The Effect of Animal-Assisted Therapy on Prosocial Behavior and Emotional Regulation in Autistic Children: Comparison Between a Live Canine and a Toy Canine
Phase: NA
Conditions: Prosocial Behavior, Emotional Regulation, Human Animal Bonding, Human Animal Interaction, Autism
Sponsor: University of Arkansas, Fayetteville

Cover Page for Clinical Trial Study 
Official Title: Comparing the Effects of a Plush Toy Dog versus a Live Therapy Canine on 
Prosocial Behavior and Emotional Regulation in Children with Autism Spectrum Disorder 
NCT#: N/A 
Date: March 13, 2025 
 
 

Study Protocol 
Clinical Study Description 
The purpose of this project is to investigate the human-animal interaction (HAI) and bond (HAB) 
between a canine trained in therapy techniques or a canine plush toy and youth with autism 
spectrum disorder (ASD) during animal-assisted therapy (AAT) sessions. We seek to explore 
identified gaps in knowledge pertaining to AAT in pediatric ASD care management. 
Specifically, we want to document human interaction between either a live canine or the plush 
toy canine during AAT sessions, evaluating behaviors observed during and after AAT sessions. 
Caregivers were given the option to enroll the child in the AAT study at the follow-up 
appointment after the diagnostic assessment was completed, or upon enrollment in the ASD 
program if the child had an ASD diagnosis. The study was conducted between June 2022 
through August 2024. Each AAT study lasted between eight to 12 weeks, and caregivers had the 
option to re-enroll the child for the next study to continue addressing behavioral concerns. 
Participants were divided into two groups: one with a therapy canine and one with a plush toy 
dog. Therapy sessions lasted 30 to 45 minutes, depending on the age and ability of the 
participant. All participants, no matter their group, received the same therapeutic strategies, such 
as sensory integration therapy and seated activity with the therapist, who is a certified pediatric 
nurse practitioner. Sessions with the therapy canine started with five to 10 minutes of free play 
with the canine, followed by sensory integration therapy based on the child’s identified sensory 
profile. Participants then entered the clinic room for 20 to 30 minutes of a seated activity in 
which the therapist who taught coping and socialization strategies to participants and caregivers. 
Sessions concluded with five minutes of play with the canine. Play activities include fetch, 
soccer, hide and seek, and puzzles. The canine was trained to lay under the table in the clinic 
room while the therapist was working with the participants. He would provide grounding, light 
pressure, and deep pressure therapy if the participant became anxious during the sessions. The 
seated work was recorded using two cameras to ensure visibility of the interactions between the 
participant and therapist, canine, and caregiver; participant vocalizations and verbalizations; and 
participant facial expressions. We used two human-animal ethograms to code behavior during 
sessions and two behavioral assessments to note behavior occurring after sessions. All sessions 
occurred in the clinic located on the university's campus. Demographic data including participant 
age, gender, race, ethnicity, referral source, prior medical diagnoses, age of ASD diagnosis, 
medications, and prior allied health, school, or psychological evaluations. The canine was 
certified as a therapy dog and  service dog certified in 10 ASD service dog tasks at the time of 
the study. The canine was present during sessions to interact with children and assist them to 
practice and develop skills to address identified deficits in social-emotional and adaptive 
functioning, prosocial behavior, and emotional regulation. AAT sessions were recorded to code 
interactions at a later time.  
 
Objectives 
This study will address the following research questions:  

1. How do children with autism ages 2 to 18 years interact with a live canine during AAT 
sessions? 
2. How do children with autism ages 2 to 18 years interact with a toy plush dog during 
AAT sessions? 
3. Is there a difference in HAI in the live canine group and the toy plush dog group?  
4. Is there a difference in prosocial behavior observed during AAT sessions between the 
live canine group and the toy plush dog group?  
5. Is there a difference in behavior after AAT sessions between the live canine group and 
the toy plush dog group? 
 
Design and Statistical Analysis Plan 
We used two human-animal ethograms to investigate human-animal interaction and bonding 
occurring during AAT sessions. Prosocial behavior and emotional regulation demonstrated by 
participants outside of AAT sessions were assessed by two self-report questionnaires completed 
by caregivers. SPSS and Microsoft Excel were used to calculate the analysis. Descriptive 
statistics were utilized to compare prosocial behavior and emotional regulation occurring apart 
from AAT sessions between the two groups. Poisson analysis was conducted to examine human-
animal bonding and human behavior occurring during AAT sessions. Independent t-tests were 
used to analyze the differences in human-animal interaction between the two groups. The 
homogeneity of the variance (HOV) assumption between two groups was checked using 
Levene’s test for equality of variances in SPSS program before conducting the t-tests analysis. 
Results of t-tests with adjusted degrees of freedom value were reported if the HOV was violated. 
The null hypothesis was set to reflect no significant difference in HAI between groups for the 
independent t-tests; therefore, a significant difference in the human-animal interaction and 
human behaviors regarding the inclusion or exclusion of the canine could be confirmed if the t-
test results reject the null hypothesis. Cohen’s d was used to report the effect sizes of the 
independent t-tests; values up to 0.20 were interpreted as small, 0.50 as medium, and 0.80 as 
large effect sizes. Analysis of variance was used to assess differences between the two groups in 
prosocial behavior and emotional regulation occurring apart from AAT sessions.  
 
Methods 
Demographic data; past, family, and social histories; and prior therapy evaluations were 
collected during the initial consultation for enrollment into the ASD program. Additionally, pet 
ownership in the family home was included in the analysis.  
 
The Observation for Human Canine Interaction for Research (OHAIRE) Coding System from 
University of Arizona was used to note human bonding and prosocial behavior occurring during 
AAT sessions. The OHAIRE Coding System was specifically created for use in research with 
participants aged 4 to 16 years but may also be suitable for individuals of other ages, provided 
appropriate validity and reliability analyses are conducted. Participants must be with at least one 

other person during sessions to allow for the coding of social behaviors. The participant being 
observed is known as the primary participant. The coding system allows for the primary 
participant to engage in social behaviors with various targets, including caregivers, therapists, 
objects, and canines. While the OHAIRE was designed to code behavior in the presence of 
common domesticated canine species, it has been tested with a restricted range of canine species 
to date. The tool has previously been used to code interactions with dogs and guinea pigs, as well 
as social behaviors before and after interactions with horses (not direct interactions with horses). 
The coded behaviors are general enough to be assumed to apply to other domesticated canine 
species. Participants were video recorded continuously during unstructured interaction 
opportunities. Available activities provided opportunities to engage in both social and isolated 
behaviors. The video sample included a wide enough angle to observe the environment and all 
potential social interaction partners. The OHAIRE-V3 calculates a human-canine bond score in 
order to quantify the interactions taking place between the primary participant and the canine. 
The human-canine bond score was calculated for each 10-second interval based on the presence 
of an interaction between the primary participant and the canine, and the type of behaviors 
shown during that interaction. Participants received one point for each of the six behaviors from 
the ‘social communication & interaction’ category in the OHAIRE tool. No points were given if 
the primary participant does not interact with the canine. The behaviors included in the definition 
of the human canine bond score are talk, gesture, look, touch, affection, and prosocial behavior 
directed toward the canine. There are a total of six 10-second intervals within each 1-minute 
video segment, and each of those 10-second intervals has six possible points: one point for 
each type of interaction. The total score from each 10-second interval is summed for a total 
overall human-canine bond score across the entire 1-minute video segment. Each 10-second 
interval will have a score between 0 and 6 points. Each 1-minute video segment will have a score 
between 0 and 36 points. 
 
The 3-AAT Observation ethogram, adapted with permission from Johns Hopkins University, 
was used to code both canine and human interaction during AAT sessions. The revised ethogram 
appraises the frequency of six domains of human interaction (affection, play, care, 
communication, comfort, withdrawal) and 24 subdomains of human behavior that can occur in 
an AAT session. The ethogram assesses the frequency, intensity, and duration of the interactions 
between the canine and child. Frequency is measured by a tally count and duration is assessed by 
rounding either up or down to the nearest 30 second mark. Each interaction has a code for 
intensity from 0 (not intense) to 3 (the most intense), and the mode of the interaction was entered 
to run the analysis. 
 
The Strengths and Difficulties Questionnaire (SDQ) is a 25-item tool developed to assess five 
domains: Emotional Problems, Conduct Problems, Hyperactivity, Peer Problems, and Prosocial. 
The SDQ is the most used instrument in measuring therapeutic effect of interventions within the 
emotional state in children and adolescents ages 2 to 18 years, demonstrating reliable internal 

consistency and validity. The SDQ has two versions, one to be administered at the initiation of 
therapy and then a follow-up version that includes two additional questions examining the 
impact of the therapeutic intervention. Scores from four behavioral domains range from zero 
(“normal”) to 10 (“very high concerns”), while Prosocial domain scores are reversed so that 10 
indicates “normal” behavior and zero signifies “very high concerns”. The SDQ also assesses the 
total, impact, internalizing, and externalizing scores to provide a complete overview of the 
child’s behavior during the past four weeks. Total scores are the sum of the behavior domains 
except the Prosocial domains and range from zero (normal) to 40 (very high). Impact scores 
range from zero (normal) to 10 (very high) and reflect overall distress and impairment interfering 
with daily social interactions. Internalizing scores reflect the Emotional Problems and Peer 
Problems domains, while Externalizing scores are the sum of the Conduct Problems and 
Hyperactivity domains. Both the Internalizing and Externalizing domain scores range from zero 
(normal) to 20 (very high). The initial SDQ was administered at the beginning of the study and 
the follow-up assessment was used subsequently every four weeks until the study concluded. 
 
Lastly, the Positive and Negative Affect Schedule (PANAS) was administered weekly to 
measure therapeutic effects occurring in everyday life outside of the AAT session. The PANAS 
is a 20-item questionnaire utilizing a 5-point Likert scale to assess positive and negative affect 
occurring the week prior to administration. Each domain has 10 items with scores ranging from 
10 to 50, with lower scores reflecting lower levels of positive or negative affect and higher 
scores signifying higher positive or negative affect. Total scores on each scale are obtained by 
adding the scores for each item. Analysis of the PANAS demonstrates very good internal 
consistency reliability, with alphas ranging from 0.86 to 0.90 for Positive affect and from 0.84 to 
0.87 for Negative affect. 

PRINCIPAL INVESTIGATOR   
Michele Kilmer, Assistant Professor 
The University of Arkansas, Eleanor Mann School of Nursing  
606 N. Razorback Rd.  
1-479-575-3904  
michelek@uark.edu  
  
PURPOSE OF STUDY  
This purpose of this study is to evaluate the effect of services for children with developmental 
delay or autism spectrum disorder while using a dog trained or toy plush dog in therapeutic 
techniques. This study’s aim is to see if therapy sessions with the dog or plush toy results in an 
improvement in your child’s social and emotional abilities. Before you decide to allow your 
child to participate in this study, it is important that you understand why the study is being done 
and what will be involved. Please read the following information carefully. Please ask 
the principal investigator if there is anything that is not clear or if you need more information.  
 
DESCRIPTION OF STUDY 
Your child will be randomly assigned to one of two study groups; one includes animal-assisted 
therapy sessions with a live dog while the other group uses a toy plush dog. Activities involved 
in this study include animal-assisted therapy sessions lasting 30 to 60 minutes that focus on your 
child’s identified developmental, social, emotional, and coping concerns. You will be provided 
with home therapeutic techniques to practice with your child in-between sessions. Therapeutic 
sessions will occur weekly. You will be asked to complete a set of assessments on your child’s 
development, social-emotional skills, functioning, parent-child interactions, and intelligence 
quotient throughout the study. If able, your child will indicate their level of anxiety before and 
after each therapy session using a picture of a thermometer with varying levels of anxiety. You 
may be asked to report how you feel your child’s socialization and emotional behaviors were 
since the last therapy session. Adolescents may also be asked to self-report how they feel their 
socialization and emotional behaviors were after the last therapy session.  
 
Animal-assisted therapy sessions include techniques aimed to help your child with identified 
concerns in social and emotional behavior. The dog is trained to assist your child to engage in 
social interaction, like playing gently and taking turns during a game. Animal-assisted activities 
include playing fetch and other turn-taking games, assisting the dog to complete puzzles, 
coloring pictures with the dog, petting the dog, and grooming the dog. The dog can also give 
“hugs” if your child is anxious by leaning his body gently against your child’s legs. Free play 
with the dog will be allowed once your child and dog have built a relationship. The sessions with 
the dog will last between 10 and 15 minutes, then the remaining time will be spent discussing 
home therapy techniques to practice until the next session. Research personnel who have been 
training the dog may be present to assist the dog during the session, and Dr. Kilmer, the dog’s 
owner and handler, will be present while the dog is in the therapy session with your child. 
 
Participants in the toy plush dog group will receive the same therapy content and will be 
encouraged to interact with the plush dog. They will have the option to brush the plush dog’s 
“fur”, hug him, talk with him, and pet him. The plush dog can be moved around in the room to 
accommodate different therapeutic activities during the sessions. 

 
All therapy sessions in the clinic will be video recorded for research purposes. 
 
RISKS  
Minimal risks are associated with this studies. Other than the normal emotional risks associated 
with therapy of this type, the only risk involved with this research is normal minimal risk 
involved with interacting with a well-behaved dog The dog is being trained as a therapy and 
service dog and attends weekly sessions with experienced trainers. Dr. Kilmer is being educated 
to properly perform animal-assisted therapy sessions. The dog will be on leash throughout the 
session and will be removed if he or your child appear to be distressed. There is a very small risk 
of injury from the dog (e.g., scratching, teething/nipping); however, given the extensive training 
of the dog and continuous monitoring of the dog at all times, this risk is considered minimal and 
unlikely.  
  
BENEFITS  
There are no direct benefits to you for allowing your child's assessments to be used in this 
research; however, results from this research could improve therapeutic care of children with 
developmental delay or autism spectrum disorder. Your child will also receive a plush toy that 
looks like the dog and a trophy for participating in the study. 
 
CONFIDENTIALITY  
Participant data will be kept confidential to the extent allowed by law and University 
policy. Your responses to the questionnaires and evaluations will have all identifying 
information removed. The principal investigator will keep data in her computer that is password 
protected. Notes, interview transcriptions, and any other hard copies of identifying participant 
information will be secured in a locked file cabinet in the personal possession of the principal 
investigator. Videos of therapeutic sessions will be downloaded to principal investigator’s 
password-protected university-issued computer within 24 hours and then immediately deleted 
from the camcorder device. Only research personnel will have access to these files, unless 
otherwise required by law. The principal investigator is legally obligated to report specific 
incidents which include, but may not be limited to, incidents of abuse and suicide risk.  
 
Your child has been identified at-risk for developmental delay or autism spectrum disorder by 
his/her primary care provider (PCP), who then referred your child to the EMSON Access for 
Autism program for further developmental assessment. As such, the referring PCP will receive 
the results of the assessments as well as recommendations for identified concerns. Also, the 
investigators may request your consent to obtain medical records from the referring provider, 
allied health, and specialty clinics who take care of your child. Your child’s schoolteacher and 
staff may be contacted to provide records or complete forms necessary for the evaluations if 
indicated. Aside from this, the co-investigators request permission to use assessment results in 
research on pediatric autism and developmental delay. 
 
CONTACT INFORMATION   
If you have questions at any time about this study, or you experience adverse effects 

as the result of participating in this study, you may contact the co-investigators, whose contact 
information is provided on the first page. If you have questions regarding your rights as a study 
participant, or if problems arise which you do not feel you can discuss with the co-investigators, 
please contact the University of Arkansas Institutional Review Board at 1-479-575-2208.  
 
VOLUNTARY PARTICIPATION  
Both you and your child’s participation in this study is voluntary. It is your decision whether or 
not to allow your child to take part in this study. If you decide to allow your child to take part in 
this study, you will be asked to sign this consent form. If your child is able, they will also be 
asked to provide their assent. After you sign this consent form, you and your child are still free to 
leave at any time and without giving a reason. Withdrawing from this study will not affect the 
relationship you have, if any, with the co-investigators.  
  
CONSENT  
I have read and I understand the provided information and have had the opportunity to ask 
questions. I understand that my participation is voluntary and that I am free to withdraw at any 
time, without giving a reason and without cost. I understand that I will be given a copy of this 
consent form. I voluntarily agree to take part in this study.   
   
Parent/Guardian signature ___________________________________ Date ___________   
  
Child assent: 
I have discussed this study with my parent/guardian, and I agree to participate. I understand that 
even if they agree, it's okay if I choose not to participate or change my mind about participating 
later. 
 
Child signature ___________________________________ Date ____________   
 
 
Investigator signature ______________________________ Date _____________   
 

Protocol Number:
2307483365
Expiration Date:
10/10/2025
Investigator:
Michele R Kilmer
Last Approval Date:
10/11/2024
University of Arkansas System
Document Overview
Description:
Human animal interaction between children and a live canine or toy plush dog
Explanation:
Organization Doc Num:
Protocol Summary
Protocol Number:
2307483365
Sequence Number:
3
Status:
Active - Open to Enrollment
Expiration Date:
10/10/2025
Last Approval Date:
10/11/2024
Investigator:
Michele R Kilmer
Protocol Details
Type:
Expedited
Summary/Keywords:
Application Date:
09/21/2024
Reference ID1:
Reference ID2:
FDA Application No:
Title:
Human animal interaction between children with ASD and a live canine or plush toy
dog
Areas of Research
Code
Description
000001
All Research Areas
Organizations
Type
Organization
Address
Performing Organization
University of Arkansas
University of Arkansas 1125 West Maple Street 316
ADMN Bldg, Fayetteville, AR 72701 USA
Funding Source
Type
Number/Code
Source
Title
Internally Funded/
Unfunded Research
unfunded
N/A

Protocol Number:
2307483365
Expiration Date:
10/10/2025
Investigator:
Michele R Kilmer
Last Approval Date:
10/11/2024
Subjects 
Subject
Count
Children
150
Investigators
Person Name:
Michele R Kilmer
Role:
Principal Investigator
Units:
CC012723
UAF | NURS | Department of
Nursing
Affiliation:
Supervisor
Office Phone:
479-575-5466
Mobile:
Email:
michelek@uark.edu
Study Personnel
Person Name
Role
Affiliation
Email
Danielle Randolph
Study Personnel
Non-Faculty
dr063@uark.edu
Caroline Elizabeth Kilo
Study Personnel
Student Investigator
cekilo@uark.edu
Delaney Rae Piantanida
Study Personnel
Student Investigator
drpianta@uark.edu
Claire Elizabeth Little
Study Personnel
Student Investigator
celittle@uark.edu
Terria Hawley
Study Personnel
Faculty
trhawley@uark.edu
Ava Wisinger
Study Personnel
Student Investigator
acwising@uark.edu
Training
Person Name
Description
Date
Completed
Expiration
Date
Danielle Randolph
CITI, Basic/Refresher Course - Human Subjects
Research, Biomedical Research, Basic Course, 1
02/21/2025
02/21/2028
Other Roles
Person Name
Role
Affiliation
Email
Minju Hong
Data Integrity Manager
Faculty
minjuh@uark.edu

Questionnaire 
Questionnaire Name:
Human Subjects Protocol Interview
Description:
Human Subjects Protocol Interview
Module:
IRB
Sub Module:
Protocol Number:
2307483365
Sequence Number:
3
Principal
Investigator:
Michele R Kilmer
Title:
Human animal interaction between children with ASD and a live canine or plush toy dog
• What is the purpose of this research? Please explain both why you are doing the research (class assignment,
thesis, etc.) AND/OR state your hypothesis. See attachment is not a sufficient response.
The proposed project will investigate the human-animal interaction (HAI) and bond (HAB) between a
canine trained in therapy techniques or a canine plush toy and youth with autism spectrum disorder (ASD) or
developmental delay (DD) during animal-assisted therapy (AAT) sessions. The purpose of this study is to explore
identified gaps in knowledge pertaining to AAT in pediatric ASD and DD care management. Specifically, we
seek to document human interaction between either a live canine or the plush toy canine during AAT sessions,
evaluating prosocial behaviors observed during and after AAT sessions. This study will address the following
research questions: 1. How do children with autism ages 2 to 18 years interact with a live canine during AAT
sessions? 2. How do children with autism ages 2 to 18 years interact with a toy plush dog during AAT sessions?
3. Is there a difference in HAI in the live canine group and the toy plush dog group? 4. Is there a difference in
prosocial behavior observed during AAT sessions between the live canine group and the toy plush dog group? 5. Is
there a difference in behavior after AAT sessions between the live canine group and the toy plush dog group?
• Are you collecting data about living individuals?
Yes
• Are you collecting data through intervention or interaction with these individuals?
Yes
• Beyond the basic Participant Types (children, UofA Students, adults, etc.) named elsewhere in this
application, do you have a target population (particular group of people) you want to recruit? Some
examples might be students in a particular class, members of a particular group or network, people
in a specific age range (whether adult or minor), children in a particular school or class, etc.
Yes
• Describe your target population.
Dr. Kilmer collaborates with the local primary care providers who refer children, ages 18 months
to 18 years, at risk for developmental delay or autism spectrum disorders to the Access for Autism
(A4A) program for further developmental evaluation and care management. Children receiving care
management by the A4A program who have developmental or behavioral concerns can volunteer to
enter this study.
• How are you recruiting participants? Are you standing in a public place asking people to take
a survey, sending out introductory emails, posting an ad or blurb on a website or social media,
posting a flyer in a public location, etc.? **Please note that all recruitment materials will need to be
uploaded in the Notes and Attachments section.

Dr. Kilmer will discuss the study with parents/guardians whose children have been referred to the A4A
program for further developmental evaluation. Participation in the study is voluntary and does not affect
other services provided by the A4A program.
• Provide a brief description of the procedures involving the participants.
Participants will be divided into 2 groups: one group will interact with the live canine while the other
group will interact with a toy plush dog identical to the canine. Dr. Kilmer will use a variety of behavioral
and developmental evaluations to identify concerns and provide strategies for home therapy to improve
delays for both groups. The O'HAIRE Coding System and 3 AAT Observation ethogram will be used to
observe and code human behavior during all sessions for both groups. Additionally, participants ages 8
years and older who are cognitively capable will be asked to self-report their emotional state before and
after each AAT session using an 11-point Likert scale chart in the shape of a thermometer, with ranges
from "no distress/totally relaxed" to "highest anxiety/stress that you've ever felt." A caregiver satisfaction
and perspectives of AAT integration in therapy sessions will be assessed via surveys. Demographic data
including participant age, gender, race/ethnicity, referral source, prior medical diagnoses, age of ASD
or DD diagnosis, medications, and prior allied health or psychological therapies will be collected on
all participants. Dr. Kilmer will incorporate AAT into the therapy sessions at the A4A clinic that are
guided by the developmental, adaptive-functioning, and social/emotional assessments to target gross
and fine motor skill, language, social, emotional, and adaptive-functioning development. Parents will
be given handouts that are designed to address deficits identified by the assessments. The O'HAIRE
Coding System will be used to observe and code human behavior during AAT sessions. Observable
behaviors categories captured by the OHAIRE Coding System include Interactive Behaviors (Social
Communication & Environmental Interaction), Emotional Display (Facial, Verbal), and Interfering
Behaviors (Aggression, Overactivity, Isolation). The OHAIRE-V3 assessment will be used to calculate
a human-animal bond score to quantify the interactions taking place between the pediatric participants
and the animal. The ELAN Coding software will be used to achieve high inter-rater reliability through
precise timing of observed interactions. The 3 AAT Observation ethogram assesses 26 canine behaviors
during human-animal interactions. The ethogram is divided into three categories: affiliative indicators,
moderate stress indicators, and high-stress indicators. All sessions will occur at the A4A clinic, which
is located on campus in the Epley Center for Healthcare Professionals. The first interaction between the
canine and the participant will focus on introducing the two and facilitating a bond through play, such as
petting or brushing the canine, or throwing a ball. The canine will be present to interact with children as
they are learning their skill for that week. For example, the canine will interact with the participant while
the participant is learning a new skill, such as improvement in handwriting, and the participant will be
able to interact and play with the canine if the participant focuses on completing the therapy assignment.
Likewise, participants will earn points if they perform their therapy strategies at home and can use those
points to interact and play with the canine at their next therapy session. Plush dog toys who look like the
canine will be given to pediatric participants in both groups as incentive to perform their home therapies.
• How long are the procedures likely to take? Include duration and frequency.
The A4A weekly therapy sessions will last about 30 to 60 minutes, with opportunities for participants to
interact with the canine or toy plush dog intermittently throughout the session, depending on the therapy
activity.
• How will information be given to people to get their informed consent to participate in this research?
Answers should include specific methods (e.g., verbal consent, information handout, online consent
form, full consent form requiring signature documentation.) **Please note that consent materials --
from a script for verbal consent to full consent forms that require participant signature -- must be
uploaded in the Notes and Attachments section.
Dr. Kilmer will contact parents/guardians of potential participants to explain the AAT program and gage
their interest. If interested, parents will come to the A4A clinic on the first floor of ECHP to meet the
canine and sign the informed consent form. Verbal assent will be obtained from pediatric patients who are
cognitively able to give it.

• Does data collection rely on a scheduled event, such as a convention or specific date?
No
• How will your data be collected? Include all that apply: online, on paper/in person, audio and/
or video recordings. **Please note that all data collection materials will need to be uploaded in
the Notes and Attachments section. This includes: surveys, questionnaires, interview questions or
anything that is given to or asked of a participant.
Data will be collected in the initial consultation form for the A4A clinic, through performing
developmental, behavioral, social/emotional, and adaptive-functioning assessments, and with surveys. The
following will be used to collect data: 1. A4A Intake form: all participants 2. Developmental screenings
such as Ages and Stages Questionnaire- 3rd edition: 1 month to 5.5 years; Ages and Stages Questionnaire:
Social/Emotional- 2nd edition: birth to age 6 years; Social and Emotional Assessment/ Measure: 2 to 66
months; Strengths and Difficulties Questionnaire: 3 to 16 years; Positive and Negative Affect Schedule:
9 to 14 years; Vineland- 3rd edition: 3 to 21 years; Social Responsiveness Scale- 2nd edition: 2.5 to
18 years; Standford-Binet IQ Test: 2 to 18 years; Autism Diagnostic Observation Scale-2: 18 months
to adulthood; and Childhood Autism Rating Scale- 2: 2 years to adulthood. All AAT sessions will be
recorded after receiving consent from families to retroactively code participant behavior during sessions
with the OHAIRE and 3 AAT ethograms.
• How will your data be stored? Include all that apply: electronically, on paper, audio and/or video
recordings.
Survey data will be stored in an Excel spreadsheet and Qualtrics, which is a HIPAA-secured software with
which caregivers of youth with complete on a personal device (iPad, laptop, cellphone).
• How will that data be kept secure?
Data saved in the Excel spreadsheet will only be accessible by approved research staff and stored in Dr.
Kilmer's password protected laptop. Any hard-copy measures of documents will be stored in Drs. Kilmer's
locked office in a locked filing cabinet. Video files will be downloaded from camcorders directly to Dr.
Kilmer's secured laptop. Only authorized research personnel will have access to these files and only
participant numbered IDs will be included on assessment documents. Participant identifying information
and associated ID numbers will be stored in Dr. Kilmer's lab in a password protected computer on a
password protected document. Dr. Kilmer and approved research personnel will have access to participant
ID information but will mainly utilize participant ID numbers. All video files will be downloaded to Dr.
Kilmer's computer within 24 hours and then immediately deleted from the camcorder device. Video files
will be stored on a password-protected computer as password-protected documents.
• Minimal Risk is defined as risks of harm not greater than those ordinarily encountered in daily
life or during the performance of routine physical or psychological examinations or tests. Will
participants be exposed to more than minimal risk? Include in your consideration the potential
of mental risks if asking sensitive questions, or legal or reputational risks in case of breach of
confidentiality.
Yes
• Describe the risks in question and any precautions that will be taken to minimize those risks.
Participants will not be exposed to more than minimal risks while receiving developmental or
behavioral evaluations. Participants will be exposed to the canine during therapy sessions. The canine
will be removed if signs of fatigue, fright, or irritation appear. He is trained off leash and will be
wearing a harness which can easily be tethered to his crate as needed. Dr. Kilmer will assess the
disposition of the pediatric participants before allowing the canine to come to the room and will
not allow the canine to participant if the pediatric participant's behavior is disruptive or potentially

dangerous for the canine. Dr. Kilmer is the canine's trained handler and is educated in observing his
behavior and will place him in the crate if he appears fatigued or irritated, or if the participant no
longer wants to play or pet him.
• Are there any direct benefits to the participants for participating in this study?
Yes
• Describe the benefits participants will or may receive.
Pediatric participants will receive one plush toy that looks like the canine or toy plush dog they are
working with.
• Will the proposed research involve deception or the withholding of information from participants?
No
• Will the proposed research necessitate medical clearance from a physician prior to participation?
No
• Will the proposed research involve gathering biological samples (blood, tissue, etc.)?
No
• Will the proposed research involve administering of substances or providing food and drink, other
than water, to participants?
No
• Will the proposed research involve physical exercise or conditioning?
No
• Does the research require review by a non-UofA IRB?
No
• Does this research require approval from another institution or agency, such as a school or privately
owned business?
No

Protocol Number:
2307483365
Expiration Date:
10/10/2025
Investigator:
Michele R Kilmer
Last Approval Date:
10/11/2024
New/Changed Attachments
Description
Last
Updated
Updated By
PANAS assessment
07/30/2023
19:06:26
michelek@uark.edu
A4A Intake Form
07/30/2023
19:08:55
michelek@uark.edu
Demographic data
07/30/2023
19:11:26
michelek@uark.edu
3 AAT Observation Ethogram
07/30/2023
19:26:49
michelek@uark.edu
Informed consent
09/19/2023
14:06:54
iwindwal@uark.edu
Protocol Notes 
Comment
By
Time
Dr. Kilmer and the canine completed therapy dog training in June
2022 and will be evaluated as a handler/canine therapy team in
December 2023. The canine is still in training learning ASD specific
service dog tasks. This training is scheduled to be completed in
December 2023 and will be evaluated as a service dog at that time.
michelek@uark.edu
09/05/2023
18:08:14
Nursing undergraduate Honors students have been educated in training
techniques used for the canine, Gryffin, who will be participating in
this study. Students meet with the canine individually and as teams,
training him in voice recognition and to obey commands that will
be used during the AAT sessions. Example of the commands are sit,
stay, come, wait, drop it, bring it, off, down, say Hi, hug, roll the ball,
and fetch. They have also worked with the canine on and off leash
and have taught him how to greet others properly without jumping,
how to hug, how to say hi, and how to ask to be petted. The canine is
accustomed to them and knows their voice. He obeys their commands
well.
michelek@uark.edu
07/30/2023
19:35:41
The Stanford-Binet Intelligence Quota Test gauges intelligence
through five factors of cognitive ability: fluid reasoning, The
Standford-Binet is published by the WPS Publishing company and is
subject to copyright laws, therefore, it cannot be uploaded. knowledge,
quantitative reasoning, visual-spatial processing and working memory.
michelek@uark.edu
07/30/2023
19:35:41
The SRS-2 identifies social impairment associated with ASD and
quantifies its severity. It can be used for children with developmental
delay as well. Domains include social awareness, social cognition,
michelek@uark.edu
07/30/2023
19:35:41

Protocol Number:
2307483365
Expiration Date:
10/10/2025
Investigator:
Michele R Kilmer
Last Approval Date:
10/11/2024
Protocol Notes 
Comment
By
Time
social communication, social motivation, and restricted interests and
repetitive behavior. The Social Responsiveness Scale is published
by the WPS Publishing company and is subject to copyright laws,
therefore, it cannot be uploaded.
The Vineland-3 measures 5 domains of adaptive functioning:
communication, daily living skills, socialization, motor skills, and
maladaptive behaviors. The Vineland-3 is published by the WPS
Publishing company and is subject to copyright laws, therefore, it
cannot be uploaded.
michelek@uark.edu
07/30/2023
19:35:41
The ASQ:SE-2 evaluates seven areas of social-emotional functioning
in children ages 1 - 72 months: self-regulation, compliance, social-
communication, adaptive functioning, autonomy, affect, and
interaction with people. The ASQ: SE-2 is published by the Brooks
Publishing company and is subject to copyright laws, therefore, it
cannot be uploaded.
michelek@uark.edu
07/30/2023
19:35:41
The Ages and Stages Questionnaire, 3rd edition, used for children ages
1 - 66 months and assesses gross motor, fine motor, communication,
problem-solving, and personal-social development. The ASQ-3
is published by the Brooks Publishing company and is subject to
copyright laws, therefore, it cannot be uploaded.
michelek@uark.edu
07/30/2023
19:35:41
The Strengths and Difficulties Questionnaire (SDQ) is a brief
behavioral screening questionnaire about 3-16 year-olds. It exists in
several versions for differing ages to meet the needs of researchers,
clinicians and educationalists. The initial Strengths and Difficulties
Questionnaire(SDQ) will be used on participants ages 3 - 17 years
to assess psychological attributes in the following categories:
emotional symptoms, conduct problems, hyperactivity/inattention,
peer relationship problems, and prosocial behaviors. The Strengths and
Difficulties Questionnaire published by Youth in Mind and is subject
to copyright laws, therefore, it cannot be uploaded.
michelek@uark.edu
07/30/2023
19:35:41
The O'HAIRE canine behavior ethogram will be used to assess
human-animal interaction. The manual is too large to upload and is
available upon request.
michelek@uark.edu
07/30/2023
19:35:41
The Autism Diagnostic Observation Schedule-Second Edition
(ADOS-2) is a standardized assessment tool that helps providers
diagnose autism spectrum disorders (ASD) in children and adults.
The ADOS involves a semi-structured play or interview session
determined by the age and communication level of the individual. The
ADOS provides standardized activities and questions that give the
examiner opportunities to observe behaviors that are directly relevant
to the diagnosis of ASD. The ADOS-2 incorporates the use of planned
social activities designed for different developmental levels and
michelek@uark.edu
07/30/2023
19:35:41

Protocol Number:
2307483365
Expiration Date:
10/10/2025
Investigator:
Michele R Kilmer
Last Approval Date:
10/11/2024
Protocol Notes 
Comment
By
Time
chronological ages that provide situations in which social interactions,
communication and particular types of behaviors are likely to appear.
The examiner chooses from five different modules depending on
age (12 months through adulthood), language and developmental
level. The assessment usually takes 40 - 60 minutes to complete. The
examiner scores the ADOS-2 based on observations noted during
the session on several aspects of social behavior. The score on the
ADOS-2 indicates whether or not the individual's presentation is
consistent with a diagnosis of an ASD. The ADOS-2 is published
by the WPS Publishing company and is subject to copyright laws,
therefore, it cannot be uploaded.
The Childhood Autism Rating Scale-Second Edition (CARS2) is
a 15-item rating scale used to identify children with autism and
distinguishing them from those with developmental disabilities. It is
empirically validated and provides concise, objective, and quantifiable
ratings based on direct behavioral observation. It was normed on a
sample of 1,034 individuals with autism spectrum disorders. This
second edition of CARS expands the test's clinical value, making
it more responsive to individuals on the "high functioning" end of
autism spectrum disorders. The clinician rates the individual on each
item, using a 4-point rating scale. Ratings are based on frequency of
the behavior in question, its intensity, peculiarity, and duration. The
CAR2 is published by the WPS Publishing company and is subject to
copyright laws, therefore, it cannot be uploaded.
michelek@uark.edu
07/30/2023
19:35:41
Actions
Description
Comments
Action Date
Expedited Approval
Renewal-001: Approved
10/11/2024
Expedited Approval
Renewal-001:
10/11/2024
Assigned to Agenda
Renewal-001:
10/11/2024
Submitted to IRB
Renewal-001: Submitted to IRB
09/21/2024
Renewal Created
Renewal-001: Created
09/21/2024
Renewal Reminder Generated
Renewal Reminder Letter #2
08/20/2024
Renewal Reminder Generated
Renewal Reminder Letter #1
07/05/2024
Expedited Approval
Amendment-001: Approved
04/26/2024
Expedited Approval
Amendment-001:
04/26/2024

