Expert Guiding Technology to Help Individuals With Developmental Challenges Build Life and Vocational Skills
Phase: NA
Conditions: Autism Spectrum Disorder, Intellectual Disability
Sponsor: John T. Nosek

Cover Page 
 
Expert Guiding Technology to Help Individuals With Developmental Challenges Build Life and Vocational 
Skills 
 
NCT04518358 
 
10/17/2019 

 
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1) Abstract of the study 
Autism affects approximately 1% of the world’s population. Applied Behavior 
Analysis (ABA) is the gold standard in treating autism. Up to 50% of young 
children with autism who undergo early, intensive ABA therapy may achieve 
normal IQs and developmentally typical language skills within 2 – 3 years.  ABA 
therapy requires highly trained instructors who implement individually designed 
educational programs in 1:1 teaching sessions. The instructor role can be filled 
by therapists, paraprofessionals such as educational assistants and family 
members. These complex teaching sessions involve precise prompting, behavior 
shaping, error correction, and reinforcement strategies. ABA therapy programs 
are developed by highly trained clinicians who provide close supervision and 
monitoring of front-line ABA instructors to ensure student progress. There is a 
growing research base showing that ABA strategies are also highly effective for 
teaching important skills to adults with autism (Tincani & Bondy, 2014). 
The purpose of this study is to evaluate the Guidance, Assessment, and 
Information System (GAINS), a mobile, hands-free™ data-driven guidance and 
data collection system to augment ABA therapy. The GAINS interface consists of 
software run on a mobile device which is carried by the ABA instructor who 
wears a Blue Tooth headset with a microphone. GAINS allows the instructor to 
select a particular ABA therapy instructional program (e.g., teaching non-verbal 
imitation), and then provides step-by-step, speech-based guidance to the 
instructor on how to implement the program with fidelity. GAINS also collects 
data on individual responses from speech-based input of the instructor, and 
adjusts therapy procedures accordingly. In the proposed study, the principal 
investigators will implement GAINS with approximately 50 adults with autism 
served by the Chimes of Delaware (support letter attached) , and collect formal 
and informal data on usability and effectiveness of the system. 
2) Protocol Title 
 
Guidance, Assessment, and Information System (GAINS): Usability Testing in 
Applied Behavior Analysis Therapy 
 
3) Investigator  
Donald Hantula, Ph.D., Department of Psychology, College of Liberal 
Arts 
Collaborators: Matt Tincani, Ph.D., Department of Teaching and 
Learning, College of Education; Judy Stull, Ph.D., Senior Research 
Associate, Institute for Schools and Society, John Nosek, Computer  
Science, College  of  Science &  technology. 
4) Objectives 

 
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The purpose of this study is to evaluate the Guidance, Assessment, and 
Information System (GAINS), a mobile, data-driven guidance and data collection 
system to augment ABA therapy. In the proposed study, the principal investigator 
and collaborators will implement GAINS with 50 adults with autism, and collect 
formal and informal data on usability and effectiveness of the system. The 
following research questions will be addressed: 
1. Can ABA instructors successfully implement basic ABA therapy programs 
to teach skills such as non-verbal imitation, expressive language, and 
object-to-object matching, as guided by GAINS? 
 
2. What are the opinions of ABA instructors, ABA program supervisors and 
other consumers about the goals of GAINS to increase the efficiency of 
ABA therapy, the ease with which GAINS can be used to guide therapy, 
and the outcomes of therapy when guided by GAINS? 
 
5) Rationale and Significance 
 
The success of ABA therapy programs depends heavily on the quality of the ABA 
intervention team, including the ABA instructors and ABA program supervisors 
(Drew et al, 2002; Sofronoff et al, 2004, Randolph et al, 2011). Traditional 
instructor training depends heavily on a didactic approach, in which supervisors 
provide a great deal of explanation, modeling, and feedback directly to the 
instructor (Granpeesheh et al. 2009). Although sometimes effective, this 
approach is time consuming and expensive as it requires significant face-to-face 
time between instructors and supervisors. Moreover, training by this traditional 
method can only occur if an expert supervisor is available, and instructors are 
prone to make many therapy mistakes without adequate supervision. In turn, 
individual progress can suffer.  
There is a trend toward standardizing intervention via computerized information 
management systems in different health areas to optimize the quality of care a 
patient receives (Balust & Macario, 2009). Hand-held computer use by medical 
residents is found to provide educational, institutional and patient care benefit, 
and this may also be the case for other professionals, such as ABA instructors 
(Tempelhof, 2009). Interventions promoting such technological information 
management and communication have the potential to not only improve the 
quality of care, but also to contain costs (Gagnon, 2009). 
It is hoped that GAINS will add to the existing knowledge base by 
improving ABA therapy in the following ways: 
 
