Enhancing IEPs of Children With ADHD Using Daily Report Cards: An Efficacy Trial
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: State University of New York at Buffalo

 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federalwide Assurance ID#: FWA00008824 
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Complete Research Protocol (HRP-503) 
 
PROTOCOL TITLE: 
Include the full protocol title. 
Response: Enhancing the Effectiveness of Individualized Education Programs 
Using a Daily Report Card 
 
 
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response: Gregory A. Fabiano, Ph.D. 
Department of Counseling, School, and Educational Psychology 
716-645-1130 
Fabiano@buffalo.edu 
 
 
VERSION: 
Include the version date or number. 
Response: Version 3 (10/16/18) 
 
 
GRANT APPLICABILITY: 
Indicate whether this protocol is funded by a grant (e.g. NIH, foundation grant).  
For a grant with multiple aims, indicate which aims are covered by this research 
proposal. 
NOTE: This question does not apply to studies funded by a sponsor contract. 
Include a copy of the grant proposal with your submission.     
Response: This protocol is funded by a grant from the Institute of Education 
Sciences. 
 

 
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RESEARCH REPOSITORY: 
Indicate where the research files will be kept, including when the study has been 
closed.  The repository should include, at minimum, copies of IRB 
correspondence (approval, determination letters) as well as signed consent 
documents.  This documentation should be maintained for 3 years after the study 
has been closed.   
Response: Research files will be kept in Diefendorf Hall Room 304. 
Location: 304 Diefendorf Hall 
Address: 304 Diefendorf Hall 
Department: Department of Counseling, School, and Educational Psychology 
1.0 Objectives 
1.1 Describe the purpose, specific aims, or objectives of this research. 
Response: The purpose of this study are to determine the effectiveness of 
the daily report card (DRC) approach to supporting children with ADHD 
in special education in schools compared to a business as usual condition.  
Children in the study will be randomly assigned (like flipping a coin) to 
business as usual, or to treatments that increases, if needed, across the 
school year. All children will have progress carefully monitored across 
the school year. 
 
The objective is to observe whether the addition of the DRC approach is 
superior to special education procedures as usual . 
 
 
1.2 
State the hypotheses to be tested, if applicable. 
NOTE:  A hypothesis is a specific, testable prediction about what you expect to 
happen in your study that corresponds with your above listed objectives. 
Response:  
Aim 1. Investigate the efficacy of using a DRC mechanism to link the 
child with ADHD’s IEP to daily classroom behavior. 
Hypothesis 1. Children who have a DRC linked directly to their IEP goals 
and objectives will exhibit better classroom behavior and exhibit better 
academic productivity outcomes than children who receive school as 
usual (SAU) in which an IEP has been developed but has not been 
enhanced through use of a DRC. Children who have a DRC will also 
demonstrate better outcomes on measures of IEP goal attainment, school 
functioning, and academic progress. 
Aim 2. Investigate moderators of treatment outcome. 

 
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Hypothesis 1. It is hypothesized that grade level will moderate 
intervention effects. It is hypothesized the DRC intervention will be more 
effective in the primary grades (i.e., K-3) relative to intermediate grades 
(i.e., 4-6) as the less complex class schedule and academic demands (e.g., 
fewer long-term assignments; fewer organizational demands on the 
student) will facilitate greater adherence and implementation and 
therefore better outcome. 
Hypothesis 2. It is hypothesized that the presence of ADHD + comorbid 
aggressive/oppositional behavior (i.e., comorbid disruptive behavior 
disorders; DBD) will moderate intervention effects. Specifically, it is 
hypothesized that the DRC intervention will be more effective for children 
with comorbid DBD because they will have increased classroom/social 
impairment and therefore more opportunity to exhibit improvement.  
Hypothesis 3. It is hypothesized that IEP quality will moderate 
intervention effects. Specifically, it is hypothesized that the DRC 
intervention will be more effective for children with low-quality IEPs as its 
use will serve to scaffold poorly constructed or incomplete IEP 
goals/objectives. 
Aim 3. Investigate mediators of treatment outcome 
Hypothesis 1. As we outline in our logic model below, the fidelity of 
implementation (Fabiano et al., 2014), which includes improved positive teacher-
child interactions, increased frequency/consistency of feedback, and enhanced 
home-based contingency management are all thought to be enhanced through the 
intervention and will mediate improvement in functional domains. These 
indicators will be investigated individually as mediators as well as jointly. 
 
2.0 Scientific Endpoints 
 
2.1    Describe the scientific endpoint(s), the main result or occurrence under 
study.   
 
NOTE:  Scientific endpoints are outcomes defined before the study begins to determine 
whether the objectives of the study have been met and to draw conclusions from the data.  
Include primary and secondary endpoints.  Some example endpoints are:  reduction of 
symptoms, improvement in quality of life, or survival.  Your response should not be a 
date.   
Response:  
Primary scientific endpoints are blinded observations of classroom behavior 
collected at the end of the school year and teacher ratings on the Disruptive 
Behavior Disorders Rating Scale, Impairment Rating Scale, Academic 
Performance Rating Scale, and BASC-2 rating scale. Teachers will also complete 
a rating of IEP goal attainment at the end of the school year.  
 

 
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Secondary outcome measures include assessments of academic achievement, 
classroom functioning, impairment, parent and teacher satisfaction with treatment, 
and student-teacher relationship. 
 
3.0 Background 
3.1 Provide the scientific or scholarly background, rationale, and significance 
of the research based on the existing literature and how it will contribute to 
existing knowledge.  Describe any gaps in current knowledge.  Include 
relevant preliminary findings or prior research by the investigator.  
Response: This proposal is submitted under goal 3 and it aims to evaluate 
“research that integrates the disciplines of special education and mental 
health with the goal of preventing school-based behavior problems and 
improving the academic outcomes for students with disabilities” (pp. 34; 
IES RFA Special Education Research Grants, Social and Behavioral 
Outcomes to Support Learning topic, FY2018). Specifically, this proposal 
will investigate the efficacy of an intervention to enhance the special 
education supports used for children with ADHD (i.e., the manner in 
which goals/objectives on the IEP are monitored and addressed; targeting 
of social/behavioral goals).  
 
The purpose of this proposed study is to provide evidence for the efficacy 
of using a daily report card intervention (DRC) as a means of linking the 
child with ADHD’s IEP goals and objectives to his/her daily functioning 
in the classroom environment. A Goal 2 study was recently completed to 
develop and provide preliminary support for the DRC intervention for this 
purpose (Fabiano et al., 2010). The proposed investigation will be a multi-
site study conducted in elementary schools throughout the Western New 
York and South Florida area. Participants will be 216 children (grades K-
6), who have been diagnosed with ADHD and have an IEP (e.g., Specific 
Learning Disability, Emotionally Disturbed, Other Health Impaired).  
 
In the proposed study, the efficacy of the DRC as an enhancement to 
children with ADHD’s IEPs will be investigated in an experimental study. 
Children will be randomly assigned on the individual level to a condition 
where a behavioral consultant works with the child’s teacher(s) to 
construct a DRC, implement it, and monitor it, or to an IEP only, school 
as usual (SAU) condition, where teachers will attempt to meet the IEP 
goals and objectives as they typically would. A DRC is an operationalized 
list of target behaviors (e.g., “completes reading assignments with 80% 
accuracy or better,” “has no office time outs during the day”) that are 
evaluated each day by the teacher. The DRC is used as a means of 
providing the child and parent feedback on progress on a daily basis, and 
it doubles as a mechanism teachers can use to track and monitor the 

 
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child’s behavior and progress on key functional domains. The DRC can be 
easily linked to IEP goals and objectives, providing a bridge between the 
IEP and the child’s daily functioning in the classroom. Parents will also 
be taught in parenting meetings how to reward their child at home for 
successful attainment of DRC goals and how to communicate effectively 
with their child’s teacher.  
 
Measures of key outcomes will include observations of behavior in the 
classroom conducted by observers naïve to group assignment or study 
hypotheses, academic performance outcomes, parent and teacher ratings 
of functioning, and IEP goal attainment. Primary measures of outcome 
will be analyzed using ANCOVA procedures. Secondary measures will 
include teacher ratings of ADHD and disruptive behavior/impairment. 
Additional analyses will investigate moderators (grade level, comorbid 
aggressive behavior, IEP quality). It is further hypothesized that 
classroom environment and fidelity of implementation at school/home will 
mediate outcomes (i.e., classroom climate, the fidelity of teacher 
monitoring/feedback regarding behavior, consistency of parent-
implemented consequences at home).  
 
 
3.2 Include complete citations or references.  
Response: Response: None included (see grant application for expanded 
background, preliminary studies, and references) 
4.0 Study Design 
4.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 
Response: This project will use a randomized, between group design. The 
sequence of recruitment, randomization, and assessment is summarized in the 
Figure below. After informed consent 
and assent is obtained, and 
completion of the intake and review 
of inclusion and exclusionary criteria, 
the child will be randomly assigned to 
one of two groups. Participants will 
be randomly assigned to either (1) 
School as Usual (SAU) or (2) Daily 
Report Card (DRC), with 108 
participants per group. The 
recruitment plan will aim for an equal 
number of subjects in the DRC and 
SAU groups, and participants will be 

 
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stratified within randomization across potential moderator variables including 
medication and grade level. 
 
5.0 Local Number of Subjects 
5.1 Indicate the total number of subjects that will be enrolled or records that 
will be reviewed locally. 
Response: The total sample will include 216 participants (108 at the Buffalo site 
and 108 at the Miami Site).  
 
5.2 If applicable, indicate how many subjects you expect to screen to reach your 
target sample (i.e. your screen failure rate).  
Response: We expect to screen three times as many subjects as are needed to meet 
recruitment goals. Our estimate is we will screen 700 participants in order to 
obtain the targeted sample size of 216. 
 
5.3 Justify the feasibility of recruiting the proposed number of eligible subjects 
within the anticipated recruitment period. For example, how many potential 
subjects do you have access to? What percentage of those potential subjects 
do you need to recruit? 
Response: Using the Common Core of Data (http://nces.ed.gov) information from 
the 2011-12 school year, the western New York district represents approximately 
16,694 students in grades K-6 and the south Florida district includes 
approximately 186,467 students in these grades. Using the same database, it is 
estimated that 4174 students (Buffalo site) and 18,647 (Miami site) in these 
grades have IEPs. Given our pilot work (Fabiano, Naylor et al., 2009) and the 
work of Forness & Kavale (2002), it is further conservatively estimated that 
approximately 25% of these students in special education will have ADHD, 
yielding a total sample of 1,044 students in Buffalo and 4,662 students in Miami 
eligible to be screened for participation in each year. These estimates suggest for 
our study recruitment plan of enrolling 36 children per site, per year, we need to 
enroll 3% of children at the Buffalo site and 0.8% at the Miami site in the total 
pool of potential participants during each of the study years. These estimates 
indicate our recruitment plan is feasible. 
 
6.0 Inclusion and Exclusion Criteria 
6.1 Describe the criteria that define who will be included in your final study 
sample.  
NOTE:  This may be done in bullet point fashion. 
Response:  

 
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Inclusion: Include all presentations of ADHD. 
Inclusion: Grades K-6 
Inclusion: Current Individualized Education Program 
Inclusion: Estimated IQ greater than or equal to 70 
6.2 Describe the criteria that define who will be excluded from your final study 
sample.   
NOTE:  This may be done in bullet point fashion.  
Response:   
Exclusion: Presence of psychosis or severe developmental delays such as autism. 
Exclusion: A child in foster care 
Exclusion: Child is home-schooled or on home-instruction 
6.3 Indicate specifically whether you will include any of the following special 
populations in your study using the checkboxes below.   
 
NOTE:  Members of special populations may not be targeted for enrollment in 
your study unless you indicate this in your inclusion criteria. 
Response:   
☐ 
Adults unable to consent 
☒ 
Individuals who are not yet adults (infants, children, teenagers) 
☐ 
Pregnant women 
☐ 
Prisoners 
 
6.4 Indicate whether you will include non-English speaking individuals in your 
study.  Provide justification if you will exclude non-English speaking 
individuals.  
In order to meet one of the primary ethical principles of equitable selection 
of subjects, non-English speaking individuals may not be routinely excluded 
from research as a matter of convenience. 
In cases where the research is of therapeutic intent or is designed to 
investigate areas that would necessarily require certain populations who 
may not speak English, the researcher is required to make efforts to recruit 
and include non-English speaking individuals.  However, there are studies 
in which it would be reasonable to limit subjects to those who speak 
English.  Some examples include pilot studies, small unfunded studies with 
validated instruments not available in other languages, studies with 
numerous questionnaires, and some non-therapeutic studies which offer no 
direct benefit. 