Protocol Number:
2307483365
Expiration Date:
10/10/2025
Investigator:
Michele R Kilmer
Last Approval Date:
10/11/2024
Actions
Description
Comments
Action Date
Assigned to Agenda
Amendment-001:
04/26/2024
Submitted to IRB
Amendment-001: Submitted to IRB
04/14/2024
Amendment Created
Amendment-001: Created
04/14/2024
Expedited Approval
09/19/2023
Assigned to Agenda
09/19/2023
Administrative Correction
Changing consent document format to PDF for approval watermark.
09/19/2023
Submitted to IRB
Submitted to IRB
09/05/2023
Specific Minor Revisions
Required
09/05/2023
Delete Review
Online reviewer Ann M Killenbeck has been deleted. Deletion reason
- Reviewer has not responded in a reasonable length of time; review
is being reassigned to another board member.
08/25/2023
Submitted to IRB
Submitted to IRB
07/30/2023
Protocol Created
Protocol created
07/29/2023

Review Comments
Protocol Number:
2307483365
Sequence Number:
3
Principal
Investigator:
Michele R Kilmer
Title:
Human animal interaction between children with ASD and a live canine or plush toy dog
Committee Id:
200
Committee Name:
IRB Expedited Review
Schedule Id:
45832
Schedule Date:
11/16/2024
Review Comments:

 
Positive and Negative Affect Schedule (PANAS-SF) 
 
Indicate the extent you have felt 
this way over the past week. 
Very 
slightly or 
not at all 
A little 
Moderately 
Quite a bit 
Extremely 
PANAS 
1 
Interested 
 
1 
 
2 
 
3 
 
4 
 
5 
PANAS
2 
Distressed 
 
1 
 
2 
 
3 
 
4 
 
5 
PANAS
3 
Excited 
 
1 
 
2 
 
3 
 
4 
 
5 
PANAS
4 
Upset 
 
1 
 
2 
 
3 
 
4 
 
5 
PANAS
5 
Strong 
 
1 
 
2 
 
3 
 
4 
 
5 
PANAS
6 
Guilty 
 
1 
 
2 
 
3 
 
4 
 
5 
PANAS
7 
Scared 
 
1 
 
2 
 
3 
 
4 
 
5 
PANAS
8 
Hostile 
 
1 
 
2 
 
3 
 
4 
 
5 
PANAS
9 
Enthusiastic 
 
1 
 
2 
 
3 
 
4 
 
5 
PANAS
10 
Proud 
 
1 
 
2 
 
3 
 
4 
 
5 
PANAS
11 
Irritable 
 
1 
 
2 
 
3 
 
4 
 
5 
PANAS
12 
Alert 
 
1 
 
2 
 
3 
 
4 
 
5 
PANAS
13 
Ashamed 
 
1 
 
2 
 
3 
 
4 
 
5 
PANAS
14 
Inspired 
 
1 
 
2 
 
3 
 
4 
 
5 
PANAS
15 
Nervous 
 
1 
 
2 
 
3 
 
4 
 
5 
PANAS
16 
Determined 
 
1 
 
2 
 
3 
 
4 
 
5 
PANAS
17 
Attentive 
 
1 
 
2 
 
3 
 
4 
 
5 
PANAS
18 
Jittery 
 
1 
 
2 
 
3 
 
4 
 
5 
PANAS
19 
Active 
 
1 
 
2 
 
3 
 
4 
 
5 
PANAS
20 
Afraid 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 

 
Scoring: 
 
Positive Affect Score: Add the scores on items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19. Scores can 
 
range from 10 – 50, with higher scores representing higher levels of positive affect. 
 
Mean Scores: 33.3 (SD±7.2) 
 
 
Negative Affect Score: Add the scores on items 2, 4, 6, 7, 8, 11, 13, 15, 18, and 20. Scores can 
 
range from 10 – 50, with lower scores representing lower levels of negative affect.  
 
Mean Score: 17.4 (SD ± 6.2) 
 
Your scores on the PANAS:  Positive: ____ 
 
Negative: ____ 
 
 
 
Watson, D., Clark, L. A., & Tellegen, A. (1988). Development and validation of brief measures of positive 
and negative affect: the PANAS scales. Journal of personality and social psychology, 54(6), 1063.