Animal Assisted Intervention With Dogs for Children With Attention Deficit/Hyperactivity Disorder; Exploring Candidate Physiological Markers of Response to AAI
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: University of California, Irvine

#20206069 - Animal Assisted Intervention with Dogs for
Children with Attention Deficit/Hyperactivity Disorder:
Exploring Candidate Physiological Markers of Response to AAI
Protocol Information
Approval Comment
The IRB Approval Letter and any approved documentation (e.g. stamped consent forms) can be
downloaded in the Attachments section of the protocol.
Protocol Renewal Form
Renewal Information
Review Type
Expedited
Status
Approved
Approval Date
Oct 19, 2022
Continuing Review
Date
--
Expiration Date
Oct 18, 2025
Initial Approval Date
Oct 21, 2020
Initial Review Type
Expedited
Feedback
PROTOCOLS
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Protocol Type
Are you submitting a renewal for an IRB, sIRB, or hSCRO
protocol?
IRB (UCI is the IRB of Record)
IRB Renewal Instructions
Timing of Submission
Exempt and Expedited IRB protocols must submit a short version of the renewal every three (3)
years unless determined otherwise by the IRB. Investigators should plan ahead and submit 60
days prior to the study's expiration date.
Full Committee IRB protocols must submit a renewal at least annually (not more than 365 days).
Investigators should plan ahead to meet required continuing review dates. For full committee
review protocols, please submit 90 days prior to the expiration date to guard against a lapse in
IRB approval.
Amendments at the Time of Renewal
Please refrain from making major changes during the renewal as this could result in a lapse of
IRB approval.
Protocol Closure
To close out an approved protocol at the time of renewal, the transaction must be submitted as
Request Close. If this option was not initially selected and closure is required, please Abandon
the draft and start again. For more information, visit Post-Review Responsibilities and select the
Protocol Renewal Tab.
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Renewal Screener
Does any of the following apply to the currently approved
protocol:
• research involves Greater than Minimal Risk (Full
Committee)
• research is subject to Food and Drug Administration (FDA)
regulations
• Involves a drug
• A clinical investigation of a medical device
• ﻿research is funded/supported by the Department of Justice
(DOJ)
• current approval period is 1 year or less
Yes (Continuing Renewal Required)
Protocol Expiration
Protocol Expiration
Has IRB approval for this protocol expired or will it expire within
3 weeks?
No
Confirmation of Protocol
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Protocol Changes
Are changes required to the protocol and/or supporting
document(s)?
Yes, changes are required (complete the amendment form)
Study Team
Review the Study Team Section and consider whether anyone
should be removed.
RP Heat Map
Are RP tracked outside the approved protocol, in accordance
with the RP Heat Map?
Yes, RP are tracked on a Study Team Log or other comparable log
Financial Interests
Review the Study Team section and verify that the financial
disclosures are accurate for each member.
See Conflict of Interest Oversight Committee (COIOC) for more details.
Yes, the financial interest disclosure for each member of the study team is
accurate
Relying Non-UCI Entity (as applicable)
When UCI is the IRB of Record for a non-UCI entity (i.e., site or
independent investigator), review the IRB Reliance section and
remove any non-UCI entities (site or independent investigator)
that are no longer engaged in research.
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ClinicalTrials.gov Registration
Confirm that the response for ClinicalTrials.gov registration is
accurate.
If the clinical trial is not registered, please specify why (skip
question if not applicable):
Current Status
Accruals
Please mark the option that represents the current status of
subject enrollments:
Enrollment ongoing - research procedures ongoing
Subject Enrollments
Please confirm the total number of subjects (i.e. individuals,
specimens, records) approved by the UCI IRB in the Subject
Populations section.
Indicate the number of new subjects enrolled since last IRB
review:
22
Indicate the total number of subjects (including the number
in the previous question) enrolled since initial UCI IRB
approval:
22
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Did the total number of subjects enrolled to date exceeds the
total number approved by the IRB?
No
Indicate the total number of subjects enrolled per group
since initial IRB approval:
Male (total)
20
Female (total)
2
Non-Binary (total)
0
Not Collected (total)
0
Adults (total)
0
Minor (total)
22
Multi-Center Studies: If known, indicate the total number of
subjects enrolled at ALL sites to date:
n/a
Subject Withdrawals
Early Termination(s)
Did the Lead Researcher or a Co-Researcher remove any
subject(s) from the study?
No
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Voluntary Withdrawal(s)
Did any subject(s) voluntarily withdraw from the study?
No
Reportable Events
Reportable Events
Have there been any problems that required prompt reporting to
the UCI IRB?
No problems that require reporting
Complaints
Have there been any complaints from UCI participants or others
that required reporting to the UCI IRB?
No
Progress Report
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UCI Progress
Please provide a detailed description of the progress of the
study, including a brief summary of any interim findings or
trends, and plans for the next approval period:
Initial participant recruitment and intervention was delayed by the pandemic,
with the first eligibility visits starting in the fall of 2021. Recruitment,
screening, eligibility visits, and intervention are presently ongoing. The
targeted enrollment for this study is 48-52 participants, with 22 participants
consented and found eligible for enrollment to date. A no-cost extension was
filed with NIH, extending the research period to 8/31/2023 in an effort to
complete recruitment of the targeted sample size indicated by power
analysis. No data has been analyzed to date. Full enrollment is targeted for
March of 2023, with intervention sessions ending by June, 2023. Data
analysis, presentation and publication of findings are expect for Summer
2023.
Relying Entity Progress (as applicable)
If UCI is the IRB of Record for a non-UCI entity, provide a progress report for each relying entity
(e.g., number of participants enrolled at the sub-site; data analysis performed, if any, etc):
N/A
Informed Consent
Confirm that there is no new information that raises concerns
about the circumstances under which informed consent is being
obtained:
No new information
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Confirm that any new findings that have developed since the last
continuing review, have been provided to enrolled subjects, as
appropriate:
No new findings
Confirm that the research team is using the most recently
approved version of the consent/assent document and that it
contains the most accurate, up-to-date information about the
research:
Yes
Confirm that all signed consent documents are on file and
available for inspection:
Yes
Specify if any subjects were enrolled using a non-English
consent document, information sheet, or script:
No
Given that some research studies have multiple consent/assent
forms, please indicate which approved consent/assent forms
should be reviewed by the IRB:
Review all consent/assent forms
Re-Consent Status
Are there approved Re-Consent Cover Memos on file? 
IMPORTANT! To verify, review the 'Approved' documents in the Attachments section.
Yes
Is the re-consenting of participants complete?
Yes, all reconsenting is complete
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REQUIRED! Review and review the Attachments section to
remove all re-consent cover memos that are no longer being
used.
Internal and External Audits
Internal Audit(s)
Have any internal (UCI/UCI Health) audits occurred since last
IRB review?
No
External Audit(s)
Have any external (FDA/OHRP/Sponsor) audits occurred since
last IRB review?
No
Risk and Safety Assessments
Relevant Recent Literature
During the past year has there been anything in relevant
literature that the IRB should consider when reviewing this
application for continuing approval?
No
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Current Risk/Benefit Assessment
Has there been a change in risk/benefit?
Take into account the information gathered during the past year such as interim results,
reportable events/problems, changes in scientific knowledge, and/or relevant regulatory actions
regarding study-wide safety and/or efficacy (e.g., product recall). This assessment should be
sufficiently detailed to assist the IRB in determining whether continuation of IRB approval is
appropriate.
No
Data Safety Monitoring Board (DSMB)
Has there been any new DSMB findings relating to subject
safety?
No new findings related to subject safety
Investigator's Brochure (IB)
For FDA regulated drug studies, enter the current version
number and date of the Investigator's Brochure in the
Supplemental Documents section.
End of renewal form!
IMPORTANT! Go to the next section to complete the amendment
form.
Protocol Amendment Form
Amendment Instructions
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Specify the type of submission:
AMENDMENT: IRB (UCI is the IRB of Record)
• Complete the amendment form to describe the change(s) and to provide rationale for the
change(s).
• After the amendment form is complete, review and revise the protocol, as necessary.
• Submit all new and/or revised supporting documents in the Attachments section near the
end of the protocol.
• If the protocol is within 30 days of the expiration date, it is recommended that a renewal be
included with the amendment. If Renew & Amend was not initially selected and a renewal
is required, please Abandon the draft and start again.
• IMPORTANT! Please refrain from making major changes during a renewal as this could
result in a lapse of approval.
