Improving ADHD Behavioral Care Quality in Community-Based Pediatric Settings
Phase: NA
Conditions: ADHD
Sponsor: Children's Hospital Medical Center, Cincinnati

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Title: Randomized Controlled Trial of ADHD Portal-Integrated Behavioral 
Reward Program Intervention 
 
Date Submitted: 3/6/20 
 
Principal Investigator: Jeffery Epstein, Ph.D.  
 
Co-Investigators: Bill Brinkman, MD, Kevin Hommel, Ph.D., Leanne Tamm, Ph.D., Aaron 
Vaughn, Ph.D., James Peugh, Ph.D., Allison Zoromski, Ph.D. 

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ABSTRACT: 
 
Though the most effective treatment for children with Attention Deficit Hyperactivity Disorder 
(ADHD) consists of combined medication and behavioral strategies, the vast majority of children 
with ADHD are treated with medication only. While effective, medication primarily targets ADHD 
symptoms and typically has little to no impact on ADHD-related areas of functional impairment 
such as academic underachievement, impaired social relationships, and disrupted family 
functioning.  One reason for the low rates of behavioral treatment is that primary care 
pediatricians, not mental health professionals, are responsible for treating the vast majority of 
children with ADHD.  We have developed, tested, and are beginning to disseminate web-based 
software (www.mehealth for ADHD.com) that has been shown in randomized clinical trials to 
improve the quality of ADHD medication care delivered by pediatricians. However, the current 
software functionality is limited entirely to medication management. The goal of the proposed 
study is to test the integration of behavioral tools into the evidence-based mehealth for 
ADHD.com software in order to improve access to behavioral treatment strategies, and 
ultimately improve outcomes for children with ADHD. The automated algorithms and decision 
rules we developed for creating and monitoring the behavioral tools will ensure that behavioral 
treatments like daily report cards and token economies are delivered in a manner that is 
consistent with the evidence-base. We will conduct a randomized control trial to assess whether 
those with access to the behavioral tools exhibit the following: 1) higher rates of behavioral 
treatment; 2) better integrity of behavioral treatments when they are used; 3) less functional 
impairment; and 4) higher satisfaction with ADHD treatment than families in the control group.  
By continuing to expand the functionality of the mehealth for ADHD.com software, we are 
increasing families’ access to evidence-based care.  This is especially critical for rural and 
underserved communities who have no or limited access to evidence-based mental health 
services. Moreover, by putting these behavioral tools in the hands of parents, teachers, and 
pediatricians, we are making it more likely that children will receive a high quality of care that 
includes both medication management and behavioral strategies, thereby improving the overall 
treatment outcomes of children with ADHD.   
 
PURPOSE OF STUDY: 
 
The primary goal of the proposed project is to test the integration of behavioral tools into the 
evidence-based mehealth for ADHD.com software in order to improve the access to and the 
integrity of evidence-based behavioral treatment strategies for children with ADHD. 
 
BACKGROUND: 
 
Statement of the problem 
The Center for Disease Control and Prevention’s (CDC’s) national survey on ADHD 
diagnosis and treatment patterns in the United States documented that 11% (6.4 million 
children) of children ages 4 – 17 years had been diagnosed with ADHD at some point in their 
lives, with 8.8% of all children currently diagnosed with ADHD(Susanna N Visser et al., 2014). 
Children with ADHD experience significant impairments across multiple domains of functioning, 
including educational, interpersonal, and family functioning(DuPaul & Stoner, 2014; Efron et al., 
2014; Wehmeier, Schacht, & Barkley, 2010; Wymbs et al., 2008). Fortunately, evidence-based 
treatments for children with ADHD exist(Steven W Evans, Owens, Mautone, DuPaul, & Power, 
2014). Pharmacological treatment is by far the most commonly used treatment for ADHD(S. N. 
Visser et al., 2015; Susanna N Visser et al., 2014). Pharmacological treatments clearly produce 
marked improvement in ADHD symptoms (e.g., improved attention, reduced 
hyperactivity)36,(Pliszka, 2007). However, ADHD symptom improvements do not translate into 

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overall improvements in functional impairment(Currie, Stabile, & Jones, 2014; J.N.  Epstein et 
al., 2010; O'Connor, Garner, Peugh, Simon, & Epstein, 2015). 
The other treatment strategy included in evidence-based treatment guidelines is behavioral 
treatment. Behavioral treatments for ADHD specifically target areas of functional impairment 
such as noncompliance, social functioning, homework completion and organization 
skills(Chronis, Jones, & Raggi, 2006; DuPaul, Eckert, & Vilardo, 2012; Steven W Evans, 
Owens, & Bunford, 2013; Pfiffner, Villodas, Kaiser, Rooney, & McBurnett, 2013; Storer, Evans, 
& Langberg, 2014) and have been shown to be quite effective (i.e., effect sizes on functional 
impairment approach 0.61 [Cohen’s d](Vannest, Davis, Davis, Mason, & Burke, 2010); see 
Fabiano et al.(Gregory A Fabiano et al., 2009) for a meta-analytic review). Given that 
pharmacological treatment primarily improves ADHD symptoms and behavioral treatments 
improve impairments, it is perhaps not surprising that combining these two treatment modalities 
is the most effective treatment option and is universally recommended(Chronis et al., 2006; Daly 
et al., 2007; Education, 2004; Pediatrics, 2011; Psychiatry, 2007). Combined treatment results 
in larger improvements than either modality alone(Conners et al., 2001). Further, it has been 
documented that when children are receiving behavioral treatment, lower doses of medication 
can be used(Gregory A Fabiano et al., 2007; W. E. Pelham et al., 2014; Vitiello et al., 2001). 
Also, parents and teachers view behavioral treatments as highly acceptable (Corkum, Bessey, 
McGonnell, & Dorbeck, 2015; Gage & Wilson, 2000; Liu, Robin, Brenner, & Eastman, 1991; 
Monastra, 2005; Power, Hess, & Bennett, 1995; Wilson & Jennings, 1996). Despite the 
acceptability and efficacy of behavioral treatments, either alone or in combination with 
medication, less than 25% of children with ADHD receive behavioral treatments (J.N. Epstein et 
al., 2014; Gellad et al., 2014). Hence, most children with ADHD are not receiving a critical 
modality of ADHD treatment - behavioral treatment - and thus remain functionally impaired. 
 
