iLook Out for Child Abuse: An Innovative Learning Module for Childcare Providers
Phase: NA
Conditions: Child Abuse
Sponsor: Milton S. Hershey Medical Center

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HRP-591 - Protocol for 
Human Subject Research
Protocol Title:
Early Childhood practitioner’s knowledge and attitudes regarding reporting child abuse/neglect: iLookOut- 
Phase III
Principal Investigator:
Benjamin H Levi, MD, PhD
Department of Humanities/Pediatrics
blevi@hmc.psu.edu
717 531- 8778
Version Date:
10/26/2021
Clinicaltrials.gov Registration #:  NCT03185728
Important Instructions for Using This Protocol Template:
1.
Add this completed protocol template to your study in CATS IRB (http://irb.psu.edu) on the “Basic 
Information” page, item 7. 
2.
This template is provided to help investigators prepare a protocol that includes the necessary information 
needed by the IRB to determine whether a study meets all applicable criteria for approval. 
3.
Type your protocol responses below the gray instructional boxes of guidance language.  If the section 
or item is not applicable, indicate not applicable.
4.
For research being conducted at Penn State Hershey or by Penn State Hershey researchers only, 
delete the instructional boxes from the final version of the protocol prior to upload to CATS IRB 
(http://irb.psu.edu).  For all other research, do not delete the instructional boxes from the final version 
of the protocol.
5.
When making revisions to this protocol as requested by the IRB, please follow the instructions outlined in 
the Study Submission Guide available in the Help Center in CATS IRB (http://irb.psu.edu) for using track 
changes. 
If you need help…
University Park and other campuses:
Office for Research Protections Human Research 
Protection Program
The 330 Building, Suite 205
University Park, PA 16802-7014
Phone: 814-865-1775
Fax: 814-863-8699
Email: irb-orp@psu.edu
College of Medicine and Hershey Medical Center:
Human Subjects Protection Office
90 Hope Drive, Mail Code A115, P.O. Box 855
Hershey, PA 17033
(Physical Office Location: Academic Support 
Building Room 1140)
Phone: 717-531-5687
Fax number: 717-531-3937
Email: irb-hspo@psu.edu
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Table of Contents
1.0
Objectives
2.0
Background
3.0
Inclusion and Exclusion Criteria
4.0
Recruitment Methods
5.0
Consent Process and Documentation
6.0
HIPAA Research Authorization and/or Waiver or Alteration of Authorization
7.0
Study Design and Procedures
8.0
Subject Numbers and Statistical Plan
9.0
Confidentiality, Privacy and Data Management
10.0
Data and Safety Monitoring Plan
11.0
Risks
12.0
Potential Benefits to Subjects and Others
13.0
Sharing Results with Subjects
14.0
Subject Stipend (Compensation) and/or Travel Reimbursements
15.0
Economic Burden to Subjects
16.0
Resources Available
17.0
Other Approvals
18.0
Multi-Site Research
19.0
Adverse Event Reporting
20.0
Study Monitoring, Auditing and Inspecting
21.0
Future Undetermined Research: Data and Specimen Banking
22.0
References
23.0
Appendices
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1.0
Objectives
1.1
Study Objectives
The following objectives are ongoing from  STUDY00001243 previously approved by the IRB: 
(1) To evaluate the effectiveness of the eLearning Module (iLook Out for Child Abuse) created 
to train and inform childcare providers (CCPs);
(2) To identify CCPs’ current knowledge and attitudes regarding child abuse and its reporting;
(3) To evaluate the impact of an online educational program on CCPs’ knowledge, attitudes, and 
patterns of decision-making regarding suspected child abuse and its reporting;
(4) To explore the factors influencing the impact of an online educational program on CCPs’ 
knowledge and attitudes regarding suspected child abuse and its reporting.
Study Objectives unique to the new study: 
(1) To evaluate the impact of iLookOut on the incidence of “High Yield” reports of suspected 
child abuse. A high yield report is defined as a report for which: child abuse was confirmed or 
social services were recommended by the State for the child/family.  
(2) To evaluate the impact of iLookOut on the costs to the state from “low yield” childcare 
provider reports of suspected child abuse.
(3) To be conducted with Childcare providers (CCPs) in the state of Maine.
(4) To evaluate the effectiveness of after learning “pings” on learner retention.
1.2
Primary Study Endpoints
Primary Outcomes are 1) child abuse confirmation rates among CCP-reported cases of suspected 
child abuse; 2) rates of social services recommended for children/families who were reported for 
suspected abuse; and 3) costs associated with intake by the State and investigation of reports of 
suspected abuse in which child abuse is not confirmed and no social services were 
recommended.
1.3
Secondary Study Endpoints
Secondary outcomes are 1) changes in the number of CCP reports of suspected abuse; 2) number 
of CCPs in each study arm who complete iLookOut and Standard training; 3) CCP knowledge 
and attitudes regarding suspected child abuse and its reporting; and 4) CCPs’ evaluation of the 
iLookOut and Standard training.
2.0
Background 
2.1
Scientific Background and Gaps
1) children <5 years-old are particularly vulnerable to being abused; 2) despite being uniquely 
positioned to detect and report suspected abuse in young children, childcare providers (CCPs) 
currently identify and report less than half of 1% of substantiated cases of child abuse; 3) CCPs 
are not adequately prepared to identify at-risk children and protect them from abuse; 4) reports of 
suspected abuse from CCPs are less likely to be substantiated (compared to other mandated 
reporters); 5) evidence-based interventions are needed to help CCPs better serve their crucial role 
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in child protection; and 6) online interventions have particular advantages for standardization, 
easy dissemination, follow-up reinforcement, and tracking of outcomes.
2.2
Previous Data
Two previous studies were completed.  The first was a field study that was completed with 60 
Penn State Harrisburg undergraduate students majoring in early childhood education to pilot a 
draft of the present study’s pre-/post-assessment instrument.  A subset of the pre-/post-
assessment’s knowledge items were subsequently pilot-tested with CCPs actively employed at 
area childcare facilities.
The second study was a randomized controlled trial involving 735 CCPs in Pennsylvania, which 
demonstrated that participants who completed the iLookOut learning module: 1) had significant 
improvements in knowledge, compared to baseline; 2) showed significant changes (in the 
expected direction) in their attitudes toward child abuse and its reporting, compared to baseline; 
and 3) reported high satisfaction with the learning program.
Additionally, there is an ongoing “open enrollment” trial in which >10,000 CCPs in 
Pennsylvania have completed the iLookOut learning module.  To date, the results are almost 
identical to the previous randomized controlled trial of iLookOut.
2.3
Study Rationale
The purpose of the present study is to examine whether (compared to Standard mandated 
reporter training, and also Control –i.e., no intervention), iLookOut affects the actual reporting 
behavior of CCPs.
3.0
Inclusion and Exclusion Criteria
3.1
Inclusion Criteria
1) Childcare providers (CCPs) in the state of Maine
a.
“CCP” refers to the various childcare professionals and others who work with young 
children, including teachers, aides, therapists, administrators, support staff, 
volunteers, and others.
2) CCPs who work (paid or volunteer) at a licensed childcare establishment in Maine.
3)  >18 years of age
3.2
Exclusion Criteria
1) CCP working in a non-licensed facility
2) <18 years of age
3.3
Early Withdrawal of Subjects
3.3.1 Criteria for removal from study
Participants will only be included in study analysis if they complete the online training 
post-test.  Data from CCPs who do not complete the online training post-test will be 
excluded from analysis, except for the purposes of identifying factors correlated with 
non-completion of the learning program.  CCPs who report that they are <18 years of age 
also will be excluded from study analysis.
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3.3.2
Follow-up for withdrawn subjects
There will be no specific follow-up with CCPs who do not complete the online training 
and/or express that they do not wish to participate.
4.0
Recruitment Methods
4.1
Identification of Subjects
The study team will work with the state of Maine to get a list of all currently licensed facilities in 
the state of Maine directly before the study begins.  This list will be updated by the state of 
Maine at various time-points throughout the study.
Childcare facilities along the I-95 corridor in southern Maine will be randomized to 3 study 
arms: iLookOut, Standard, and Control.  Any childcare facility within the recruitment area will 
have an equal chance of being in each study arm.  Those randomized to the iLookOut and 
Standard arms will be contacted by the study team to complete online training during years 2, 3, 
and/or 4 of the study, while those in the Control Arm will only be contacted beginning in the 
Spring of 2020  to complete the iLookOut program.
Directors of the childcare facilities will be provided with cards to distribute to their staff 
(uploaded as iLookOut- Recruitment Individual Access Cards), which will provide access to the 
online training (iLookOut or Standard) to which their childcare facility has been randomized.  
Additionally, brief questionnaires will be distributed at the end of years 2, 3, 4, and 5 to all 
childcare facilities groups (iLookOut, Standard, and Control) to learn about CCP exposure to the 
various mandated reporter trainings.
During year 3 of the study, individual child care providers who have already completed the 
Standard Maine training as a part of the standard group will be sent a message letting them know 
that the iLookOut training is now available in their training home page.  Individual learners who 
have previously been engaged in the iLookOut training or the iLookOut advanced training 
pinging program will be sent an individual email letting them know that the program has 
returned (iLookOut Email Recruitment Communication ALL)
In the spring of 2020, the iLookOut learning module will be publicly available to CCPs who have 
access to a program license number throughout the state of Maine.  In the summer of 2021, 
iLookOut will be available to all licensed and non-license CCPs throughout the state of Maine.  
The program will be publicly listed as a Maine mandated reporter training for CCPs in Maine 
and on CCP professional development lists.  
After the October 2021 submission, learners who selected that they would participate in future 
research during program registration and completed the iLookOut  Core Mandated Reporter 
training will be sent a one-time follow-up REDcap survey.  The survey will be offered through 
December 2021.  
4.2
Recruitment Process
Early childhood groups in Maine such as Maine Roads to Quality (MRTQ), Child Abuse and 
Neglect Councils, Home childcare alliance, and other similar groups may share approved Email 
and blanket messaging throughout the study with child care providers in our catchment area.  
The language that early childhood groups may use is included in the Community Group Support 
Language and Email. 
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The iLookOut project has developed a website (www.ilookoutproject.org) and a Facebook page 
as a way to inform colleagues and community groups about the study.  The website and 
Facebook page is publicly available, and it is included in study team email signatures and could 
be shared by community groups; therefore, it may be viewed by potential participants.  Approved 
Facebook posts may be placed into Facebook ads.  
Any information created by the iLookOut team will be posted to our Facebook page will be 
submitted to the IRB for approval before posting.  If the iLookOut team is sharing information 
from a community partner, we will use one of a few pre-approved postings and share the 
information from our community partner or other relevant organization.  
Once active enrollment has ended, the iLookOut program will remain publicly available to all 
CCPs in the state of Maine.  It will be listed on various CCP websites and listservs as training 
opportunities for mandated reporter and professional development credit.  
Those randomized to the iLookOut and Standard arms will be contacted by a study team member 
to complete an online training during years 2, 3, 4 and/or 5 of the study, while those in the 
Control Arm will only be contacted beginning in the spring of 2020 to complete iLookOut.  
Directors/owners of licensed child care facilities in the state of Maine will be sent a mailing with 
information about the study.  Additionally, the directors/owner will receive an email contact 
(included in uploaded iLookOut- Recruitment Email Communications ALL) The study team will 
also contact the center director by phone.  If requested during a phone conversation, the study 
team will visit the center in-person to answer questions.  
The study team will contact the center director/owner by phone to ask if s/he would like 
additional information and/or in-person contact.  If the study team is not able to make contact 
during the initial phone call (using the previously approved iLookOut- Phone Script), an email 
will be sent to directors/owners with emailed content that is similar to the phone script.  This 
email has been included in the 11-22-17 revision of the iLookOut email communication 
document (ALL).  
If the director/owner does not respond to the initial email and/or call, the study team will 
continue to re-send the recruitment email 1 time per week for up to 8 months.  Follow-up phone 
calls will be made monthly for up to 8 months.  One phone call per month will be followed-up 
with the follow-up email included in the 11-15-17 revision of the iLookOut communication 
document (ALL).  If the director, owner, or other primary staff member indicates they no longer 
wish to be contacted by the study team, all contact with that site will stop.  
If a director/owner has indicated that they would like to offer the iLookOut program to the staff 
at their program, but they have not completed the training, once monthly calls and emails  
During study year 3, standard sites who have not completed the standard training will still be 
contacted to complete the iLookOut arm of the study - unless the site has explicitly stated that 
they no longer wish to be contacted by the study team.  The iLookOut training is an entirely 
different training from the standard Maine version, and it is a new opportunity for child care 
providers to receive additional professional development credit than the previously offered 
Maine Standard state training.
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Centers in the standard arm of the study will receive a second mailing that will include the 
information sent to the iLookOut arm during year 2.  
During year 3 of the study, individual child care providers who have already completed the 
Standard Maine training as a part of the standard group will be sent a message letting them know 
that the iLookOut training is now available in their training home page.  Individual learners who 
have previously been engaged in the iLookOut training or the iLookOut advanced training 
pinging program will be sent an individual email letting them know that the program has 
returned (Learner Messages).  A learner will receive one of these messages weekly for up to 6 
months.  At the point a learner re-engages with the program, this message will stop.  If a learner 
indicates they no longer wish to be contacted by the study team, all contact with that site will 
stop.  
Beginning in the spring of 2020,, centers in the control arm will receive a information by email 
or mail asking them to complete the iLookOut program.  During year 4 will be the first time 
control group centers are recruited to complete a learning program for this study.  Emails will be 
sent out 1 time per week to center owners/directors and phone calls will be made 1 time per 
month.  Centers randomized to the iLookOut or Standard arms that have not yet completed the 
iLookOut training will be contacted 1 time per week by email and 1 time per month by phone.  
This communication will continue for 8 months –unless the center requests that we no longer 
contact them.  
Individuals from the control arm who have asked to be notified when the program is available in 
their area will be emailed directly 1 time.    
The study mailing sent to directors/owners of the childcare facilities will include cards (upon 
request) and/or handouts to distribute to their staff, which will provide information about 
accessing the online training to which their childcare facility has been randomized.  In addition 
to contact by a study team member, directors of the childcare facilities will receive handouts and 
other information about enrolling in the study, which will be sent by the study team, as well as 
various groups in Maine that provide educational resources to CCPs.
Additionally, brief questionnaires (uploaded as Maine End- of Year Survey) (about CCPs’ 
exposure to various mandated reporter trainings) will be distributed at the end of year 2 to all 
child care programs in our study catchment area.  This includes iLookOut, standard, and control 
arms.  This survey will be sent out to the Maine Roads to Quality (MRTQ) email list  using a 
RedCap link.  MRTQ is the group who oversees child care professional development in the state 
of Maine.  MRTQ will not have access to any iLookOut data; they will simply distribute an 
iLookOut approved e-mail and RedCap link.  All data will go directly into the Penn State 
RedCap system.  MRTQ has a comprehensive list of all child care providers in the state of 
Maine- including those in all arms of our study (iLookOut; Standard; & Control).  This will give 
us an idea of bleed across all child care providers in the state of Maine.  
A one-time follow-up REDcap survey will be sent out only to learners who have selected that 
they are willing to be contacted for future research.  This one-time survey and a new summary of 
research will be sent through email and REDcap email tools upon IRB approval for the October 
2021 submission.  The survey will be offered through December 2021.  
4.3
Recruitment Materials
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A mailed packet will be provided to directors of the childcare facilities in the iLookOut and 
Standard arms, which will include a summary explanation of research, a welcome letter 
dependent on the study group, a study brochure (uploaded as iLookOut- Brochure), and a 
handout with program license number (Uploaded as iLookOut handout).  The following 
documents may be sent on a requested or as needed basis: cards that explain how to access the 
online training (uploaded as iLookOut- Recruitment individual access cards) and Frequently 
Asked Questions handouts depending on the group randomized that further explain the nature 
and purpose of the study.  In addition, directors and owners will receive an email about the 
iLookOut research project.  In addition to an electronic copy of the previously mentioned 
materials, this email will include director talking points. Please see appendix 3 for a list of 
recruitment materials sent to each group. The documents provided to the child care 
director/owner can be distributed to staff and volunteers as the director/owner sees fit.  Childcare 
facilities in the iLookOut and Standard arms will receive recruitment materials from the study 
team during years 2, 3, 4, and 5of this project.  Those in the Control Arm will ONLY receive an 
end of the year survey (uploaded as Maine End-of Year Survey) and summary explanation of 
research in year2 participants will receive recruitment materials from the study.  Due to the 
release of the program to all child care providers in the spring of 2020, year 3 and year 4 end of 
year surveys will not be distributed.    In the spring of 2020, , iLookOut training will be made 
available to all CCPs in the state of Maine completion of the iLookOut training will still meet 
State requirements for mandated reporter training, and will give CCPs professional development.
Early childhood groups in Maine such as Maine Roads to Quality (MRTQ), Child Abuse and 
Neglect Councils, Home childcare alliance, and other similar groups may share approved Email 
and blanket messaging throughout the study with child care providers in our catchment area.  
The language that early childhood groups may use is included in the Community Group Support 
Language and Email.  
The iLookOut project has developed a website (www.ilookoutproject.org) and Facebook page as 
a way to inform colleagues and community groups about the study.  The website and Facebook 
page is publicly available, and it is included in study team email signatures and could be shared 
by community groups; therefore, it may be viewed by potential participants.  Approved 
Facebook posts may be used in Facebook ads.
Any information created by the iLookOut team will be posted to our Facebook page will be 
submitted to the IRB for approval before posting.  If the iLookOut team is sharing information 
from a community partner, we will use one of a few pre-approved postings and share the 
information from our community partner or other relevant organization.  
All materials referenced in this section have been included in this submission or previously 
reviewed. 
The one-time follow-up REDcap survey will be sent upon approval of the October 2021 
submission- December 2021 using email recruitment and REDcap tools (included in this 
submission as Follow-up Survey Communication).  Learners will receive one email per week 
until the survey is completed for ~4-6 weeks. 
4.4
Eligibility/Screening of Subjects
No specific eligibility or screening questions will be used for this study.  However, participants 
will be informed that they must be >18 years of age to participate in the study, and participants 
will be informed that by completing the online training they are certifying that they are >18 years 
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old.  If an individual identifies him- or her-self as <18 years old and still completes the online 
training, their data will be excluded from any research analysis.
The one-time follow-up RedCap survey sent out upon approval of the October 2021 submission 
will include only individuals who completed iLookOut Core mandated reporter training and 
indicated in program registration that they were willing to be contacted for future research.  If the 
participant has indicated or indicates that they do not want to be contacted by our research team, 
they will not be sent the survey or survey communication will be discontinued upon request.  
5.0
Consent Process and Documentation 
5.1
Consent Process 
 