 
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Response: The present study focuses on students in special education settings.  
Children who require additional school supports, including supports for English-
language learning are not eligible due to the study aims. In addition, this study 
includes numerous norm-based questionnaires that are normed on English-
speaking samples, and there are not routinely equivalent norm-referenced 
measures available for alternative languages.  
7.0 Vulnerable Populations 
If the research involves special populations that are considered vulnerable, 
describe the safeguards included to protect their rights and welfare.   
NOTE: You should refer to the appropriate checklists, referenced below, to ensure you 
have provided adequate detail regarding safeguards and protections. You do not, 
however, need to provide these checklists to the IRB. 
7.1 For research that involves pregnant women, safeguards include: 
NOTE CHECKLIST: Pregnant Women (HRP-412) 
Response: 
  
☒ 
N/A:  This research does not involve pregnant women. 
7.2 For research that involves neonates of uncertain viability or non-viable 
neonates, safeguards include: 
NOTE CHECKLISTS: Non-Viable Neonates (HRP-413), or Neonates of Uncertain 
Viability (HRP-414) 
Response:  
 
☒ 
N/A:  This research does not involve non-viable neonates or neonates of 
uncertain viability. 
7.3 
For research that involves prisoners, safeguards include: 
NOTE CHECKLIST: Prisoners (HRP-415) 
Response:  
 
☒ 
N/A:  This research does not involve prisoners. 
7.4 For research that involves persons who have not attained the legal age for 
consent to treatments or procedures involved in the research (“children”), 
safeguards include:   
NOTE CHECKLIST: Children (HRP-416) 
Response:  
The project will safeguard the rights of children by requiring parenting permission 
for one legal guardian (similar to the approach utilized in school and pediatric 
settings) and will also assent children over the age of seven.  Children seven and 
under will not be assented due to their developmental level and cognitive 

 
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capability making it unlikely they could reasonably provide informed assent to the 
procedures (See Attached Checklist HRP-416). 
☐ 
N/A:  This research does not involve persons who have not attained the 
legal age for consent to treatments or procedures (“children”). 
7.5 For research that involves cognitively impaired adults, safeguards include: 
NOTE CHECKLIST: Cognitively Impaired Adults (HRP-417) 
Response:  
 
☒ 
N/A:  This research does not involve cognitively impaired adults. 
7.6 Consider if other specifically targeted populations such as students, 
employees of a specific firm, or educationally or economically 
disadvantaged persons are vulnerable.  Provide information regarding 
their safeguards and protections, including safeguards to eliminate 
coercion or undue influence. 
Response: N/A 
 
8.0 Eligibility Screening  
8.1 
Describe screening procedures for determining subjects’ eligibility.  
Screening refers to determining if prospective participants meet inclusion and 
exclusion criteria.  
Include all relevant screening documents with your submission (e.g. screening 
protocol, script, questionnaire).  
Response: 
Parents interested in participating in the study will contact the University at 
Buffalo investigators, and the family will be screened for study eligibility. This 
will be done over the phone or in person and initial eligibility criteria will be 
confirmed (e.g., child is in an eligible grade level). Families will then be invited to 
a meeting with the investigators where parents will be asked to enroll following 
an informed consent process. 
 
☐ 
N/A:  There is no screening as part of this protocol. 
9.0 Recruitment Methods 
☐ 
N/A:  This is a records review only, and subjects will not be 
recruited.  NOTE:  If you select this option, please make sure that 
all records review procedures and inclusion/exclusion screening 
are adequately described in other sections. 
9.1 
Describe when, where, and how potential subjects will be recruited.  
NOTE:  Recruitment refers to how you are identifying potential participants and 
introducing them to the study.  Include specific methods you will use (e.g. 

 
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searching charts for specific ICD code numbers, Research Participant Groups, 
posted advertisements, etc.). 
Response: Multiple approaches will be utilized to recruit participants into this 
study.  We will ask that our partner schools in Western New York distribute study 
recruitment flyers in their family resource centers, during parent/teacher 
conferences, to children referred to school-problem solving teams or school 
counselors, and in backpack mail folders sent home each week. 
We will also utilize direct mailings to families in the Western New York area 
using every door direct mailers, marketing company lists, and targeted zip code 
mailings (specific flyers will be approved via amendment if different than already 
approved study flyers).  We will also advertise on the radio and social media such 
as Facebook and Instagram (final form ad to be approved prior to air date).   
 
Parents who receive mailers or view the advertisement on social media will have 
the option of calling a study number, or inputting their contact information in a 
web-based form that will be emailed directly to the study team.  
Parents who provided prior verbal permission to send information via the Center 
for Children and Families mailing list will be mailed flyers as well. 
We will also disseminate the IRB-approved flyer to local professionals, post in 
public places (e.g., libraries, coffee shops), and email/mail to professional lists. 
 
For any parent who calls the study number, or who has requested to be added to a 
list for contact in the future about studies from the Center for Children and 
Families, the IRB-approved phone screen will be conducted to determine initial 
study eligibility.  
9.2 Describe how you will protect the privacy interests of prospective subjects 
during the recruitment process.   
NOTE:  Privacy refers to an individual’s right to control access to him or herself.   
Response: Recruitment materials will be general in nature, and they will require 
the participant to call the study line for more information rather than directly 
approach a subject (i.e., control of communication is in the hands of the potential 
participant rather than the researcher). Screenings will only collect identifiable 
information if the participant appears to meet eligibility criteria. 
 
9.3 Identify any materials that will be used to recruit subjects.  
NOTE:  Examples include scripts for telephone calls, in person announcements / 
presentations, email invitations.  
For advertisements, include the final copy of printed advertisements with your 
submission. When advertisements are taped for broadcast, attach the final 
audio/video tape.  NOTE:  You may submit the wording of the advertisement prior 

 
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to taping to ensure there will be no IRB-required revisions, provided the IRB also 
reviews and approves the final version. 
 Response: Please see attached telephone screening form, study information sheet, 
and recruitment flyer. Additional recruitment materials will be submitted for 
approval as appropriate. 
10.0 
Procedures Involved 
10.1 Provide a description of all research procedures or activities being 
performed and when they are performed once a subject is screened and 
determined to be eligible. Provide as much detail as possible.   
NOTE:  This should serve as a blueprint for your study and include enough detail 
so that another investigator could pick up your protocol and replicate the research.  
For studies that have multiple or complex visits or procedures, consider the 
addition of a schedule of events table in in your response. 
Response: This project will use a randomized, between group design. The 
sequence of recruitment, randomization, and assessment is summarized in 
the Figure below. After informed consent and assent is obtained, and 
completion of the intake and review of inclusion and exclusionary criteria, 
the child will be randomly assigned to one of two groups. Participants will 
be randomly assigned to either (1) School as Usual (SAU) or (2) Daily 
Report Card (DRC), with 108 participants per group. Pre and post-test 
assessment occur in January and May of the academic year, respectively, 
resulting in approximately 16-20 weeks of treatment delivery.  
The recruitment plan will aim for an equal number of subjects in the DRC 
and SAU groups, and participants will be block randomized across 
potential moderator variables including medication and grade level. In the 
Goal 2 study, for which these variables were unselected, 52% of the final 
sample was prescribed medication and 66% were in grades K-3 and 34% 
were in grades 4-6. Thus, it appears that the plan to have an equal number 
of subjects in each block is feasible with careful attention to recruiting 
participants in the older grades in the present application. Block 
randomization based on child psychoactive medication status will promote 
equal distribution of participants across this variable. The medication 
variable will be defined as “no medication” if the child is not prescribed 
psychoactive medication immediately prior to randomization and as 
“taking medication” if the child is prescribed psychoactive medication 
and it is being actively administered at the time of randomization. In sum, 
an equal number of participants (N=72/year) will be enrolled in four 
blocks each year (i.e., No medication/Primary grade; No medication/ 
Intermediate grade; Taking medication/Primary grade; Taking 
medication/Intermediate grade). Random assignment will be conducted 
following the completion of all baseline measures by a blinded member of 
the study team (Dr. Yu). Following randomization, a form letter will be 
generated that informs the study staff and participating family of group 

 
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assignment. Consultants will then be randomly assigned to the case with 
an equal number of DRC and SAU cases assigned to each consultant.  
For those students who are medicated with stimulant medication, we will 
ask parents to obtain permission from the child’s doctor to withhold 
medication for the assessment days in January and May so as to collect 
information on the child’s behavior when unmedicated. 
 
Intervention Groups 
 
DRC group. Students assigned to the DRC group will have a 
consultant assigned to the student for the duration of the school year. 
During the month of January, the consultant will work with the child’s 
primary special education teacher (or regular education teacher if the 
child spends the majority of his or her day mainstreamed) to establish a 
DRC over the course of three consultation visits. The How to Establish a 
Daily Report Card manual contains a standard DRC instruction packet 
that is provided to teachers to explain the rationale of the DRC, 
procedures for creating, modifying, and evaluating the DRC, procedures 
for parents to create home-based rewards for DRC performance, and 
information on trouble-shooting. In addition, the packet contains 
consumable hand-outs that may be used to facilitate the meeting of these 
goals. This packet will be used as a starting point in all DRC 
consultations, and it was successfully modified, used, and evaluated in our 
Goal 2 project.  
The first visit will be spent reviewing the IEP with the child’s teacher(s) 
and conducting an interview to determine the behavioral procedures the 
teacher currently uses to manage child behavior as well as identify 
potential target behaviors not currently included on the IEP. At this 
meeting, target behaviors will be identified, operationally defined, and 
integrated into a DRC. The teacher will be asked to implement the 
intervention during the week between the first and second visit. At the 
second consultant visit, target behaviors will be refined, and using the 
data collected by the teacher, criteria for each target behavior will be 
modified (e.g., a child who averaged 10 verbally intrusive behaviors per 
class would have a target behavior changed to “Has 8 or fewer verbally 
intrusive behaviors”). The third consultant visit will be conducted to fine-
tune and trouble-shoot the DRC and inform the teacher of the home 
rewards established by the parents. During this visit, the consultant will 
also establish a weekly time for the teacher to fax/call in a summary of 
DRC results for the week. DRCs will be implemented across settings and 
classes; however, a single teacher will be identified for assessment 
completion, observations will be conducted in that teacher’s class, and 
this individual will be required to attend all consultant meetings. 
The DRC will include direct accounting for IEP goals as well as other 
behavior problems common to a child with ADHD, and it is necessarily 

 
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idiosyncratic to address the heterogeneity that is typical in samples of 
children with ADHD. For example, a child with an IEP due to low 
achievement in reading, who also exhibits disruptive behaviors and 
noncompliance, might have targets established such as “Completes 
assigned reading tasks with 80% or better accuracy;” “Interrupts class 
discussion 4 or fewer times per class/interval;” and “Has 2 or fewer 
instances of noncompliance during the transition to lunch.” A standard 
list of common DRC goals has been created and will be used to facilitate 
initial target behavior selection. These goals clearly overlap with the 
actual goals created as part of the development project (Fabiano et al., 
2010). The DRC would be evaluated and completed by the teacher daily, 
and feedback will be provided to the child throughout the day on progress 
made toward DRC goals.  
 
At the end of each day, the teacher will send the DRC home with 
the child so that the parent is provided feedback on a daily basis 
regarding the child’s behavior at school. Parents will attend three 
individual parent training meetings to introduce them to the DRC also 
conducted in January in the child’s school, and they will establish home-
based rewards contingent on the child’s DRC performance. For example, 
for a child with three DRC goals evaluated twice per day (i.e., before 
lunch and before dismissal), there are six possible “yes’s.” A given parent 
might remove computer access for this child previously provided non-
contingently and only provide 10 minutes for each “yes” reported for the 
day (i.e., a child who earned all “yes’s” on a particular day would be 
rewarded with 60 minutes of computer time). This binary approach of 
yes/no is easier to explain to the child, and permits the child to track 
his/her own progress across the day (i.e., number of yes’s earned), 
relative to a continuous rating, which may be harder for the child to 
comprehend/quantify. In addition to the home-based contingency 
management based on school feedback, which makes the child 
accountable at home for school-based behavior, the DRC serves as a 
mechanism of daily communication between the parent and teacher. Given 
the variability in behavior expected with a child with ADHD, such daily 
communication is often crucial for preventing deterioration in functioning 
and presents the parent and teacher with multiple opportunities to 
problem-solve.  
 