1. Reduce ABA therapy expense and increase availability. The technology 
will reduce costs in ABA therapy by increasing the efficiency of therapy and 
reducing the need for direct supervision of front-line instructors. Lower costs of 
ABA therapy will stretch limited funding and provide opportunities for more 

 
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ABA therapy for more children an adults.  
2. Improve effectiveness and quality of those who fulfill ABA therapist role. 
Training those who fulfill the ABA therapist role, including parents, can 
improve ABA outcomes (Drew, 2002; Sofronoff et al, 2004, Strauss et al, 
2012, Weinkauf et al, 2011, Sarokoff & Sturmey, 2004). Many functions of the 
senior therapist, for example, showing the trainee how to give instructions, 
prompt correct responses, correct errors, and deliver reinforcement, could be 
facilitated by the technology.   
3. Improve guidance and support for ABA therapists. Appropriate guidance 
will increase the effectiveness and efficiency of instruction.  The technology 
will guide the instructor in a way that offloads the burden of remembering what 
to do, while facilitating data collection and report generation. For example, 
during instructor training and therapy sessions, instead of the instructor 
remembering what to do, the software agent will guide the instructor on 1) 
what task to initiate; 2) how to initiate the task; 3) what prompts to use to 
prompt/assist the student in task completion; and 4) if reinforcers should be 
used, what reinforcers of what strength and duration to use.  
4. Improve Program Fidelity.  The technology will incorporate precise 
instructions to guide the instructor. This will motivate instructors to follow good 
practice insuring improved program fidelity.  
5. Improve instructor-student interaction with improved interfaces.  The 
support technology will be smoothly integrated into the instructional 
environment to reduce instructional distractions and limit the need for manual 
input.  
 
6) Resources and Setting  
The principal investigator for the study, Dr. Hantula, and collaborators, 
Drs. Tincani and Stull, will meet on an as needed basis to discuss the 
purpose of the study, the study’s procedures, and data, in terms of their 
respective roles. Drs. Hantula and Tincani will collaborate in the usability 
and effectiveness testing of GAINS as described in this proposal. Dr. Stull 
will focus on program evaluation. 
Approximately fifty adults with autism and their direct support staff who 
implement ABA programming will participate. A support letter from Chimes 
Delaware, the agency where the research will take place, including a 
contact person, is attached. If additional sites are added, support letters 
and the contact person at the site will be provided to the IRB prior to 
conducting trials. 
7) Prior Approvals 
Support letters from settings are provided as separate attachments. 
8) Study Design 

 
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a) Recruitment Methods 
Approximately fifty subjects will be recruited for the study. Initial potential 
subjects will be identified through discussions with the contact person at 
each setting, who will identify adults with autism who receive behavioral 
interventions from the therapy service provider. One member of the 
research team or supervisor at the therapy service provider will contact 
the parents of each potential subject by phone or in person, and will 
explain the purpose, procedures, benefits, and potential risks of the study 
in detail, and will provide a copy of the informed consent form.  If 
additional sites are added to Appendix A, the person at the site who will 
help recruit subjects will be identified in a similar way and this information 
will be provided to the IRB with the contact information and letter of 
support. 
b) Inclusion and Exclusion Criteria 
Subjects in the study will be adults with autism who receive behavioral 
therapy for at least five hours per week. Individuals will not be excluded on 
the basis of gender, race, or ethnicity.  
c) Study Timelines 
Subject recruitment, as described above, will take approximately two 
weeks.The timeline for the study is expected to occur for up to a year; we 
anticipate 4-8 hours of participation per week for each subject during a 
total of 360 calendar days during normal therapy sessions. Approximately 
two sessions with each instructor may be observed. We anticipate that all 
data will be collected by August 31, 2020.  
 
d) Study Procedures and Data Analysis 
 
Each study session, lasting approximately 30 minutes, will occur as follows: 
 
1.  The subject’s instructor will be provided with the GAINS interface, 
comprised of a mobile device equipped with GAINS software, and a 
Bluetooth headset. 
 