5.1.1 Obtaining Informed Consent
5.1.1.1 Timing and Location of Consent
While all owners/directors of childcare facilities asked to complete 
iLookOut or Standard training will receive a copy of the summary 
explanation of research in the recruitment packet, to ensure that all 
participants receive it individual CCPs will receive the summary 
explanation online.
Upon accessing the website, participants will be asked to provide their 
name and email address.  After this, an authentication process must be 
completed to ensure that the individual is a real person and not a computer 
attempting to gain access to the website.  For security and validity 
purposes, it is important this process be completed first.
After successfully clicking on the authentication link and completing the 
registration process, a summary explanation of research will appear.  The 
summary explanation will inform potential participants that choosing to 
proceed with the online training constitutes consent for their data to be 
collected.  Individuals not wishing to participate need not proceed to the 
online training, and it will be made clear that participants may stop at any 
time.
The one-time follow-up survey sent upon approval of the October 2021 
submission- December 2021 will send participants electronic/email 
communication (included in the submission) with a summary of research. 
5.1.1.2 Coercion or Undue Influence during Consent
Child care facility directors/owners can indicate that they do not want the 
study team to contact the center and/or child care staff at any time during 
the study.  
Individual participants can choose to proceed (or not proceed) with the 
online training (iLookOut or Standard), and members of the research team 
will not individually contact CCPs to influence their decision to 
participate.  The iLookOut team will stop individual learner 
communication upon request.  
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The iLookOut staff will respect any request of a director or owner to stop 
all contact with a child care program.  
5.1.2 Waiver or alteration of the informed consent requirement
Implied consent will be obtained by providing the participant with a summary 
explanation of research, which will inform the participant that by continuing with the 
online training they are agreeing to the terms of the study outlined in the summary.  A 
summary explanation of research is necessary for this research study, as the training is 
completed completely online at the time and choosing of the participant.
5.2
Consent Documentation
5.2.1
Written Documentation of Consent
Participants will not complete consent in writing; instead, participants will be asked to 
provide implied consent during the online registration process.
5.2.2
Waiver of Documentation of Consent (Implied consent, Verbal consent, etc.)
Participants will be asked to provide implied consent for research.  A summary 
explanation for research will be provided to participants online prior to starting the online 
training.  Within the summary, participants will be informed that they are providing 
implied consent for research by completing the online training.
This research study does not provide any additional risk beyond what is typically 
encountered in daily life.
5.3
Consent – Other Considerations 
5.3.1
Non-English Speaking Subjects
The online training was designed only for individuals who speak English; therefore, non-
English speakers will not be able to complete the online training at this time.  
5.3.2
Cognitively Impaired Adults
5.3.2.1 Capability of Providing Consent
Individuals completing the online training are required to read the 
instructions and complete registration prior to receiving the summary 
explanation of research document.  Progression to this point in the online 
training will provide evidence of capability to consent. 
5.3.2.2 Adults Unable To Consent
Only those individuals capable of understanding the instructions will 
proceed, which itself will provide evidence of the capacity to provide 
informed consent.
5.3.2.3 Assent of Adults Unable to Consent
This section does not apply.  
5.3.3
Subjects who are not yet adults (infants, children, teenagers) 
5.3.3.1 Parental Permission
Participants will be asked not to complete this research study unless they are 
18 years of age or older.  If a CCP under 18 completes disregards the 
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warning or completes the module solely for certification purposes, the data 
from that participant will be excluded from analysis. 
5.3.3.2 Assent of subjects who are not yet adults
Participants will be asked not to complete this research study unless they are 
18 years of age or older.  If a CCP under 18 completes disregards the 
warning or completes the module solely for certification purposes, the data 
from that participant will be excluded from analysis. 
6.0
HIPAA Research Authorization and/or Waiver or Alteration of Authorization
6.1
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures of 
PHI
Check all that apply:
 
