracking 
results will be displayed graphically to make it easy to assess trends over time relative to 
interventions that have been implemented to improve medication continuity.  
 
Measures to characterize the sample 
1. Demographics: Adolescents, parents, and pediatricians will report on age and 
race/ethnicity. Parents will also report on child insurance status, and their own level of 
education and mental health history. 
2. Technology Use Survey: Adolescents and parents will complete this 30-item phone 
survey from the Pew Research Center’s Internet & American Life Project 
(PewResearchCenter 2011). Items query respondents about use of various types of 
devices (e.g. desktop, tablet, smartphone, etc.), internet connections (e.g. cable modem, 
etc.), and activities (e.g. internet browsing, emailing, texting, downloading apps, etc.). 
3. Vanderbilt ADHD Parent Rating Scale: (VADPRS) (Wolraich et al. 2003) has subscales 
for Inattention and Hyperactivity/Impulsivity. In addition, a symptom count score can be 
derived for DSM-IV items and includes a subscale to assess parents’ perceptions of 
youth school and social functioning. 
4. ADHD Self-Report Scale: The ASRS is a self-report measure of the 18 DSM ADHD 
symptoms (Kessler et al., 2005). Items reflect symptoms of inattention and hyperactivity-
impulsivity, and in this study all items will be rated by teens on a 4-point scale (0 = never; 
3 = very often) consistent with the parent- and teacher-completed VADRS. 

 
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5. Pittsburgh Side Effects Rating Scale: (Pelham et al. 1993) is a 13-item measure that 
allows adolescents and parents to report whether ADHD medicine side effects were 
none, mild, moderate, or severe. 
6. The Columbia Impairment Rating Scale (CIS) Parent and Child Versions (Appendix Q & 
R): The Columbia Impairment Rating Scale (CIS) assesses impairment in behavioral, 
emotional, interpersonal, and task-related functioning. Behavioral functioning includes 
problems with behavior at home and school; emotional impairment involves feeling 
nervous or sad; interpersonal impairment taps problems in relationships with peers, 
siblings, parents, and other adults; and task-related functioning includes problems with 
schoolwork and involvement in leisure activities. Parents reported how much of a 
problem each of these areas of impairment was for their child on 13 items using a 7-
point scale (“No problem” to “Extreme problem”). The CIS has shown high internal 
consistency, excellent test–retest reliability, and good validity when correlated with a 
clinician’s score on the Children’s Global Assessment Scale. 
7. COVID-19 Adolescent Symptom and Psychological Experience Questionnaire (CASPE): 
The COVID-19 Adolescent Symptom and Psychological Experience (Ladouceur, 2020) 
is an adolescent and parent report of the psychological impacts of the pandemic. Items 
assess negative affect and changes in caregiver employment or income due to COVID-
19.  
8. Remote and In-Person Learning during COVID-19: This is a 25-item measure that allows 
parents to report on adolescent engagement in remote, blended, and in-person learning 
during COVID-19. Two items were used from the Home Adjustment to COVID-19 Scale 
(HACS) (Becker et al., 2020) to assess parent confidence and challenges experienced 
when assisting with remote learning. 
 
Outcome measures 
9. Fidelity to intended use of intervention components: For each adolescent and parent, we 
will calculate the proportion of intervention components completed relative to the 
components that were recommended by the portal based on adolescent/parent 
responses to the assessment battery. For intervention components that are used once 
(e.g. trial on/off medicine), we will identify a portal data element to characterize 
intervention component completion. For intervention components that are used more 
than once (e.g. refill reminders, pill taking reminders, etc.), we will define “intended use” 
of the feature as use for at least 2 months since research suggests that, on average, it 
takes 2 months to develop a new habit (Lally et al. 2010). Mehealth for ADHD will 
capture and report on these data elements to characterize fidelity to the intended use of 
intervention components for each adolescent and parent. 
10. Pre-intention factors of UTBC influencing medication continuity (Appendix G & H): Our 
measurement strategy for the adolescent and parent pre-intention factors closely follow 
well-developed procedures (Ajzen et al. 1981). We will use standard scales that have 
been used in hundreds of previous studies using the UTBC and closely related basic 
science theories. For example, an item to assess social norms would be ‘‘Most of the 
people who are important to me think I should take ADHD medicine regularly.’’ 
Responses are on a 7-point scale from strongly agree (+3) to strongly disagree (-3). The 
internal consistency of items within each construct is good (0.7 ≤ alpha ≤ 0.9) (Steele et 
al. 2005; Bentley et al. 2009; Cornelio et al. 2009; Boyko et al. 2011). For this study, we 
will assess pre-intention factors (i.e. expectations, social norms, self-concept/image, 
affect and emotions, and self-efficacy) framed around the behavior of ‘‘taking ADHD 
medicine regularly” following published methods (Francis et al. 2004) and informed by 
our prior qualitative research (Brinkman et al. 2009, 2012). 