Why don’t children with ADHD receive evidence-based behavioral treatments? 
Despite being regarded as a mental health disorder, the majority of children with ADHD are 
evaluated and treated by primary care physicians - generally pediatricians - rather than by 
mental health specialists (Bernal, 2003; Zito et al., 1999). Most pediatricians accept the 
evaluation and treatment of children with ADHD as being a core job responsibility(Stein et al., 
2008). However, pediatricians are inclined to provide medication to children with ADHD but very 
rarely provide, facilitate, or refer children/families for behavioral treatments(J.N. Epstein et al., 
2014; Gellad et al., 2014).  
Fortunately, the reasons that the vast majority of children with ADHD treated by community-
based pediatricians do not receive behavioral treatments are fairly well understood. First, 
pediatricians consistently report that they do not have the time or knowledge to deliver 
behavioral treatments to their patients with ADHD(S. M. Horwitz et al., 2007). Second, most 
communities lack access to effective and affordable behavioral treatment. For example, only 
33% of pediatricians believe that behavioral treatments are readily accessible in their 
communities(Rushton, Fant, & Clark, 2004). This belief is supported by recent data from the 
Health Resources and Services Administration which concluded that more than four-fifths of US 
counties do not have enough mental health professionals to accommodate the need for mental 
health services(Services, 2012).  Further, pediatricians are concerned that if they refer families, 
the behavioral treatments available will be low quality, unaffordable(Fiks, Hughes, Gafen, 
Guevara, & Barg, 2011) and will require long wait times(S. M. Horwitz et al., 2007). Third, 
parents of children with ADHD share these concerns, with 53% of parents reporting system 
barriers (e.g., insurance reimbursement) to receiving ADHD behavioral treatment(Bussing, 
Zima, Gary, & Garvan, 2003; P. L. Owens et al., 2002).  
 
How can the accessibility and integrity of behavioral treatments be addressed? 

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It is clear innovative methods are needed to 1) increase the accessibility of behavioral 
treatments to children with ADHD as well as to 2) improve the integrity of treatment delivery of 
behavioral treatments. Realizing that pediatricians are likely to remain the primary mental health 
providers, many have argued that the best approach to improving mental health outcomes is to 
support primary care physicians in their delivery of mental health services(J. Geller & Muus, 
1997; J. M. Geller, 1999). One promising method for providing this support is through the use of 
technology.  In fact, the US government has promoted the use of technology to address health 
care disparities through both American Recovery and Reinvestment Act funding initiatives and 
mandates within the recent Patient Protection and Affordable Care Act which specifically 
proposes the meaningful use of technology to improve health care for all citizens (Public Law 
111-148; March 23, 2010). 
In response to these governmental mandates, technologically-based and telehealth 
interventions have increased rapidly across the US (Medicine, 2012). While many of these 
online interventions offer some form of professional support, many are self-guided and involve 
merely interaction with a web-based interface. Though early technological intervention research 
demonstrated the advantage of supported types vs. self-guided web-based 
interventions(Richards & Richardson, 2012), several recent studies using more interactive 
interfaces have demonstrated that self-guided technological-interfaces are as effective as 
supported technological interventions (Berger, Hammerli, Gubser, Andersson, & Caspar, 2011; 
Dear et al., 2015; Furmark et al., 2009; Leykin, Muñoz, Contreras, & Latham, 2014). Moreover, 
some of these web-based self-guided interventions produce similar treatment effect sizes to 
clinician-delivered interventions(Carlbring, Westling, Ljungstrand, Ekselius, & Andersson, 2001; 
Proudfoot et al., 2004), and have similar levels of satisfaction as traditional face-to-face 
interventions(Spence, Holmes, March, & Lipp, 2006). To date, effective self-guided web-based 
cognitive-behavioral interventions have been developed and demonstrated to be efficacious for 
several disorders, which similar to ADHD have established evidence-based treatments. These 
include interventions for social phobia(Berger, Caspar, et al., 2011), OCD(Wootton, Dear, 
Johnston, Terides, & Titov, 2014), depression(Berger, Hammerli, et al., 2011) and 
insomnia(Lancee, van den Bout, van Straten, & Spoormaker, 2013).   
The development of behavioral interventions for children with ADHD (e.g., daily report 
cards, token economies) which involve the development and refinement of appropriate 
behavioral goals, defining the monitoring schedule, monitoring performance, and deriving 
effective rewards can all be facilitated through web-based algorithms and interfaces. 
Specifically, we propose to develop web-based software that allows multiple users (e.g., 
parents, teachers) to work collaboratively to develop behavioral goals, monitoring schedules, 
and reward plans. Program routines, called wizards, will guide parents and teachers though a 
series of customized steps to develop and implement behavioral treatments for home and/or 
school. A software wizard or setup assistant is a type of user interface that presents a sequence 
of dialog boxes that lead the user through a series of steps towards goal completion. Wizards 
can prompt parents and teachers to identify and prioritize behavioral targets, aid in the collection 
of baseline data on behavioral targets, and assist with the creation of rewards and reward 
schedules. Moreover, a web-based platform allows for online data capture and graphing of 
children’s performance, providing a simple way for parents to track progress towards behavioral 
performance goals. Also, the wizard will be programmed to ensure that behavioral targets, 
monitoring schedules, and rewards are realistic and evidence-based. Further, the wizard can 
provide suggestions for improving the integrity of the intervention (e.g., frequency of monitoring, 
saliency of reward, level needed for goal attainment), when adequate progress is not being 
made. A major advantage of such online behavioral tools is that they remove the need for a 
pediatrician to implement the behavioral treatments and do not require referral to a mental 
health professional when access is limited due to cost, transportation issues, scheduling 
difficulties, or a shortage of mental health providers. 

