Open-Label Trial of Personalized Medication Experiments to Inform Decisions About Future Attention-Deficit/Hyperactivity Disorder (ADHD) Medication Use
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Children's Hospital Medical Center, Cincinnati

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Title: Open-Label Trial of personalized medication experiments to inform decisions about future 
ADHD medication use 
 
Principal Investigator: Bill Brinkman, MD. 
Co-Investigators: Jeffery Epstein, Ph.D., Kevin Hommel, Ph.D. 
Document name: Study Protocol 
 
 
 

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ABSTRACT:  
Medication is an efficacious treatment strategy for adolescents with attention-
deficit/hyperactivity disorder (ADHD);1 however, use significantly declines during adolescence 
when the consequences of ADHD are most severe (e.g. dropping out of school, delinquency, 
etc.).2 The Unified Theory of Behavior Change (UTBC)3 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.4 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.3 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.5 For example, an adolescent may 
repeatedly forget to take their medicine. 
Pediatrician-supervised trials on and off medicine are recommended in ADHD practice 
guidelines6-8 to shape expectations related to benefit vs. unwanted effects of continued medicine 
use. However, these rarely occur in practice,9 leaving adolescents and parents10 to conduct 
impromptu experiments stopping their medicine and often experiencing a negative outcome 
before realizing that medicine is still needed.5 Interventions to support such trials have been 
described,11 but not tested. In previous research (IRB #2020-0236), our research team created an 
intervention that addresses each of the main UTBC factors influencing the intention and 
implementation of regular medicine taking. The current study will test an intervention 
component to support structured medication experiments to inform decisions about future 
medication use. 
 
PURPOSE OF STUDY:  
 
The primary goal of the proposed project is to test personalized medication experiments to 
inform decisions about future medication use. Our central hypothesis is that our intervention will 
lead to within subject increases in adolescent involvement in decision making and decreases in 
uncertainty about future medication use.  We view this open label trial as a pilot study to test the 
feasibility, acceptability, and preliminary efficacy of the medication experiment intervention and 
therefore warrants further testing in a future larger trial. 
 
BACKGROUND: 
 
Statement of the problem 
ADHD is the most common mental health condition of childhood12 affecting 6.4 million 
children aged 4-17 years in the United States.2 Children with ADHD experience impairments 
across a wide range of areas of functioning including academics, social relationships, and family 
functioning.13 Fortunately, efficacious treatments for ADHD exist. Medications, either alone or 
in combination with behavior therapy, reduce ADHD symptoms and some areas of impairment1, 

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14 and are recommended as a first-line treatment in clinical practice guidelines.6, 7, 15 Medication 
use is quite common among children with ADHD, but use plummets after age 11 even though 
adolescents continue to demonstrate symptoms and impairment.2, 16 Moreover, those who 
continue to take medicine take their medications inconsistently (i.e., only 50% of days covered 
with medicine17). 
 
Developmental influences 
Changes during adolescence likley contribute to the decline in medication continuity. 
Most adolescents 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.18, 19 Adolescent involvement in medical decisions may positively 
impact self-efficacy, satisfaction with medical care, adherence, and, ultimately, the transition to 
adult health care.18-23 However, many parents are afraid to give their adolescent with ADHD a 
say in decisions about medicine because they believe it helps and worry that adolescent goals are 
short sighted.5, 24 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 adolescents describe feeling ‘zoned out’ 
or less social, less creative, more irritable, or experience other somatic side effects (e.g. 
headache, etc.).5, 25-27 Moreover, many adolescents are given the day-to-day responsibility for 
medication taking, and are increasingly without the safety net of parental supervision.5, 28 
 