 
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11. Behavioral Intentions (Appendix I & J): Teen and parent intention for teen to take ADHD 
medicine regularly will be measured using the standard measure of intention from the 
UTBC (Ajzen and Fishbein, 1981). 
12. Implementation factors of UTBC influencing medication continuity (Appendix K & L): 
These factors will be measured using the Adolescent and Parent Medication Barriers 
Scales (AMBS and PMBS) (Simons et al. 2007; Simons et al. 2010). Adolescents and 
parents respond using a 5-point Likert-like scale from ‘‘strongly disagree’’ to ‘‘strongly 
agree’’ to report perceived barriers to medication taking. Both the adolescent scale (17-
items) and parent scale (16-items) have strong internal consistency for total score and 
the four factor-analytically derived subscales: ‘Disease frustration/adolescent issues’, 
‘Regimen adaptation/cognitive’, ‘Ingestion issues’, and ‘Parent reminder’. For criterion-
related validity, adolescents classified as non-adherent had significantly higher barrier 
scores than those classified as adherent. In prospective validation studies, the 
adolescent-perceived barriers of ‘Disease frustration/adolescent issues’ and parent-
perceived barriers of ‘Regimen adaptation/cognitive issues’ were associated with poorer 
adherence to medication taking (Simons et al. 2010). 
13. Medication Continuity: We will calculate the percentage of days covered with medicine 
based pharmacy dispensing records and verified by parent report of ADHD service use 
using the reliable Services for Children & Adolescents – Parent Interview (Eaton 
Hoagwood et al. 2004). This measures ADHD service use, including office visits and 
medication use. We have successfully obtained pharmacy dispensing records via 
parental permission for 95% (155/164) of subjects across 2 studies (R01 MH074770, 
K23 MH083027) (Brinkman et al. 2013; Brinkman et al. 2016). Pharmacy dispensing 
records provide an objective, unobtrusive, reliable measure that is a well-accepted proxy 
for medication consumption (Steiner et al. 1997) that was significantly correlated with the 
more expensive and invasive Medication Event Monitoring System (MEMSCap™) which 
uses a microprocessor in the medication container cap to record the day and time of 
each vial opening (Farley et al. 2003). 
14. Medication Diversion: Self-report of giving away, trading, or selling ADHD medicine to 
someone for whom it was not prescribed will be collected via a confidential web-based 
survey used in past population-based studies of middle/high school students. (Boyd et 
al. 2007; McCabe et al. 2011a). 
15. Client Satisfaction Questionnaire (CSQ) (Attkisson et al. 1982) is an 8-item 
unidimensional measure of client satisfaction with services. Psychometric properties, 
operating characteristics, and coefficient alpha (.93) are very strong for this measure 
which we will collect from adolescents and parents. 
16. Decision Making Involvement Scale (DMIS) (Miller et al., 2012): is a 30-item scale to 
measure adolescent involvement in a decision. The five subscales are: “Child Seek” 
(child asks for an opinion or information from parent), “Child Express” (child expresses 
an opinion or information to parent), “Parent Seek” (parent expresses advice or opinion 
to child), “Parent Express” (parent expresses advice or opinion to child), and 
“Joint/Options” (negotiation or brainstorming between parent and child). We will collect 
this measure from adolescents and parents. 
 
DATA ANALYSIS 
 
Hypothesis testing:  
 
Each hypothesis examines part of the mechanism underpinning intervention impact on 
medication continuity. 