After the three initial meetings with the child’s teacher, consultants 
will meet monthly with the teacher (and parent if available) to provide 
feedback on the child’s behavior during the month using a graphical 
representation of the child’s DRC performance. This information will be 
used for data-driven decision making, a procedure shown to be better than 
teacher impressions/ judgments when intervention planning/monitoring 
(Fuchs et al., 2000) and potentially critical for IEP monitoring. DRC 
goals will be adjusted as needed. It is expected that these monthly 
meetings will serve the purpose of ensuring IEP goals and objectives are 
consistently addressed on the DRC throughout the year.  

 
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SAU group. Consultants will conduct an initial meeting with each 
teacher of children in the SAU group to describe study procedures, 
establish regular classroom observation times, and obtain an updated 
copy of the child’s IEP. All procedures will be implemented in the IEP as 
planned (e.g., counseling, school interventions). This condition is 
conceptualized as a school as usual control and serves as the counter-
factual condition for the study.  
To account for consultant contact with the teacher, consultants will meet 
with the teachers in the SAU group once per month. During these 
meetings they will collect information on how the child is functioning, and 
obtain information on any new, discontinued, or modified interventions 
(reward and/or punishment). The consultant will work with the teacher to 
construct a list of goals and criteria for meeting goals consistent with the 
approach used in the DRC group. This list of goals will not be used to 
develop DRCs or other classroom interventions but will be used by the 
observer to record teacher feedback to the child related to targeted 
behaviors. Our goal 2 study had teachers fill out an Individualized Target 
Behavior Checklist (ITBC; Pelham, Fabiano, & Massetti, 2005), which 
was constructed in the same manner as a DRC, but feedback on target 
behaviors was not provided to the child or parents and contingencies were 
not provided at school or home. Our Goal 2 study suggested that the ITBC 
had no appreciable effect on behavior (Fabiano et al., 2009, 2010) 
replicated by other studies (Pelham, Fabiano, et al., 2016).  
In order to control for consultant effects, following random assignment to 
study group, each child will be randomly assigned a behavioral consultant 
in a counter-balanced fashion (i.e., therapists will be equally distributed 
across DRC and SAU groups to control for therapist effects), and will then 
work with the teacher for the school year. Consultants will be M.A. level 
school/clinical psychology specialists or special education teachers 
appointed to the project at each site. We have chosen to use individuals 
with these credentials to increase the external validity of the intervention 
as these individuals are likely to be called upon to consult with teachers 
regarding the behavior of children with ADHD as well as be involved in 
the assessment of children with ADHD and creation of IEPs in many 
school districts. 
Our approach in this study will be to work directly with parents and 
teachers rather than through a formal IEP amendment process as we 
expect this to be consistent with the manner this intervention will 
eventually be used in practice, if found to be efficacious. We expect that 
similar to our Goal 2 project, districts will informally implement the DRC 
procedures through collaboration with the consultant.  Should a district 
wish for a more formal approach, it is actually quite easy to amend the 
IEP through a parent and/or district request without convening an IEP 
meeting. As stated in the law [34 CFR 300.324(a)(6)], amendments to a 
child’s IEP after the annual IEP meeting may be made by the entire IEP 

 
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team at an IEP meeting or by amending the IEP without another IEP 
meeting. Thus, “in making changes to a child's IEP after the annual IEP 
Team meeting for a school year, the parent of a child with a disability and 
the public agency may agree not to convene an IEP Team meeting for the 
purposes of making those changes, and instead may develop a written 
document to amend or modify the child's current IEP” [34 CFR 
300.324(a)(4)(i)]. Thus, the proposed study procedures will be consistent 
with regulations mandated under P.L.108-446 (IDEA, 2004). Of note 
procedures were implemented with 100% of participants in a prior study 
across numerous districts without issue (Fabiano et al., 2010).  
10.2 Describe what data will be collected.   
NOTE:  For studies with multiple data collection points or long-term follow up, 
consider the addition of a schedule or table in your response. 
Response:  
Measures will be used that capture the domains of functioning important 
for children with ADHD classified as students in need of special 
education. Therefore, measures will span aspects of behavioral and 
academic functioning in the school setting and use multiple sources (child, 
observer, teacher, and parent). Below we describe measures of these 
relevant study outcomes as well as information on the reliability and 
validity of the selected measures. Although sometimes implemented in 
studies of ADHD treatment (AACAP, 2007), we elected not to require that 
students be taken off medication for the study duration for practical and 
ethical reasons; our block randomization approach for the medication 
variable addresses this issue.  
Primary Measures of Behavioral Functioning. 
Observations of Classroom behavior. Independent observations will be 
conducted using the Student-Behavior Teacher-Response observation 
system (SBTR; Pelham, Greiner, & Gnagy, 2008; Vujnovic, Fabiano et 
al., 2014). The SBTR is an observation code that collects information on: 
(1) the frequency of student rule violations; (2) whether a teacher 
observed the misbehavior; (3) if observed, the teacher consequence 
employed and whether it was an appropriate consequence. The SBTR 
system also records the number of praise statements and commands 
issued. The SBTR is a well-defined and validated observation system for 
use with children with ADHD in classroom settings. The SBTR system 
documents child functioning across a number of disruptive behavior 
categories (e.g., be respectful, obey adults, work quietly, stay on task), and 
it is consistent with an evidence-based assessment procedure for ADHD 
(Pelham, Fabiano, & Massetti, 2005). It represents the evolution in a 
well-established observational code, as it is a modified version of the 
behavioral observation code used in the analogue classroom studies noted 
above (Atkins, Pelham, & Licht, 1985, 1988, 1989; Fabiano et al., 2007; 
Pelham et al., 1993), as well as including the procedures used in the STP 

 
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classrooms to measure teacher fidelity to behavior management (Pelham, 
Fabiano, et al., 2005; Pelham & Hoza, 1996). 
The SBTR has been successfully employed as a primary outcome in our 
Goal 2 project (Fabiano, Vujnovic et al., 2010; see preliminary study 2), 
along with two other IES-funded projects, one a between-group study of 
school-wide social and character development programs (Pelham, P.I., 
http://www.sacdprojects.net), and the other a study designed to investigate 
the best dose and sequencing of school-based treatments for children with 
ADHD (Pelham, P.I., R324B06045). The SBTR observation system has 
good inter-rater reliability – the mean difference between the observers on 
total rule violations recorded was 1.8 (SD=2.3; Range=0-12). For the 
total rule violations variable, the correlation between the two observers 
was .96 (p < .001), supporting the inter-rater reliability of the observation 
measure. The SBTR observation system also demonstrated moderate 
correlation with the DRC recorded by the teacher (r= -.46), suggesting 
the half-hour observation relates in the expected manner to the DRC 
completed over an entire school day (Fabiano, Vujnovic, et al., 2009). 
 
The SBTR observations will occur on three separate days in the 
month of January (before intervention begins) and three separate days in 
the month of May for each child. Each observation will last for thirty 
minutes. Time of day and activity will be controlled. Observers will be 
blind to the child’s treatment condition. To ensure the reliability of this 
measure, 20% of observations will be completed simultaneously with a 
second observer to allow the calculation of estimates of reliability. Please 
see the Table in the Treatment Integrity section below for how these 
observations are independent and distinct from the integrity observations.  
Teacher ratings of behavior. Teachers will be administered the following 
measures during the first two weeks of the month of January and again in 
May. The following measures will be used as indicators of student 
outcomes as secondary measures to the primary observational measure.  
Disruptive Behavior Disorders (DBD) Rating Scale. ADHD, ODD, and 
CD Diagnostic and Statistical Manual of Mental Disorders (DSM-IV; 
APA, 2000) symptoms will be measured using the DBD rating scale 
(Pelham, Gnagy et al., 1992). The DBD is a 45-item measure that asks 
parents to rate the DSM symptoms of ADHD, ODD, and CD on a 0-3 
point Likert scale (i.e., Not at all, Just a little, Pretty Much, or Very 
Much). For this study, the average score for the DSM ADHD symptoms 
will be used as one outcome. The teacher DBD rating scale has good 
internal consistency (coefficient alpha = .91-.96). Across a number of 
studies the DBD has also shown sensitivity to behavioral treatment effects 
(Pelham, Fabiano, & Massetti, 2005).  
Strengths and Difficulties Questionnaire (SDQ): In order to obtain 
information about the child’s functioning across inattentive/hyperactive, 
emotional symptoms, peer problems, conduct problems, and prosocial 

 
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behavior, the SDQ will be administered at intake and during the pre-post 
assessments during the subsequent academic year. There is an SDQ for 
parents and teachers, and there is a version for 4-10 year olds and 11-17 
year olds (all versions are attached in CLICK).  
Domain-Specific Improvement Rating. At the endpoint assessment, 
teachers will complete impressions of improvement on each of the child’s 
academic and socially related behaviors (Guy, 1976; Pelham et al., 2000). 
This measure will ask teachers to rate improvement on each goal/objective 
at the end of the school year on a seven-point Likert scale (Very much 
worse to Very much improved; the midpoint indicates No change). Thus, 
scores can range from 1.0-7.0. Scores will be averaged across items to 
provide an overall index of improvement at post-treatment. Ratings of 
improvement have long been used in numerous pharmacological and 
behavioral treatment studies. This scale has been shown to be sensitive to 
behavioral treatment effects in Summer Treatment Program classrooms 
(Pelham & Hoza, 1996; Pelham et al, 2000), parent training interventions 
(Fabiano, Chacko, et al., 2009), our Goal 2 Study (Fabiano, Vujnovic, 
Pelham, et al., 2010), and a randomized trial of a school-wide behavioral 
intervention (Pelham, Massetti, et al., 2007). The global improvement 
rating has demonstrated inter-rater reliability (e.g., Tolin et al., 2007; r = 
.81), and clinician-rated improvement scores correlate with parent reports 
of improvement for individualized target behaviors (Arnold et al., 2003).  
Impairment Rating Scale (Evans, Allen, Moore, & Strauss, 2005; Fabiano 
et al., 2006). The IRS is a rating scale that asks teachers to rate the 
severity of the child’s problems and need for treatment and/or special 
services in important functional domains (i.e., relationship with peers, 
relationship with the teacher(s), academic progress, classroom 
functioning, self-esteem, overall need). There are six items on the scale, 
and scores on the measure range from zero (Not a problem/Definitely 
does not need treatment or special services) to six (Extreme 
problem/Definitely needs treatment or special services). Test-retest 
reliability estimates range from .60-.89 over a period of six months, and 
.54 to .76 over one-year. Ratings on the IRS predict mental health or 
school services, and there is evidence of convergent and discriminant 
validity on the measure (Fabiano et al., 2006). The average score for each 
of the individual domains rated will be used in the analysis; scores range 
from 0.0-6.0. 
Rating of IEP Goals (Fabiano, et al., 2010; Guy, 1976; Pelham & Hoza, 
1996; Pelham et al., 2000). At each of the classroom observations, 
observers will be furnished with a copy of the child’s DRC. In the case of 
the SAU group, an Individualized Target Behavior Checklist (ITBC) will 
be provided (Fabiano et al., 2010; Pelham et al., 2005). The observer will 
complete this DRC/ITBC each day following the whole-day observation. 
In addition, the observer will ask teachers in the DRC group for a copy of 
the day’s DRC and ask teachers in the SAU group to complete the same 

 
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ITBC. Therefore, we will have the teacher ratings of IEP goal attainment 
over the three days at baseline and endpoint with built-in procedures to 
assess inter-rater reliability.  
At the endpoint assessment, teachers will complete impressions of 
improvement on each of the child’s academic and socially related IEP 
goals and objectives with those unrelated to social or academic outcomes, 
such as fine motor or speech goals, removed (Guy, 1976; Pelham et al., 
2000). This measure will ask teachers to rate improvement on each 
goal/objective at the end of the school year on a seven-point Likert scale 
(Very much worse to Very much improved; the midpoint indicates No 
change). Thus, scores can range from 1.0-7.0. Scores will be averaged 
across items to provide an overall index of improvement at post-treatment. 
Ratings of improvement have long been used in numerous 
pharmacological and behavioral treatment studies. This scale has been 
shown to be sensitive to behavioral treatment effects in Summer Treatment 
Program classrooms (Pelham & Hoza, 1996; Pelham et al, 2000), parent 
training interventions (Fabiano, Chacko, et al., 2009), our Goal 2 Study 
(Fabiano, Vujnovic, et al., 2010), and a randomized trial of a school-wide 
behavioral intervention (Pelham, Massetti, et al., 2007). The global 
improvement rating has demonstrated inter-rater reliability (e.g., Tolin et 
al., 2007; r = .81), and clinician-rated improvement scores correlate with 
parent reports of improvement for individualized target behaviors (Arnold 
et al., 2003).  
Primary Measures of Academic Functioning. 
 