2. For the first session, the instructor will be instructed on how to start and 
use the interface.  
 
3. The instructor will run one of the adult’s ABA instructional programs using 
the system, which provides speech-based guidance to the instructor on 
the specific steps of implementing the program. Each program 
implemented by the instructor will be part of the adult’s normal habilitative 

 
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program, and will include such skills as non-verbal imitation, expressive 
language, and matching identical objects or identical pictures.  
 
4. For observed sessions, a member of the research team will use a paper 
and pencil checklist which contains each of the steps of the program to 
record whether the instructor has implemented the steps accurately, as 
measured by a percentage of steps correctly implemented. For some 
observed sessions, the researcher may ask the instructor to first run one 
of the individual’s ABA instructional programs without using GAINS, 
followed by the instructor using GAINS to run the individual’s instructional 
program. 
 
5. Following sessions at approximately the following schedule: first time, first 
month, quarterly, the instructor will complete a survey to assess his or her 
opinions about the usability of GAINS and usefulness of GAINS in 
increasing the efficacy of ABA therapy. For example, “What did you like 
about using GAINS?” “Did GAINS make delivering the X program easier? 
How?”  
 
6. Data on accuracy of student responses will be collected by the GAINS 
system and stored on a secure, remote database server. Later these data 
will be analyzed to evaluate the extent to which students responded 
accurately to therapy augmented by GAINS. This analysis could include 
looking for patterns in data collected such as data mining. 
 
7. Demographic data of instructors, such as their education level and number 
of years experience teaching individuals with autism will be collected. 
Investigators will be accessing clinical records for the following 
background information: a) demographic information on the individual 
(gender, educational background, etc.); b) results of previously given 
autism diagnostic Instruments; c) prescriptions and dosage. 
 
e) Withdrawal of Subjects 
There are no anticipated circumstances in which the subjects would be 
withdrawn from the study without their consent. 
There will be no penalties or other consequences for subjects whose 
parents choose to withdraw them from the study. To withdraw an 
individual from the study, a parent or guardian may contact the principal 
investigator and request that his or her son or daughter be withdrawn.  
 
f) Privacy & Confidentiality 
The study will not use or disclose subjects’ Protected Health Information 
(PHI).  

 
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All electronically collected research data will be transferred to a private, 
secure database.  Any paper records of subjects’ data or other confidential 
information will be kept in a locked filing cabinet.  Only the research team 
will have access to the data.  Any identifying information will be omitted 
from published or disseminated reports of the data to maintain 
confidentiality of subjects. 
Results of the study may be shared through conference presentations or 
written reports disseminated in peer-reviewed journals or other formats 
(e.gs., book chapters or grant proposals). In such cases, pseudonyms will 
be used and no identifying information (e.g., geographical location of 
subjects’ residences) will be included when discussing results.  
As the research procedures are part of normal educational procedures 
and settings for the individual, it not anticipated that subjects will feel 
uneasy during the experiment.  
9) Risks to Subjects 
 
There are no foreseeable risks to the study other than loss of instructional time. 
Given that the research employs normal educational procedures, we anticipate 
loss of instructional time to be very minimal (i.e., a few minutes per day), even if 
that occurs. No aspect of the research will cause discomfort or physical danger to 
subjects.  Subjects will not be inconvenienced, as the research will take place as 
part of their typical  therapy sessions. The   individuals with autism will  not   use   
or  interact  with  the  GAINS  technology -  only  the  instructor  will  do  so,  
hence  there  is   no  additional  risk  for  the  individual. 
 
10) 
Potential Benefits to Subjects 
Potential benefits of the study to subjects include increased learning 
opportunities provided through GAINS augmented therapy sessions.  
 
11) 
Costs to Subjects 
There is no cost for participation in this research. 
. 
12) 
Informed Consent  
Informed consent will be obtained by a member of the research team or 
supervisory personnel of the therapy service provider. Following recruitment, a 
member of the research team or supervisory personnel of the therapy service 
provider will explain the purpose, procedures, benefits, and potential risks of the 
study in detail, and will provide a copy of the informed consent form.    
Because subjects will be individuals with autism who have limited communication 
skills and/or cognitive deficits, it is highly unlikely that they will understand the 

 
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purpose, procedures, and benefits and risks of the study; therefore, assent will 
not be sought from the subjects. 
 
13) 
Vulnerable Populations 
The study will involve a vulnerable population, adults with autism. The 
study involves minimal risk to subjects as it uses normal educational 
procedures and settings and the benefits of the study in terms of 
enhanced learning outweigh the risks.  

 
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Appendix A – List of Settings for the Study 
 
CHIMES, Newark, DE