For more information, visit:
• IRB Protocol Amendments
• hSCRO Protocol Amendments
ATTENTION! Amendments are NOT required for the following determinations:
• Non-Human Subjects Research (NHSR)
• Exempt Self-Determinations
These amendments are to be tracked by the Lead Researcher independently. If the amendment
changes the level of review to where IRB review is required, a new protocol must be submitted.
IRB Amendment
What type of changes are being proposed for this request?
Minor Revision(s)
Current Status of Enrollments:
Enrollment ongoing - research procedures ongoing
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Number of subjects currently receiving active research
intervention or if on hold, the number of subjects who were
receiving active intervention prior to the hold:
8 subjects are actively engaged in research intervention at this time.
Re-consent
Are there approved Re-Consent Cover Memos on file?
IMPORTANT! To verify, review the 'Approved' documents in the Attachments section.
Yes
Is the reconsenting of participants complete?
Yes, all reconsenting is complete
REQUIRED! Review and review the Attachments section to remove all re-consent cover memos
that are no longer being used.
Is there significant new information that would warrant
notification or reconsenting of participants?
No
List of Protocol Changes
List all requested changes below and provide justification for the
change, as applicable.
IMPORTANT! The list below must be complete / comprehensive of all changes as it will be reflected
in the IRB Approval Letter. Failure to provide a complete list of changes will delay IRB approval.
Change in Consent
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Provide the details and reason for the change in consent:
The approved consent form indicates participants will be paid by check but
they will be paid in cash. The Informed Consent has been modified with
tracked changes and will be attached.
Other Change(s)
Provide the details and reason for the other change(s):
The approved Protocol Narrative indicates participants will be paid by check
but they will be paid in cash. The Protocol Narrative has been modified with
tracked changes and will be attached.
Confirmation of Changes:
Check here to confirm that all changes to the protocol are listed above
End of amendment form!
Project Details
Specify the study title (this title should not exceed more than 100 words):
Animal Assisted Intervention with Dogs for Children with Attention
Deficit/Hyperactivity Disorder: Exploring Candidate Physiological Markers of
Response to AAI
Lead Researcher/Investigator:
Sabrina E Brierley Schuck
Enter the Lead Unit:
***IR-7462 - PEDIATRICS (Lead Unit)***
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Project Screener
Submit a Human Subject Protocol for UCI Institutional Review Board (IRB)
Review
Will this protocol be reviewed under a sIRB process?
No, there is no reliance involved. UCI serves as the IRB of record
Are the research procedures limited to the use/analysis of identifiable private information and/or
identifiable biospecimens (no subject contact)?
No
Select the required level of review for this protocol:
Minimal Risk (Expedited)
Check all sites where UCI investigator(s) will conduct research activities (e.g., recruitment,
informed consent, and research procedures including accessing identifiable, private information
about participants):
UCI Facilities or Sites (e.g. school, hospital or clinics, etc.)
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Provide a non-technical summary of the project that can be understood by IRB/hSCRO members
with varied research backgrounds, including non-scientists and community members (this
summary should not exceed more than 250 words):
Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly
occurring neurodevelopmental disorder in the US. Common treatments are
stimulant medications and counseling but these practices are not always
feasible or acceptable due to adverse side-effects, cost, and poor adherence.
As such individuals remain at risk for poor outcomes. ADHD is considered to
be a result of a disruption of select physiological systems and related under-
arousal of parts of the brain involved in executive functioning (EF). Our
previous research indicates that Animal Assisted Intervention (AAI) with dogs
is effective for improving outcomes related to EF deficits (Schuck, et al.,
2018a; 2018b). The mechanisms by which AAI improves outcomes for this
group however, is not yet understood. These gaps in understanding hinder
progress in the application of AAI, limiting the acceptability and availability of
this integrative healthcare practice. We contend that dogs elicit physiological
responses related to arousal of EF systems, thereby enhancing response to
treatments. Furthermore, individual differences potentially mediate outcomes.
This purpose of this research is to replicate our previous work(Schuck,
Emmerson, Fine, & Lakes, 2015; Schuck et al., 2018a; 2018b), to determine if
physiological responses to AAI change over time, and to ascertain if individual
differences during AAI mediate findings. To explore these hypotheses our
research procedures will include conducting an exploratory parallel-group
randomized controlled clinical trial with 48 young children with ADHD,
participating in intervention with/without AAI during which we will collect and
analyze physiological measures (candidate salivary analytes and heart-rate-
variability) thought to play an important role in AAI for children with ADHD.
Instructions
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IRB Protocol Instructions
• For research with a Master Protocol or with a detailed project proposal, specify this in the
protocol and an abbreviated protocol will be generated.
• Submit all new and/or revised supporting documents in the Protocol Attachments section
near the end of the protocol.
• The Lead Researcher (LR) is responsible for maintaining all supplemental documentation
(as indicated in the form) in the research records. This documentation may be requested
by Human Research Protections for quality assurance review.
For regulatory or institutional guidance:
• Visit Human Research Protections
• Contact the Human Research Protections staff
For technical issues or questions:
• Visit the Kuali Research Protocols (KRP) User Guide
• Contact Electronic Research Administration (ERA)
Type of Research
The purpose, specific aims or objectives of the research is:
Social/Behavioral/Educational
The research protocol is:
Investigator-Initiated
Does the investigator-initiated study have any industry support?
No
Is this study an extension of a UCI IRB approved study (e.g., resubmission of ongoing exempt
research; Open Label Extension) or is it otherwise related to a UCI IRB approved study?
No
Does this research meet the definition of a clinical trial that requires adherence to
Clinicaltrials.gov?
Yes
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If currently available, provide the CT.gov registration NCT # (Enter 8-digit sequence of numbers
only):
NCT #05102344
Specify the rationale for Clinicaltrials.gov registration:
NIH-funded Clinical Trial
STOP! All clinical trials must be conducted under the auspices of an Organized Lead Unit (OLU).
Please update. Go to Project Details and choose the appropriate OLU for the trial.
Level of Review
Minimal Risk - No more than minimal risk to subjects
Select the applicable category(ies):
3. Prospective collection of biological specimens for research purposes by
noninvasive means
4. Collection of data through noninvasive procedures (not involving general
anesthesia or sedation) routinely employed in clinical practice, excluding
procedures involving x-rays or microwaves
6. Collection of data from voice, video, digital, or image recordings made for
research purposes
7. Research on individual or group characteristics or behavior (including, but
not limited to, research on perception, cognition, motivation, identity,
language, communication, cultural beliefs or practices, and social behavior) or
research employing survey, interview, oral history, focus group, program
evaluation, human factors evaluation, or quality assurance methodologies
Study Funding
Select the funding source(s) (check all that apply):
Grant/Contract
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Select the sponsor type(s) (check all that apply):
Health and Human Services (HHS) (includes National Institutes of Health
(NIH)
List below all extramural proposals or awards that will support the study (if applicable):
IMPORTANT! Skip this table if extramural funding is not available.
Sponsor Name
NICHD
Title of Proposal/Award (if different from study title):
Animal Assisted Intervention with Dogs for Children with Attention
Deficit/Hyperactivity Disorder; Exploring Candidate Physiological Markers of
Response to AAI
Proposal or Award #:
5R21HD103422-02
Scientific/Scholarly Review
Is the research Sponsor-Initiated?
Yes
The proposed research qualifies as minimal risk research. The Department Chair, Division Chief,
or Institute Director provides assurance that the research uses procedures consistent with sound
research design, the study design can be reasonably expected to answer the proposed question,
and the importance of the knowledge expected to result from the research is known.
Check here to confirm the above assurance
Potentially Hazardous Materials
If any of the following hazardous materials are involved in this research please check below:
N/A
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Other UCI Committee Reviews
Check all ancillary committees that apply:
N/A
Study Team
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Study Team:
• List only study team members who are engaged in human subjects research below.
• Administrative Contact (AC): Do not add ACs to the study team table. To add ACs,
navigate to the Permissions tab on top-right-hand-side of form. All ACs must
complete the requisite Human Research Protections CITI Training.
• Lead Researcher (LR): LRs must meet requirements specified on the Lead Researcher
Eligibility page for study to be approved.
• Select ‘Oversight of Research’ along with other applicable duties.
• Select 'Full Access'.
• Faculty Sponsor (FS): FSs are required when the person serving the LR role is not qualified
to serve as LR-- the FS must be eligible to be LR.
• Select ‘Oversight of Research’ along with other applicable duties.
• Select 'Full Access'. 
• Co-Researcher (CR): CRs are faculty, staff, students and other academic appointees who
the LR considers to be key personnel for conducting the research study. These individuals
work closely with the LR to design, conduct, and/or report on the research.