Academic Performance Rating Scale (APRS). The APRS is a 22-
item measure that asks teachers to rate different aspects of a child’s 
academic performance in the classroom (DuPaul, Rapport, & Perriello, 
1991). The APRS (DuPaul et al., 1991) includes an Academic Productivity 
factor (7 items) that relates to work completion and accuracy, independent 
work, and following directions (coefficient alpha = .94; test-retest 
reliability over two weeks = .93), an Academic Success (12 items) factor 
related to the child’s academic achievement, recall, and ability 
(coefficient alpha = .95; test-retest reliability over two weeks = .91).  
The factors demonstrate predictive validity as children with ADHD were 
rated by teachers as significantly worse than students without ADHD and 
the measure correlated significantly with measures of academic 
achievement and academic efficiency, even with ADHD symptoms 
partialed out (DuPaul et al., 1991). Items are rated by teachers on a five-
point Likert scale, and scores were summed for each of the two factors. 
Scores from 5-35 for the Academic Success factor ranged and from 5-60 
for the Academic Productivity factor.  
Secondary measure of distal academic achievement -- Wechsler Individual 
Achievement Test – III (Pearson, 2009). Participants will be administered 
the WIAT-III at the beginning and end of the study year to assess 

 
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academic achievement.  This standardized, norm-referenced measure will 
take approximately 90 minutes to complete and has strong test-retest 
reliability (r > .90; Pearson, 2009) yielding composites of Total Reading, 
Basic Reading, Reading Comprehension and Fluency, Written Expression, 
Mathematics, and Math Fluency.  
 
Social Validity (i.e., whether outcomes are acceptable, relevant, and 
useful) 
Student-Teacher Relationship Scale (STRS; Birch & Ladd, 1998; Pianta, 
1994, 1996, 1997; Pianta, Steinberg, & Rollins, 1995). To investigate 
differences in the student-teacher relationship, the STRS will be 
administered. The STRS a 28-item scale completed by the teacher. 
Teachers respond to items on a five point Likert scale ranging from 1 
(Definitely does not apply) to 5 (Definitely applies). The STRS total score 
(coefficient alpha = .89; test-retest reliability over four weeks = .89) will 
be used as an index of the student-teacher relationship. The STRS also 
exhibits predictive validity (Pianta, 1996). Scores on the STRS range from 
5-140. 
Parent and Teacher Satisfaction. To obtain a measure of teacher and 
parent satisfaction with the intervention, and compare it to satisfaction in 
the SAU condition, raters will complete a measure of consumer 
satisfaction at the end of school. The measure used will be the satisfaction 
measure used with teachers and parents in the MTA study (Pelham et al., 
under review). The measure may be divided into three factors: treatment 
satisfaction, perceived improvement, and demands of treatment. The 
internal consistency of the items on the parent factor were acceptable for 
the treatment satisfaction (coefficient alpha = .87), perceived 
improvement (coefficient alpha = .72), and demands of treatment 
(coefficient alpha = .84). On the parent version, test-retest correlations 
ranged from .42 to .62, representative of this type of measure.  
 
Moderators 
 
Grade. The grade of the children in the study will be used as a 
proxy for age. Students will be grouped as K-3 (primary) and 4-6 
(secondary) for moderator analyses. The grade level moderator is 
important to investigate given clear evidence that effective behavior 
modification procedures decrease incrementally as children move up in 
grade (Brophy, 1986; Fabiano et al., 2002; White, 1975) and that more 
teachers are typically involved in working with the student at the 
intermediate/middle school level relative to the primary grade level. 
Comorbidity. To investigate outcomes for disruptive behavior, the scores 
for ratings on ODD/CD symptoms will be used to identify the presence of 
comorbid Oppositional Defiant Disorder or Conduct Disorder. In the 

 
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Goal 2 study sample, the coefficient alpha for disruptive behavior disorder 
items from the DBD scale was .96. Comorbid disruptive behaviors were 
significantly improved in the Goal 2 study (Fabiano et al., 2010), making 
this a reasonable candidate for moderational analyses.  
IEP Quality. IEP quality will be assessed using a composite rating by 
study investigators. Prior to quality ratings, IEPs will be de-identified to 
remove the participant name and information as well as any information 
about the school or district. Ratings will evaluate the alignment between 
needs listed in the IEP with goals/objectives stated in the IEP. This will be 
one way to determine the quality of the IEP document itself – well-written 
IEPs should have IEPs with close alignment between academic, behavior, 
and social/emotional needs and the goals to realize improvement (see 
appendix C for an outline of the coding sheet to be used in the present 
study; Pariseau, 2011). We will also track which goals are added by 
consultants to the DRC that were noted as needs by the teacher, but not 
listed on the IEP.  The occurrence of these issues may indicate that the 
IEP is outdated, poorly constructed, or not reflective of current behavior. 
These indicators will comprise an IEP quality score investigated as a 
moderator. Specifically, the score will be calculated as: (Alignment 
between needs and goals + additional targets added)/overall alignment).  
A score of 1 would indicate perfect alignment whereas a score below 1 
would indicate discrepancy between needs and goals.  
 
Mediators 
Three key components of the DRC intervention that are central to our 
logic model (see figure in the introduction) will be investigated as 
mediators of treatment outcome. It is expected that relative to the SAU 
group, the children in the DRC condition will experience a more positive 
classroom environment, receive more consistent feedback from teachers, 
and experience more consistent home-based consequences for school 
behavior. These three variables will each have a partial mediating effect, 
and the sum total will fully mediate the effect on treatment outcome. 
Positive Student-Teacher Interactions. The ratio of positive to negative 
statements issued by the teacher on the SBTR observational measure will 
be used as an indicator of student-teacher interactions, with classrooms 
that have a positive environment having a larger number (i.e., more 
positives than negatives) relative to those that have a negative 
environment (i.e., fewer positives than negatives). Prior studies have 
demonstrated this information can be reliably collected (Vujnovic, et al., 
2014). Further, these rates of positive to negative statements can be 
reliably modified based on background behavioral interventions such as 
the DRC (Fabiano et al., 2007). This measure will be collected across 
SAU and DRC groups.  

 
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Teacher Feedback for Targeted Behaviors. Observers in the DRC and 
SAU groups will have a list of the child’s DRC/ITBC targets for each of 
their classroom observations. Observers will record the frequency of 
targeted behaviors exhibited as well as the number of targeted behaviors 
that receive appropriate feedback from the teacher. Observers will be 
blind to treatment condition. This approach to recording targeted 
behaviors and denoting which were responded to appropriately is part of 
the SBTR observation system developed by our group and used 
successfully in a number of school settings (Fabiano et al., 2010; Pelham 
et al., 2007; Vujnovic, Fabiano, et al., 2014). In this case we will modify 
the rule violations typically observed to be the individual child’s targeted 
behaviors. The SBTR observation system has good inter-rater reliability: 
in one study the mean difference between the observers on total number of 
challenging behaviors was .53 (SD=3.3; Range=0-12). In an early 
childhood setting, agreement on the appropriate acknowledgement of 
challenging behavior was .68 (p<.05). For the total challenging behaviors 
variable, the correlation between the two observers was .94 (p < .001; 
Fabiano et al., 2010), supporting the inter-rater reliability of the 
observation measure. As a measure of validity, classroom challenging 
behaviors were negatively correlated with class climate r=-.45 (Massetti 
et al., 2007). The proportion of DRC/ITBC behaviors that were exhibited 
by the child that received feedback from the teacher will be used as an 
indicator of teacher monitoring and feedback of IEP goals.  
Parent-Implemented Contingency Management. Families will be 
contacted in the morning and will be asked what contingencies were 
administered in the home the prior evening based on school behavior. For 
the SAU group, it is expected that the answer for most contacts will be 
none, unless the parent/school have arranged some contingency 
management program. For the DRC group, it is expected that the parent 
will report contingencies administered within the bounds of the DRC 
reward program. The number of days contingent rewards were accurately 
provided will be considered as a mediating variable. The collection of 
home reward related data suggested predictive validity in a recent meta-
analysis (Vannest et al., 2010) and in our Goal 2 project. In the Goal 2 
project, the percent of DRCs rewarded appropriately was negatively 
related to frequency of disruptive behavior at the end of the school year 
(r= -.53, p=.002; Fabiano et al., 2010). It is expected that the repeated 
morning phone calls will result in increased reliability for this measure. 
Teachers will also ask the child the next morning what reward was 
received and record this for the investigators. Teacher collected data 
should be less susceptible to reactivity for this variable than information 
provided by the parent.  
 
Treatment Integrity and Fidelity of the Intervention as Implemented 

 
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 Multiple methods will be used to document treatment integrity and 
fidelity. To record the integrity and fidelity (Cordray & Pion, 2006; 
Gresham, 1989; Lane, Beebe-Frankenberger, Lambros, & Pierson, 2001; 
Waltz, Addis, Koerner, & Jacobson, 1993) with which the DRC 
intervention is implemented, multiple procedures will be used that have 
been previously developed (Pelham, Greiner, & Gnagy, 1998; Pelham et 
al., 2000). Treatment fidelity will be defined as the skill, care, and 
genuineness with which the intervention is implemented, and integrity will 
refer to the degree to which the intervention was implemented as intended.  
Fidelity of Teacher Implemented Interventions. Observers will collect 
information each month (January to May) on teacher responses to student 
behavior and general classroom management techniques. These 
observations will include a recording of frequency counts of social 
reinforcement (e.g., praise statements) as well as commands and negative 
feedback (i.e., reprimands) directed toward the individual student across 
the entire school day. These frequency counts will be combined into a 
ratio of positive to negative statements and used as an indicator of 
classroom environment. After each observation, observers will also 
complete a post-observation inventory form. These forms will ask the 
observer to rate the teacher’s use of social reinforcement, commands, tone 
of voice, and the overall classroom climate on a 7-point Likert scale. An 
example of this rating to be completed after the observation is in Appendix 
C.  
Integrity of DRC/Targeted Behavior Feedback. Once per month, observers 
blind to treatment group assignment will spend a full school day in the 
child’s classroom. The observer will be provided a copy of the child’s 
DRC/ITBC and will record a frequency count of the occurrence of each 
targeted behavior. In addition, targeted behaviors for which the child 
received specific feedback from the teacher (i.e., were acknowledged; 
recorded on the DRC/tracking mechanism if appropriate) will also be 
recorded. This will yield a daily rate of target behavior occurrence, as 
well as the proportion of targeted behaviors that received appropriate 
feedback. Observers will also record the latency between the occurrence 
of a targeted behavior and teacher feedback regarding the behavior using 
a stop-watch (a decision rule of latency greater than 1 minute will be used 
to document “no response” to a target behavior).  
For children in the DRC group, we will be able to obtain a sample of the 
proportion of DRC targets appropriately monitored by the teacher with 
feedback provided. The observer’s completed DRC tracking sheet will also 
be compared to the DRC completed by the teacher to ascertain a sample 
of the accuracy of the report sent home to the parent each afternoon. This 
comparison will be made by the investigators/project coordinator to 
maintain observer blinds.  
Integrity of Home Rewards for School Performance. Following each of the 
all-day school observations (i.e., monthly), SAU/DRC families will be 

 
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called/texted the next morning and the child and parent will be asked what 
contingencies were administered based on school behavior. In addition, 
teachers will be asked in the SAU and DRC groups about the provision of 
any school-based rewards. SAU 
parents will also be asked 
whether they received any 
feedback from the teacher 
regarding the child’s behavior 
in school that day and in what 
form (email, DRC, etc.).  
In addition, for participants in 
the DRC group, parents will be 
asked each day to sign the DRC 
and record the reward 
administered, if any. Then, they 
will return the DRC to the 
teacher the next morning. This 
will help promote home-school communication, and was a procedure used 
successfully in the Goal 2 project. It is hypothesized that the phone calls to 
query reward administration will replicate and extend these preliminary 
findings. Such phone calls have been successfully implemented by our lab 
on other funded projects (e.g., Fabiano, et al., 2012; NIMH # 
R34MH078051). The interface between observations of primary outcome 
and observations of integrity/fidelity during the course of the study is 
illustrated above. Finally, parents/teachers in both groups will complete a 
checklist at post-treatment reporting how often they used the components 
of the DRC intervention (i.e., provided home reward; daily feedback).  
 