Not applicable, no identifiable protected health information (PHI) is accessed, used, 
or disclosed in this study. [Mark all parts of sections 6.2 and 6.3 as not applicable]
Authorization will be obtained and documented as part of the consent process. [If 
this is the only box checked, mark sections 6.2 and 6.3 as not applicable]
Partial waiver is requested for recruitment purposes only (Check this box if 
patients’ medical records will be accessed to determine eligibility before 
consent/authorization has been obtained). [Complete all parts of sections 6.2 and 6.3]
Full waiver is requested for entire research study (e.g., medical record review 
studies). [Complete all parts of sections 6.2 and 6.3]
Alteration is requested to waive requirement for written documentation of 
authorization (verbal authorization will be obtained). [Complete all parts of sections 
6.2 and 6.3]
6.2
Waiver or Alteration of Authorization for the Uses and Disclosures of PHI
NOT APPLICABLE:  While this study does use private information (i.e. name, email address, 
and  registration ID number), participants in this study are NOT medical center patients.  Patients 
will not be recruited from the medical center and no health information will be used in this study.  
6.2.1
Access, use or disclosure of PHI representing no more than a minimal risk to the 
privacy of the individual
6.2.1.1 Plan to protect PHI from improper use or disclosure
Not applicable
6.2.1.2 Plan to destroy identifiers or a justification for retaining identifiers 
Not applicable
6.2.2
Explanation for why the research could not practicably be conducted without access 
to and use of PHI
Not applicable
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6.2.3
Explanation for why the research could not practicably be conducted without the 
waiver or alteration of authorization
Not applicable
6.3
Waiver or alteration of authorization statements of agreement
Not applicable
7.0
Study Design and Procedures
7.1
Study Design
This 5-year study will use a randomized controlled trial design to evaluate the efficacy of an 
innovative educational intervention, iLook Out for Child Abuse (iLookOut), for improving 
childcare provider (CCP) reporting of suspected child abuse. Year 1 is devoted to establishing 
necessary infrastructure and completing development of study materials. 
During Year 2, childcare facilities in the state of Maine will be randomized to iLookOut, 
Standard, or Control arms.  CCPs in the Standard arm will be recruited to complete Maine’s 
existing online mandated reporter training, read 4 brief articles, and answer 1 question for each 
article (needed to receive 1 hour of professional development credit).  CCPs in the iLookOut arm 
will be asked to complete iLookOut (which includes follow-up engagement activities), and those 
in the Control arm will not be recruited to complete any training.  At the end of year 2, 
participants in all groups will be asked to complete an end-of-the year survey.  A separate 
summary explanation of research will accompany this survey.   
During Year 3, CCPs in both the iLookOut and Standard arms will be recruited to complete 
iLookOut (which includes follow-up engagement activities), and those in the Control arm will 
not be recruited to complete any training.   
In the spring of 2020, CCPs in all three study arms will be recruited to complete iLookOut 
(which includes follow-up engagement activities- pinging).  
This sequential enrollment to receive the target intervention (iLookOut) is a uni-directional 
crossover design referred to as a “stepped wedge design.”  This study design will allow the 
research team to examine both the immediate effect of iLookOut, as well as its effect over time.
In the spring of 2020, iLookOut will be made available (free-of-charge) to all CCPs in Maine, 
and outcomes data will continue to be collected for analysis.  Child care license numbers will 
continue to be collected.  This will allow the study team to continue separating the data by study 
arms (iLookOut, Standard, Control, and All other CCPs in Maine) without limiting the access to 
the mandated reporter program. 
To estimate uptake/penetrance of the iLookOut and Standard training in each arm, surveys 
(uploaded as Maine End-of Year Survey) will be administered at the end of year 2, asking if 
individuals have heard of either training, and if they completed either training.  This will be 
identified with the center licensing number, but it will not ask the individual participant for any 
private information.  
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Data from Maine’s Office of Children and Family Services will be used to compare baseline and 
post-intervention outcomes for each of the 3 study arms, and over time.  In this examination of 
reporting behaviors of CCPs, the Primary Outcomes are 1) child abuse confirmation rates 
among CCP-reported cases; 2) rates of social services recommended by the State for 
children/families who were reported; and 3) costs associated with intake and investigation of 
reports in which abuse was not confirmed and no social services were recommended.  
Secondary Outcomes are 4) changes in the number of CCP reports of suspected abuse; 5) 
number of CCPs in each study arm who complete iLookOut and Standard training; 6) CCP 
knowledge and attitudes regarding reporting suspected child abuse; and 7) CCPs’ evaluation of 
the iLookOut and Standard training.  8) the impact of after learning engagement actives 
“pinging” on knowledge retention.  
7.2
Study Procedures
7.2.1
Pre-Registration
During the randomization phase (years 2-3), the center director/owner will be asked to 
indicate if they would like to be contacted by the study team during an initial recruitment 
email.     
In the spring of 2020the study will be available to the entire state of Maine.  The study 
team will continue to recruit center directors/owners by sending an initial recruitment 
email and mailing.  Center license numbers will continue to be collected, so the study 
team can continue to analyze data by study arm.  Previously mentioned community 
partners –like Maine Roads to Quality and Maine Office of Children and Families- may 
also distribute information about the iLookOut training widely.   
7.2.2
Recruitment
Prior to accessing the online training, childcare facilities in selected areas of Maine will 
be randomized to receive iLookOut, Standard training, or Control.  CCPs in facilities 
randomized to receive iLookOut will be recruited during Years 2-5 to complete the 
iLookOut online training included in this submission.  CCPs in facilities randomized to 
the Standard arm initially will be recruited during Year 2 to complete Maine’s current 
online child abuse training, and then during Years 3-5 will be recruited to complete 
iLookOut.  CCPs in facilities randomized to the Control arm will not be recruited to 
complete any training during Years 2-3, but then will be recruited beginning in the spring 
of 2020 (during Years 4 and 5) to complete iLookOut.
To accomplish recruitment goals, study staff will send mailings, call, and/or meet with 
Directors of childcare facilities and provide recruitment packets appropriate for the group 
to which that childcare facility was randomized.  This packet will include a summary 
explanation of the research, responses to frequently asked questions, fliers for the study, a 
study brochure, a study handout, and recruitment cards (optional) that will explain how 
CCPs in that facility can access the designated online training (the uploaded names of the 
documents used for each group can be found in appendix 3).  Study staff will follow-up 
with the childcare facility Directors/owners periodically to address questions and/or other 
issues related to the study, including ensuring that CCPs who completed the training have 
received their certificates documenting hours of earned professional development credit.
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Beginning in the spring of 2020 years 4 & 5), iLookOut will be available to the entire 
state of Maine, and Maine’s Office of Child and Family Services may choose to promote 
or advertise the training separate from this study.  Centers originally randomized to 
iLookOut, Standard, or Control will continue to be recruited by center.   As in Years 2-4 
of the study, CCPs who choose to complete iLookOut will be asked to complete the 
registration, pre-test, post-test, and evaluation, and will be provided a summary 
explanation of research, their participation, as well as data collection and use.  
7.2.3
Registration and Learning Module
Because the study team will talk primarily with childcare facility 
directors/owners/administrators responsible for maintaining staff training, consenting 
must take place as a part of the study’s online registration process.  This will ensure that 
all study participants taking the online training receive the same standard summary 
explanation of research.
Participants will begin registration by providing the center’s state license number, their 
name, and email address.  The center state license number is required because center staff 
are randomized to the standard, iLookOut, or control training arms based on the center’s 
licenses number.  Then, participants will activate their online account through the link 
provided to them via email.  After authentication and registration has been completed, 
participants will be provided with a summary explanation of research, and participants 
will continue to complete the registration process and collection of demographic data.  
Participants will then be asked to complete the pre-assessment.  All participants will then 
be asked to complete the online training, followed by the post-assessment, followed by an 
evaluation of the online training.  This can be completed at one time point or at various 
time points, at the discretion of the participant.
After the participant completes the online training, the host of online training will store 
the research data and provide documentation necessary for participants to receive 
professional training credit and appropriate state credit for mandated reporter training.
7.2.4
Post-training “Pinging”
NOTE: This portion of the project will be taken down for redevelopment on a new 
platform between October 1st. 2018 and spring of 2019.  Learners will not have any 
access to this portion of the program during this time.  All other aspects of the 
project will remain fully functional as descripted in this protocol.  Currently 
engaged learners and those who complete the iLookOut program by September 28th 
will be offered an opportunity to complete after learning pinging modules 1-53 
before October 1st.  Learners will be able to pick-up where ever they left off in the 
after learning pinging program in the Spring of 2019.
During registration, CCPs randomized to receive iLookOut will be informed that they can 
receive additional educational resources via a web-based App that can be downloaded to 
a cell phone or tablet or accessed online using a computer.  This process of providing 
follow-up education is called ping-ing, and the individual notifications “pings.”  After the 
initial online training is complete, participants will be asked to sign-in to the online or 
App-based program to receive a training certificate.  Post-training pinging will only occur 
for participants after they have completed the iLookOut child abuse training.  Child care 
providers in Maine do not standardly receive Pings or after-training resources.  
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In this study, participants completing the iLookOut program can opt out of receiving 
these pings by contacting study staff or following directions provided on how to stop 
further pinging.  Participation in pinging will not affect future use of the learning 
program discussed elsewhere in this submission.  
CCPs may receive weekly messages per, whose content will include updates, 
supplementary training materials, practical resources, questions/quizzes, games, videos, 
resources, etc.  Each week learners will be asked to complete approximately 3-6 activities 
within the pinging program for up to 3 years.  The actual pings may evolve throughout 
the study –based on what the research team learns about the efficacy of different kinds of 
pinging.  Pinging content will be developed 3 months in advance of use.  The first 3 
months of content and screen shots of the activities will be provided in this submission on 
or before have been included in this submission. This process will be a part of the actual 
training, and a vital piece to continuing and improving the online learning process.  CCPs 
may opt out of receiving these pings at any time. 
To allow for learner flexibility, learners will be asked to choose if they would like to 
receive the pinging content over the course of a 2 month, 4 month, or 6 month time 
period.  Learners can change this setting at any time, and they are able to extend this 
time.  This can be seen by click on the gear settings option beside the advanced training 1 
or 2 courses on the iLookOut demo program.  
Learners will also be able to select a theme to complete the course in.  These themes can 
also be seen by clicking on the gear settings option beside the advanced training 1 or 2 
courses.  These themes include: a space adventure, an underwater adventure, a farm 
theme, a bake-a-cake theme, and a movie theater theme.  Learners can also change their 
theme throughout the program. 
Learners who do not engage in the iLookOut Advanced Training 1 program for a period 
of 4 months or more after completing the iLookOut core training will be asked to 
complete the iLookOut post-test (iLookOut Learning Module Pre- and Post- test) again.  
This provides the study team with an updated base-line of knowledge upon re-entry into 
the Advanced Training 1 program.  All iLookOut advanced training users who have not 
completed Advanced Training 1 at program re-launch in April 2019 will be asked to re-
take this knowledge test.  In the demo, it can be seen in the tile, iLookOut training check, 
and this box will only appear for learners who have not engage in the iLookOut 
Advanced Training 1 program in 4 months.  Learners will also be asked to complete the 
iLookOut post-test (iLookOut Learning Module Pre- and Post- test) after completing the 
iLookOut Advanced Training 1 course.  This test will not be administered after Advanced 
Training 1 is complete.  
  