Impact of poor medication continuity 
As a result of these developmental changes, adolescents 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.17, 29, 30 Given that medicine has large effects on adolescent 
performance across a variety of domains (e.g. academic tasks, social skills, etc.),1, 31, 32 poor 
medication continuity represents a significant public health problem. Because the vast majority 
of adolescents receive ADHD care from pediatricians in primary care practices33 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 
adolescent’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 
influences, self-efficacy beliefs, and the degree to which any individual actually intends to adopt 
a behavior).34 Hundreds of studies have demonstrated that interventions must address these 
underlying mechanisms in order to reliably change behavior.3, 35-37 The UTBC3 has been 
proposed as a conceptual model to explain the mechanism underlying ADHD medication 
continuity and guide the development of interventions to improve it.4 

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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 ADHD38 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;39 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.24, 40 
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.23 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 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 

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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 depression41 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 was used in 
our past research to guide efforts to develop interventions. 
 
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.28 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).10, 42 
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 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 

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are at higher risk for ADHD themselves,41 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,43 though these approaches have not been 
applied to ADHD medication continuity. 
 
Intervention development involved adolescent, parent, and pediatrician participation to 
ensure all needs are met 
By engaging parents in the intervention development process, 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 conducted, adolescents voiced a similar need. Adolescents 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 adolescents get along with peers, but only the adolescent can 
say whether they feel accepted by their peers or experience stigma. Adolescents we met with 
were 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 care44 leading to children with 
significantly fewer ADHD symptoms.45 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 60,801 patients cared for by 2,153 pediatricians in 
886 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).45 Moreover, the portal is devoid of features for adolescents. In focus groups, 
pediatricians, parents, and adolescents have repeatedly requested such features. 
 
STUDY DESIGN: 
We will conduct a pilot, single-arm, open-label trial of the medication experiment feature 
among 30 adolescents experiencing uncertainty about continued medicine use (see Figure 2). 
Because the medication experiment feature is not clinically relevant for adolescents taking a non-
stimulant ADHD medication, they will be excluded. At the time of enrollment, families will 
complete baseline measures electronically and schedule an in-person visit. We will verify the 
medication prescribed and the number of days covered with medicine in the past year using 

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dispensing data. During the visit, parents and adolescents will receive training on how to use 
mehealth for ADHD and will choose one of the five medication experiments to complete 
together and track the effects for the desired amount of time. Once dyads have completed the 
medication experiment, they will complete a follow-up study visit to review the results from the 
experiment, discuss feasibility of the software, and complete end of study measures. 
 
 
DURATION: 
This IRB protocol covers the phase of the study during which we will test the medication 
experiment feature developed in collaboration with our stakeholders during the first phase of the 
study. Families can customize the start and end date as well as the amount of time they track 
effects in the medication experiment. Thus, families could be enrolled in the study for up to 4-
Figure 2.
Recuitment
Recruit 30 
parent-
adolescent  
dyads 
Electronic 
consent/assent 
Collect BL 
pharmacy 
dispensing 
records 
*Electronic 
baseline surveys
Create and 
activate 
mehealth 
account 
Visit 1
Meet with study 
physician
Select and set up 
med experiment 
Complete visit 1 
measures: 
Decision Making 
Involvement 
Scale w/ 
Interview, 
Decisional 
Conflict 
Questionnaire, 
Control 
Preferences 
Scale 
Payment 
Intervention
Complete 
selected 
medication 
experiment and 
outcome 
tracking 
Visit 2
De-brief 
medication 
experiment with 
study physician 
Complete visit 2 
measures: 
Decisional 
Conflict Scale, 
Control 
Preferences 
Scale, Decision 
Making 
Invovlement 
Scale, Behavioral 
Intention, 
System Usability 
Scale 
Payment 
Data collection
Collect end of 
study pharmacy 
dispensing 
records 3 
months after 
study visit 2
*Electronic baseline surveys: Demographics, Health-Care Literacy Scale, Vanderbilt Scale/ADHD Self-report, Columbia Impairment Scale, 
Pittsburgh Side-Effect Rating Scale, Pre-Intention Factors, Medication Barriers, Behavioral Intention, Conflict Behavior Questionnaire, and 
(adolescents only) Medication Diversion  