  
 
10.3 List any instruments or measurement tools used to collect data 
(e.g. questionnaire, interview guide, validated instrument, data collection 
form).   
 
Include copies of these documents with your submission. 
Response: See description in 10.2 above.  In addition, a table of measures and 
administration schedule is included with the submission.  
 
10.4 Describe any source records that will be used to collect data about subjects 
(e.g. school records, electronic medical records). 
Response: N/A 
 

 
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10.5 Indicate whether or not individual subject results, such as results of 
investigational diagnostic tests, genetic tests, or incidental findings will be 
shared with subjects or others (e.g., the subject’s primary care physician) 
and if so, describe how these will be shared. 
Response: All subjects will have a diagnostic report generated following the 
intake/screening procedures sent to them for their clinical records. The report will 
be sent directly to the parents of the participant so that the parents can decide with 
whom to share it, if anyone. 
 
10.6 Indicate whether or not study results will be shared with subjects or others, 
and if so, describe how these will be shared. 
Response: At the end of the school year, all subjects will have a treatment 
summary report generated following the school year sent to them for their clinical 
records. The report will be sent directly to the parents of the participant so that the 
parents can decide with whom to share it, if anyone. 
 
11.0 
Study Timelines 
11.1 Describe the anticipated duration needed to enroll all study subjects. 
Response: Participants will be enrolled fall of each year. 
 
11.2 Describe the duration of an individual subject’s participation in the study. 
Include length of study visits, and overall study follow-up time. 
Response: Participants will be invited to a 3-hour intake visit to have study 
eligibility and screening procedures completed. Participants will enroll in the 
study for the entire school year as random assignment and assessment/study 
procedures will be implemented starting in January and continued until May.   
 
11.3 Describe the estimated duration for the investigators to complete this study 
(i.e. all data is collected and all analyses have been completed). 
Response: All data and analyses should be completed for this study by summer 
2022. 
 
12.0 
Setting 
12.1 Describe all facilities/sites where you will be conducting research 
procedures.  Include a description of the security and privacy of the 
facilities (e.g. locked facility, limited access, privacy barriers).  Facility, 
department, and type of room are relevant.  Do not abbreviate facility 
names.   

 
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NOTE:  Examples of acceptable response may be:  “A classroom setting in the 
Department of Psychology equipped with a computer with relevant survey 
administration software,” “The angiogram suite at Buffalo General Medical 
Center, a fully accredited tertiary care institution within New York State with 
badge access,” or, “Community Center meeting hall.” 
Response: University at Buffalo Site. Research activities will be conducted within 
the context of the Center for Children and Families (CCF) at the University at 
Buffalo (SUNY). The CCF is an interdisciplinary center that focuses on a 
tripartite mission of education, research, and service. The CCF is a research, 
clinical, and training facility and its goals are to advance knowledge of mental 
health and learning problems. It is a 12,000 square foot clinical research facility 
that consists of two children’s classrooms (with observational windows), five 
clinical rooms (with observational windows), waiting rooms, a journal library, 
copy room, and offices. All offices are equipped with telephones and networked 
computers. A large number of current statistical software packages are available 
to researchers, and statistical consultation is available. Also, all the required 
assessment materials are housed in the CCF. CCF staff includes Ph.D. level 
faculty, graduate trainees in clinical psychology and school psychology, full-time 
research staff, and undergraduate trainees. Faculty from numerous departments 
and schools across the university are affiliated with the CCF. Located in Buffalo, 
the CCF is close to local schools. 
 
12.2 For research conducted outside of UB and its affiliates, describe: 
• Site-specific regulations or customs affecting the research 
• Local scientific and ethical review structure 
NOTE:  This question is referring to UB affiliated research taking place outside 
UB, i.e. research conducted in the community, school-based research, 
international research, etc.  It is not referring to multi-site research.  UB affiliated 
institutions include Kaleida Health, ECMC, and Roswell Park Cancer Institute.   
Response: A considerable amount of research activities will occur within 
classrooms in local school districts. Prior to engaging in any research activities 
within classrooms, the principal investigator will obtain a Permission to Conduct 
Research in Schools form from a leader in the school and/or district. These 
permission forms will be kept on file and submitted to the IRB during annual 
reviews or amendment requests. 
 
☐ 
N/A:  This study is not conducted outside of UB or its affiliates. 
13.0 
Community-Based Participatory Research 
13.1 Describe involvement of the community in the design and conduct of the 
research.  

 
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NOTE:  Community-Based Participatory Research (CBPR) is a collaborative 
approach to research that equitably involves all partners in the research process 
and recognizes the unique strengths that each brings.  CBPR begins with a 
research topic of importance to the community, has the aim of combining 
knowledge with action and achieving social change to improve health outcomes 
and eliminate health disparities. 
Response:  
 
☒ 
N/A:  This study does not utilize CBPR. 
13.2 
Describe the composition and involvement of a community advisory 
board. 
Response:  
 
☒ 
N/A:  This study does not have a community advisory board. 
14.0 
Resources and Qualifications 
14.1 Describe the qualifications (e.g., education, training, experience, expertise, 
or certifications) of the Principal Investigator and staff to perform the 
research.  When applicable describe their knowledge of the local study sites, 
culture, and society.  Provide enough information to convince the IRB that 
you have qualified staff for the proposed research.  
NOTE:  If you specify a person by name, a change to that person will require prior 
approval by the IRB.  If you specify a person by role (e.g., coordinator, research 
assistant, co-investigator, or pharmacist), a change to that person will not usually 
require prior approval by the IRB, provided that the person meets the 
qualifications described to fulfill their roles. 
Response: Gregory A. Fabiano, Ph.D., Principal Investigator. Dr. 
Fabiano is Professor in the Department of Counseling, School, and 
Educational Psychology at the University at Buffalo, SUNY. Academic 
year (9 mos) salary support is requested at 20% and 20% summer salary 
support is requested in Years 1-4. His expertise is in the area of school-
based behavioral treatments for children with ADHD, and he was 
principal investigator on the Goal 2 project that investigated how DRCs 
could be used to enhance IEP implementation as well as a Co-Investigator 
on the prior Adaptive Treatment study (Preliminary Study 6). Dr. Fabiano 
has extensive experience with classroom-based behavioral interventions in 
both analogue and regular school settings as well as in the measurement 
of classroom-based teacher and student outcomes (i.e., he was co-I on two 
IES Goal 5 studies). Dr. Fabiano will serve as principal investigator for 
this project at the Buffalo site, and he will be responsible for all research 
and project implementation. At the Buffalo site, he will oversee 
recruitment of participants, coordinate assessments, and provide 
supervision of research staff. During the final year of the project, he will 

 
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participate in analyzing and interpreting the results and in writing reports 
and publications. 
Describe other resources available to conduct the research.  
14.2 Describe the time and effort that the Principal Investigator and research 
staff will devote to conducting and completing the research. 
NOTE:  Examples include the percentage of Full Time Equivalents (FTE), hours 
per week.  The question will elicit whether there are appropriate resources to 
conduct the research. 
Response: Dr. Fabiano’s time is budgeted Academic year (9 mos) salary support 
is requested at 22% and 25% summer salary support is requested in Years 1-4. 
 
 
14.3 Describe the availability of medical or psychological resources that subjects 
might need as a result of anticipated consequences of the human research, if 
applicable. 
NOTE:  One example includes: on-call availability of a counselor or psychologist 
for a study that screens subjects for depression. 
Response: Study PI (Dr. Fabiano) will be available on-call for participants 
throughout the study via cell-phone. 
 
14.4 Describe your process to ensure that all persons assisting with the research 
are adequately informed about the protocol, the research procedures, and 
their duties and functions. 
Response: All study staff will complete CITI training, complete UB’s training for 
working with children and have a background check completed to ensure the 
appropriateness for working with children. 
 
15.0 
Other Approvals 
15.1 Describe any approvals that will be obtained prior to commencing the 
research (e.g., school, external site, funding agency, laboratory, radiation 
safety, or biosafety). 
Response: Any participating school district will complete the Permission to 
Complete Research in Schools form prior to any classroom visits or research 
conducted in the school.  
 
☐ 
N/A:  This study does not require any other approvals. 
16.0 
Provisions to Protect the Privacy Interests of Subjects 
 

 
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16.1 Describe how you will protect subjects’ privacy interests during the course 
of this research. 
NOTE:  Privacy refers to an individual’s right to control access to him or herself.  
Privacy applies to the person.  Confidentiality refers to how data collected about 
individuals for the research will be protected by the researcher from release.  
Confidentiality applies to the data.   
Examples of appropriate responses include:  “participant only meets with a study 
coordinator in a classroom setting where no one can overhear”, or “the 
participant is reminded that they are free to refuse to answer any questions that 
they do not feel comfortable answering.”   
Response: During all interactions with parents, only first names will be used, not 
last names. When meeting with teachers, we will not tell office staff about the 
specific nature of our visit. All intake and follow-up appointments will occur in 
private, secure offices at the University at Buffalo or at private locations at the 
schools.  Any correspondence to participant families or teachers will be mailed in 
sealed envelopes. 
 
16.2 Indicate how the research team is permitted to access any sources of 
information about the subjects.   
NOTE:  Examples of appropriate responses include:  school permission for review 
of records, consent of the subject, HIPAA waiver.  This question does apply to 
records reviews. 
Response: Only graduate students, direct study staff, and the principal investigator 
will have access to those rooms and cabinets where the data will be stored. 
Undergraduate research assistants will have access to the data initially for entry 
into a computerized database, but this will all be monitored and controlled by the 
graduate students, direct study staff, or principal investigator. School related data 
(e.g., teacher rating scales) will be obtained from the school via a Release of 
Information Authorization signed by the parent. 
 