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STUDY DESIGN: 
 
The primary goal of the proposed project is to develop and test the integration of behavioral 
tools into the evidence-based myadhdportal.com software in order to improve the access to and 
the integrity of evidence-based behavioral treatment strategies for children with ADHD. To 
accomplish this objective, we propose the following specific aim: 
 
1) Conduct a cluster-randomized controlled trial in community pediatric settings to test 
whether integration of the behavioral tools into the myADHDportal.com software: 
a) increases access to and rates of behavioral treatment; 
b) facilitates better integrity of behavioral interventions when implemented; 
c) improves functional impairment in children with ADHD; and 
d) generates higher satisfaction with ADHD care.  
 
SELECTION AND RECRUITMENT OF PARTICIPANTS 
 
Up to 200 parents will be recruited and randomized.  Parents of children in the K-6 grade 
range was selected because the vast majority of research establishing the efficacy of behavioral 
treatments was conducted with elementary school age children. For medicated patients, we will 
require that they be on a stable medication/dosage for 1 month prior to their participation in the 
study to reduce the possibility that medication or dosing changes occur during the period of 
study enrollment. By reducing medication/dosing changes, we can more accurately attribute 
child outcomes to implementation of behavioral strategies. Even with this specification, 
medication/dosage changes will occur. We will assess for medication/dosage changes 
throughout the study and statistically control for these in analyses.  
To recruit participants, we will ask local pediatricians that are currently using the mehealth 
for ADHD portal to send out correspondence to their patients’ parents that are registered on the 
mehealth for ADHD portal inviting them to participate in the study. The pediatricians we have 
identified to date that we will use for this research protocol have more than 1,500 patients 
registered on the mehealth for ADHD portal. The correspondence from the physician’s office to 
their patient’s parents will either occur via phone, mail, email, or using the messaging system 
within the mehealth for ADHD portal.  It will be up to the physician’s office which method of 
correspondence to utilize for contacting their patients’ parents.  If contacted by phone, office 
staff will use a phone script. If parent expresses willingness to be contacted, office staff will 
gather the parent’s contact information over the phone and provide the parent’s contact 
information to the research team.  Email, mail, and messaging system correspondence will 
contain a link to a REDCap form that will allow parents to enter their contact information if they 
wish to be contacted by research staff. As needed, we may also recruit additional pediatrician’s 
which use the mehealth for ADHD portal. 
Participants will also be recruited from a patients previously seen at Cincinnati Children’s 
Hospital Medical Center (CCHMC) Division of Behavioral Medicine and Clinical Psychology 
(BMCP) who are in the right age range and have a diagnosis of ADHD. Potentially eligible 
families will be sent a letter indicating that they were identified because of having been seen 
previously at BMCP along with a “do not contact” postcard. The letter will include a written link 
to a REDCap form that will allow parents to send their contact information to study staff. Contact 
information for study staff will also be provided to allow parents to call or email study staff 
directly. Families not returning the “opt out” postcards within 2 weeks of mailing may be called 
by research staff to share more about the study and invite participation.    
A research assistant will contact the parent to provide them with additional information 
about the study. If the parent is interested in participating, the parent will be asked several 
questions to ensure that the parent meets the study’s inclusion criteria.  Specifically, the parent 

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will be asked whether their child: 1) is in grades K-6; 2) has been diagnosed with ADHD; 3) if 
currently being prescribed ADHD medication, ensuring they have been on a stable 
medication/dosage for 1 month; and 4) is still experiencing ADHD-related impairment at school 
as evidenced by a score of 3 or higher on any item related to academics or school on the parent 
or teacher Impairment Rating Scale. Parents must also have access to a computer or 
smartphone to participate. In order to characterize the sample and to ensure that the sample is 
representative, parents will also be asked their Medicaid status and race/ethnicity information. 
Research staff will also explain to the parent that if their child is randomized to receive the 
intervention, they will be encouraged to use the behavioral tools during the next year. If the 
parent states that they are not interested or unwilling to use the tools, they will not be eligible to 
participate.   
 
PROCESS OF OBTAINING CONSENT  
 
In order to obtain physician consent, the PI or study staff will review and have physicians 
sign the consent form at the initial meeting. 
If the parent was recruited from a participating pediatrician’s practice and meets criteria, the 
research assistant will review the consent and discuss the study in detail with the parent. If the 
participant continues to be interested in participating, a study staff member will request specific 
information (i.e., parent’s first and last name, date of birth, zip code, and e-mail address) in 
order to enroll them in the e-consent software. This information on all eligible participants will be 
entered/uploaded into the web-based consent management application hosted at CCHMC. An 
email notification will be sent to the email address provided by the parent. All email notifications 
sent for this study will not contain any PHI. The email will contain a link which will allow the 
parent to view the e-consent web site.  This link will be unique to the participant and will have a 
pre-defined expiration date.  Parents will log into the consent application and the password will 
be their current ZIP code. They will then be presented with the consent form.  After reading 
through the form (i.e., scrolling to the bottom), they will have an opportunity to check a box 
stating that they agree to provide their consent.  There will also be fields for full name. Once 
they have typed their full name, they will be able to submit. Included in the email and the e-
consent document will be contact information for parents to message a study staff member if 
they have questions. Parents can also provide a phone number via the e-consent application if 
they wish for study staff to call them about their questions.  If parents have questions, they will 
be asked to come back to the application after those questions have been resolved.  After a 
participant has submitted their consent, a link will appear giving them the option to print a copy 
or save the consent form.  
If the parent was recruited because their child was a patient at BMCP and meets criteria, 
the research assistant will review the consent and discuss the study in detail with the parent. If 
the participant continues to be interested in participating, a study staff member will request 
specific information (i.e., parent’s first and last name and e-mail address) in order to send the 
parent a link to a REDCap consent form. After reading through the form (i.e., scrolling to the 
bottom and selecting “Yes” to consenting), they will have an opportunity to submit their 
consenting signature. All email notifications sent for this study will not contain any PHI. The 
email will contain a link which will allow the parent to view the REDCap form and study consent 
form. This link will be unique to the participant.  Parents will view the REDCap application and 
will be presented with the consent form.   
As children are not the targeted research participants and all data will be obtained from 
parents only, we do not intend to obtain children’s assent for this study.  
In addition to the parent’s participation, we will also recruit one of the child’s teachers to 
participate in the study. If participant is consented with less than a month remaining in the 
current school year, the child’s teacher for the subsequent school year will be contacted about 

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participating at the beginning of the next school year. To contact teachers, research staff will 
send the parent a letter that the parent can deliver to the child’s teacher telling them about the 
research and asking them for permission to be contacted by research staff. In this letter, there 
will be a REDCap survey link allowing them to provide their contact information (i.e. first and last 
name, email address, phone number) as well as the first and last name of the student that is 
requesting their participation in the study. Two methods will be used to inform teachers about 
the study. Either a member of the research staff will call the teacher and describe the research 
study to the teacher using a phone script for teachers.  Or a member of the research staff will 
email teachers an email script describing the study and a link to their REDCap survey. The 
phone script and email text explicitly ask teachers to complete forms about the child’s behavior 
at school. If a teacher is contacted prior to randomization and is not willing to use the behavioral 
features or complete forms about the child’s behavior, the family will not be eligible to participate 
in the study. 
 
 
STUDY PROCEDURES 
 
PI or study staff will meet with each pediatrician to go over study procedures and obtain 
informed consent. After this meeting, study staff will perform a brief orientation with pediatricians 
of the software and their role in the study. 
Once informed consent is collected from the parent, the parent will be emailed a link to 
complete baseline measures using REDCap survey. The parent will also be called to complete 
a phone interview regarding service use assessment.  The teacher will be emailed a link to a 
REDCap survey to complete the teacher-completed forms.  Once parent and teacher (for 
students whose parents consent prior to 1 month before the end of the school year) have 
completed the forms, the parent will be randomly assigned to either receive 1) immediate 
access to the integrated behavioral tools on the mehealth for ADHD portal, or 2) wait-list control 
group whereby they will receive access to the integrated behavioral tools on the mehealth for 
ADHD portal after 1 year.  In order to control for the types of patient populations and settings 
across the two groups, randomization will occur within each pediatrician.  That is, an equal 
number of families of each pediatrician will be assigned to the intervention and control groups.  
Randomizing in this manner should ensure equal representation of Medicaid status and 
race/ethnicity across the two groups. During the brief orientation with pediatricians, they will be 
made aware of the integrated behavioral tools intervention that their families may have access. 
Both intervention and control families will continue to have access to the mehealth for 
ADHD software. However, the intervention group will have access to integrated behavioral tools 
immediately (see description below) while the control group will not receive access to the 
behavioral tools for 1-year.  
Families enrolled in this research study will have access to the mehealth for ADHD.com 
software with the randomized features for at least a 1-year period.  At 6-, and 12-months post-
baseline, research assistants will contact parents and teachers and administer measures 
related to behavioral tool implementation, patient outcomes (i.e., functional impairment), and 
consumer satisfaction.  If the 6- or 12-month post-baseline time point will fall during the summer 
months, we will collect an additional set of questionnaires from the parent and teacher at the 
end of the child’s academic year in order to capture how well the child is doing in school.  These 
surveys will be administered preferably using online surveys (REDCap) but research assistants 
will administer these surveys by phone if parents are not responsive to online administration or 
indicate that they prefer phone administration.   
At the end of the study, physicians will be asked to fill out a Pediatrician Consumer 
Satisfaction Survey that will ask how satisfied they were with the software.  
 

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Integrated Behavioral Tools 
Evidence-based behavioral strategies employ operant procedures (i.e., rewarding desired 
behaviors) in order to increase the chances that the desired behavior will be emitted again in the 
future. For example, one of the most widely used behavioral treatments is a Daily Report Card 
(DRC). The DRC provides children with ADHD with specific, immediate, and frequent feedback 
to facilitate behavior change. A DRC typically consists of up to three specifically defined target 
behaviors that a teacher monitors and tracks during the school day. The DRC is sent home to 
parents each day after school where rewards/consequences are applied based upon the child’s 
performance. The efficacy of DRCs has been evaluated for children with ADHD as part of large 
multi-modal interventions (e.g., MTA Study(MTA Cooperative Group, 1999)), as a stand-alone 
intervention(J. S. Owens et al., 2012), and as implemented through IEPs(Gregory A Fabiano et 
al., 2010). DRCs have been shown to improve parent-teacher communication and to improve 
the behavioral and academic functioning of children with ADHD(Gregory A Fabiano et al., 2010; 
J. S. Owens et al., 2012). Other evidence-based behavioral interventions such as a token 
economies are effective(Reitman, Hupp, O'Callaghan, Gulley, & Northup) (also see(Antshel & 
Barkley, 2008; W. E. Pelham, Jr. & Fabiano, 2008) for reviews) and utilize the same principles 
of behavior change, but instead focus on behavior in the home setting. 
 
Description of integrated behavioral tools 
1. Orientation to behavioral tools 
Within the existing mehealth for ADHD.com software, each registered patient has a record 
page which includes a section for treatment. As described above, there was previously only 
functionality to initiate or track medication treatment. We have added a link that pediatricians 
can click to recommend the use of behavioral tools to a family. Once clicked, the parent will 
receive an email message via the mehealth for ADHD.com software’s communication system 
that 1) indicates that their pediatrician is recommending the use of this tool for their child; 2) 
describes the behavioral tool feature; and 3) provides them with a link to initiate the behavioral 
tool online within the parent-accessible module of the mehealth for ADHD.com software. A 
similar link exists on the parent page that allows a parent to initiate the behavioral tool for their 
child. Also, we included a link on the teacher page that allows a teacher to recommend the 
behavioral tool to parents. Whether initiated by the pediatrician, parent, or teacher, the 
behavioral tool wizard begins with a description of the behavioral tool and a delineation of the 
required steps to create and implement the tool. A critical feature to orienting parents to the 
behavioral tools is motivating and engaging them to initiate the behavioral tool with their child. 
We have relied heavily on our stakeholders to provide feedback regarding best methods for 
engaging parents in this process. Indeed, in developing the current mehealth for ADHD.com 
software, we relied heavily on pediatrician stakeholders to guide us regarding methods for 
engaging pediatricians in the use of the mehealth for ADHD.com software. As a result, the 
mehealth for ADHD.com homepage now employs video testimonials from pediatricians as well 
as a brief informational video regarding functionality of the mehealth for ADHD.com software to 
motivate pediatricians to sign up to use the portal. We explored similar methods with our 
stakeholders for motivating parents to utilize the behavioral tools. 
2. Identify the child’s behaviors that require targeting 
The next step is for parents and/or teachers to identify the child’s behaviors they would like 
to target with behavioral treatment. Parents or teachers can select from a list of potential target 
behaviors or they can customize their own behaviors to target. If the parent has selected a 
school-based goal, the automated wizard sends a message to the teacher 1) describing the 
behavioral tool that the parent is in the process of creating; 2) delineating the steps that the 
teacher will need to take to create and implement this tool at school; and 3) providing a link to 
allow the teacher to engage with the automated wizard to engage with the tool creation process. 
Similar to engaging parents to initiate the behavioral tool, we have also explored methods for 

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engaging teachers in the creation and use of the behavioral tool with their student. After 
teachers log on to the mehealth for ADHD.com software, teachers see the full list of school-
based behaviors identified as targets and are prompted to prioritize this list of behaviors.   
3. Collect baseline data about target behaviors 
Once target behaviors have been identified, a behavioral grid (see Figure 3) is generated 
that allows behaviors to be tracked daily over the course of 
a single week to establish a baseline frequency for that 
behavior. The behavioral grid can be maintained online and 
is able to be accessed via computer or using a mobile 
interface on a smartphone or it may be printed out and 
completed on paper and then entered daily into the online 
grid by either the parent or teacher at their convenience.  
4. Finalize target behavior goals  
After the baseline week’s behavioral data is 
collected/entered, computerized algorithms within the 
wizard will derive SMART (Specific, Measurable, Attainable, 
Relevant, and Time-limited) behavioral goals. Behavioral 
goals must be achievable during the initial weeks of the 
behavioral intervention in order for children to experience success and become motivated by 
their receipt of the rewards. Thus initial SMART behavioral goals are set to require a defined, 
realistic, percent improvement from baseline for each behavior.  
5. Create plan for monitoring child’s target behaviors 
After SMART behavioral goals are generated by the wizard, a behavioral grid is generated 
along with a suggested monitoring schedule. Monitoring intervals are the time points each day 
when parents and/or teachers provide the student with feedback regarding their performance on 
the behavioral goals for the past interval. After parents/ teachers have suggested modifications 
and agreed upon a final monitoring schedule, the behavioral grid will be finalized and behavioral 
monitoring will begin. As during baseline data collection, parents and teachers can record the 
child’s performance directly into the online system or they can print out the behavioral grid, 
record on the printed version, and enter the data online at their convenience. Parents and 
teachers are also able to choose if they would like to receive reminders by text or email to 
complete ratings. 
6. Reward child for performance 
Right before monitoring begins, the automated wizard prompts the family to develop a daily 
reward system. An effective daily reward system includes multiple reward levels. We used 
green, yellow, and red levels based on children meeting defined thresholds for each level. 
Again, we collaborated with our stakeholders to develop these thresholds. Parents and children 
derive a list of daily rewards that will occur at each level if that behavioral target is met. The 
online wizard helps the parent and child come up with a suggested daily reward hierarchy (e.g., 
green level = 1 hour of video games; yellow level = ½ hour of video games; red level = no video 
games) and a weekly reward. Once the behavioral monitoring begins, parents will receive daily 
and weekly email or text communications from the wizard alerting them to the daily rewards 
earned by their child.  
7. Modify behavioral goals over time 
Behavioral performance over time is charted using annotated behavioral run charts (see 
Figure 4) which will be continuously monitored by computerized algorithms. Parents are able to 
view these charts from within the software. In addition, teachers are able to view progress on 
school-based behaviors when they log on. If algorithms detect that a behavioral goal is being 
consistently met (e.g., child earns green level for 5 consecutive days), the parent and teacher 
are notified via messaging that performance goals have been met and need to be modified. 
Algorithms will then suggest a modification for the next performance goal. For example, if the 
 Figure 3: Sample behavioral grid for 
recording performance on target behaviors 

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initial goal of raising your hand before speaking with less than 6 violations per day is being met 
consistently, the suggested next performance goal might be “interrupting the teacher less than 3 
times per day.” Once a child consistently meets a performance goal which eliminates that 
behavior (e.g., 0 class disruptions), the automated wizard will suggest another behavior to target 
based on previously identified behaviors. In addition, each time a new behavioral goal is 
selected, families are prompted to update the monitoring schedule and schedule of rewards if 
necessary. 
Interface with pediatrician 
While the behavioral tools are designed in such a way to eliminate the need for 
pediatricians to manage the provision of these behavioral tools, it is important for pediatricians 
to be involved in monitoring the child’s progress. Pediatricians have the ability to review 
graphing of behavioral goals which have been modified to not only show medication and dosage 
changes, but also annotate the initiation of behavioral treatment as well as modifications to the 
behavioral treatment. This allows pediatricians to track any improvements or deterioration in 
behavior and functional impairment as a result of behavioral treatment.  
 
 
Measures: The table below provides information about the measures and timeline for 
administration. Parent measures will take about 30 minutes to complete and teacher measures 
will take about 10 minutes to complete. 
 
*This time-point will only be collected if the 6- or 12-month timepoint falls during the summer 
months. 
a. Services Use Assessment: This phone interview will be administered to parents at all 
assessment points to capture children’s ADHD service use across mental health, 
primary care, school, and community settings. Data from this interview will be used to 
determine if behavioral treatments were implemented and whether mental health 
professionals were involved in setting up and monitoring its use (access to behavioral 
treatments). For each behavioral intervention, the Service Use Assessment will include 
detailed questions about the estimated percent of time that behavioral monitoring was 
Measure 
Completed by Baseline 
End of 
school 
year* 
6-month 
post 
12-month 
post 
Services Use 
Assessment 
Parent 
X 
X 
X 
X 
Impairment 
Rating Scale 
(IRS) 
Parent, 
Teacher 
X 
X 
X 
X 
Consumer 
Satisfaction 
Questionnaire 
Parent, 
Teacher, 
Pediatrician  
 
X 
X 
X 
Demographics 
Questionnaire  
Parent 
X 
 
 
 
Parental 
Motivation 
Inventory 
Parent 
X 
 
 
 
Adult ADHD 
Self-Report  
Parent 
X 
 
 
 
ADHD 
Knowledge 
and Opinion 
Parent 
X 
 
 
 

11 
 
Version 03-06-20 
 
completed, the estimated percent of time that rewards were provided, and examples of 
behavioral targets and rewards. Furthermore, for post-baseline assessments for 
children treated by intervention providers, we will be able to query the web portal for 
much of this information.  Two clinical child psychologists, blinded to study condition but 
familiar with behavioral interventions, will code the behavioral targets on a 1-10 scale as 
being appropriately operationalized or not. Also, reward schedules will be coded on a 
similar 1-10 scale. Reliability of codings will be established and monitored. 
b. Impairment Rating Scale (IRS): The IRS consists of 4 items included on both the 
parent- and teacher-report versions, including peer relations, academic progress, self-
esteem items as well as an overall severity/impairment rating. The parent-report version 
also has items assessing sibling relations, parent–child relations, and impact of the 
child’s behavior on the family, whereas the teacher-report version has items assessing 
teacher-child relations and classroom functioning. Items are rated on a scale ranging 
from 0 (no impairment) to 6 (extreme impairment). The IRS demonstrates excellent 
temporal stability and evidence of convergent and discriminant validity(G.A. Fabiano et 
al., 2006) and is sensitive to treatment effects(S. W. Evans, Langberg, Raggi, Allen, & 
Buvinger, 2005; S.W.  Evans, Serpell, Schultz, & Pastor, 2007). Parents and teachers 
will complete their respective versions of this scale at baseline, follow-up (if the 6- or 12-
month timepoint falls during the summer months), 6- and 12-months post-baseline.  
c. Family/Teacher consumer satisfaction questionnaire: Parents’ and teachers’ satisfaction 
will be assessed with a consumer satisfaction questionnaire that asks specifically about 
how satisfied they were with the myADHDportal.com software. Collected at baseline, 
follow-up (if the 6- or 12-month timepoint falls during the summer months) and 6- and 
12-months post-baseline. At the conclusion of the study, we will invite some parents 
and teachers to participate in a post-study interview.  Parents and teachers will be 
selected based on whether they provide negative feedback on the consumer 
satisfaction questionnaires.  Those families will be contacted to query them further 
about their experience in order to explore ways to improve the software. Procedurally, 
we will email families asking them if they wish to participate in a follow-up phone call 
and ask them to contact us if interested.  
d. Pediatrician consumer satisfaction questionnaire: Pediatricians’ satisfaction will be 
assessed at the end of their participation in the research study with a consumer 
satisfaction questionnaire that asks specifically about how satisfied they were with the 
myADHDportal.com software.  
e. Demographics questionnaire: We will ask parents to report on race/ethnicity, 
socioeconomic status, and level of education. Collected at baseline only. 
f. Parental Motivation Inventory: 25 item scale to assess parent motivation for treatment.  
The measure has good psychometric properties and has been shown to predict 
treatment adherence(Nock & Photos, 2006).  Collected at baseline only. 
g. Adult ADHD Self-Report Scale: 18-item parent-completed measure to screen parents 
for ADHD. Collected at baseline assessment only. 
h. ADHD Knowledge and Opinions Scale: Used to query parents about their acceptability, 
feasibility, and perceived competence of treatment.  Items are summed in each of these 
domains to provide estimates of these constructs(Bennett, Power, Rostain, & Carr, 
1996).  Collected at baseline only. 
 
 
DURATION: 
 
The entire project will take place over a 2-year time period.  
 

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DATA ANALYSIS: 
 
Data management and methods to prevent and handling of missing data 
Specific data structure routines will be utilized including double-entry bookkeeping and 
regular backup. Data discrepancies will be resolved by checking source documents to correct 
any inaccuracies. In order to ensure that missing data are not affecting the pattern of our results 
or affecting the representativeness of our sample, we will conduct a missing data attrition 
analysis to identify potentials for non-random or systematic attrition (MNAR) related to key 
independent and dependent variables. In cases of MNAR missing data, selection and pattern 
mixture models will be used to appropriately address non-random attrition. 
 
Hypothesis testing 
The primary set of analyses will be conducted following “intent to treat” principles (i.e., 
including all randomized subjects). Specifically, Hierarchical Linear Mixed Models (HLMM) will 
be used to evaluate the effectiveness of the interventions. We will use HLMM models to model 
individual variability in developmental trajectories in response to treatment and to model 
potential non-linear effectiveness(Kreft & DeLeuw, 1998). Further, HLMM models do not make 
assumptions requiring equal sample sizes, and allow for missing observations, subjects being 
measured at differing time points, as well as estimation of random subgroup specific effects. 
Thus, HLMM provides an efficient and powerful means of assessing time-invariant 
characteristics (e.g., gender or age) on mean changes in the dependent variable(Diggle, Liang, 
& Zeger, 1994). 
Before conducting any analyses, comparability of patients across the intervention and 
control groups at baseline on a variety of variables will be assessed (e.g. gender, age, % of 
public insurance patients). These variables should be held equal via our randomization 
procedures. If they are not equal, these pediatrician variables will be used as covariates in the 
HLMM models. 
 
Hypothesis #1: Children with ADHD who have access to the behavioral treatment tools on 
mehealth for ADHD.com will receive behavioral treatments at significantly higher rates as 
compared to children who do not have access to mehealth for ADHD.com-integrated behavioral 
tools. 
Hypothesis #2: Children with ADHD who have access to the behavioral treatment tools on 
mehealth for ADHD.com will receive behavioral treatments of higher quality, as indicated by 
higher codings of the appropriateness of behavioral targets and rewards, compared to children 
who do not have access to mehealth for ADHD.com-integrated behavioral tools. 
Analyses: A one-level (pediatricians) HLMM analysis will be conducted comparing intervention 
and control patients on rates and quality of behavioral treatment over time. Using data regarding 
use of behavioral treatment from baseline, 6-, and 12-month SCA-PI interviews, we will include 
Group (Intervention vs. Control) and Time (baseline, 6-, and 12-months) variables in the 
analyses. A Group x Time interaction term will indicate whether intervention effects are present.  
 
Hypothesis #3: Children treated with access to the mehealth for ADHD.com enhanced with 
behavioral tools will have fewer areas of parent- and teacher-rated functional impairment than 
children treated for ADHD without access to the behavioral tools. 
Analyses: The primary dependent measures for measurement of child outcomes will be the IRS 
total score as rated by parents and teachers. HLMM modeling will use a rater variable to allow 
parent and teacher ratings to be entered into the same model. These HLMM analyses will 
evaluate whether growth curves using baseline, 6-, and 12-month data are different across the 
two groups. For all analyses, our primary hypothesis predicting improved outcomes for children 
with access to the behavioral tools will be tested by examining the Group x Time interaction 

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effect. In order to control for additional treatments received by children in the intervention and 
control groups, we will add time-varying covariates indicating medication/dosing changes (for 
children in both groups) and institution of behavioral treatment (for children in the control group) 
to the HLMM models. Exploratory analyses will also assess for intervention effects across the 
separate IRS domains. 
 
Hypothesis #4: Families treated for ADHD with access to the mehealth for ADHD.com 
enhanced with behavioral tools will have experience higher satisfaction with ADHD treatment 
compared to families treated for ADHD without access to the behavioral tools. 
Analyses: The dependent measure for these analyses will be satisfaction summary scores from 
the consumer satisfaction measures. Similar to the child outcome analyses (Hypothesis #3), a 
HLMM analysis will be conducted using between-group comparisons of 6- and 12-month data 
from the randomized trial.  
 
Exploratory moderator analyses: Possible moderators of treatment effects on rates of and 
integrity of behavioral treatment and patient outcomes include parental psychological distress, 
parental ADHD, and parental motivation for treatment. Each of these variables measured at 
baseline will be inserted into the hierarchical models as a main effect and as an interaction with 
time. Any interaction between the moderator variable and time would indicate that the 
moderator variable is impacting intervention efficacy. 
 
Power analysis  
The proposed study was powered to detect treatment effects on improving child outcomes since 
this is the ultimate goal of the proposed intervention. Effect size estimates for child outcomes 
were obtained from and from two randomized trials examining the efficacy of behavioral 
interventions (e.g., daily report cards) on functional impairment outcomes in children with ADHD 
(Gregory A Fabiano et al., 2010; J. S. Owens et al., 2012). Both of these studies report 
behavioral treatment effect sizes on functional impairment outcomes in the range of .40-.65 
(Cohen’s d). We used Optimal Design Software© (University of Michigan, 2005) to determine 
the appropriate sample size using the following assumptions: 1) α = 0.05, 2) T = 3 repeated 
(baseline, 6 months, & 12 months) measurements, 3) repeated measures variance (σ2) equal to 
1, 4) family level variance (τ00&τ11) equal to 1, and 4) a maximum 20% rate of longitudinal 
attrition (based on Epstein et al.(J.N. Epstein et al., 2007)). Based on these assumptions, we 
determined that power > 0.80 could be achieved if we recruited up to 200 parents.  
 
POTENTIAL BENEFITS: 
 
Although we cannot guarantee a benefit to any individual participating parent, or teacher, 
the behavioral tools are 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 
(i.e., combined treatment with medication and behavioral interventions) which is recommended 
by the American Academy of Pediatrics for the care of ADHD (American Academy of Pediatrics, 
2011). 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.  Several safeguards 
will be put in place.  Study staff will have access to view participant data upon e-consent.  

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Database and system administrators in the Division of Biomedical Informatics at CCHMC will 
also have access to the database in order to perform quality assurance and system 
maintenance.  The database of the consent management application is encrypted to prevent 
unauthorized data disclosure.  The connection between the application front-end and the 
database and between the application front-end and the user’s web browser is also encrypted. 
Using e-consent methods, if a participant declines to participate, the parent’s records will be 
marked to denote his/her refusal.  If a parent chooses not to consent, the data will no longer be 
used for research.  Similarly, if a participant elects to withdraw consent at a later date, the 
participant’s consent records will also be marked.  
 
DATA MANAGEMENT AND SECURITY 
 
All data collected on pediatricians, parents, and teachers 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 
family’s clinical information is protected in mehealth for ADHD.com.  The HIPAA regulations and 
their application to this product will be clearly defined to ensure compliance within their 
guidelines.  Mehealth for ADHD.com 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). 
At the end of the study after analysis have been complete and publication of results 
completed, data will be anonymized.  Any physical data will be kept in a locked file cabinet in 
the Center for ADHD.  Any electronic data will be kept on a secure server with access limited to 
Center for ADHD employees. An IRB amendment or new proposal will be submitted prior to 
using the data for any future research.  
 
PROTECTION OF VULNERABLE POPULATION: 
 
The following procedures will be followed to avoid issues related to coercion or undue 
influence. Parents 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 participate in the study. 

15 
 
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DATA SAFETY & MONITORING: 
 
 
The randomized controlled trial will evaluate the effectiveness of the integration of 
behavioral tools into the mehealth for ADHD.com software compared to the wait list control 
group on rates of behavioral treatment, quality of behavioral treatment, children’s functional 
impairment, and families’ satisfaction with pediatrician-delivered ADHD care among up to 200 
children with ADHD.  Participants assigned to the intervention group will receive access to the 
mehealth for ADHD.com software with integrated behavioral tools.  Participants assigned to the 
control condition will receive access to the regular mehealth for ADHD.com software and access 
to the integrated behavioral tools after 1 year.  It is important to note here that the mehealth for 
ADHD.com software includes functionality whereby when a parent or teacher inputs rating scale 
information into the web portal during the course of monitoring treatment outcomes, 
computerized algorithms score and interpret this information and a report is produced.  In 
addition, pediatricians are immediately alerted via email if there appears to be any exacerbation 
of side effects or deterioration in ADHD symptoms.  Since (1) most of the risk in treating children 
with ADHD comes from pharmacological treatment which is not a part of the proposed study 
and (2) all participants are already using the mehealth for ADHD.com software that includes 
functionalities to automatically warn the pediatrician about side effects or behavioral 
deterioration, the safety risks of the study are minimal and there does not appear to be the need 
for an external monitoring board.  Rather, Drs. Epstein (PI) and Brinkman (Co-I) will assume 
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 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 and Dr. Epstein has psychological expertise 
related to using behavioral treatments for use in treating children with ADHD to address study-
related psychological issues.  All research staff will complete education in the protection of 
human research subjects prior to study approval by the CCHMC IRB. 
Drs. Epstein and Brinkman will continuously evaluate the project’s performance, safety, 
treatment fidelity, 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. Epstein and Brinkman as well as at the periodic meetings with the 
stakeholders.  Any deviation in achieving recruitment targets will be reported to the program 
officer.  In order to assure intervention fidelity, mehealth for ADHD.com will capture and report 
on data elements to characterize the use of behavioral tools.  In order to assure the accuracy of 
data entry, data will be verified by double entering all data into a RedCap database.  
Inaccuracies will be addressed by double-checking the report forms.    
 
COST OF PARTICIPATION:  
 
There will be no costs to the subject for participating in this study. 
 
PAYMENT FOR PARTICIPATION: 
 
Materials collected from families will include questionnaires and interviews including 
questions related to family demographic characteristics, service use, and outcomes measures.  
These will all be administered via REDCap online or via phone at the time of enrollment, 6 
months later, and finally 12 months later. An additional survey will be collected at the end of the 
school year if the 6- or 12-month assessment falls during the summer months. Families will be 

16 
 
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reimbursed $20 for their time completing each set of questionnaires at each time point.  
Teachers will be asked to complete questionnaires by online REDCap surveys or via phone 
about children’s behavior at the time of study entry, 6 months later, and 12-months later.  An 
additional survey will be collected at the end of the school year if the 6- or 12-month 
assessment falls during the summer months. Teachers will be reimbursed $20 for their time 
completing these questionnaires at each time point. Parents and teachers will be reimbursed 
$50 for their time participating in the post-study consumer satisfaction questionnaire feedback 
interview. 
Each pediatric practice will be compensated $80 for every 6 patients that consent to 
participate in the study up to a total of 30 patients. In addition, after 30 patients from the practice 
have consented to participate, the practice will be compensated an additional $100. 
Participating pediatrician practices will also have access to the mehealth for ADHD web portal 
for 2 years at no charge. 
 
 
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