 
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Hypothesis #1: Adolescents will use greater than 80% of relevant intervention components. 
For each subject, we will calculate the proportion of recommended intervention components 
that were utilized by the subject during the study intervention period. The mean and 95% 
confidence interval (CI) will be computed to give a range estimate of the fidelity measure. To 
evaluate our hypothesis, we will utilize the computed CI to determine if 80% or greater is a 
plausible value, such that if the CI includes a value of 80% or greater we will reject the null 
hypothesis. We will also examine the temporal distribution of use for each of the recommended 
components. 
Hypothesis #2: Use of the intervention components will be related to improvements in the 
targeted UTBC factors. Using a generalized linear model, we will test whether the intervention 
addressed the UTBC factors (i.e., pre-intention factor scales and ABMS/PBMS total and 
subscale scores). Model predictors will include a fixed effect indicator of time point (baseline or 
end of study). A significant effect of time point in the expected direction would indicate UTBC 
factor improvement. 
Hypothesis #3: Medication continuity will be higher at the end of the study compared to the 
baseline period. We will compare the percentage of days covered with medicine using a paired 
t-test.  In exploratory analyses, we will compare this cohort’s percentage of days covered at end 
of study with the percentage of days covered in a control group that is accruing as part of 
another study (IRB# 2020-0236). 
Hypothesis #4: Pre-post changes in UTBC factors will be related to increases in medication 
continuity. We will calculate the change score for each relevant UTBC factor (end of study 
minus baseline) and the change score for medication continuity (end of study minus baseline). 
We will model the association between change in UTBC factor scores (independent variable) 
with change in medication continuity (dependent variable) using generalized linear model. A 
significant effect of change in UTBC factor scores (beta coefficient) in the expected direction 
would indicate changes in UTBC factor scores were associated with medication continuity 
improvement. 
Exploratory analyses: 
 
We will conduct descriptive analyses to characterize rates of diversion at baseline and end of 
study using a McNemar's test to see if rates differ. We will summarize responses to the client 
satisfaction questionnaire descriptively as this may facilitate future dissemination. 
Power and Sample Size:  
We are adequately powered for our exploratory analysis of Hypothesis #3.  The study would 
require a sample size of 18 for each group (i.e. a total sample size of 36), to achieve a power of 
80% and a level of significance of .05 (two sided), to detect a difference in means between the 
intervention and the control groups of 15.7% (i.e. 66.2% vs. 50.5%) on the percentage of days 
covered with medicine assuming a pooled standard deviation of 16.5.  Due to the low intra-class 
correlations observed in previous studies of ADHD medication continuity (ICC = 0; Brinkman et 
al. 2018), the analyses will not account for the nesting of patients within physicians.  We will 
recruit 44 patients (22 in this cohort and 22 in control group from 2020-0236) to ensure that 36 
are retained for this analysis.  A retention rate of 80% (36/44) is conservative in light of the 12-
month retention rate of 92% achieved by Dr. Hommel in his current trial.   
Scientific Rigor: 
Our open label trail is an appropriate design to initially examine whether the intervention 
engages the mechanism underlying medication continuity and therefore warrants further testing 
in a future larger trial. Our preliminary data strongly supports the importance of the problem, 
intervention targets identified, and the feasibility of the approach in our hands. 
 
FACILITIES 

 
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Cincinnati Children’s Hospital is the performance site for this study. 
POTENTIAL BENEFITS 
Although we cannot guarantee a benefit to any individual participating pediatrician, 
adolescent, or parent, the intervention components we propose to integrate into the ADHD web 
portal are theory- and evidence-based strategies with significant support from the research and 
clinical literature. Thus, families have the potential to benefit from state-of-the-art treatment.  
Benefits of the study outweigh any potential risks because our interventions are likely to improve 
care and outcomes for children who receive them. 
 
POTENTIAL RISKS, DISCOMFORTS, INCONVENIENCES, AND PRECAUTIONS 
 
There is minimal risk to the participants in this study other than a potential for invasion of 
privacy. Because confidential information about study participants will be available to study staff, 
procedures to safeguard the confidentiality of this information are required. Given the sensitive 
nature of some of the teen-reported outcome measures (e.g. ADHD medication diversion), we 
will apply for a Certificate of Confidentiality that will allow collection of these measures but will 
protect this information from being divulged to other parties. Additionally, several safeguards will 
be put in place.  All data collected on pediatricians, adolescents, and parents will be assigned a 
unique code that will be linked to identifying information.  The master coding sheet that will link 
the information will be kept in the study coordinator’s office under lock and key. In addition to 
assuring confidentiality of the research data, it is also critical that the confidentiality of the 
patient’s clinical information is protected in mehealth for ADHD.  The HIPAA regulations and 
their application to this product will be clearly defined to ensure compliance within their 
guidelines. Mehealth for ADHD was designed with a procedure for encrypting and storing the 
data in such a manner to only allow pediatricians to view identifiable data.  This design employs 
a key-based encryption structure.  This method does require extra security information to be 
maintained by the parties who are encrypting the data.  For example, parties needing access to 
the data are assigned a "key" that is used to encrypt and decrypt the data in addition to a user 
ID.  Such a key will be maintained by the PI and kept under lock and key.  Implementation of 
additional methodologies to keep the confidential information off the server will be implemented 
including such methodology as ensuring the CCHMC server is secure (i.e., firewalled). 
Data from this study may be submitted to the National Institute of Mental Health (NIMH) 
that allows researchers studying mental health and substance use to collect and share 
deidentified information with each other. If participants consent to have their information shared 
in the data repository, all personal information about research participants such as name, 
address, and phone number will be removed and replaced with a code number. Participants 
may decide at any point that they do not want to share their information to the NIMH data 
repository. If a family consents to have their data shared, the information required to create their 
deidentified code number will be collected during the phone screen by a member of the 
research team.  
 
 
PROTECTION OF VULNERABLE POPULATION 
Because children are being invited to participate in the study, the following procedures 
will be followed to avoid issues related to coercion or undue influence. First, study staff will 
review the consent form with participating children, in language appropriate for their intellectual 
functioning and developmental levels, and ask whether or not the child agrees to participate. 

 
Page 14 of 20 
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Similarly, they will be told that they can opt not to participate or answer any questions which 
they do not want to answer at any time. This will be re-iterated whenever necessary.  
 
RISK/BENEFIT ANALYSIS 
The risks to participants are minimal and unlikely, largely stemming from the possibility 
of loss of confidentiality. We have instituted provisions to minimize this risk and will assure 
participants of the voluntariness of their participation and their right to withdraw participation at 
any time. We will also take appropriate steps to safeguard confidentiality. We would suggest 
that this study falls under the “Minimal Risk” category. 
 
ALTERNATIVES 
Participation in the present study is completely voluntary. The alternative to participation 
in the study is to choose not to participate in the study.  
DATA SAFETY & MONITORING 
Intervention development will design and optimize the prototype intervention. Physicians, 
adolescents, and parents who agree to participate will receive access to mehealth for ADHD 
that has been enhanced with new intervention components. Given that the risks to participants 
are minimal, there does not appear to be the need for an external monitoring board. Rather, the 
Drs. Brinkman (PI) and Epstein (co-I) will assume primary responsibility for the ongoing 
monitoring of the data and safety of the study, and will provide reports of this with annual 
renewal application to the IRB and annual progress report to the sponsor. Both are experts in 
ADHD management, ADHD research, and have experience conducting community-based 
research such as that proposed in this application. Dr. Brinkman has medical expertise related 
to pharmacotherapy of children with ADHD to address study-related medical issues.  All 
research staff will complete education in the protection of human research subjects. 
Drs. Brinkman and Epstein will continuously evaluate the project’s performance, safety, 
and need to stop. Performance will be monitored by examining subject recruitment, comparison 
with targeted recruitment retention, protocol adherence, and quality of data collection 
procedures. This will primarily be accomplished in weekly staff meetings attended by Drs. 
Brinkman and Epstein.  
Drs. Brinkman and Epstein will be available at all times to address any safety issues. 
Any serious adverse events will be determined by Drs. Brinkman and Epstein and reported to 
the IRB within 24 hours, specifying the nature of the event and outcome, if related to the study 
and if anticipated or not. If a serious adverse event as a result of participation in the study 
occurs, recruitment will be immediately discontinued until the serious adverse event has been 
reported to the IRB and the IRB has deemed it appropriate for the study to continue. 
 
COST OF PARTICIPATION 
There will be no costs to the subject for participating in this study. 
PAYMENT FOR PARTICIPATION 
Each parent/adolescent dyad will be compensated $50 for each survey completed 
during the trial for a total of $100 throughout the intervention. We will pay $250 per enrolled 
pediatrician at each practice to reimburse office staff members such as a nurse or office 
manager for identifying eligible subjects and obtaining their consent to be contacted by the 

 
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research team. All payments will be made upon completion of each survey battery. ClinCards 
will be used for all payments.  
 
 
 
 
 
 
 
 
 
 
 

 
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