 
17.0 
Data Management and Analysis 
17.1 Describe the data analysis plan, including any statistical procedures.  This 
section applies to both quantitative and qualitative analysis.  
Response: To ensure appropriate manipulation of the independent 
variable the treatment integrity data described above will be collected and 
analyzed. The distributional characteristics of all dependent variables will 
be examined. If outcomes are appreciably non-normal, we will consider 
power transformations where appropriate. Although we expect that our 
cross-site and cross-cohort training efforts will mitigate the possibility of 
any site, cohort, or consultant differences, we will still conduct sensitivity 
analyses that evaluate treatment effects separately by cohort, site, and 

 
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consultant. As the study is powered for efficacy analyses and we do not 
anticipate being powered to detect cohort/site/consultant effects, these 
analyses will emphasize effect size comparisons. To the extent that any 
differences are revealed, we will improve cross-site and cross-cohort 
training and fidelity observations, as well as to consider the inclusion of 
site, cohort, or consultant as additional covariates. Benjamini-Hochberg 
adjustments will be used throughout in order to control for the false 
discovery rate associated with multiple comparisons across outcomes 
(Benjamini & Hochberg, 1995). This strategy is implemented in SAS® 
using PROC MULTEST. Multiple imputation methods will be used to 
accommodate missing data (Allison, 2002). This strategy is implemented 
in SAS® using PROC MI and MIANALYZE.  
Aim 1. Investigate the effectiveness of using a DRC to link the child with 
ADHD’s IEP to daily classroom behavior. 
Aim 1 will be evaluated using Analysis of Covariance (ANCOVA) models 
of the following form 
 
Specifically, each outcome score will be regressed on the corresponding 
pre-test score, a treatment indicator, and four covariates (medication 
status, grade level, comorbid DBD, and child gender)—the first three of 
which will be evaluated as potential moderators of treatment in Aim 2. 
Although the pretest score can be conceived as simply another covariate, 
it is distinguished here to emphasize the point that its inclusion results in 
improved statistical power relative to a repeated measures approach for 
evaluating treatment efficacy (Van Breukelen, 2006). Group differences on 
adjusted post-test scores (i.e., the significance test of γ2) will inform the 
efficacy of using the DRC to enhance academic performance and 
behavioral outcomes beyond that associated with the routine use of IEP. 
Measures of primary outcome will be observations of classroom behavior 
and teacher ratings of academic performance. Measures of secondary 
outcome will include teacher ratings of symptoms and impairment related 
to ADHD.  
Aim 2. Investigate moderators of treatment outcome. 
Aim 2 will be evaluated by extending the ANCOVA model from Aim 1 as 
follows 
 

 
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Specifically, Aim 2 will extend the models estimated from Aim 1 by 
including three additional terms (i.e., the product of each of the three 
moderators—age group, comorbid DBD, IEP Quality–with the indicator 
of treatment). Tests of each of these three terms (i.e., γk1, γk2, γk3) will 
inform Aim 2. Each DRC X moderator term that is statistically significant 
will be probed using simple main effects (i.e., comparisons between DRC 
and SAU outcomes within each level of the moderator variable) in order 
to delineate the differential magnitude of treatment on adjusted post-test 
scores as a function of a given covariate (i.e., primary vs. secondary 
grade; ADHD only vs. ADHD+DBD; High Quality vs. Low Quality IEP).  
Aim 3. Investigate mediators of treatment outcome. Aim 3 will be 
evaluated using a path analytic approach for testing mediation. The path 
model will extend the ANCOVA models above by simultaneously 
estimating equations for both 
the post-test score and 
mediators. Specifically, a 
path model will be estimated 
in which post-test scores are 
regressed on a dichotomous 
indicator of treatment, 
covariates described above 
(including pre-test scores and 
moderators), and on three mediators, measured as aggregate variables 
across the treatment period, including the quality of the classroom 
environment (ratio of positive to negative comments direct to the target 
child), consistency of teacher feedback in the classroom and home-based 
consequences related to school behavior. Moreover, the mediators will be 
simultaneously regressed on the indicator of treatment. A prototypic 
model is depicted below. The dashed line from covariates to post-test 
indicates that this actually refers to a block of variables that are omitted 
for presentation purposes A formal evaluation of mediation comes from 
tests of whether the product of the coefficients relating treatment to 
mediators and mediators to outcomes (i.e., the indirect effects) differs 
from 0 (Bollen, 1987; MacKinnon, 2008). Whereas the joint test of the set 
of product terms (i.e., a*d = b*e = c*f = 0) provides an omnibus test of 
mediation, individual tests of products (i.e., a*d = 0; b*e = 0; c*f = 0) 
informs the contribution of each specific mediator. When combined with 
information regarding tests of indirect effects, the statistical significance 
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Classroom
Environment
Consistency
Teacher Feedback
Consistency
Home Rewards
Post-test
Treatment
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b
c
d
e
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t

 
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of the direct effect of treatment on post-test scores informs whether partial 
(i.e., if the path ‘t’ is statistically significant) or complete (i.e., if the path 
‘t’ in the figure is not statistically significant) mediation is present. All 
tests of mediation will be based on the use of bootstrapped standard 
errors, which results in better statistical power and avoids having to make 
potentially unrealistic distributional assumptions about the mediated 
effect (MacKinnon et al., 2004; Preacher & Hayes, 2008). All mediated 
effects will be tested using Mplus software which includes facilities for 
testing individual and compound sets of mediated effects, as well as the 
use of bootstrapped standard errors (Muthén & Muthén, 2006).  
 
 
17.2 If applicable, provide a power analysis.   
NOTE:  This may not apply to certain types of studies, including chart/records 
reviews, survey studies, or observational studies.  This question is asked to elicit 
whether the investigator has an adequate sample size to achieve the study 
objectives and justify a conclusion.  
Response:  
We relied on our previous (N = 63), randomized study 
contrasting DRC and SAU conditions in order to compute effect sizes for 
the proposed study (see Preliminary Study 2). Results from that study 
indicated an effect size of approximately Cohen d = .50 (or larger) across 
the majority of outcomes considered. The weighted random effects effect 
size of between groups studies for ADHD such as this one was .74; thus 
we are using a conservative effect size relative to the larger literature 
(Fabiano et al., 2009). We also assumed that covariates (most prominently 
the pre-test score) would explain at least 45% of the observed variation in 
post-test scores (in the Goal 2 study using comparable covariates 47% of 
the variance for post-test scores for objective observations and teacher 
ratings of ADHD was explained by pre-test scores).  
 
Given these assumptions, Aim 1 will have power of .80 to detect 
effects of Cohen d = .50 with N = 71 participants. In order to estimate 
power for Aim 2, we assumed treatment effects of Cohen d = .4 and .6 
within moderator groups (e.g., the treatment effect would be Cohen d = .4 
in intermediate grades compared to Cohen d = .6 in primary grades), 
which, given the sampling plan that balances participants across levels of 
dichotomous moderators, is consistent with the marginal treatment effect 
of Cohen d = .50 used for Aim 1. In order to detect treatment effects as 
small as Cohen d = .40 (given R2 = .45, as per Aim 1) with power of .80, 
N = 105 participants are necessary. Hence, the total sample size needed 
to power Aim 2 at .80 is adequate at N = 216 (i.e., 108 participants X 2 
levels of moderator). Based on recent work by Fritz and MacKinnon 
(2007), the proposed total sample size of 216 will provide power of 
greater than .80 to detect moderate sized indirect (mediated) effects (there 
is no standard metric for reporting effect sizes for indirect effects). We 

 
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conclude that N=216 participants results in power of .80 or greater to 
address all three motivating aims. The use of modern methods for dealing 
with missing data (Multiple Imputation for Aims 1 and 2, Full Information 
Maximum Likelihood estimation for Aim 3) ensure that all N = 216 
participants will contribute to each analysis.  
17.3 Describe any procedures that will be used for quality control of collected 
data. 
Response:  
Treatment Integrity and Fidelity of the Consultant Activities 
 
Consultants will partner with teachers/parents to develop DRCs based on 
the IEP of the participating student.  Procedures for establishing DRCs are 
manualized (see Appendix D) and all visits with teachers and parents have a 
checklist that is to be completed by the consultant to ensure all procedures were 
implemented (see Appendix C). Further, to ensure that the consultant checklists 
are being completed appropriately, we will have consultants audio-record all 
consultant meetings, and 20% of each consultant’s recordings will be evaluated 
for integrity to the checklists (all meetings will be recorded to prevent reactivity 
or positive presentation solely during selected recorded sessions).  In prior work 
we were able to obtain permission from 100% of teachers to audiotape 
comparable meetings (N=89; Fabiano, Reddy, et al., 2017). To obtain 
information on the fidelity of consultants we will ask parents and teachers to 
complete an evaluation of the consultant following the final assessment through 
submission of a sealed envelope to a staff member uninvolved with the case to 
prevent reactivity. Adherence will be measured by contact logs and the collection 
of behavioral products (e.g., completed DRCs). 
 
18.0 
Confidentiality 
 
A. Confidentiality of Study Data 
 
Describe the local procedures for maintenance of confidentiality of study data 
and any records that will be reviewed for data collection.   
 
18.1 
A.  Where and how will all data and records be stored?  Include 
information about:  password protection, encryption, physical controls, 
authorization of access, and separation of identifiers and data, as applicable.  
Include physical (e.g. paper) and electronic files. 
Response: All data will be immediately deidentified and stored on a secure, 
password protected server at the University of Buffalo. All deidentified measures 
will be stored in locked filling cabinets at each respective site. Data will be 
entered electronically into the Research Electronic Data Capture system 
(REDCap; project-redcap.org), a secure web application engineered for data 
collection purposes, or into data files on secure UB servers. 

 
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18.2 
A.  How long will the data be stored? 
Response: The data will be kept on file for approximately 3 years following any 
professional publication according to the American Psychological Association 
guidelines.  Deidentified, anonymous data will be kept in a database indefinitely. 
18.3 
A.  Who will have access to the data? 
Response: Only trained study personnel and staff will have access to the data.  
 
 
18.4 
A.  Who is responsible for receipt or transmission of the data? 
Response: Data that are collected from participants will be immediately stored 
electronically via REDCap, entered into data files on secure UB servers, or 
immediately placed into locked filing cabinets at the University at Buffalo. Only 
deidentified data will be available through the REDCap system. No other 
transmission or receipt of data will be necessary. 
 
 
18.5 
A.  How will the data be transported? 
Response: Not applicable. Recordings or study measures completed at either the 
University at Buffalo will stay at their respective site. Only deidentified data will 
be available through the REDCap system. 
 
B. Confidentiality of Study Specimens 
 
Describe the local procedures for maintenance of confidentiality of study 
specimens.   
 
☒ 
N/A:  No specimens will be collected or analyzed in this research.   
(Skip to Section 19.0) 
 
18.6 
B.  Where and how will all specimens be stored?  Include information 
about:  physical controls, authorization of access, and labeling of specimens, as 
applicable.   
Response:  
 
18.7 
B.  How long will the specimens be stored? 
Response:  

 
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18.8 
B.  Who will have access to the specimens? 
Response:  
 
18.9 
B.  Who is responsible for receipt or transmission of the specimens? 
Response:  
 
18.10 B.  How will the specimens be transported? 
Response: 
 
 
19.0 
Provisions to Monitor the Data to Ensure the Safety of 
Subjects 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
 
NOTE:  Minimal risk studies may be required to monitor subject safety if the research 
procedures include procedures that present unique risks to subjects that require 
monitoring.  Some examples include:  exercising to exertion, or instruments that elicit 
suicidality or substance abuse behavior.  In such cases, N/A is not an acceptable 
response. 
 
19.1 Describe the plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe. 
Response:  
The principal investigator will oversee and be responsible 
for monitoring the safety and efficacy of the trial.  An annual report will 
be sent to NIMH outlining recruitment of participants and their 
demographic characteristics and how these compare to expected 
recruitment rates, retention rates in the project, summaries of any adverse 
events, and any actions taken with respect to the protocol.  The study will 
be approved by the University at Buffalo and Florida International 
University Institutional Review Boards.   
 
 
All data collected will be coded with study numbers (computer-
generated data, videotapes, and paper ratings) and the sheet linking study 
code numbers to individuals will be keep in a locked filing cabinet inside a 
locked room.  All data entered into computer databases will use study 
numbers to protect the confidentiality of the participants.  Data entry will 
be checked by an individual other than whomever entered the data, and 
errors will be corrected and discrepancies corrected by a supervisor 

 
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based on the original source documents.  Data will be entered and 
screened for accuracy immediately after it is obtained, and preliminary 
blind analyses will be conducted immediately after each funded year to 
determine whether the results indicate an overwhelming treatment effect 
that suggests the study should be stopped, or suggests any potential 
unforeseen adverse effect of the behavioral parent training programs.  All 
source documents and recordings will be kept in locked filing cabinets 
inside a locked room.   
 
Experimental integrity will be ensured by the creation of program 
manuals, checklists and materials to ensure consistent implementation of 
planned manipulation components.  In addition, all sessions will be video-
recorded so that the principal investigator can review implementation and 
provide feedback as necessary. Data will be collected by research 
assistants who have completed the Biomedical Sciences CITI course on 
research ethics, and who are trained by the study investigators in the 
research procedures. 
The safety of all participants in these proposed studies is paramount.  
After the initial intake interview, records will be reviewed by the principal 
investigator to determine the participant’s eligibility for the study.  
Careful attention will be directed toward any potential reports of child 
abuse or neglect or reports of suicidal ideation or behavior on the part of 
the parent or child.  Should child abuse or neglect be suspected, the 
parent will be notified that a mandated report is being made to the state 
child abuse hotline.  Any additional actions that might be necessary to 
ensure the child’s immediate safety will occur.  Similarly, if a parent 
reports suicidal ideation, intent, or behavior on the part of the child or 
parent, the participant will not be enrolled in the study, but instead 
directed to mental health or psychiatric treatment, and if interested can 
enroll in the project once their behavior has stabilized.   
 