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months.  We expect that all 30 dyads will be recruited and complete the study participation over 
the course of one year.   
PROCEDURES: 
Research Participant Recruitment and Obtaining Informed Consent 
All participants will be recruited from Cincinnati Children’s Hospital. We will advertise 
the study to CCHMC employees via flyers and emails to recruit their eligible adolescents to 
participate. Parents will be able to contact the research team to receive additional information. 
Those who express interest will complete screening questions needed to verify eligibility criteria. 
If they are eligible, the research assistant will review the full electronic consent and assent forms 
with the parent and adolescent via phone call. After we review the content of the consent form 
with the parent, they will record their consent on REDCap using a study-specific consent form 
modeled after the eConsent demo on the REDCap Resource Center. We will also explain the 
study to adolescents (in language appropriate to them; see below), and document their assent in 
REDCap. Once 30 dyads have been consented and enrolled, parents that filled out the interest 
form that were never called by the study team will be sent a blind carbon copy email via 
REDCap that explains that the target participant goal has been met and they will be put on a 
waitlist in the case of participant attrition. They will also be contacted at study completion to 
inform them that the study is no longer recruiting.  
Inclusion/Exclusion Criteria 
Inclusion Criteria: Participants for the study must meet all of the following criteria:  
a. Consent: A parent or legal guardian must provide written informed consent 
b. Assent: Adolescents must provide written 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. Filled at least one prescription for a stimulant medication in the past year 
g. Uncertainty about continued ADHD medication use  
h. Only one child per household can participate in the study. For families who have more 
than one child who is potentially eligible, they may decide which of their children would 
be the best fit for the study. 
Exclusion Criteria: Participants will be excluded from the study if they meet any of the following 
criteria: 
a. Do not have reliable access to the internet at their home or another location. 
b. Will not permit their child to access the internet for study related activities. 
c. Are not able or willing to send or receive text messages. 
 
Intervention 
At baseline we will collect items from standard UTBC scales46 to assess the relevance of 
pre-intention factors and the strength of their intention to take/give medicine, and items from the 
validated Adolescent and Parent Medication Barriers Scales47, 48 to assess the relevance of 

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implementation factors (see Measurement). Once baseline surveys have been completed, we 
will create a meHealth account for the dyad and schedule an in-person study visit at the Center 
for ADHD.  Study visits will not be scheduled if there is missing survey data as parent and 
adolescent engagement providing responses electronically is critical to success of completing the 
medication experiment which involves tracking outcomes.. The study physician will meet with 
the dyad to gather history and better understand their past experience with medication. The study 
physician and research assistant will collect the DMIS introductory interview to identify the most 
recent ADHD medication decision made by family (e.g. stop for summer, resume for school 
year, adjust dosage, change medication, etc.) and then each will complete the decision making 
involvement scale independently.   
During our development process, we identified the following types of experiments that 
are often relevant: 
1. Make no changes. Track current state: continue to take medication as it is currently 
prescribed. 
2. Take medication on non-school days. Track effects: If not currently taking medication on 
non-school days, start taking medication on those days and track the effects. 
3. Stop taking medication on non-school days. Track effects. If currently taking medication 
on non-school days, stop taking medication on those days and track the effects. 
4. Do a formal trial off of medication. Take current medication as currently prescribed for 2 
weeks while tracking, then stop taking medication for 2-4 weeks while continuing to 
track. 
5. Change dose or change medication. Consider a different medication or different dose of 
current medication in consultation with study doctor. Track the effects. 
 