• Research Personnel (RP): List RP as required per the Research Personnel Heat Map. For
those RP who do not need to be listed on the protocol, they may be tracked by alternative
methods, see below.
• IMPORTANT! Do NOT list non-UCI researchers below, in the Permissions tab at top or on
the Study Team Tracking Log (or equivalent); instead, follow the Single IRB Reliance (sIRB)
process.
• Collaborative Institutional Training Initiative (CITI) Human Research Protections Training
Courses
• Confirm CITI training is complete and current for all study team members.
• Incomplete or expired CITI training will delay IRB approval.
• For more information, visit HRP Training and Education.
Researcher
Sabrina E Brierley Schuck
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Training
To promote the objectivity of the research, all researchers are required to disclose their related
disclosable financial interests, per the IRB COI Policy. If you have any questions about the COI
process in general, contact the COI team.
Each member of the study team for this protocol must be asked the following question to
comply:
“Do you, your spouse/registered domestic partner, and dependent children have any
disclosable financial interests* (i) that would reasonably appear to be affected by this research
study; or (ii) in entities whose financial interests would reasonably appear to be affected by
this research study?"
No
Degree
PhD
Position/Title
Assistant Professor
Department
Affiliation
UCI Faculty
Researcher Role
Lead Researcher
Permissions
Full Access
Social/Behavioral Investigators - Refresher Course
03/02/22 - (no expiration)
Social/Behavioral Investigators - Basic Course
02/24/17 - 02/23/22
error Expired
IR-6125 - PEDIATRICS-DEVELOPMENTAL/BEHAVIORAL
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Duties
Oversight of Research
Screen/Recruit Subjects
Finalize Informed Consent
Access/Analyze Identifiable Information
Access/Analyze Identifiable Biospecimens
Specify relevant training and experience for the referenced duties/responsibilities:
All study team members will be certified in CITI and HIPPA compliance
trainings. Those team members who will be handling saliva samples will
also be certified and trained specifically in the collection, handling,
coding/labeling and transport of saliva samples for the purpose of analysis
of salivary analytes. All study personnel have been trained in all procedures
involved with conducting psychosocial intervention groups and animal
assisted intervention groups with children. Furthermore, prior to each
treatment cohort, the study consultant, will provide a thorough review of the
safe and effective protocol standards for working with therapy animals and
children.
Are RP tracked outside the approved protocol, in accordance with the RP Heat Map?
Yes, RP are tracked on a Study Team Log or other comparable log
Supplemental Documents
Does this study include supplemental documents?
No
Background & Purpose of the Research
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Describe the purpose, specific aims or objectives and specify the hypotheses or research
questions to be studied:
The purpose of this research is to address gaps in understanding of the
mechanisms of AAI and how these mechanisms may differ across special
populations hinder progress in the application of AAI, and limit the
acceptability and availability of this integrative health care practice. Our bio-
social mechanistic hypothesis contends that dogs elicit physiological
responses related to arousal of EF systems, thereby enhancing response to
treatments. Furthermore, candidate individual differences potentially mediate
outcomes. This work will explore these hypotheses; 1) we suspect AAI will
result in enhanced social-behavioral outcomes and improved diurnal patterns
of HPA and ANS activity for these children and 2) we suspect acute
physiological responses to AAI (markers of HPA &amp; ANS) and social
interaction quality (child/child and child/dog) will mediate main outcomes.
Specific Aims Specific Aim 1: To replicate previous findings that social-
behavioral outcomes are improved for children with ADHD when they
participate in an 8- 10 week manualized AAI with therapy dogs. Specific Aim
2: To explore if diurnal patterns of physiological markers of Hypothalamic
Pituitary Adrenal axis (HPA) activity (salivary cortisol; Cort and uric acid; sUA)
and Autonomic Nervous System (ANS) activity (heart-rate variability; HRV, and
salivary alpha-amylase; sAA) are improved over time for children with ADHD in
response to an 8- 10 week manualized AAI with therapy dogs. Specific Aim 3:
To explore if potential individual differences in children with ADHD are
manifested during intervention sessions and if these differences mediate
primary and exploratory main outcomes from an 8- 10 week manualized AAI
with therapy dogs. Specific individual differences explored include; acute
physiological responses during intervention sessions as measured by
markers of HPA &amp; ANS activation (Cort, sUA, sAA, &amp; HRV) and the
quality of social interaction (child/child and child/animal) during sessions.
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Provide the scientific or scholarly rationale for the research and describe the relevant
background information and the specific gaps in current knowledge that this study intends to
address:
This project explores physiological mechanisms thought to underlie the
positive effects of AAI for children with ADHD and posits that interaction with
dogs during treatment improves social behavioral and physiological
outcomes and that individual differences in bio-markers and interaction style
mediate outcomes for this group. Rationale & Background Despite decades of
research aimed to optimize outcomes for children with ADHD, the condition
remains a significant public health problem adversely impacting individuals,
families and schools. The annual cost of ADHD is estimated at $266 billion
(Doshi et al., 2012). Pharmacotherapy (e.g., methylphenidate) is the mainstay
of traditional medical intervention for ADHD, but treatment failures are
common (Caye, Swanson, Coghill, &amp; Rohde, 2018; Schneider &amp;
Enenbach, 2014; Swanson et al, 2018), and affected children often require
medications during what are now recognized as critical periods of growth and
development. It is not surprising that parents find alternative therapies,
including Animal Assisted Intervention (AAI), to be more acceptable than
medication (Rabbit, Kazdin, &amp; Hong, 2014). Our research found AAI to be
effective in reducing ADHD symptoms and improving social skills and self-
perception (Schuck et al., 2015; Schuck et al., 2018a, Schuck et al., 2018b).
Gaps in Current Knowledge While we demonstrated the effectiveness of AAI
for this group, the underlying mechanisms of these effects is unknown; a
critical gap in our developing body of evidence for AAI needed to increase the
acceptability and accessibility of this integrative health care strategy. The
research proposed in this application will break ground in this nascent area
and contribute to the rapidly developing discipline of HAI research by (1)
contributing to our understanding of bio-social mechanisms which may
underlie outcomes, (2) identifying individual responses thought to mediate
outcomes and (3) informing the development of future large scale, multi-site
trials aimed to informing best practices for delivering AAI in special pediatric
populations and improving accessibility to this practice.
Provide relevant preliminary data (animal and/or human):
N/A
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Describe the primary outcome variable(s), secondary outcome variables, and predictors and/or
comparison groups as appropriate for the stated study objectives/specific aims:
N/A
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List up to ten relevant references/articles to support the rationale for the research:
Berry, D., Blair, C., Willoughby, M., & Granger, D. A. (2012). Salivary alpha-
amylase and cortisol in infancy and toddlerhood: Direct and indirect relations
with executive functioning and academic ability in childhood
Psychoneuroendocrinology, 37(10), 1700-1711.
doi:http://dx.doi.org/10.1016/j.psyneuen.2012.03.0 Chen, F. R., Raine, A.,
Glenn, A. L., & Granger, D. A. (2015). Hypothalamic pituitary adrenal activity
and autonomic nervous system arousal predict developmental trajectories of
children's comorbid behavior problems. Developmental Psychobiology,
doi:http://dx.doi.org/10.1002/dev.21379 Esposito, L., Gee, N. R., Freund, L. S.,
McCune, S., & McCardle, P. (2016). Future research: Needs and promise. In L.
S. Freund, S. McCune, L. Esposito, N. R. Gee & P. McCardle (Eds.), The social
neuroscience of human animal interaction; the social neuroscience of human-
animal interaction (pp. 249-253, Chapter x, 271 Pages) American
Psychological Association, Washington, DC.
doi:http://dx.doi.org/10.1037/14856-016 Griffiths, K. R., Quintana, D. S.,
Hermens, D. F., Spooner, C., Tsang, T. W., Clarke, S., & Kohn, M. R. (2017).
Sustained attention and heart rate variability in children and adolescents with
ADHD. Biological psychology, 124, 11-20. Keller, P. S., El-Sheikh, M., Granger, D.
A., & Buckhalt, J. A. (2012). Interactions between salivary cortisol and alpha-
amylase as predictors of children's cognitive functioning and academic
performance. Physiology & Behavior, 105(4), 987-995.
doi:http://dx.doi.org/10.1016/j.physbeh.2011.11.005 Lee, S. H., Shin, D., &
Stein, M. (2010). Increased cortisol after stress is associated with variability
in response time in ADHD children. Yonsei Med J, 51, 206-211 Loo, S. K., Hale,
T. S., Macion, J., Hanada, G., McGough, J. J., McCracken, J. T., & Smalley, S. L.
(2009). Cortical activity patterns in ADHD during arousal, activation and
sustained attention. Neuropsychologia, 47(10), 2114-2119.
doi:http://dx.doi.org/10.1016 Schuck, S.E.B., Emmerson, N., Abdullah, M.M.,
Fine, A.H., Stehli, A. & Lakes, K. D. (2018a). A randomized controlled trial of
traditional psychosocial and canine-assisted interventions for ADHD. Human
Animal Interaction Bulletin (6) 1, 64-80 (2 citations) Schuck, S. E. B.,
Emmerson, N., Fine, A. H., & Lakes, K. D. (2015). Canine-assisted therapy for
children with ADHD: Preliminary findings from The Positive Assertive
Cooperative Kids Study. Journal of Attention Disorders, 19 (2): 125-137. doi:
10.1177/1087054713502080 Schuck, S.E.B., Johnson, H.L., Abdullah, M. M.,
Stehli, A., Fine, A. H. & Lakes, K. D. (2018b). The Role of Canine Assisted
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Intervention on Improving Self-Esteem in Children with Attention
Deficit/Hyperactivity Disorder. Frontiers in Veterinary Science, 08, November
2018 Shin, D. W., & Stein, M. A. (2010). Increased cortisol after stress is
associated with variability in response time in ADHD children. Yonsei medical
journal, 51(2), 206-211. Thayer, J. F., Åhs, F., Fredrikson, M., Sollers III, J. J., &
Wager, T. D. (2012). A meta-analysis of heart rate variability and neuroimaging
studies: implications for heart rate variability as a marker of stress and health.
Neuroscience & Biobehavioral Reviews, 36(2), 747-756. Van West, D., Claes, S.,
& Deboutte, D. (2009). Differences in hypothalamic–pituitary–adrenal axis
functioning among children with ADHD predominantly inattentive and
combined types. European child & adolescent psychiatry, 18(9), 543-553.
Subject Population(s) (Individuals/Records/Biospecimens)
Check all subject populations/data sources that apply to the research:
Adults Competent to Provide Informed Consent
Children
Use of identifiable or coded data, specimens, records, charts
Maximum and Expected Number of Persons/Records/Biospecimens to be Enrolled
1. Click "Add Line" button above Enrollment Table to add a Category/Group
a. To change visibility of columns, click "Columns" button above Enrollment Table and
select which Column rows to view.
2.  Specify the maximum and expected numbers of individual-level information and/or
biospecimens to be accessed/analyzed within each Category/Group
Category/Group
Parents
Age Range
18 or older
Maximum Number of Subjects, Subjects to be Consented or Reviewed/Collected
160
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Number Expected to Complete the Study or Needed to Address the Research Question
48
Category/Group
Children
Age Range
7 years to 9 years, 11 months
Maximum Number of Subjects, Subjects to be Consented or Reviewed/Collected
80
Number Expected to Complete the Study or Needed to Address the Research Question
48
Will this study only take place at UCI and does not involve other sites?
Yes
Eligibility Factors (Inclusion/Exclusion Criteria)
1. Click "Add Line" button above Eligibility Factors Table to add a inclusion/exclusion criteria
a. To change visibility of columns, click "Columns" button above Eligibility Factors Chart
and select which Column rows to view.
2. Identify the factors for limited eligibility and provide a scientific rationale. Include additional
rows for factors, as needed.
Category/Group Eligibility
Children
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Inclusion Criteria
Participating children ages 7 to 9 years with ADHD and up to two parents
per participating child among 4 cohorts across 2 years will be included.
Children who are at least 7 years of age on the day of their consent and who
are no older than 9 years, 11 months, and 30 days of age (not 10 years of
age) on the day of their consent may be included in the samples. Eligibility
will be determined utilizing a multi-gate screening procedure, including a
semi-structured diagnostic interview schedule for mental disorders of
childhood, standardized parent and teacher rating scales, and a brief
assessment of intellect. Eligible and consenting participants and their
parents will then be randomly assigned to intervention groups. Initial
assessment visits, and randomization will take place within a 21-day
window prior to the commencement of the treatment phase.
Exclusion Criteria
This study aims to explore specific candidate physiological mechanisms of
HPA and ANS activation during intervention that are suspected to be
different in young children with ADHD from typically developing children and
children with other mental health disorders, as such this study will exclude
children with a primary or comorbid diagnosis of Autism Spectrum Disorder
(ASD) and/or Major Mood Disorder, in efforts to maximize power with a
feasible sample size. Additionally, a careful screening for child and/or family
history of mistreatment, neglect, or cruelty to animals will be used to
excluded children or families that may put the participating animals at risk.
Children with a known allergy or phobia of dogs will also be excluded.
Is eligibility based on age, gender, pregnancy/childbearing potential, social/ethnic group, or
language spoken (e.g., English Speakers only)?
Yes
Limited Eligibility Factors (Special Populations)
1. Click "Add Line" button above Limited Eligibility Factors Table to add a special population
a. To change visibility of columns, click "Columns" button above Limited Eligibility Factors
Table and select which Column rows to view.
2. Identify the special populations and provide a scientific rationale. Add additional rows, as
needed.
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Eligibility Limited to the Following Factors
Gender
Specify the rationale for this group:
ADHD reportedly occurs in a 3:1 boy to girl ratio in epidemiological samples.
We therefore expect our sample to be disproportionately male. The
proportion of girls in this study will likely reflect the typical population
distribution of girls with ADHD. Recruitment strategies aim to be non-bias in
the selection of females and minorities.
Eligibility Limited to the Following Factors
Age
Specify the rationale for this group:
The sample of this study is composed of individuals under the age of 18. As
Attention Deficit/Hyperactivity Disorder (ADHD) is by definition a
neurodevelopmental disorder of childhood onset exclusive of intellectual
deficiency, the sample for the proposed project is restricted to children with
at least low-average estimated intellectual capabilities (estimated IQ>79).
School-aged children between the ages of 7 and 9 will be studied as the first
aim of this study is to replicate previous research conducted with this age
group.
Subpart D - Children
Select the category that best describes your proposed research (45 CFR 46 - Subpart D):
Category 1 (§46.404) This proposed research poses no greater than minimal
risk to children. (Note: for research that qualifies for Expedited level of review)
Indicate why the proposed research poses no greater than minimal risk to children:
The risk to children involved in the study poses no greater risk than that of the
risks children experience in their everyday lives at school, in social situations
or sports teams, or in the presence of family pets
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If there is more than one group of children being enrolled in the research (e.g., patients, healthy
controls) and the groups fall into different risk/benefits categories, describe the groups below
listing the applicable category for each group:
N/A
Parental Permission
Select one statement that best describes how you will obtain parental permission:
I will obtain the permission of one parent or guardian
Assent
Select which best describes how you will be obtaining assent and answer the corresponding
questions:
I will obtain assent from all children
Enrollment of People Under 18 Who Can Consent for Themselves
Will people under the age of 18 who are permitted under California law to consent for themselves
be enrolled in this study?
No
Children who are Wards of the State (45 CFR 46.409; 21 CFR 50.56)
Do you intend to enroll wards of the state or any other agency, institution, or entity?
No
Does the study fall under §46.406 or §46.407 (FDA §50.53 or §50.54)?
No
Pre-Screening and Determining Eligibility without Informed Consent
Will Identifiable information be obtained for the purpose of screening, recruiting, or determining
eligibility of prospective subjects?
Yes
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The 2018 Common Rule allows for Pre-Screening activities (i.e., determining if potential subjects
may be eligible to participate in research) performed without the written informed consent of the
prospective subject or legally authorized representative (LAR). This means that the IRB does not
need to grant a waiver of informed consent.
Provide a complete list of the data points, variables, and/or information that will be collected
during Pre-Screening (i.e. data abstraction form):
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Or specify variables or information required for Pre-Screening:
The following variables will be collected at the Screening Visit to help
determine eligibility: 1. K-SADS-PL DSM-5 Eligibility Screening Visit Parent The
Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged
Children, Present & Life-Time Version (K-SADS-PL DSM-5; Kaufman, et al.,
2016) is a semi-structured interview designed capture dimensional and
categorical assessment to the contribute to the diagnosis of current and
present levels of psychopathology in children according to the DSM-5.
Parents will complete the K-SADS interview at the Screening Visit to help
determine eligibility. 2. ASRS-Short Form Eligibility Screening Visit Parent The
Autism Spectrum Rating Scales-Short Form (ASRS; Goldstein & Naglieri,
2013) is a brief assessment designed to provide an estimate of symptoms of
Autism Spectrum Disorder and takes 5-10 min to complete. Parents will
complete the ASRS-Short Form at the Screening Visit to determine help
eligibility. 3. ADHD-RS Eligibility Screening Visit Parent The Attention
Deficit/Hyperactivity Disorder Rating Scale, (ADHD-RS; DePaul, 2012) takes
about 10-15 minutes to complete. Parents will complete the ADHD-RS at the
Screening Visit to help determine eligibility. 4. WASI-II Eligibility Screening
Visit Participant The Wechsler Abbreviated Scale of Intelligence-Second
Edition (WASI-II, Wechsler, 2011) is a brief assessment designed to provide an
estimate of intellectual skills. The assessment takes about 10-15 minutes to
complete each of 4 sub-tests, or a total of 40-60 minutes. Participants will
complete the WASI-II at the Screening Visit to help determine eligibility for the
trial. 5. TOWRE-2 Eligibility Screening Visit Participant The Test of Word
Reading Efficiency-Second Edition (TOWRE-2, Torgesen, Wagner & Rashotte,
2012) measures reading skills and takes about 5-10 minutes to complete.
Participants will complete the TOWRE at the Screening Visit to help determine
eligibility for the trial. 6. PERM-P Eligibility Screening Visit Participant The
Permanent Product test (PERM-P, Wigal & Wigal, 2006) is a validated written
mathematics test designed to determine math fluency skills in children ages
7-9 and takes about 5-10 minutes to complete. Participants will complete the
PERM-P at the Screening Visit to determine basic math achievement levels at
eligibility and inform level appropriate assessment prior the trial baseline data
collection day.
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Check all the Pre-Screening activities that apply:
Study team will obtain information through oral or written communication
with the prospective subject or LAR (i.e. self-report of medical information;
medical records will not be screened)
Will the study team screen stored identifiable biospecimens?
No
Will the study team contact subjects for eligibility or recruitment purposes?
No
Recruitment Methods
Will this study involve NO direct contact with participants (i.e., passive observation of public
behavior)?
No
Indicate all methods that will be used to recruit subjects for this study:
Recruitment Method
Flyers/Brochures
Specify Where Posted
UCI Zot Mail
Type of Space
Public (i.e., site/media that allows open access to content)
Recruitment Method
Center for Clinical Research (CCR) Find a Trial web page
Confirm that the study from the Center for Clinical Research (CCR) Find a Trial web page
is registered on ClinicalTrials.gov
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Recruitment Method
Clinicaltrials.gov
Confirm that the ClinicalTrials.gov statement is in all applicable consent documents
Recruitment Method
Colleagues provide subjects with information about the research and how to
contact investigators
Confirm that colleagues may provide a copy of the consent and other UCI IRB approved
materials but do not obtain subjects’ consent for the research or act as representatives of the
investigators
Recruitment Method
Colleagues, who are treating physicians, will send UCI IRB approved
recruitment letter to their patients
Confirm that:
1. The recruitment letter to be signed by the treating physician will be submitted in the
Attachments Section
2. Colleagues do not obtain subjects’ consent for the research or act as representatives of
the investigators
Recruitment Method
Online/Social Media
Specify Where Posted
Research Unity website
Type of Space
Public (i.e., site/media that allows open access to content)
Informed Consent Process
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Does this study involve the creation, use, or disclosure of Protected Health Information (PHI)?
No
Methods of Informed Consent
Identify the consent or assent process as applicable for each participant population (check all
that apply):
Paper-based signed informed consent/assent
Paper-based Signed Informed Consent
Indicate the paper-based signed informed consent/assent (check all that apply):
Signed Informed Consent
Signed Child Assent
Does this recruitment method include all subjects?
Yes
REQUIRED! Submit the Adult Consent Form, Child Assent Form and/or Parental Permission
Form in the Attachments Section.
Circumstances of Consent
Indicate the location where the consent process will take place (check all that apply):
Private room
Specify how the research team will assure that subjects, their parents, or their legally authorized
representative (LAR) have sufficient time to consider whether to participate in the research:
Subjects or their LAR will be allowed 'X amount of time' to consider whether to
consent
Specify hours, days or weeks for subjects, parents or their LAR will be allowed to consider
whether to consent:
1 hour
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Describe the parental permission process:
Informed parent consent will be obtained prior to children beginning the
screening assessment. If parents do not wish to have children in the room
during informed consent process, child care will be provided by the research
team in the waiting room (see signed written consent forms attached).
Describe the child assent process:
Once parents provide informed consent, the research team will review the
child assent form prior to beginning the screening assessment to determine
eligibility (see assent forms attached).
This study does NOT include Non-English Speaking Participants. Scientific justification/rationale
is required in the Eligibility Criteria Section for Subject Populations.
Research Procedures
Check all boxes that apply to the research:
Audio, Video, Digital or Image Recording and/or Photography for Collection of
Research Data
Clinical Investigation involving an Investigational Device
Collection of Other Samples/Specimens (e.g.,tissue, saliva, urine)
Other Non-invasive Physical Measurements (e.g., ECG, EEG, moderate
exercise, muscular strength testing, body composition assessment)
Surveys/Questionnaires/Interviews/Oral Histories
Will deception or incomplete disclosure be involved in the research?
No
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Study Design
Include an explanation of the study design (e.g., randomized placebo-controlled, cross-over,
cross-sectional, longitudinal, etc.) and, if appropriate, describe stratification/
randomization/blinding scheme:
The proposed research will run a Parallel-Group Randomized Controlled Trial,
employing an exploratory parallel-group randomized controlled trial study
design and utilizing a multi-method and multi-source assessment protocol. a.
The study is currently planned to take place at The Children’s School at 3400
Michelson #200, Irvine, CA 92612 b. We will use a repeated-measure within-
subject design, gathering measurement of main outcomes at three time
points to assess the efficacy of AAI for children with ADHD who are
participating in a short-term intervention with or without the assistance of
therapy dogs. A linear, repeated measures design will be utilized for our
primary, and exploratory main outcome. c. Over the course of about 4 months,
children will participate in treatment and assessment for a total up to
approximately 16-20 hours) and parents will participate in approximately 6-9
hours of assessment. d. Children and their parents will first attend a
screening visit that will last 2-3 hours to determine eligibility. e. If eligible,
participation will require participants to attend group sessions for integrative,
non-medical treatments for ADHD, once weekly (one weekday after school to
be determined as space permits for about 2 hours per session (for a total of
about 16-20 hours). These play group sessions may or may not include the
participation of up to 3-4 certified therapy dog/handler dyads. These group
sessions will be video recorded to capture child-child, child-dog, and dog
behavior. f. Participation will also require child participants to attend three (3)
Saturday “Laboratory School” assessment visits, immediately prior to and
after the intervention period and then five weeks later. Each of these
assessments will last approximately five to six (5-6) hours (about 18 total
hours over three visits) for child participants and up to 2 hours each of three
visits for parents (about 6 hours total). “Laboratory School” recess sessions
will be video taped to capture observed child-child interactions. g.
Participants will also be requested to wear a device used to collect heart rate
(FirstBeat monitor) during the assessment days (3) and intervention sessions
(3) and on the night prior to participation in the three (3) Saturday "Laboratory
School" assessment visits. The FirstBeat monitors which have been found to
be acceptable, feasible, safe and reliable for collection in several youth
samples. For heartrate collection, parents will be instructed on how to affix a
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small heartrate monitor device, the FirstBeat Bodyguard 2 on their child’s
chest the night before (and then again on the morning of each of the
Laboratory School visits. The devices are small, unobtrusive and do not
require an uncomfortable halter band as they easily affix with two small hypo-
allergenic adhesive electrodes designed to remain comfortable and has been
found to remain in place during moderate to heavy physical activity, safe and
acceptable in children ages 7-9. Additionally, this device has been found safe
and feasibly deployed in studies in both typically developing children and
specials population as young as 4 years of age. FirstBeat devices will be
distributed to parents at the same time as the saliva kits and parents will
receive verbal and written instructions on how and when to affix and remove
the device. At the conclusion of each Laboratory School visit, parents will
remove the device from their child prior to departure. De-identified heartrate
data collected on the device will be immediately downloaded to Dr. Schuck’s
protected drive in Health Sciences for analysis.
Provide precise definitions of the study endpoints and criteria for evaluation; if the primary
outcomes are derived from several measurements (i.e., composite variables) or if endpoints are
based composite variables, then describe precisely how the composite variables are derived:
See above
Statistical Considerations
Is a statistical analysis plan appropriate for this qualitative study design?
Yes
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Describe the statistical methods for the stated specific aims and hypotheses. Your analysis
plans should match the stated study specific aims and hypotheses:
Statistical Method per Outcome Specific Aim 1: Replicate Previous Favorable
Behavioral Response to AAI Primary Main Outcome: Behavior responses. This
parallel-group randomized design and will utilize a multi-method and multi-
source assessment protocol. The assessment protocol will use a repeated-
measure within-subject design, gathering main outcomes at three time points
to assess the efficacy of AAI on outcomes for children with ADHD who are
participating in a short-term intervention with or without the assistance of
certified therapy dogs (see Figure 1). Our previous research indicated that
after just 2 weeks of intervention, participants in the AAI condition showed
significantly greater improvement in symptoms compared to control
participants and that these gains were maximized by 10 weeks and then
maintained at 6 weeks post intervention (Schuck et al., 2018a), suggesting
that 10 weeks is an ideal duration of treatment to detect significant benefits
from AAI with dogs. Outcomes from AAI utilizing a manualized treatment with
therapy dogs (AAI) will be compared to standard of care evidence-based
psychosocial treatment at usual (control). Specific Aim 2: Determine
Physiological Response over time to AAI for children with ADHD. Exploratory
Main Outcome: Diurnal HPA and ANS responses. To determine if children with
ADHD present with measurable changes in physiological responses to a
short-term AAI (10 weeks) on measures of HPA and ANS we will gather
candidate salivary analytes (salivary cortisol, uric acid, and alpha-amylase;
Cort, sUA, sAA, respectively) and measures of cardiac rhythm, (heart rate
variability; HRV) prior to and post intervention for children participating in both
treatment conditions before, immediately after, and upon treatment follow up.
Specifically, for each domain we will ascertain changes in diurnal patterns of
candidate physiological measures utilizing a linear, repeated measures design
gathered across three (3) points in time; establishing individual baseline
patterns, end of treatment patterns, and then patterns at 6 weeks post-
treatment. Specific Aim 3; Explore Individual Differences as potential
mediators of response to AAI in children with ADHD. Secondary Outcome
Exploratory Mediator Analysis; In the proposed study, we will explore how
children’s individual (a) acute physiological responses during intervention
sessions and their individual (b) social interaction quality during intervention
sessions may play a role in each of the Main Outcomes. Specifically, we will a)
ascertain acute HPA activity (as measured by Cort, and sUA) and acute ANS
activity (as measured by HRV and sAA) during intervention sessions across
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both treatment conditions and we will b) ascertain the quality of in-session
social relationships (child-child) across both treatment conditions as well as
the quality of in-session child animal interaction (child-dog) during the AAI
sessions (observed child/child & child/dog interaction) at three (3) time
points across the 10-week study intervention period (weeks 1, 5, & 10). The
acute response and interaction quality measures from each of the three
sessions will then be correlated with the degree of change in the primary main
outcomes. (e.g., pre-post change in ADHD symptoms, social skills, regulation)
and the exploratory main outcomes (e.g., pre-post change in diurnal HPA
activity and ANS activity) to examine the potential mediation of individual
differences on response to AAI with therapy dogs for children with ADHD.
Here we provide an example of one mediation analysis for treatment group
(AAI vs Control) as the primary predictor, salivary cortisol response slope at
session 5 the potential mediator, and behavioral change (pre-post change) the
outcome: First, cortisol response slope2 means will be compared between
the groups (the mediator must be related to the predictor). If significant, then
the relationship between cortisol response slope2, and behavioral change will
be evaluated for a significant correlation/slope (the mediator must be related
to the outcome). Finally a model will be run with both treatment group and
cortisol response slope2 predicting behavioral change. If the relationship
between treatment group and behavioral change is reduced compared to the
primary analysis (i.e., with treatment group alone), saliva cortisol response2 is
interpreted as providing a mediated effect. To obtain estimates of the size
and significance of the indirect effects, bootstrapping procedures as
described by Shrout and Bolger (2002) will be implemented. Due to the fact
that bootstrapping procedures are still limited in the case of multilevel
models, an approximation of the Sobel test will also be performed, along with
Monte Carlo estimation of confidence intervals but because this aim is
exploratory and this is not a fully powered study, results presented will include
descriptive and confidence intervals.
Describe the statistical method(s) that will be used to analyze the primary outcome(s) or
endpoints:
see previous section
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If appropriate describe secondary or post hoc analyses of primary outcome(s) or other
exploratory analysis and if necessary, provide a breakdown of the methods used per outcome or
endpoint:
Statistical Method to Inform Randomization Bias: Intent to treat bias. To
establish equivalence of randomly assigned groups pre-intervention, t-tests
will be performed on outcome measures comparing the groups. Means and
standard deviations will be obtained and effect sizes calculated. Demographic
profiles will be obtained and bivariate significant tests performed to assess
the balance expected with randomization. Cohort effects on outcome as well
as participation rates will be evaluated to assess any bias related to location,
calendar time, or other session characteristics. Participation rates across the
intervention will be tracked and compared between the randomized groups. In
the spirit of the intent to treat principle (White, Carpenter, and Horton 2012)
every effort will be made to conduct follow-up assessments on all
randomized participants. Withdrawals will be documented with reason
provided. In addition, multi-level modeling allows all cases to remain in a
repeated measures model and will be done as a sensitivity analyses to
primary analyses done on individuals with at least one follow-up point.
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Sample Size Determination: Explain how the overall target sample size was determined (e.g.,
power analysis; precision estimation), providing justification of the effect size for the primary
outcome based on preliminary data, current knowledge/literature and/or cost consideration; if
appropriate, provide sample size justification for secondary outcomes. Power analysis should (at
least) match the primary outcome/endpoint:
Sample Size. This exploratory study will employ a parallel-group randomized
clinical trial design in which 48 participants will be randomly allocated to one
of two (2) treatment/intervention groups (AAI and Control) delivered across
four (4) cohorts in two (2) waves over the span of two (2) years (n = 12 per
parallel ten-week cohort) in efforts to inform the specific aims of the study.
Power & Expected Effect Size. Sample size analysis was conducted for
randomized controlled design, using SAS PROC power. For the primary
analysis of the main outcome domain (Aim 1: ADHD Behavior) with type I
error rate of .05 was implemented for a repeated measures analysis
evaluating group main effect, treatment main effect, as well as the
group*treatment interaction. Effect size estimates from the authors’ previous
parallel-group randomized study of HAI demonstrated large AAI vs control
effect size for problem behaviors (.86) and moderate effects on inattention
(.45) (Schuck et al., 2018a). For Aim 1, with a projected analysis of n=48, this
exploratory study will exceed 90% power to detect effect sizes of .19 and
above. At a level of 80% power, the minimum detectable effect was
determined to be .21. For Aim 2, n= 48 will, for each of the two primary
physiological outcome domains (Aim 2: Diurnal Pattern Hypothalamic
Pituitary Adrenal axis activity; HPA and Autonomic Nervous System activity;
ANS), a multilevel model will be constructed to assess pre-post intervention
change, post-follow up change, group differences at each assessment, and
group differences in degree of change. Models will account for within-subject
correlation and within-cohort correlation. Four (4) cohorts of 13 participants
each will be recruited for a total enrolled target sample size of 52 families
over Years 1 and 2, accounting for an anticipated attrition rate of about 8%
which is based on our recently completed study of AAI with ADHD (Schuck, et
al., 2018a) in efforts to yield a total sample of 48.
Research Procedures
Provide a detailed chronological description of the clinical or treatment plan:
See Study Design
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List all procedures involving the use and/or collection of photographs, or audio/video recording:
Facial image will be in video or photo Participants’ first names may be
collected or recorded in either video or audio recording
Specify the total duration of a subject’s participation in the study and clearly outline the duration
of participation for each study visit and sub-study, as applicable:
See Study Design
List data collection tools (e.g., measures, questionnaires, observational tool) below by clicking the
'Add Line' button. Include additional rows for study instruments, as needed:
The 'Columns' button allows you to display or hide columns in the Study Instrument List.
Name of Tool:
The Child’s Sleep Habits Questionnaire (Owens, Spirito, & McGuinn 2000)
Is the data collection tool standardized or validated?
Yes
Please provide data collection tool citation:
Owens, J. A., Spirito, A., & McGuinn, M. (2000). The Children's Sleep Habits
Questionnaire (CSHQ): psychometric properties of a survey instrument for
school-aged children. Sleep-New York-, 23(8), 1043-1052.
Will this study require clinical items/ services from UC Irvine Health?
No
Does the research involve the use of identifiable private information?
No
Sharing Results with Subjects
Will Individual results be shared with subjects?
No
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Will overall study results will be shared with subjects?
The overall study results will be listed on Clinicaltrials.gov
Medical Devices
Risk Assessment
Risks and Discomforts
1. Describe and assess any reasonably foreseeable risks and discomforts associated with each
procedure for each subject population — physical, psychological, social, legal or other:
2. If this study will involve the collection of identifiable private information, even temporarily, for
which the disclosure of the data outside of the research could reasonably place the subjects at
risk, include the risk of a potential breach of confidentiality:
The greatest potential risk for children interacting with dogs include the danger of an animal bite or
that a dog might carry diseases with potential transmission to humans. 
Also, should there be a breach in confidentiality of data, there is a slight risk that private health
information could be shared with individuals who are not members of the study team. 
This study involves the collection of participant identifiable data (even if temporary such as for
recruitment or compensation purposes), and as such, a breach of confidentiality is a risk associated
with the research.
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Discuss what steps have been taken and/or will be taken to prevent and minimize any
risks/potential discomforts to subjects:
Though these are potential dangers, risks of interacting with participating
therapy dogs are minimized by a strict safety screening protocol including a
review of animal health, history, certification by reputable therapy animal
certification organizations, and dog/handler interview. This safety protocol
was developed in a prior study by the Lead Investigator which included eight-
one children and over a dozen therapy animals over the course of 4 years and
resulted in zero incidents of injury or disease transmission (Schuck,
Emmerson, Abdullah, Stehli, Fine, & Lakes, 2018) and has since been used in
clinical treatment in a wide variety of settings across the nation for over 10
years now. The FirstBeat Bodyguard 2 device is small, unobtrusive and does
not require an uncomfortable halter band as they easily affix with two small
hypo-allergenic adhesive electrodes designed to remain comfortable and has
been found to remain in place during moderate to heavy physical activity, and
is safe and acceptable in children ages 7-9 [Martinez, et al, 2016]. Additionally,
this device has been found safe and feasibly deployed in studies in both
typically developing children and specials population as young as 4 years of
age [Jerger et al., 2018, Riquelme, et al, 2018]. There is a minimal risk of
discomfort from removing the adhesive discs, similar to removing an
adhesive bandage. Wiping the skin with a clean cloth or alcohol prep pad will
minimize the risk of irritation. All paper and digital records and saliva samples
are de-identified using a coding system in which there is only one linking
document for record keeping, recruitment and compensation purposed. Only
the LR and the study coordinator have access to this document. All identifying
information and digital images and recordings are destroyed immediately
after analysis unless participants have given explicit consent to use those
images or names for explicit media purposes as designated in the Release
Form. Only de-identified data will be shared with non-UCI collaborating
researchers.
Certificate of Confidentiality
Is the research partially or wholly funded by NIH (including NIH Institutes and Centers), or does
the research involve identifiable sensitive information that require CoC protections?
Yes
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Indicate whether the research is protected by a NIH Certificate of Confidentiality (CoC):
This research is partially or wholly funded by NIH, including NIH Institutes and
Centers. A CoC is automatically issued
Indicate in what situations identifiable private information protected by a CoC will be disclosed
(check all that apply):
As required by Federal, State, or local laws, excluding instances of disclosure
in any Federal, State, or local civil, criminal, administrative, legislative, or other
proceeding. Some examples are laws that require reporting of child or elder
abuse, some communicable diseases, and threats to harm yourself or others
Potential Benefits
Is there the prospect of a direct benefit anticipated for subjects?
Yes
Describe the potential benefits subjects may expect to receive from participation in this study:
Participants and their parents may experience improved social skills including
improved self-esteem and pro-social behavior and reduced symptoms of
inattention and oppositional behavior.
Specify the expected potential societal/scientific benefit(s) of this study:
The possible benefits to science and society include providing information
about how potential biological responses to animals may enhance treatments
for children with ADHD. This information is important as there are few
evidence-based non-pharmacological interventions for this group of
individuals who remain at risk for poor life outcomes despite the
effectiveness of medicines for the symptoms of ADHD.
Alternatives to Participation
Describe the alternatives to participation in the study available to prospective subjects. Include
routine (standard of care) options as well as other experimental options, as applicable (check all
that apply):
Routine standard of care available
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Specify the routine standard of care:
The known alternative procedures for decreasing the symptoms of ADHD
include treatment with medicines that have been found to decrease
symptoms (e.g., Dexedrine®, CONCERTA®, Focalin®, Adderall®, Adderall®
XR, Ritalin®, Ritalin LA®, etc.). The known alternative procedures for
improving social skills for children with ADHD include behavioral parent
training. These alternatives will not be administered during the course of this
study.
Participant Compensation
Will subjects be compensated?
Yes
Specify whether compensation is applicable and, if so, the method, amount and schedule of
compensation (Check all that apply):
Cash
Cash Compensation
Specify cash amount:
$60.00
Cash schedule:
Other
Specify 'Other' cash schedule:
After each Laboratory School Day
(3)
Will the cash compensation method include all subjects?
Yes
Will subjects be reimbursed for out-of-pocket expenses?
No
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Confidentiality of Research Data
Information and/or Biospecimens Storage
Indicate how information and/or biospecimens (including signed consent forms) will be stored
(check all that apply):
Biospecimens will be stored in a locked lab/refrigerator/freezer that is not
accessible to non-study team members
Information will be maintained electronically. Information will be password
protected and maintained in an encrypted format
Information will be maintained in hard copy. Information will be stored in a
locked area that is not accessible to non-study team members
Biospecimens Storage
Specify where the biospecimens will be stored in a locked lab/refrigerator/freezer:
Biospecimens will be stored in a locked lab freezer at the contracted lab,
Salimetrics, Inc.
Encrypted Format
Specify where the information will be maintained electronically:
All electronic information is maintained in Redcap
Hard Copy
Specify where the information will be maintained in hard copy:
Hard copy data will be stored in a locked cabinet in the private office of
the LR and not accessible to non-study team members.
Will subject/patient identifiers be collected or retained?
Yes
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Subject/Patient Identifiers
Will any subject/patient identifiers be collected or retained for data analysis, recruitment,
consenting and/or compensation (check all that apply)?
All elements of dates (except year) for dates that are directly related to an
individual: birth date, admission date, discharge date, death date, and all ages
over 89
All geographic subdivisions smaller than a state: street address, city, county,
precinct, ZIP code, and geocodes
Any other unique identifying number, characteristic, or code
Email addresses
Full-face photographs and any comparable images
Names
Telephone numbers
Specify any other unique identifying number, characteristic or code:
audio-video recordings
Will a code be used to link subject/patient identifiers with the information and/or biospecimens?
A code will be used. Subject/Patient identifiers will be kept separately from
the information and/or biospecimens. The code key will be destroyed at the
earliest opportunity, consistent with the conduct of this research
Will research data/biospecimens be transported or maintained on portable devices (e.g., laptop,
smartphone, external hard drive, etc.)?
Yes
Specify the device(s) or method(s) of
transportation:
portable devices
Explain why transporting or maintaining
subject/patient identifiable data/biospecimens
on portable devices is necessary:
Audio and video recordings will be
recorded on portable devices, which
will be placed in a locked cabinet
following evening sessions and then
immediately downloaded to a secure
server within 24 hours of recording
and deleted from the portable device.
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Specify who will have access to subject/patient identifiable information/biospecimens as part of
this protocol (check all that apply):
Authorized UCI personnel (such as the research team) and appropriate
institutional officials: such as the Office of Human Research Protections
(OHRP) Regulatory entities such as the Food and Drug Administration (FDA),
the National Institutes of Health (NIH)
Specify whether subject/patient identifiers be disclosed in presentations and/or publications:
Subject/Patient identifiers will not be disclosed
Specify how long all subject/patient identifiers will be retained. This includes identifiers stored in
paper format, stored electronically as well as video recordings, audio recordings, photographs,
etc.:
Destroyed after publication/presentation or end of protocol
Will any identifiable photos or audio/video recordings be collected or used?
Yes
Collection of Photographs, or Audio/Video Retention & Recording
Will identifiable audio recordings be collected?
Yes
How will the audio recordings be transcribed?
Identifiable audio recordings
transcribed by the study team
Specify timeframe for the audio transcription:
within 2 years of the study
completion
Will the identifiable audio recordings be de-identified?
No
Provide rationale on why identifiable audio recordings will not be de-identified:
First names may be called during the audio recording of intervention group
sessions. No identifiable information will be used in the labeling of audio
recordings
Will identifiable video recordings be collected?
Yes
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How will the video recordings be transcribed?
Identifiable video recordings
transcribed by the study team
Specify timeframe for the video transcription:
within 2 years of the study
completion
Will the identifiable video recordings be de-identified?
No
Provide rationale on why identifiable video recordings will not be de-identified:
Provided parents or LAR provide explicit permissions, photographs and/or
audio/video recordings may be used as specifically specified (i.e., training,
presentation). See Release Form
Will identifiable photographs be collected?
Yes
Will the identifiable photographs be de-
identified?
No
Provide rationale on why identifiable
photographs will not be de-identified:
Provided parents or LAR provide
explicit permissions, photographs
and/or audio/video recordings may
be used as specifically specified (i.e.,
training, presentation). See Release
Form
Research Information and/or Biospecimens Retention
Indicate how long research information/biospecimens will be retained:
In accordance with UCOP policy, information/biospecimens will be retained
for 10 years after the end of the calendar year in which the research is
completed, unless otherwise specified in the award agreement
Will research information and/or biospecimens be shared?
No
Attachments
If required documentation is not provided, the submission is incomplete and your Application will be
returned to you. Be sure to upload each document as required. If changes are needed, go back to
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the sub-section to revise your selections.
Maximum file size is 30MB
All UCI templates are available on the Human Research Protections Applications & Forms page or
Human Stem Cell Research Applications & Forms page.
To access approval documents where UCI will rely on another IRB, including commercial IRBs, visit
their respective online portals. Frequently used commercial IRB portals include:
• WIRB Copernicus Group's WCG IRB Connexus
• Advarra’s CIRBI
• SMART Online Reliance System (ORS)
Attachment
Attachment Type
Recruitment Material
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Recruitment Material
File Comments
2020-6069 Phone Scripts 10-21-20_normal_397124.docx
2020-6069 Phone Scripts 10-21-20_approved_397124.pdf
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File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Other
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Assent Form
File Comments
File Name
2020-6069 Release Form 10-21-20_normal_397126.doc
2020-6069 Assent Form 08-27-21_normal_418576.doc
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Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Assent Form
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Recruitment Material
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
2020-6069 Assent Form 08-27-21_approved_418576.pdf
2020-6069 Flyer 08-27-21_normal_418577.doc
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Attachment
Attachment Type
Recruitment Material
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Consent Form
File Comments
Word version
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
2020-6069 Flyer 08-27-21_approved_418577.pdf
20206069 Parent Consent 10-19-2022.doc
20206069 Parent Consent 10-19-2022.pdf
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Attachment Type
Consent Form
File Comments
stamped pdf version
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Data Collection Tool/Instrument
File Comments
File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
File Comments
Measures.png
FirstBeat_Bodyguard2_Manual.pdf
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File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
UCI IRB Approval Letter
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Lead Researcher Certification
20206069 Renew & Amend Approval Letter 10-19-2022.pdf
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Investigator's Assurance
As Lead Researcher, I have ultimate responsibility for the performance of this study, the
protection of the rights and welfare of the human subjects, and strict adherence by all co-
investigators and research personnel to all Institutional Review Board (IRB) requirements, federal
regulations, and state statutes for research involving human subjects.
I hereby assure the following:
1. The information provided in this application is accurate to the best of my knowledge.
2. The information provided in this application has been discussed and shared with my
Department Chair. Any requests for changes based on this discussion are included in this
application upon submission or will be initiated by the research team either during the IRB
review process or via an amendment.
3. All named individuals on this project have read and understand the procedures outlined in
the protocol and their role on the study.
4. All named individuals on this project have completed the required Educational research
tutorials and have been made aware of the "Common Rule" (45 CFR Part 46), applicable
Food and Drug Administration (FDA) regulations (21 CFR Parts 50, 56, 312 and 812), have
read the Belmont Report, and UCI's Federalwide Assurance (FWA) that are available on the
Human Research Protections Program (HRP) website.
5. All experiments and procedures involving human subjects will be performed under my
supervision or that of another qualified professional listed on this protocol.
6. I understand that, if the study described in this IRB application is supported by a federal
award or used as a basis for a proposal for funding, it is my responsibility to ensure that the
description of human subjects activities in the proposal/award is identical in principle to
that contained in this application. I will submit modifications and/or changes to the IRB as
necessary to assure the proposal/award and application are identical in principle.
I and all co-investigators and research personnel agree to comply with all applicable
requirements for the protection of human subjects in research including, but not limited to, the
following:
1. Obtaining the legally effective informed consent of all human subjects or their legally
authorized representatives (unless waived) and using only the currently approved, stamped
consent form (if applicable).
2. Per federal regulations, once a human research study has received IRB approval, any
subsequent changes to the study must be reviewed and approved by the IRB prior to
implementation except when necessary to avoid an immediate, apparent hazard to a
subject. See Reporting of Unanticipated Problems.
3. Reporting any unanticipated problems involving risk to subjects or others, including
protocol violations per UCI IRB policy. In addition, HIPAA privacy violations must be
PROMPTLY disclosed to the UCI Privacy Officer. There are time requirements for reporting
these breaches of confidentiality, which, if not met, may result in monetary damages to the
researcher and the institution.
4. Responding appropriately to subjects' complaints or requests for information about the
study; and reporting to the IRB any subject complaints that are not resolvable by the study
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team.
5. Promptly providing the IRB with any information requested relative to the project.
6. Assuring the appropriate administration and control of investigational test articles (i.e.,
investigational drugs, biologics or devices) by a qualified investigator or other appropriate
individual or entity (e.g., UCI Health pharmacy), and assuring use and maintenance of an
Investigational Drug/Biologic Accountability Log or Device Accountability Log.
7. Registering applicable clinical trials with clinicaltrials.gov. For more information about this
topic, visit the ClinicalTrials.gov web page or the HRP webpage. The consequences of not
meeting the registration and reporting requirements include monetary damages to the
researcher and the institution.
8. Obtaining continuing review prior to study expiration (I understand if I fail to apply for
continuing review, approval for the study will automatically expire, and all human research
activities must cease until IRB approval is obtained).
9. Promptly and completely complying with an IRB decision to suspend or terminate its
approval for some or all research activities.
10
. Submitting to a routine review of human subject research records. The Compliance &
Privacy Office at UCI Health performs ongoing routine reviews of open biomedical research
protocols, in an effort to ensure in part that human subject research activities are
conducted in accordance with regulations, laws and institutional policies regarding the
protection of human subjects. In addition, the HRP unit of the Office of Research has
developed the Education Quality and Improvement Program (EQUIP). Through EQUIP, HRP
staff conduct periodic quality improvement monitoring and educational outreach.
11
. For clinical trials initially approved by the IRB on or after January 21, 2019, posting one (1)
IRB-approved clinical trial consent form at a publicly available federal website. The consent
form must be posted after recruitment closes, and no later than 60 days after the last study
visit. For additional guidance, refer to the OHRP FAQs on Informed Consent.
12
. Filing a final report with UCI HRP at the conclusion of this project.
As the Lead Researcher, I assure all of the above
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Financial Disclosure
Investigators' Disclosure of Financial Interest
In order to inform research subjects of circumstances that may affect their decision to
participate in this study, all researchers are required to disclose their financial interests with
outside institutions.  
The Lead Researcher of the protocol must ask the following question of all study team
members:     
“Do you, your spouse/registered domestic partner, and dependent children together have any
disclosable financial interests (i) that would reasonably appear to be affected by the research; or
(ii) in entities whose financial interests would reasonably appear to be affected by the
research?"
A member of the study team who answers in the affirmative will be contacted by the Conflict of
Interest Oversight Committee (COIOC) to obtain additional information regarding their specific
financial interest(s). 
IMPORTANT! If there has been a change in the financial disclosures of the LR or the study team,
please also request a 'Change in Financial Interests'.
As Lead Researcher, I certify that the disclosures for all study team members
are accurate
End of form. Please review responses for accuracy and
completeness.
Please ignore the Admin Details Section below. This section is for
IRB/hSCRO use only.
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Administrative Details Form
Project Status
Committee:
IRB C
Project Status:﻿
Approved
Date of Project Determination:
October 19, 2022
Amendment Status:
Approved
Date of Amendment Determination:
October 19, 2022
Date of ERA Transcription:
November 10, 2021
Pre-2018 Common Rule:
No
Date of Transition to 2018 Common Rule:
No date entered
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