 
19.2 Describe what data are reviewed, including safety data, untoward events, 
and efficacy data. 
Response: See response to 19.1 
 
19.3 Describe any safety endpoints. 
Response: Safety endpoints will be the collection of endpoint data in May 
 
19.4 Describe how the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with participants). 

 
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Response: See response to 19.1 
 
19.5 Describe the frequency of safety data collection. 
Response: Data will be collected at intake, in January, and in May. Spontaneous 
reports will also be collected, documented and reviewed by the PI and the team at 
least weekly. 
 
19.6 Describe who will review the safety data. 
Response: Final review will be conducted by Dr. Fabiano 
 
19.7 Describe the frequency or periodicity of review of cumulative safety data. 
Response: At least weekly or more often if needed. 
 
19.8 Describe the statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
Response: Each year, preliminary analyses will be conducted to ensure there is no 
untoward effect of the DRC intervention.  
 
19.9 Describe any conditions that trigger an immediate suspension of the 
research. 
Response: Documentation of a significant untoward effect of the DRC.  
 
20.0 
Withdrawal of Subjects 
☐ 
N/A:  This study is not enrolling subjects.  This section does not apply. 
 
20.1 Describe anticipated circumstances under which subjects may be withdrawn 
from the research without their consent. 
Response: Subjects may be withdrawn due to failure to comply with study 
protocol, or pursuing of treatments incompatible with study procedures (e.g., 
home instruction). 
 
20.2 Describe any procedures for orderly termination.   
NOTE:  Examples may include return of study drug, exit interview with clinician.  
Include whether additional follow up is recommended for safety reasons for 
physical or emotional health. 

 
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Response: At the end of the school year, all participants will be invited to an exit 
interview, complete ratings of effectiveness and satisfaction, and review study 
outcomes with the investigators. Recommendations for continued treatment will 
be provided. 
 
20.3 Describe procedures that will be followed when subjects withdraw from the 
research, including retention of already collected data, and partial 
withdrawal from procedures with continued data collection, as applicable. 
Response: If participants withdraw from the research, any data collected up until 
that point will be retained. If a participant withdraws from a particular part of the 
protocol (e.g., declines school intervention) other procedures and assessments will 
continue, if the participant agrees to continued participation in other aspects of the 
study. 
 
21.0 
Risks to Subjects 
21.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related to their participation in the research. 
Consider physical, psychological, social, legal, and economic risks.  Include 
a description of the probability, magnitude, duration, and reversibility of the 
risks.  
NOTE:  Breach of confidentiality is always a risk for identifiable subject data. 
Response: Risk: Participants may experience mild and transitory psychological 
discomfort from completing research measures, including reporting on child 
emotional and behavior problems and academic difficulties. Procedure: 
Participants and their parents will be advised to ask questions of study personnel 
if confidentiality is of a concern, and to refrain from answering questions that 
cause them person distress.  
Risk: Participants may face risk as they may experience mild and transitory 
psychological discomfort from changing their behaviors as part of the study 
interventions. Procedure: The centers at FIU and at UB are quite experienced at 
running psychosocial intervention for youth with ADHD in school and with 
parents. We experience very low attrition rates (under 5% from our clinical and 
research programs. None the less, children and parents can refuse to continue to 
participate in the study at any time. 
Risk: Teachers may find the additional consultation and implementation of new 
strategies to be burdensome. Procedure: We are quite experienced in teacher 
consultation both in IES- and NIH-funded studies and in nonresearch work in the 
Buffalo and Miami-Dade schools.  Our groups are well known to teaching staff, 
given that we provide regular inservice instruction and consultation to the 
districts, and we have excellent rapport with principals, teachers, 
psychologists/social workers, and administrators. We have had very low rates of 
teacher refusal to participate in the studies, and we anticipate that to continue for 

 
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this project.  Indeed, the vast majority of teachers find the consultations to be 
helpful in coordinating school-based supports for their students with ADHD. We 
will work with teachers to schedule consultations at times teachers identify as 
most convenient. Furthermore, consultations are intended to be collaborative and 
teachers’ input is encouraged.. Efforts will be made to collaborate with and 
reengage teachers who refuse to contribute to any specific intervention or study 
activity.  
Risk: Randomization to the treatment arms. Procedure: This risk will be 
addressed through the informed consent/assent process, where parents and 
children will agree to be assigned to treatment groups. Parents and children are 
free to withdraw from the study at any time and are not obligated to participate in 
the treatment group to which they are assigned. Withdrawing from this study will 
not affect any future interactions or their participation any future clinical services 
or studies at the FIU or the UB centers.   
Risk: Participants may experience a worsening of ADHD if ADHD medication is 
withheld for the study assessments. Procedure: Only those participants who 
obtain permission from the prescribing physician will have medication withheld. 
This is a procedure common in studies of ADHD treatment (Fabiano et al., 2010; 
Pelham, Wheeler, & Chronis, 1998).  
 
 
21.2 Describe procedures performed to lessen the probability or magnitude of 
risks, including procedures being performed to monitor subjects for safety. 
Response: See 21.1 
 
21.3 If applicable, indicate which procedures may have risks to the subjects that 
are currently unforeseeable. 
Response: There are no procedures included for which there are unforeseeable 
risks. 
 
21.4 If applicable, indicate which research procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response: N/A 
 
21.5 If applicable, describe risks to others who are not subjects. 
Response: N/A 
 
22.0 
Potential Benefits to Subjects 

 
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22.1 Describe the potential benefits that individual subjects may experience by 
taking part in the research.  Include the probability, magnitude, and 
duration of the potential benefits.  Indicate if there is no direct benefit.   
NOTE:  Compensation cannot be stated as a benefit. 
Response: All participants in the study will have monitoring of school-based 
treatments, which may help inform future treatment efforts and decisions. 
Participants in the DRC condition will have evidence-based interventions for 
ADHD (i.e., behavior therapy) delivered which may directly benefit the 
functioning of the participants in schools. 
 
23.0 
Compensation for Research-Related Injury 
☒ 
N/A:  The research procedures for this study do not present risk of 
research related injury (e.g. survey studies, records review studies).  This 
section does not apply.   
23.1 
If the research procedures carry a risk of research related injury, 
describe the available compensation to subjects in the event that such injury 
should occur.   
Response: 
 
23.2 
Provide a copy of contract language, if any, relevant to compensation for 
research related injury. 
NOTE:  If the contract is not yet approved at the time of this submission, submit the 
current version here.  If the contract is later approved with different language regarding 
research related injury, you must modify your response here and submit an amendment 
to the IRB for review and approval. 
Response:  
 
24.0 
Economic Burden to Subjects 
24.1 Describe any costs that subjects may be responsible for because of 
participation in the research.   
NOTE:  Some examples include transportation or parking. 
Response: Participants are responsible for providing transportation to study 
meetings and follow-up visits or a home visit will be arranged if preferred. 
 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
25.0 
Compensation for Participation 

 
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25.1 
Describe the amount and timing of any compensation to subjects, 
including monetary, course credit, or gift card compensation. 
Response: Parents and teachers will receive a $45 gift card for completing ratings 
at the January Baseline Assessment as well as the June endpoint assessment. 
 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records 
review procedures only.  This section does not apply. 
☐ 
N/A:  There is no compensation for participation.  This section 
does not apply. 
26.0 
Consent Process 
26.1 Indicate whether you will be obtaining consent.   
NOTE:  This does not refer to consent documentation, but rather whether you will 
be obtaining permission from subjects to participate in a research study.   
Consent documentation is addressed in Section 27.0. 
☐ 
Yes 
(If yes, Provide responses to each question in this Section) 
☐ 
No 
(If no, Skip to Section 27.0) 
 
26.2 Describe where the consent process will take place.  Include steps to 
maximize subjects’ privacy. 
Response: Adult consent, child assent and parental permission will be obtained 
during initial intake and eligibility meetings at the University at Buffalo and 
Florida International University.  
 
As we have done for other IRB-approved studies, teachers will be provided with 
an Information Sheet (described further below) with a packet of ratings by the 
consented parents of the assenting child following the parent and child’s initial 
intake and eligibility meeting. 
As teachers are asked to complete rating forms based on their observations 
of the child and implement the study interventions only, written consent to 
participate will not be obtained. This is because the child is the participant 
in this study, and the teacher is simply a reporter of the child’s behavior 
and implements positive behavioral supports, which are a standard part of 
educational practice for students with ADHD.  Instead, an Information 
Sheet will be provided to teachers outlining relevant sections of a typical 
consent form according to Section 7 of the Criteria for Approval 
Worksheet.  This would meet the criteria of Section 1 of the Waiver of 
Written Documentation of Consent Checklist as: 
a. 
The research presents no more than minimal risk and  
b. 
The research involves no procedures for which written consent is 
normally required outside of the research context. The information 

 
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obtained from teachers is used to supplement other information provided 
by the parents of the child relevant to diagnosis and treatment of the child 
only, and is common in psychological and educational practice.  
The teacher’s refusal to complete rating forms in no way impacts the 
eligibility of the child or parent participant. 
 
 
26.3 Describe how you will ensure that subjects are provided with a sufficient 
period of time to consider taking part in the research study.   
NOTE:  It is always a requirement that a prospective subject is given sufficient 
time to have their questions answered and consider their participation.  See “SOP: 
Informed Consent Process for Research (HRP-090)” Sections 5.5 and 5.6. 
Response: All participants will be provided with time to read/discuss the informed 
consent form, and will be encouraged to take as much time as they need, up to 
including scheduling a follow-up appointment at a later time to prevent the 
participant from feeling any urgency to make an immediate decision. 
 
26.4 Describe any process to ensure ongoing consent, defined as a subject’s 
willingness to continue participation for the duration of the research study.   
Response: Families will be told that their participant is completely voluntary and 
they can discontinue at any time without any consequence. Should our procedures 
change in a manner that necessitates re-consent, all parents and children will be 
asked to re-consent or discontinue.  
26.5 Indicate whether you will be following “SOP: Informed Consent Process for 
Research (HRP-090).” If not, or if there are any exceptions or additional 
details to what is covered in the SOP, describe: 
• 
The role of the individuals listed in the application who are involved in 
the consent process 
• 
The time that will be devoted to the consent discussion 
• 
Steps that will be taken to minimize the possibility of coercion or 
undue influence 
• 
Steps that will be taken to ensure the subjects’ understanding 
Response:  
 
☒ 
We have reviewed and will be following “SOP: Informed Consent Process 
for Research (HRP-090).” 
 
Non-English Speaking Subjects  

 
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☒ 
N/A:  This study will not enroll Non-English speaking subjects.   
(Skip to Section 26.8) 
26.6 Indicate which language(s) other than English are likely to be 
spoken/understood by your prospective study population or their legally 
authorized representatives. 
 
NOTE: The response to this Section should correspond with your response to 
Section 6.4 of this protocol. 
Response:  
 
26.7 If subjects who do not speak English will be enrolled, describe the process 
to ensure that the oral and written information provided to those subjects 
will be in that language.  Indicate the language that will be used by those 
obtaining consent. 
NOTE:  Guidance is provided on “SOP:  Informed Consent Process for Research 
(HRP-090).” 
Response:  
 
 
Cognitively Impaired Adults 
☒ 
N/A:  This study will not enroll cognitively impaired adults.   
(Skip to Section 26.9) 
26.8   Describe the process to determine whether an individual is capable of 
consent.  
Response:  
 
 
Adults Unable to Consent 
☒ 
N/A:  This study will not enroll adults unable to consent.  
(Skip to Section 26.13) 
When a person is not capable of consent due to cognitive impairment, a legally 
authorized representative should be used to provide consent (Sections 26.9 and 
26.10) and, where possible, assent of the individual should also be solicited 
(Sections 26.11 and 26.12). 
26.9  Describe how you will identify a Legally Authorized Representative (LAR).  
Indicate that you have reviewed the “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013)” for research in New 
York State.  