The study physician will discuss these options with the dyad, they will then select the 
medication experiment they would like to complete.  Next, the study physician and research 
assistant will use the meHealth software with the dyad to identify, prioritize, and discuss 
behavioral targets to monitor during the experiment.   
Subsequently, the adolescent and parent will be asked to independently indicate the 
option they expect to prefer after the experiment ends (continue [medication regimen from 
experiment], resume previous medication/dosage, conduct another experiment, return to 
pediatrician to adjust dosage or change medication, other), their certainty about the decision, and 
their preferred role in decision-making (see Measures). 
The study physician will confirm that there are no cardiac risk factors (adolescent history 
of heart disease, family history of sudden death in children, hypertrophic cardiomyopathy, long 
QT syndrome) that might preclude the use of stimulant medications and complete a brief 
physical exam.  The adolescent’s pediatrician likely assessed this prior to starting stimulant 
medication. 
All medication experiments involving a change in medication regimen will involve tracking 
outcomes for 2 weeks on their current regimen and a minimum of 2 weeks after making a 
change.  We will partner with dyads to select the order, typically starting with current regimen.  
In randomized controlled trials of ADHD medication discontinuation, relapse is typically noticed 

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within 2 weeks.49 Hence, we are confident that most participants won’t require repeated cycles of 
treatment and non-treatment as classically described in the N-of-1 trial literature.50 Dyads will be 
able to reach the study team between visits if untoward effects (e.g. relapse of 
symptoms/impairment, side effects, etc.) convince them to end the experiment early and/or 
resume their previous regimen. We will follow best practices for medication experiments 
recommended in ADHD clinical practice guidelines6, 7 These include conducting when there are 
few transitions or demands (i.e. mid school year), and avoiding at beginning of any school year, 
especially at the start of middle school or high school. The trial on/off medicine is designed to 
reduce ambivalence about medicine (i.e. document improvement among adolescents who still 
benefit) which may motivate self-directed changes to support medication continuity.  
Symptom & side effect monitoring: The mehealth for ADHD software 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. It is important to 
note that parents and adolescents may track different outcomes.  This reflects differences in 
what's important to them as well as differences in what they are best positioned to report on.  For 
example, only adolescents can report on how the medicine makes them feel.  Only parents can 
report on what they observe.  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. The research assistant and study physician will also be available by phone to answer 
questions and/or address concerns that arise. 
 
We will monitor on-going medication experiments for each dyad and will be available if 
questions or concerns arise. We will additionally reach out to parents if we identify any 
difficulties using the website. 
 
At the conclusion of the medication experiment, the research assistant will schedule an in-
person study visit at the Center for ADHD. The study physician, adolescent and parents will 
discuss what was learned using a report generated by mehealth for ADHD to visualize the 
outcome data that was collected. Subsequently, the adolescent and parent will be asked to 
independently indicate their preference for what to do next (continue [medication regimen from 
experiment], resume previous medication/dosage, conduct another experiment, return to 
pediatrician to adjust dosage or change medication, other), and their preferred role in decision-
making. The study physician will then facilitate a discussion to resolve any differences between 
adolescent and parent preferences and come to a consensus. The parent will receive a study 
summary document to share with their child’s pediatrician so s/he is aware of what was learned 
and can use this to guide future management decisions.  The adolescent and parent will report 
this decision, their certainty about the decision, their preferred role in decision-making, their 
involvement in the process of making this decision, and their intentions about taking/giving 
medicine.  We will also ask the parent and adolescent about the usability the medication 
experiment software (see Measures). 

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Measurement Strategy: Aggregation of individual trials to estimate a population level 
treatment effect isn’t needed given the strong evidence of stimulant effectiveness among 
adolescents.1  Rather, it is important to ascertain whether the use of medication experiments 
helps adolescents and parents work together to resolve uncertainty about future use of medicine.  
We will describe the type and number of medication experiments conducted as well as the 
personal outcomes selected for tracking. We will examine process outcomes like the decision-
making involvement, comfort with the decision made, and whether the decision was 
implemented. 
 
Measures to characterize the sample on demographic, ADHD, and psychosocial factors 
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. Digital Health Care Literacy Scale: Adolescents and parents will complete this 3-item 
measure with responses on a 5 point strongly disagree to strongly agree scale: 1. I can use 
applications/programs (such as Zoom) on my cell phone, computer, or another electronic 
device on my own (without asking for help from someone else), 2. I can set up a video 
chat using my cell phone, computer, or another electronic device on my own (without 
asking for help from someone else), 3. I can solve or figure out how to solve basic 
technical issues on my own (without asking for help from someone else).  Total score 
with range of 0 to 12 is created by summing the score of individual items, with higher 
scores indicating higher literacy. The scale has excellent reliability (Cronbach α=.90) and 
discriminates between those with and without access to and/or use of technology.51   
3. Vanderbilt ADHD Parent Rating Scale: (VADPRS)52 has subscales for Inattention and 
Hyperactivity/Impulsivity. In addition, a symptom count score can be derived for DSM-
IV items.  
4. ADHD Self-Report Scale: The ASRS is a self-report measure of the 18 DSM ADHD 
symptoms.53 Items reflect symptoms of inattention and hyperactivity-impulsivity, and in 
this study, all items will be rated by adolescents on a 4-point scale (0 = never; 3 = very 
often) consistent with the parent-completed VADPRS. 
5. Pittsburgh Side Effects Rating Scale: The Pittsburgh Side Effects Rating Scale54 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 (See 
Compendium of Measures) 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. For each area of 
impairment, parents report how much of a problem for “your child” and adolescents self-
report how much of a problem for “you”.  There are 13 items with a 7-point scale (“No 
problem” to “Extreme problem”).  The CIS has shown high internal consistency, 

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excellent test–retest reliability, and good validity when correlated with a clinician’s score 
on the Children’s Global Assessment Scale. 
7. Conflict Behavior Questionnaire (CBQ), parent and adolescent versions. Each will 
complete the CBQ, which is a 20-item scale that assesses the relationship between parent 
and adolescent.57 The scale measures conflict and negative communication between 
parents and adolescents through dissatisfaction with the other’s behavior and evaluations 
of the interaction between the two members. This instrument has demonstrated high 
reliability (⍺ = .9 - .95).57 
8. Pre-intention factors of UTBC influencing medication continuity (See Compendium of 
Measures): Our measurement strategy for the adolescent and parent pre-intention factors 
closely follows well-developed procedures.46 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).58-61 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 methods62 and informed by our prior qualitative 
research.10, 42 
9. Implementation factors of UTBC influencing medication continuity (See Compendium of 
Measures):): These factors will be measured using the Adolescent and Parent Medication 
Barriers Scales (AMBS and PMBS).47, 48 Adolescents and parents respond using a 5-point 
Likert-type scale with ratings 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.48 
10. Past Year Medication Continuity: We will calculate the percentage of days covered with 
medicine based pharmacy dispensing records. We have successfully obtained pharmacy 
dispensing records via parental permission for 95% (155/164) of subjects across 2 studies 
(R01 MH074770, K23 MH083027).63, 64 Pharmacy dispensing records provide an 
objective, unobtrusive, reliable measure that is a well-accepted proxy for medication 
consumption65 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.66 
11. Medication Diversion: Adolescent 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.67, 
68 

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Decision-Making Preferences—The Control Preferences Scale69 assesses the degree of 
control an individual wants to assume when decisions are being made about medical 
treatment. The Control Preferences Scale will be modified so that adolescents and parents 
choose preferred control options that range from the adolescent solely making the 
decisions regarding choice of medication experiment, to the adolescent making the 
decisions jointly with the parent, to the parent solely making the decisions. 
Outcome Measures 
 
12. 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 use the 
Decision-Making Involvement interview guide to collect this measure at study visit 1 and 
the stand-alone version to collect it study visit 2.  
13. Certainty about the decision will be measured using the Decisional Conflict Scale (DCS): 
The DCS70 has an initial question to ascertain the option that has been selected.  Options 
presented will be: continue [medication regimen from experiment], resume previous 
medication/dosage, conduct another experiment, return to pediatrician to adjust dosage or 
change medication, other [write in]. The DCS then has 16 questions that are divided into 
five subscales: informed subscale, values clarity subscale, support subscale, uncertainty 
subscale, and an effective decision subscale. The informed subscale measures how 
informed participants feel about the benefits and risks of the decision. The values clarity 
subscale measures a participant's feelings about personal values for benefits and 
risks/side effects. The support subscale measures perceived levels of support during 
decision-making. The uncertainty subscale measures a participant's level of certainty 
about the best choice to make. The effective decision subscale measures the satisfaction 
with the decision made. The total DCS score equally weighs all five subscales. Responses 
to each question are reported on a 5-point Likert scale (0 = strongly agree to 4 = strongly 
disagree). The total DCS scores are calculated by summing item scores and then 
converting the scores to a 0-100 scale, where 0 implies no decisional conflict and 100 
implies extremely high decisional conflict. Scores <25, 25 to 37.5, >37.5 indicate low, 
moderate and high decisional conflict, respectively. Scores 25 and higher reflect 
clinically significant decision conflict.  
14. Behavioral Intention questions that will assess the adolescent and parent intention to 
take/give ADHD medicine regularly will be measured using the standard measure of 
intention from the UTBC.46 Responses are on a 7-point scale from strongly agree (+3) to 
strongly disagree (-3) that assess intention to take medicine for ADHD on weekdays, 
weekends, and school vacations. 
15. System Usability Scale (SUS)71 is a validated 10-item unidimensional scale with 
response options on a 5-point agreement scale which results in a score from 0 to 100, 
with higher scores indicating greater usability.   

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V5. 11/15/2023 
Implementation of decision: 3 months after study visit 2, we will obtain pharmacy dispensing 
records to ascertain whether their joint decision was implemented. If medication was continued, 
we will calculate the percentage of days covered. 
 
DATA ANALYSIS 
We will conduct descriptive analyses to summarize measures that characterize the sample 
in terms of demographic, ADHD, and psychosocial factors, the experiments selected, and 
decisions made, as well as feasibility and usability data. In order to determine overall feasibility 
and usability of our pilot intervention, we will compare retention, participation, and usability 
ratings to a priori criteria based on previous research (i.e., retention ≥ 80%, participation ≥ 80%, 
usability ≥ 70),72 using Chi-square tests. 
 
Power and Sample Size 
We selected a target sample size of 30 to exceed the recommended sample size (n = 20) 
for a pilot trial designed to inform a larger efficacy trial with 80% power to detect a medium 
effect.73 Of note, we aren't powering the study to examine differences in outcomes by experiment 
type.  Paired-samples t-tests will be used to calculate the change in DMIS,DCS, and behavioral 
intentions for all adolescents and parents, and for medication continuity among the subset who 
choose to continue medication after completing their experiment. Cohen’s d will be calculated to 
estimate effect size for each pre- to post-outcome and interpreted as small (.20), medium (.50), 
and large (.80).74  
 
Hypothesis testing  
 
We will test the following hypotheses: 
 
1. From pre to post, within-subject report on DMIS subscales “child express” will increase 
and “parent seek” will increase. 
a. Paired sample t-test 
2. From pre to post, within-subject DCS will decrease. 
a. Paired sample t-test 
3. Higher post-DMIS joint/decision scores will be reported by dyads who differ on initial 
preferences following the experiment compared to those who don’t. 
a. Two sample t-test 
4. Higher post-child express scores will be reported by adolescents who want to make the 
decision alone compared to those who prefer to share decision or have parent make 
decision. 
a. Two-sample t-test 
5. Adolescent-parent conflict as measured at baseline by the CBQ will be positively 
associated with discordance in independent preferences following the medication 
experiment. 
a. Biserial correlation coefficient 
6.  The difference between the adolescent’s intention to take ADHD medication and the 
parent’s intention to give ADHD will decrease from pre to post.  
a. Linear mixed model  
 
Scientific Rigor: 

Page 15 of 20 
V5. 11/15/2023 
An open label trial is an appropriate design to test the feasibility, acceptability, and 
preliminary efficacy of the medication experiment intervention 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 
Cincinnati Children’s Hospital Center for ADHD is the performance site for this study. 
POTENTIAL BENEFITS 
Although we cannot guarantee a benefit to any individual participating adolescent or 
parent, medication experiments are recommended in clinical practice guidelines to help resolve 
uncertainty about continued medication use.  Benefits of the study outweigh any potential risks 
because this intervention will likely improve care. 
 
POTENTIAL RISKS, DISCOMFORTS, INCONVENIENCES, AND PRECAUTIONS 
 
There is minimal risk to the participants in this study.  For dyads who select a medication 
experiment involving not taking medicine for some period of time, it is possible the adolescent 
could experience more ADHD symptoms than usual and/or a decline in functioning.  Indeed, 
adolescents often experience such effects when conducting impromptu experiments without 
physician supervision.75 For dyads who select a medication experiment involving taking 
medication on additional days (e.g., non-school days) or trying a different medication or dosage, 
it is possible the adolescent could experience side effects which s/he may or may not have 
experienced in the past.  Both of these scenarios are the reason why clinical practice guidelines 
recommend that medication experiments are personalized, structured, and physician supervised.  
Dyads will be able to reach the study team between visits with any concerns.  Medication 
experiments will end early if needed. 
 
Because confidential information about study participants will be available to study staff, 
procedures to safeguard the confidentiality of this information are required. Several safeguards 
will be put in place. Electronic data will be protected by username and password requirements. 
All data collected on 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 
are 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 
confidential information off the server will be implemented including such methodology as 
ensuring the CCHMC server is secure (i.e., firewalled).  

Page 16 of 20 
V5. 11/15/2023 
 
 
PROTECTION OF VULNERABLE POPULATION 
Because adolescent 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 assent form with participating adolescents, in language appropriate for their 
intellectual functioning and developmental levels, and ask whether or not the adolescent agrees 
to participate. 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 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 
Adolescents and parents who agree to will receive access to a version of the 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, Dr. Brinkman (PI) will assume primary responsibility for the ongoing monitoring of the 
data and safety of the study, and will provide reports of this with the annual renewal application 
to the IRB and annual progress report to the sponsor. Dr. Brinkman is an expert in ADHD 
management and ADHD research, and has experience conducting 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. 
Dr. Brinkman 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.  
Dr. Brinkman will be available at all times to address any safety issues. Any serious 
adverse events will be determined by Dr. Brinkman 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. 
 

Page 17 of 20 
V5. 11/15/2023 
Figure 3
COST OF PARTICIPATION 
There will be no costs to the subject for participating in this study. The study physician 
will provide prescriptions, as needed, during trial participation, but participants will be 
responsible for obtaining ADHD medication from their pharmacy as they do for typical clinical 
care. 
PAYMENT FOR PARTICIPATION 
Each parent/adolescent dyad will be compensated $50 for survey completion and $100 for 
completing each study visit. They will additionally receive up to $100 for time spent submitting 
data during the medication experiment .  This will be pro-rated based on the % of days with 
complete data reported over days expected.  For example, if the medication experiment lasts for 
6 weeks and both parent and adolescent entered data for 34 out of the 42 days, they would 
receive 80.9% of $100 = $80.90. Therefore the maximum total compensation throughout the 
study is $350. 
 
 
$50
•Parent and 
adolescent 
complete all 
initial online 
survey 
measures 
$100
•Parent and 
adolescent 
attend study 
visit 1
$100 
•Parent and 
adolescent 
complete 100% 
of medication 
experiment 
daily tracking 
measures 
$100
•Parent and 
adolescent 
attend study 
visit 2

Page 18 of 20 
V5. 11/15/2023 
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