At the end of each course, learners will receive an iLookOut badge and additional 
professional development credit.  
Learners who complete the iLookOut course will have the option of adding an iLookOut 
flag to their conference name tag at conferences and similar events in Maine that child 
care providers frequently attend (Optional: iLookOut Conference Training Badge/Flag).  
iLookOut flags will be left at a table for child care providers to pick up. Completion of 
iLookOut will not be verified.  There will be a sign or individual who simply says if an 
individual completed the iLookOut training they may take a flag. Again, no verification 
will be required.  
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The iLookOut after learning program mentioned in the paragraph above will be 
temporarily taken down between October 1st 2018- Spring 2019.  This program will 
temporarily be down while we re-develop this learning content on a new platform with a 
different developer.  Learners who are actively engaged in the after-learning program or 
learners who complete the iLookOut learning program during this time will have the 
opportunity to complete 1 year of after-learning activities (Modules 1-53) between 
August 7th- October 1st.  We will notify learners of this opportunity by replacing the 
standard, weekly iLookOut After-Learning (pinging) email messages with the iLookOut 
Open Access Email included in this submission.  The iLookOut Open Access Email will 
be sent out weekly between August 7th-October 1st.  
The iLookOut learning program will remain active during this time.  Once the iLookOut 
after learning program is fully functional on the new platform in Spring of 2019 all 
current learners will be notified, and they will be able to pick-up in the after-learning 
program where they left off. Each transition will require a new IRB submission to 
approve new language to keep learners informed.  
7.2.5
Post-training Data Collection
Over the course the study, the state of Maine will provide the research team de-identified 
aggregate data on CCP reports of suspected abuse, including: the number of reports; their 
outcomes (confirmed vs. unfounded); kinds of abuse identified; whether social services 
were recommended (and what kind); and whether the CCP making the report completed 
any training on child abuse (and if so, which).
To identify which CCP report data need to be examined for the research study, intake 
workers at Maine’s Office of Child and Family Services (OCFS) will ask all individuals 
making a report whether they have worked (paid or volunteer) at a childcare facility since 
Aug. 1, 2017.  Those who answer “yes” will then be asked whether they completed any 
training on child abuse, and if so which.  Responses to these questions will then be 
entered into a separate data field within Maine’s Automated Child Welfare Information 
System, which then can be queried to create the de-identified aggregate reports 
mentioned above.
As a back-up to ensure that participants in the iLookOut, Standard, and control arms are 
not missed, the names of CCPs who make reports of suspected abuse will also be cross-
checked against the names of CCPs who have completed the iLookOut and Standard 
online trainings used in the research study.  Child Care providers will be informed that 
some registration information will be used to verify and connect various data sets 
including: learning module data, pinging data, and data from Maine’s child abuse 
reporting system.  The connecting information will be kept as a code book and destroyed 
after all data are connected.  Because the vast majority (>99%) of CCPs do not report 
suspected child abuse during any given year, there is no expectation that a given 
individual who completes the iLookOut or Standard training will report suspected abuse.  
As such, it will not be seen as a red flag that a given study participant did not make a 
report.
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7.2.6
End-of-Year Survey (DISCONTINUED Uploaded as Maine End- of Year Survey)
In addition to data collection associated with the iLookOut and Standard online trainings, 
research staff will distribute surveys at the end of Year 2 to CCPs in all three arms of the 
study to evaluate penetration of the study interventions.  These brief surveys will be sent 
out to the Maine Roads to Quality (MRTQ) email list using a RedCap link.  MRTQ is the 
group who oversees child care professional development in the state of Maine.  MRTQ 
will send out the end-of-year survey link and end-of-year survey message 1 time per 
week for up to 4 weeks.  
MRTQ will not have access to any iLookOut data; they will simply distribute an 
iLookOut approved e-mail and RedCap link.  All data will go directly into the Penn State 
RedCap system.  MRTQ has a comprehensive list of all child care providers in the state 
of Maine- including those in all arms of our study (iLookOut; Standard; & Control).  This 
will give us an idea of bleed across all child care providers in the state of Maine. The 
survey will ask for the participant to provide the childcare facility license number that 
they used to complete training.  This number is not personally identifiable and only 
identifies a childcare facility.   The survey will not include (nor request) any personally 
identifying information.  These surveys will ask whether the individual has heard of, 
and/or completed, the iLookOut and/or Standard online trainings.  
Note that control group participants do not receive any training or research study contact 
in years 2-3, except for the end-of-year survey. Learners will receive a separate summary 
explanation of research (uploaded as Summary Explanation of Research to Accompany 
End of the Year Survey) to accompany this survey.  This summary explanation will be 
provided at each time point the survey is provided.  
7.2.7
One-time Follow-up Survey
A one-time follow-up survey will be sent out to learners who have completed the 
iLookOut Core training at the time the survey is being sent out.  This will not impact 
ongoing completion of the iLookOut programs.  The follow-up survey will populate 
different questions based on where the iLookOut learner is within the iLookOut programs.  
The survey will account for 1) iLookOut Core completion ONLY 2) Starting iLookOut 
Advanced Training pinging or 3) Completing at least one iLookOut Advanced Training 
pinging course.  The survey is designed to ask the learner questions that are relevant to 
their experience without asking unnecessary questions. 
This survey is estimated to take ~20-30 minutes, and learners will be able to complete the 
survey at their own pace.  The survey will ask learners to provide additional information 
on their experiences completing core training and post-training pinging.  The survey 
purposes to learn more about the barriers learners face wen completing ongoing training.  
Learners will have 4-6 weeks from the first recruitment email to complete the survey.  
7.3
Duration of Participation
CCPs who chose to participate will be randomized to complete either iLookOut or the Standard 
online training.  Those asked to complete iLookOut may complete the training in one sitting, or 
over multiple sittings, while those asked to complete the Standard training will need to do so in 
one sitting.  For iLookOut, it is expected that most participants will take 5-10 minutes to 
complete registration, 10-15 minutes to complete the pre-assessment; 90-120 minutes to 
complete the training itself; 10-20 minutes to complete the post-assessment; 20-30 minutes to 
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review the resource materials provided; and 5 minutes to complete the evaluation of the training.  
For the Standard training, it is expected that most participants will take 5-10 minutes to complete 
registration, 10-15 minutes to complete the pre-assessment; 30-60 minutes to complete the 
training itself; 10-20 minutes to complete the post-assessment; and 5 minutes to complete the 
evaluation of the training.  Those who complete the standard training in year 2 of the study will 
be asked to complete the iLookOut training in year 3 of the study.  
CCPs who complete iLookOut will receive weekly after-learning messages (or “pings”) (via App 
and/or  email), whose content will include updates, supplementary training materials, practical 
resources, questions/quizzes, etc.  It is anticipated that these pings will take 1-5 minutes to read 
and/or respond to, and will occur with variable frequency after completion of iLookOut.  CCPs 
may opt out of receiving these messages at any time.  This pinging information will only be sent 
to participants who have completed the iLookOut program.  Child care providers will not receive 
“pings” without completing the iLookOut program, and will be told that the iLookOutApp will 
allow them to receive pings (i.e., updates, additional educational materials, and brief questions) 
after completing the iLookOut training.  Because the term “pinging” is only used in specific 
learning gamification circles, our research population is not likely to be familiar with this term, 
and hence the term is not referenced in the materials shared with CCPs.  
The iLookOut after learning program mentioned in the paragraph above will be temporarily 
taken down between October 1st 2018- Spring 2019.  This program will temporarily be down 
while we re-develop this learning content on a new platform with a different developer.  Learners 
who are actively engaged in the after-learning program or learners who complete the iLookOut 
learning program during this time will have the opportunity to complete 1 year of after-learning 
activities (Modules 1-53) between August 7th- October 1st.  We will notify learners of this 
opportunity by replacing the standard, weekly iLookOut After-Learning (pinging) email 
messages with the iLookOut Open Access Email included in this submission.  The iLookOut 
Open Access Email will be sent out weekly between August 7th-October 1st.  
The iLookOut learning program will remain active during this time.  Once the iLookOut after 
learning program is fully functional on the new platform in Spring of 2019 all current learners 
will be notified, and they will be able to pick-up in the after-learning program where they left 
off. Each transition will require a new IRB submission to approve new language to keep learners 
informed.  
A learner who participants in the iLookOut course and pinging program could participate in the 
study for more than 4 years. 
The one-time follow-up survey will be sent to learners who agree to participate in future research 
and completed the iLookOut Core mandated reporter training.  They will be sent a survey 
invitation over a ~ 4-6 week period after IRB approval, and it will take ~20-30 minutes to 
complete all questions in the survey.  
8.0
Subject Numbers and Statistical Plan
8.2
Number of Subjects
Efforts will be made to recruit ~4,500 CCPs during Years 2, 3, 4, and 5 of the study, and it is 
expected that ~84 CCPs reports of suspected child abuse will be needed for successful analysis.  
However, because the exact number of paid and volunteer staff at childcare facilities is not 
known, it is difficult to determine how many individuals may choose to participate in the study.  
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In the spring of 2020, CCPs throughout Maine will have access to iLookOut, which may result in 
additional numbers of research participants.
8.3
Sample Size Determination
In the spring of 2020, iLookOut will be made available to all CCPs in Maine.  Therefore, while 
we will actively recruit ~4,500 CCPs in the targeted study area to participate during the grant 
period, we also will collect data from additional CCPs who choose to register and complete the 
iLookOut outside of the catchment area.  As such, there is no official limit at this time for the 
number of CCPs who may participate in the study.
Sample size estimation for the number of needed reports is based on multivariate analysis of 
variance (MANOVA) for the 4 repeated measurements of the 2 primary dependent variables, and 
using the historical data in the past 5 years from Maine (see Appendix 4.7). Assuming a medium 
effect size of 0.33111 with regard to MANOVA analysis of the repeated measurements, at alpha 
level of 0.05, to obtain a statistical power of 80% to detect the effect of intervention and time, 22 
reports from each of the 3 arms (66 total), are needed annually. Given the nature of 
social/behavior research, a conservative drop-off rate of 20% will be expected (to account for 
CCPs recruited to the study, but who leave before outcomes are measured at year’s end). This 
results in a final sample size estimation of 84 (= 66 ÷ 0.8) in total (28 reports per arm).
8.4
Statistical Methods
The primary statistical analysis will be the analysis for repeated measurement of the 2 primary 
dependent variables as defined in the Specific Aims, using the arm and time as the 2 primary 
independent variables, through MANOVA. According to recent literature on the stepped wedge 
design, the common linear mixed model (LMM) will be utilized instead of the generalized 
estimating equations (GEE) or generalized linear mixed models (GLMM), given that the 3 arms 
have equal size. We will use the PROC MIXED software, version 9.4, including modeling the 
polynomial trends over time and comparisons of the 2 primary dependent variables among the 3 
groups at different time points. 
Additional analyses will be performed to explore the relationship between the primary dependent 
variables and the covariates, using appropriate statistical analyses (e.g., ANCOVA, t-test, non-
parametric tests, chi-square, etc.), whose choice will depend upon study outcomes data and their 
distribution. However, the results from these additional analyses should only be interpreted as 
exploratory (not confirmatory) because the sample size estimation is not based on these 
covariates, and therefore these analyses may not have enough power to detect any meaningful 
effect for these covariates. 
Moreover, since individual level data will be collected (e.g., CCPs’ knowledge and attitude 
scores), additional analyses of these data also will be performed (e.g., t-test, chi-square, 
ANOVA, non-parametric tests, and psychometric analyses), again based upon the data and their 
distribution –with the results likewise interpreted as exploratory. The same analytic approaches 
will be applied to the data on Report Rate, Confirmation Rate, Social Service Rate, and Cost 
data, as for the supplementary analyses.
9.0
Confidentiality, Privacy and Data Management 
9.2
Confidentiality
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9.2.6
Identifiers associated with data and/or specimens
See the Research Data Plan Review Form
9.2.6.1 Use of Codes, Master List
See the Research Data Plan Review Form
9.2.7
Storage of Data and/or Specimens
See the Research Data Plan Review Form
9.2.8
Access to Data and/or Specimens
See the Research Data Plan Review Form
9.2.9
Transferring Data and/or Specimens
See the Research Data Plan Review Form
9.3
Subject Privacy
Every participant will be assigned a unique participant ID number when registering for the 
iLookOut or Standard online training.  This will link individual names to contact information 
(necessary to verify completion, appropriate certificate and professional development credit, and 
send pings), and will allow for cross-checking with Maine’s Automated Child Welfare Information 
System to identify which research arm CCPs who reported suspected abuse were enrolled in (if 
any). 
10.0
Data and Safety Monitoring Plan
10.2
Periodic evaluation of data
This section does not apply at this time. 
10.3
Data that are reviewed
This section does not apply at this time. 
10.4
Method of collection of safety information
This section does not apply at this time. 
10.5
Frequency of data collection
This section does not apply at this time.  
10.6
Individuals reviewing the data
This section does not apply at this time. 
10.7
Frequency of review of cumulative data
This section does not apply at this time. 
10.8
Statistical tests
This section does not apply at this time. 
10.9
Suspension of research
This section does not apply at this time.  
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11.0
Risks
The study poses no risk beyond those encountered in everyday life, nor does participation impose ay 
expectations (professional, legal, or otherwise) not already incumbent on child care professionals.  
Participants may experience psychological discomfort due to the subject matter, though efforts will 
continue to be made to minimize this discomfort.  There is no violence nor graphic images in iLookOut, 
and all scenarios and language are carefully constructed to reduce any potential discomfort.  
There is a risk of loss of confidentiality if participant information is obtained by someone other than the 
study team or the host of the online training.  Precautions will be taken to prevent this from happening.  
For subjects who have elected to receive after-training contact through an App and/or online, we are 
including the following in the Summary Explanation of Research: 
“It is illegal in the state of Maine to text while driving.  It is also dangerous to pay attention to your cellular 
phone while driving, walking, or doing any activity that requires your attention. You should continue to 
exercise good judgment on this while participating in this study.”
12.0
Potential Benefits to Subjects and Others
12.2
Potential Benefits to Subjects
Successfully completing the online training that is part of this research study will provide 
participants with education about child abuse and their responsibilities as mandated reporters, as 
well as appropriate professional development credit.
12.3
Potential Benefits to Others
To the extent that iLookOut is effective in improving participants’ awareness and knowledge, 
participants will be better prepared to take the appropriate steps to identify and report children at 
risk for child abuse –which would benefit society as a whole.
To the extent that iLookOut causes an increase in high quality reports of child abuse and better 
use of limited resources for investigating child abuse reports, other states and society as a whole 
may benefit from implementing similar training.  A reduction in low quality reports also may 
reduce psychological burdens experienced by families who are incorrectly reported.
13.0
Sharing Results with Subjects
Upon successful completion of the online training, participants would learn the results of their responses 
on the post-assessment tool.  We anticipate that aggregate results will be published, and generally 
available to the public. Participants will also be able to share any course completion certificate with their 
program owner or director; however, the participant will not be able to share their specific score.  If the 
learner desires to share their completion certificate(s) or badges with an outside source, they will be 
required to send the information to the source.  
14.0
Subject Stipend (Compensation) and/or Travel Reimbursements
Participants will not be provided with a monetary stipend or compensation beginning in the spring of 
2021.  .
15.0
Economic Burden to Subjects
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15.2
Costs 
There will be no costs to childcare facilities or CCPs associated with this project.  The iLookOut 
and Standard online trainings are provided to learners for free.  
15.3
Compensation for Research-related Injury
There is no reasonable expectation that participation in this research will result in any form of 
injury.  That said, it is the policy of the institution to provide neither financial compensation nor 
free medical treatment for research-related injury.  In the event of injury resulting from this 
research, medical treatment is available but will be provided at the usual charge.  Costs for the 
treatment of research-related injuries will be charged to subjects or their insurance carriers.
16.0
Resources Available
16.2
Facilities and Locations
This study will occur in the state of Maine.  CCPs will participate in the online training from 
their place of employment, their home, or location for public internet use (e.g., Library).  While 
the PI has not conducted a project in the state of Maine, the PI and study team have conducted 
two other projects using a similar version of the iLookOut learning module, and the study team 
has an excellent working relationship with Maine’s Office of Child and Family Services, which 
oversees both the provision of continuing education to CCPs and child abuse reporting in the 
state of Maine.
16.3
Feasibility of Recruiting the Required Number of Subjects
The study team will have access to contact information for all registered child facilities (centers, 
home-based, Head Start, and other registered childcare facilities) in the state of Maine.  
16.4
PI Time Devoted to Conducting the Research
Benjamin H. Levi, MD, PhD will continue to devote the time and attention required for 
managing this research project.
16.5
Availability of Medical or Psychological Resources
Medical and psychological resources can be obtained at the Penn State Hershey Medical Center 
or some other healthcare facility; however, this will be at the cost of the participant or the 
participant insurance.  At this time, it is not anticipated there will be any need for medical or 
psychological resources due to participation in this study.
16.6
Process for informing Study Team
Routine study meetings, emails, and phone calls.
17.0
Other Approvals
17.1
Other Approvals from External Entities
We have received approval from the state of Maine to conduct this project, and we will be 
working closely with Maine throughout the project.  The state of Maine has signed an MOU with 
the Penn State Hershey agreeing to work with the study team to meet the needs of the research 
project, including data collection.
=
During the Spring of 2020, the study will be available to the entire state of Maine.  At this time, 
the study team will continue to collect program license numbers, so data can be analyzed by 
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assigned study arms. Study arms will continue to be recruited by center director/owner.  
However, community partners previously mentioned- like Main Roads to Quality, Maine’s 
Office of Children and Families, and other CCP organizations in Maine- may broadly distribute 
information about the iLookOut program throughout the state.  
17.2
Internal PSU Committee Approvals
Check all that apply:
  Anatomic Pathology – Hershey only – Research involves the collection of tissues or use of 
pathologic specimens. Upload a copy of the Use of Human Tissue For Research Form on the 
“Supporting Documents” page in CATS IRB. This form is available on the IRB website at: 
http://www.pennstatehershey.org/web/irb/home/resources/forms
  Animal Care and Use – All campuses – Human research involves animals and humans or the 
use of human tissues in animals
  Biosafety – All campuses – Research involves biohazardous materials (human biological 
specimens in a PSU research lab, biological toxins, carcinogens, infectious agents, 
recombinant viruses or DNA or gene therapy). 
  Conflict of Interest Review – All campuses – Research has one or more of study team 
members indicated as having a financial interest.
  Clinical Research Center (CRC) Advisory Committee – Research involves the use of CRC 
services in any way.  
  Radiation Safety – Hershey only – Research involves research-related radiation procedures. 
All research involving radiation procedures (standard of care and/or research-related) must 
upload the Radiation Review Form on the “Supporting Documents” page in CATS IRB. This 
form is available on the IRB website at: 
http://www.pennstatehershey.org/web/irb/home/resources/forms
  IND/IDE Audit – All campuses – Research in which the PSU researcher holds the IND or 
IDE or intends to hold the IND or IDE.
  Scientific Review – Hershey only – All investigator-written research studies requiring 
review by the convened IRB must provide documentation of scientific review with the IRB 
submission. The scientific review requirement may be fulfilled by one of the following: (1) 
external peer-review process; (2) department/institute scientific review committee; or (3) 
scientific review by the Clinical Research Center Advisory committee.  NOTE: Review by 
the Penn State Hershey Cancer Institute Scientific Review Committee is required if the study 
involves cancer prevention studies or cancer patients, records and/or tissues. For more 
information about this requirement see the IRB website at: 
http://www.pennstatehershey.org/web/irb/home/resources/investigator 
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18.0
Multi-Site Research
Though this study takes place in Maine, Dr. Benjamin Levi will be the only PI for this study, and the 
Maine site will be the only site of the research.  Therefore, this section does not apply.  
18.1
Communication Plans
This section does not apply.  
  
18.2
Data Submission and Security Plan
This section does not apply.  
18.3
Subject Enrollment
This section does not apply.  
18.4
Reporting of Adverse Events and New Information
This section does not apply.  
18.5
Audit and Monitoring Plans
This section does not apply.  
19.0
Adverse Event Reporting
19.1
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB
In accordance with applicable policies of The Pennsylvania State University Institutional Review 
Board (IRB), the investigator will report, to the IRB, any observed or reported harm (adverse 
event) experienced by a subject or other individual, which in the opinion of the investigator is 
determined to be (1) unexpected; and (2) probably related to the research procedures. Harms 
(adverse events) will be submitted to the IRB in accordance with the IRB policies and 
procedures.
20.0
Study Monitoring, Auditing and Inspecting
20.1
Auditing and Inspecting
The investigator will permit study-related monitoring, audits, and inspections by the Penn State 
quality assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all 
study related documents (e.g., source documents, regulatory documents, data collection 
instruments, study data etc.).  The investigator will ensure the capability for inspections of 
applicable study-related facilities (e.g., pharmacy, diagnostic laboratory, etc.).
21.0
Future Undetermined Research: Data and Specimen Banking
The data collected as part of this research study will only be used for the purposes and objectives 
described in this protocol and for the purpose of evaluating and/or improving education, and/or 
interventions related to child abuse.  No specimens are collected as part of this research.  
21.1
Data and/or specimens being stored
Not applicable
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21.2
Location of storage
Not applicable
21.3
Duration of storage
Not applicable
21.4
Access to data and/or specimens
Not applicable
21.5
Procedures to release data or specimens
Not applicable
21.6
Process for returning results
Not applicable
22.0
References
B Mathews, C Yang, EB Lehman, C Mincemoyer, N Verdiglione, BH Levi, Educating Early Childhood 
Care and Education Providers to Improve Knowledge and Attitudes about Reporting Child 
Maltreatment: A Randomized Controlled Trial, PLOS One (in press).
Levi BH, Boehmer S, Dellasega C. What is Reasonable Suspicion of Child Abuse? J. Public Child 
Welfare. 2012;6(5):569-589.
Crowell K, Levi BH. Mandated Reporting Thresholds For Community Professionals. Child Welfare. 
2012;91(1):35-53.
Levi BH, Crowell K. Child Abuse Experts Disagree About The Threshold For Mandated Reporting. 
Clinical Pediatrics. 2011;50(4):321-9.
Levi BH, Portwood S. Reasonable Suspicion of Child Abuse: Finding a Common Language, J. Law and 
Medicine. 2011;39(1):62-69.
23.0
Appendices
23.1
Appendix 1: Learning Objectives for iLook Out for Child Abuse
After completing iLook Out for Child Abuse childcare providers should be able to:
1. Understand and recognize possible child abuse, including:
- What does and does not constitute child abuse
- How and where abuse occurs
- Risk factors for abuse
- Signs and symptoms of abuse
- Consequences of abuse
- Strategies and resources for responding to suspected abuse
2. Understand your responsibilities as a mandated reporters of suspected abuse, including:
- Legal responsibilities as a mandated reporter
- Steps for carrying out these responsibilities
- Consequences of failing to report suspected abuse
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- legal immunity so long as a report is made in good faith
3. Become empowered and motivated to protect children who are at risk for abuse, including:
- What to do when there are barriers to reporting suspected abuse
- How to initiate a dialogue with colleagues about concerns involving child abuse
23.2
Appendix 2: Explanation of “Ping-ing” 
Originally (and technically), to “ping” someone (or their computer) involved sending a test unit of data that 
would generate a return message, allowing the sender to measure the lag time between sending and retrieving 
data.  As such, the term “PING” originally stood for “Packet Inter-Network Groper,” and was intended to mimic 
the term submarine operators used to indicate a returned sonar pulse.
Over the past decade, the term “ping” has evolved to also mean "getting the attention of" or "to check for the 
presence of" another party online.  Forms of ping-ing include tweets, Facebook alerts, and other instant 
messaging that provide updates, reminders, and queries.  Some pings simply convey information, while some 
have response-options for the recipient to select, and others provide web-links to videos, download-able 
documents, or interactive activities.
There are multiple commercial services that allow individuals, businesses, and other groups to send out both 
generic and tailored pings to specified individuals.  Typically, pings are sent to smart-phones or other mobile 
technology, but they can also be sent to emails or other computer-based addresses.
We have contracted with the company CAIT to use ping-ing technology to send prompts to childcare providers 
(after they have completed iLook Out for Child Abuse) to both reinforce learning and provide opportunities for 
real-time interactive engagement that follows on the goals and learning objectives of the intervention.
23.3
Appendix 3: iLookOut documents/Materials by group (i.e. iLookOut, Standard, Control)
iLookOut Study Group: 
Year 2: (COMPLETED 2018) 
Recruitment Mailing Inludes  (initially sent in study YR 2 Fall 2017): 

Summary Explanation of Research

OCFS Endorsement Letter

iLookOut Welcome Letter iLookOut Arm (Center Based) OR iLookOut- Welcome Letter 
iLookOut (Home Care ONLY) 

Note: This is dependent on the type of child care center

iLookOut Brochure

iLookOut Recruitment Handout with License Number

iLookOut individual Access Cards

iLookOut- FAQ 1 pg Handout

iLookOut- Pinging FAQ Handout

iLookOut- FAQ 5 pg Program Owner/Manager FAQ
Recruitment Email(s) with Attachments (initially sent in Study YR 2 Fall 2017):

Summary Explanation of Research

iLookOut- Recruitment Email Communication (ALL)

iLookOut- Recruitment Handout 

iLookOut- Director Talking Points
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
iLookOut individual Access Cards

iLookOut Welcome Letter iLookOut Arm (Center Based) OR iLookOut- Welcome Letter 
iLookOut (Home Care ONLY) 

Note: This is dependent on the type of child care center

iLookOut- FAQ 1 pg Handout

iLookOut- Pinging FAQ Handout

iLookOut- FAQ 5 pg Program Owner/Manager FAQ

Program Recruitment Survey (with Branching Logic) AND RedCap PDF- Program 
Recruitment Survey * Note this is the same survey with 2 REDCap viewing options)
Phone Recruitment (initially Study YR 2 Fall 2017):

iLookOut- Recruitment Phone Script

iLookOut- Check in Phone Script
Content/Screen shots included in the iLookOut online Learning program (initially open for iLookOut 
group in YR2 Fall 2017):  *Note- Learners will be exposed to these items online at 
demo.ilookoutmaine.org and www.ilookoutmaine.org  .  You can view these items online as they are 
intended by using the instructions included in the “Memo to the IRB  re. Learning Module.”

Summary Explanation of Research

iLookOut- Learning Module Screen Shots

iLookOut: Phase III Video and Training Script (this includes the text used to create training 
videos and layout of training)

Learning Module Handouts (provided throughout training)

iLookOut- Certificate of Completion

iLookOut Measures included in the online learning program uploaded as: 
o
iLookOut Learning Demographics 
o
iLookOut- Learning Module Pre and Post Test
o
iLookOut- Learning Module Evaluations
After learning (pinging) content/screen shots (Can be sent/accessed by iLookOut group after completing 
the iLookOut program through the end of the study)
 *Note- Learners will be exposed to these items using the iLookOut App or the website associated with 
the iLookOut app.  You can view these items online as they are intended by using the instructions 
included in the “Memo to the IRB re. After-Learning Engagement (pinging).”  These items will be sent 
from the time of learning module completion until the study ends or the participant requests to stop 
receiving after-learning content.

iLookOut Certified Badge (provided after training completion)

After-learning (pinging) email messages

After-learning (pinging) App messages 

iLookOut- After-learning (pinging) Activity screen shots 

iLookOut- After- learning (pinging) content modules 1-12

iLookOut- Phase III After Packet Vignettes
Throughout Study: 
End-of Year Survey (Sent once per year at the end of Year 2)

Summary Explanation of Research to Accompany End of Year Survey

Maine End- of Year Survey
Year 3- 5: (SPRING 2019- Fall 2021)
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Continued After-learning pinging contact and continued enrollment of child care providers and 
volunteers who are new to centers in the iLookOut group and/or haven’t completed iLookOut by using 
approved recruitment materials.
For Programs that have not yet completed iLookout or have new staff: 
Recruitment Mailing Includes (initially sent in study YR 3 Spring 2019): 

Summary Explanation of Research

OCFS Endorsement Letter

iLookOut Welcome Letter iLookOut Arm (Center Based) OR iLookOut- Welcome Letter 
iLookOut (Home Care ONLY) 

Note: This is dependent on the type of child care center

iLookOut Brochure

iLookOut Recruitment Handout with License Number

iLookOut individual Access Cards (Optional/Upon Request) 

iLookOut- FAQ 1 pg Handout
Recruitment Email(s) with Attachments:

Summary Explanation of Research

iLookOut- Recruitment Email Communication (ALL)

iLookOut- Recruitment Handout 

iLookOut- Director Talking Points (Optional/Upon Request)

iLookOut individual Access Cards (Optional/Upon Request) 

iLookOut Welcome Letter iLookOut Arm (Center Based) OR iLookOut- Welcome Letter 
iLookOut (Home Care ONLY) 

Note: This is dependent on the type of child care center

iLookOut- FAQ 1 pg Handout
Phone Recruitment (initially Study YR 3 Fall 2018):

iLookOut- Recruitment Phone Script

iLookOut- Check in Phone Script
Content/Screen shots included in the iLookOut online Learning program (initially open for Standard 
group in YR3 Fall 2018):  *Note- Learners will be exposed to these items online at 
demo.ilookoutmaine.org and www.ilookoutmaine.org  .  You can view these items online as they are 
intended by using the instructions included in the “Memo to the IRB  re. Learning Module.”

Summary Explanation of Research

iLookOut- Learning Module Screen Shots

iLookOut: Phase III Video and Training Script (this includes the text used to create training 
videos and layout of training)

Learning Module Handouts (provided throughout training)

iLookOut- Certificate of Completion

iLookOut Measures included in the online learning program uploaded as: 
o
iLookOut Learning Demographics 
o
iLookOut- Learning Module Pre and Post Test
o
iLookOut- Learning Module Evaluations
After learning (pinging) content/screen shots (Can be sent/accessed by Standard group after completing 
the iLookOut program in YR 3 through the end of the study)
 *Note- Learners will be exposed to these items using the iLookOut App or the website associated with 
the iLookOut app.  You can view these items online as they are intended by using the instructions 
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included in the “Memo to the IRB re. After-Learning Engagement (pinging).”  These items will be sent 
from the time of learning module completion until the study ends or the participant requests to stop 
receiving after-learning content.

iLookOut Certified Badge (provided after training completion)

After-learning (pinging) email messages

After-learning (pinging) App messages 

iLookOut- After-learning (pinging) Activity screen shots 

iLookOut- After- learning (pinging) content modules Year 1

iLookOut- After- learning (pinging) content modules Year 2 (Modules 1-3)
Throughout Study: 
End-of Year Survey (Sent once per year at the end of Year 2)

Summary Explanation of Research to Accompany End of Year Survey

Maine End- of Year Survey
Standard Study Group: 
Year 2: (COMPLETED 2018) 
Recruitment Mailing Includes (initially sent in study YR 2 Fall 2017): 

Summary Explanation of Research

OCFS Endorsement Letter

iLookOut Welcome Letter Standard Arm Only

iLookOut Recruitment Handout with License Number

iLookOut individual Access Cards

iLookOut- FAQ 1 pg Handout

iLookOut- FAQ 5 pg Program Owner/Manager FAQ
Webinar and Recruitment Email(s) with Attachments (initially sent in Study YR 2 Fall 2017):

Summary Explanation of Research

Webinar Handout

iLookOut- Recruitment Email Communication (ALL)

iLookOut- Recruitment Handout 

iLookOut individual Access Cards

iLookOut Welcome Letter Standard Arm Only

iLookOut- FAQ 1 pg Handout

iLookOut- FAQ 5 pg Program Owner/Manager FAQ

Program Recruitment Survey (with Branching Logic) AND RedCap PDF- Program 
Recruitment Survey * Note this is the same survey with 2 REDCap viewing options)
Phone Recruitment (initially Study YR 2 Fall 2017):

iLookOut- Recruitment Phone Script

iLookOut- Check in Phone Script
Content included in the online Standard learning program (initially open for standard group in YR2 Fall 
2017):  *Note- Learners will be exposed to these items online at demo.ilookoutmaine.org and 
www.ilookoutmaine.org .

Summary Explanation of Research
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
Standard Maine Child Abuse Training

Standard- Certificate of Completion

Measures included in the online learning program uploaded as: 
o
iLookOut Learning Demographics 
o
iLookOut- Learning Module Pre and Post Test
o
iLookOut- Learning Module Evaluations
Throughout Study: 
End-of Year Survey (Sent once per year at the end of Year 2)

Summary Explanation of Research to Accompany End of Year Survey

Maine End- of Year Survey
Year 3 (BEGINNING APRIL 2019)
Recruitment Mailing Includes (initially sent in study YR 3 Spring 2019): 

Summary Explanation of Research

OCFS Endorsement Letter

iLookOut Welcome Letter iLookOut Arm (Center Based) OR iLookOut- Welcome Letter 
iLookOut (Home Care ONLY) 

Note: This is dependent on the type of child care center

iLookOut Brochure

iLookOut Recruitment Handout with License Number

iLookOut individual Access Cards (Optional/Upon Request) 

iLookOut- FAQ 1 pg Handout
Recruitment Email(s) with Attachments (initially sent in Study YR 3 Spring 2019):

Summary Explanation of Research

iLookOut- Recruitment Email Communication (ALL)

iLookOut- Recruitment Handout 

iLookOut- Director Talking Points (Optional/Upon Request)

iLookOut individual Access Cards (Optional/Upon Request) 

iLookOut Welcome Letter iLookOut Arm (Center Based) OR iLookOut- Welcome Letter 
iLookOut (Home Care ONLY) 

Note: This is dependent on the type of child care center

iLookOut- FAQ 1 pg Handout
Phone Recruitment (initially Study YR 3 Fall 2018):

iLookOut- Recruitment Phone Script

iLookOut- Check in Phone Script
Content/Screen shots included in the iLookOut online Learning program (initially open for Standard 
group in YR3 Fall 2018):  *Note- Learners will be exposed to these items online at 
demo.ilookoutmaine.org and www.ilookoutmaine.org  .  You can view these items online as they are 
intended by using the instructions included in the “Memo to the IRB  re. Learning Module.”

Summary Explanation of Research

iLookOut- Learning Module Screen Shots

iLookOut: Phase III Video and Training Script (this includes the text used to create training 
videos and layout of training)

Learning Module Handouts (provided throughout training)

iLookOut- Certificate of Completion

iLookOut Measures included in the online learning program uploaded as: 
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o
iLookOut Learning Demographics 
o
iLookOut- Learning Module Pre and Post Test
o
iLookOut- Learning Module Evaluations
After learning (pinging) content/screen shots (Can be sent/accessed by Standard group after completing 
the iLookOut program in YR 3 through the end of the study)
 *Note- Learners will be exposed to these items using the iLookOut App or the website associated with 
the iLookOut app.  You can view these items online as they are intended by using the instructions 
included in the “Memo to the IRB re. After-Learning Engagement (pinging).”  These items will be sent 
from the time of learning module completion until the study ends or the participant requests to stop 
receiving after-learning content.

iLookOut Certified Badge (provided after training completion)

After-learning (pinging) email messages

After-learning (pinging) App messages 

iLookOut- After-learning (pinging) Activity screen shots 

iLookOut- After- learning (pinging) content modules Year 1

iLookOut- After- learning (pinging) content modules Year 2 (Modules 1-3)
Throughout Study: 
End-of Year Survey (Sent once per year at the end of Year 2)

Summary Explanation of Research to Accompany End of Year Survey

Maine End- of Year Survey
Year 4- 5: 
Continued After-learning pinging contact, continued enrollment of child care providers and volunteers 
who are new to centers in the Standard  group and/or haven’t completed iLookOut.
Throughout Study: 
End-of Year Survey (Sent once per year at the end of Year 2)

Summary Explanation of Research to Accompany End of Year Survey

Maine End- of Year Survey
Control Study Group: 
Years 2-3:
No direct recruitment contact or recruitment materials sent
Throughout Study: 
End-of Year Survey (Sent once per year at the end of Year 2)

Summary Explanation of Research to Accompany End of Year Survey

Maine End- of Year Survey
Year 4: 
Recruitment Mailing Includes (initially sent in study YR 4Spring 2020): 

Summary Explanation of Research

OCFS Endorsement Letter

iLookOut Welcome Letter iLookOut Arm (Center Based) OR iLookOut- Welcome Letter 
iLookOut (Home Care ONLY) 

Note: This is dependent on the type of child care center
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
iLookOut Brochure

iLookOut Recruitment Handout with License Number

iLookOut individual Access Cards (Upon Request/Optional)
iLookOut- FAQ 1 pg Handout (Upon Request/Optional)
Recruitment Email(s) with Attachments (initially sent in the spring of 2020)):

Summary Explanation of Research

iLookOut- Recruitment Email Communication (ALL)

iLookOut- Recruitment Handout 

iLookOut- Director Talking Points (Optional/upon request)

iLookOut individual Access Cards (Optional/upon request)

iLookOut Welcome Letter iLookOut Arm (Center Based) OR iLookOut- Welcome Letter 
iLookOut (Home Care ONLY) 

Note: This is dependent on the type of child care center

iLookOut- FAQ 1 pg Handout (Optional/upon request)
Phone Recruitment (initially in the spring of 2020):

iLookOut- Recruitment Phone Script

iLookOut- Check in Phone Script
Content/Screen shots included in the iLookOut online Learning program (initially open for Control 
group in Spring 2020):  *Note- Learners will be exposed to these items online at 
demo.ilookoutmaine.org and www.ilookoutmaine.org  .  You can view these items online as they are 
intended by using the instructions included in the “Memo to the IRB  re. Learning Module.”

Summary Explanation of Research

iLookOut- Learning Module Screen Shots

iLookOut: Phase III Video and Training Script (this includes the text used to create training 
videos and layout of training)

Learning Module Handouts (provided throughout training)

iLookOut- Certificate of Completion

iLookOut Measures included in the online learning program uploaded as: 
o
iLookOut Learning Demographics 
o
iLookOut- Learning Module Pre and Post Test
o
iLookOut- Learning Module Evaluations
After learning (pinging) content/screen shots (Can be sent/accessed by control group after the Spring of 
2020))
 *Note- Learners will be exposed to these items using the iLookOut App or the website associated with 
the iLookOut app.  You can view these items online as they are intended by using the instructions 
included in the “Memo to the IRB re. After-Learning Engagement (pinging).”  These items will be sent 
from the time of learning module completion until the study ends or the participant requests to stop 
receiving after-learning content.

iLookOut Certified Badge (provided after training completion)

After-learning (pinging) email messages

After-learning (pinging) App messages 

iLookOut- After- learning (pinging) content modules Year 1

iLookOut- After- learning (pinging) content modules Year 2 (modules 1-3)

iLookOut- Phase III After Packet Vignettes
Throughout Study: 
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End-of Year Survey (Sent once per year at the end of Year 2)

Summary Explanation of Research to Accompany End of Year Survey

Maine End- of Year Survey
Year 5: 
Continued After-learning pinging contact,  and continued enrollment of child care providers and 
volunteers who are new to centers in the iLookOut, standard, or control groups and/or haven’t 
completed iLookOut.
After Year 5: 
The iLookOut program will remain available to licensed and non-licensed child care programs across the 
state of Maine.  
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