 
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NOTE:  Examples of acceptable response includes: verifying the electronic 
medical record to determine if an LAR is recorded. 
Response:  
 
☒ 
We have reviewed and will be following “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).”  
26.10 For research conducted outside of New York State, provide information 
that describes which individuals are authorized under applicable law to 
consent on behalf of a prospective subject to their participation in the 
research.  One method of obtaining this information is to have a legal 
counsel or authority review your protocol along with the definition of 
“legally authorized representative” in “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).” 
Response: N/A 
 
26.11 Describe the process for assent of the adults: 
• 
Indicate whether assent will be obtained from all, some, or none of the 
subjects.  If some, indicate which adults will be required to assent and 
which will not. 
Response: N/A 
 
• 
If assent will not be obtained from some or all subjects, provide an 
explanation of why not. 
Response: N/A 
 
26.12 Describe whether assent of the adult subjects will be documented and the 
process to document assent.   
NOTE:  The IRB allows the person obtaining assent to document assent on the 
consent document using the “Template Consent Document (HRP-502)” Signature 
Block for Assent of Adults who are Legally Unable to Consent. 
Response: N/A 
 
 
Subjects who are not yet Adults (Infants, Children, and Teenagers) 
☐ 
N/A:  This study will not enroll subjects who are not yet adults.   
(Skip to Section 27.0) 

 
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26.13 Describe the criteria that will be used to determine whether a prospective 
subject has not attained the legal age for consent to treatments or 
procedures involved in the research under the applicable law of the 
jurisdiction in which the research will be conducted (e.g., individuals under 
the age of 18 years).  For research conducted in NYS, review “SOP: 
Legally Authorized Representatives, Children, and Guardians (HRP-013)” 
to be aware of which individuals in the state meet the definition of 
“children.”  
NOTE:  Examples of acceptable responses include: verification via electronic 
medical record, driver’s license or state-issued ID, screening questionnaire. 
Response: Only consenting adults and assenting children with parental permission 
will be enrolled. Assent will be obtained from children 7 years of age and older as 
younger children are likely to be unable to provide informed assent given their 
developmental cognitive level. 
 
26.14For research conducted outside of New York State, provide information 
that describes which persons have not attained the legal age for consent to 
treatments or procedures involved the research, under the applicable law of 
the jurisdiction in which research will be conducted.  One method of 
obtaining this information is to have a legal counsel or authority review 
your protocol along the definition of “children” in “SOP: Legally 
Authorized Representatives, Children, and Guardians (HRP-013).” 
Response: N/A 
 
26.15 Describe whether parental permission will be obtained from: 
Response:  
☒  One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the 
child. 
☐ 
Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for 
the care and custody of the child. 
☐ 
Parent permission will not be obtained.  A waiver of parent permission is 
being requested. 
NOTE:  The requirement for parent permission is a protocol-specific determination 
made by the IRB based on the risk level of the research.  For guidance, review the 
“CHECKLIST: Children (HRP-416).”  
26.16Describe whether permission will be obtained from individuals other than 
parents, and if so, who will be allowed to provide permission.  Describe 

 
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your procedure for determining an individual’s authority to consent to the 
child’s general medical care. 
Response: Permission will be obtained from legal guardians, including parents, 
but may include other adults as determined by judicial review and determination. 
 
26.17 Indicate whether assent will be obtained from all, some, or none of the 
children.  If assent will be obtained from some children, indicate which 
children will be required to assent. 
Response: Assent will be obtained from all children over 7 years of age. 
 
26.18 When assent of children is obtained, describe how it will be documented. 
Response: Assent will be documented via child signature and assenter signature. 
 
27.0 
Waiver or Alteration of Consent Process 
Consent will not be obtained, required information will not be disclosed, or the 
research involves deception. 
☒ 
N/A:  A waiver or alteration of consent is not being requested. 
27.1 If the research involves a waiver or alteration of the consent process, please 
review the “CHECKLIST: Waiver or Alteration of Consent Process (HRP-
410)” to ensure that you have provided sufficient information for the IRB to 
make the determination that a waiver or alteration can be granted.   
NOTE:  For records review studies, the first set of criteria on the “CHECKLIST: 
Waiver or Alteration of Consent Process (HRP-410)” applies.  
Response:  
 
27.2 If the research involves a waiver of the consent process for planned 
emergency research, please review the “CHECKLIST: Waiver of Consent 
for Emergency Research (HRP-419)” to ensure you have provided sufficient 
information for the IRB to make these determinations.  Provide any 
additional information necessary here: 
Response:  
 
28.0 
Process to Document Consent 
☐ 
N/A:  A Waiver of Consent is being requested.   
(Skip to Section 29.0) 
28.1 Indicate whether you will be following “SOP: Written Documentation of 
Consent (HRP-091).” If not or if there are any exceptions, describe whether 

 
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and how consent of the subject will be obtained including whether or not it 
will be documented in writing.   
NOTE:  If your research presents no more than minimal risk of harm to subjects 
and involves no procedures for which written documentation of consent is normally 
required outside of the research context, the IRB will generally waive the 
requirement to obtain written documentation of consent.  This is sometimes 
referred to as ‘verbal consent.’  Review “CHECKLIST: Waiver of Written 
Documentation of Consent (HRP-411)” to ensure that you have provided sufficient 
information.  
If you will document consent in writing, attach a consent document with your 
submission.  You may use “TEMPLATE CONSENT DOCUMENT (HRP-
502)”.  If you will obtain consent, but not document consent in writing, attach the 
script of the information to be provided orally or in writing (i.e. consent script or 
Information Sheet).   
Response:  
 
☒ 
We will be following “SOP:  Written Documentation of Consent” 
(HRP-091). 
29.0 
Multi-Site Research (Multisite/Multicenter Only) 
☐ 
N/A:  This study is not an investigator-initiated multi-site study.  This 
section does not apply. 
 
29.1 If this is a multi-site study where you are the lead investigator, describe the 
processes to ensure communication among sites, such as: 
• 
All sites have the most current version of the IRB documents, including 
the protocol, consent document, and HIPAA authorization. 
• 
All required approvals have been obtained at each site (including 
approval by the site’s IRB of record). 
• 
All modifications have been communicated to sites, and approved 
(including approval by the site’s IRB of record) before the 
modification is implemented. 
• 
All engaged participating sites will safeguard data as required by 
local information security policies. 
• 
All local site investigators conduct the study appropriately. 
• 
All non-compliance with the study protocol or applicable requirements 
will be reported in accordance with local policy. 
Response: This study is a multi-site study where the University at Buffalo is the 
lead site, and Florida International University is the subcontracted site.  Both sites 
will obtain study approval from their respective IRBs. 
 
29.2 Describe the method for communicating to engaged participating sites: 

 
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• 
Problems 
• 
Interim results 
• 
Study closure 
Response: As a multi-site project, careful attention will be provided 
toward consistent implementation of the protocol across both sites (e.g., 
see our description of treatment integrity and fidelity measures described 
above). Dr. Pelham and Dr. Fabiano are both experienced in multi-site 
collaboration. Dr. Pelham has successfully completed numerous multi-site 
studies including a longitudinal follow-up of young children with ADHD 
(e.g., Lahey, Pelham et al., 1998), an investigation of the impact of 
alcohol on parent-child interactions (e.g., Pelham et al., 1998), and he 
was a member of the steering committee for the largest multi-site study in 
the field of ADHD, the multi-modal treatment study for ADHD (MTA 
Cooperative Group, 1999). Dr. Fabiano has also participated in multi-site 
studies investigating time out as an intervention for children with ADHD 
(Fabiano et al., 2004), the development of a measure of impairment for 
children with ADHD (Fabiano et al., 2006), and he is Co-I on two multi-
site, IES Goal 5 projects (Reddy, P.I.; #R305A080337; Chafouleas, P.I., 
#R324A110017). Furthermore, Dr. Fabiano and Dr. Pelham have 
collaborated on ADHD intervention studies for 13 years at the Buffalo 
site, and nearly every study has included behavioral treatments as a 
component of the project similar to the present project. Further, Dr. 
Pelham was the P.I., and Dr. Fabiano was the Co-P.I. on another IES-
funded SMART trial with adaptive treatment tailoring (#R324B060045). 
Thus, the key personnel on the study at both sites will use a protocol for 
intervention that is similar to ones implemented successfully in the past 
(e.g., Fabiano, et al., 2010; Pelham et al., under review), and the team has 
a strong record of collaboration.  
For this project specifically, Dr. Fabiano will meet in person with Dr. 
Pelham each year in tandem with the IES investigator meeting to review 
data collection and management procedures, review procedures for 
training clinicians with the same training protocol, and meet with project 
personnel. Detailed manuals and protocols for all aspects of the study 
were written for the prior Goal 3 project, and Drs. Fabiano and Pelham 
will modify these for the present project. Project investigators will 
participate in a monthly conference call to review study procedures, 
prevent drift, trouble-shoot, and discuss implementation of the procedures. 
Finally, behavioral consultants will have weekly supervision on site. Every 
other week, extended supervision will be held via conference call where 
consultants can discuss current issues, barriers, or successful cases with 
supervisors and peers from both sites. This procedure will be used to 
prevent drift and encourage consistency across sites. To ensure reliability 
of the observational measure, observers will be trained using identical 
procedures are each site in the SBTR observational coding scheme and 
pass a uniform reliability assessment. A data codebook will be established 

 
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for use in data entry at both sites – monthly investigator phone calls will 
include a review of data entry to ensure minimal missing data across study 
years.  
Drs. Fabiano and Pelham will enter data into databases housed on a 
RedCap server. The data server is backed up nightly, and it permits 
remote access from anywhere in the country. This server will also be 
available to statisticians and methodologists to review and work on 
methodological and statistical issues throughout the project, and it will 
also ensure the entire team is using verified and finalized versions of all 
study databases for analysis. 
 
 
29.3 
Indicate the total number of subjects that will be enrolled or records that 
will be reviewed across all sites. 
Response: 216 subjects total will be enrolled across sites. 
 
29.4 
If this is a multicenter study for which UB will serve as the IRB of record, 
and subjects will be recruited by methods not under the control of the local site 
(e.g., call centers, national advertisements) describe those methods.  
Response: N/A 
 
30.0 
Banking Data or Specimens for Future Use 
☒ 
N/A:  This study is not banking data or specimens for future use or 
research outside the scope of the present protocol.  This section does not 
apply. 
30.1 If data or specimens will be banked (stored) for future use, that is, use or 
research outside of the scope of the present protocol, describe where the 
data/specimens will be stored, how long they will be stored, how the 
data/specimens will be accessed, and who will have access to the 
data/specimens.  
NOTE:  Your response here must be consistent with your response at the “What 
happens if I say yes, I want to be in this research?” Section of the Template 
Consent Document (HRP-502). 
Response:  
 
30.2 List the data to be stored or associated with each specimen. 
Response:  
 

 
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30.3 Describe the procedures to release banked data or specimens for future 
uses, including: the process to request a release, approvals required for 
release, who can obtain data or specimens, and the data to be provided with 
specimens. 
Response:  
 
31.0 
Drugs or Devices 
☒ 
N/A:  This study does not involve drugs or devices.  This section does not 
apply. 
31.1 If the research involves drugs or devices, list and describe all drugs and 
devices used in the research, the purpose of their use, and their regulatory 
approval status.  
Response:  
 
31.2 Describe your plans to store, handle, and administer those drugs or devices 
so that they will be used only on subjects and be used only by authorized 
investigators. 
Response: 
 
If the drug is investigational (has an IND) or the device has an IDE or a claim 
of abbreviated IDE (non-significant risk device), include the following 
information: 
31.3 Identify the holder of the IND/IDE/Abbreviated IDE. 
Response:  
 
31.4 Explain procedures followed to comply with FDA sponsor requirements for 
the following:   
 

 
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Applicable to: 
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated 
IDE studies 
21 CFR 11 
X 
X 
 
21 CFR 54 
X 
X 
 
21 CFR 210 
X 
 
 
21 CFR 211 
X 
 
 
21 CFR 312 
X 
 
 
21 CFR 812 
 
X 
X 
21 CFR 820 
 
X 
 
Response:  
 
32.0 
Humanitarian Use Devices 
☒ 
N/A:  This study does not involve humanitarian use devices.  This does 
not apply. 
32.1 
For Humanitarian Use Device (HUD) uses provide a description of the 
device, a summary of how you propose to use the device, including a description 
of any screening procedures, the HUD procedure, and any patient follow-up 
visits, tests or procedures. 
Response:  
 
32.2 
 For HUD uses provide a description of how the patient will be informed 
of the potential risks and benefits of the HUD and any procedures associated with 
its use. 
Response: