Coordinated Oral Health Promotion (CO-OP) Chicago
Phase: NA
Conditions: Dental Caries in Children, Health Behavior, Healthcare Disparities
Sponsor: University of Illinois at Chicago

COordinated Oral Health Promotion (CO-OP) Chicago Trial 
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COordinated Oral health Promotion (CO-OP) 
Chicago Randomized Controlled Trial 
NIDCR Protocol Number: 17-074-E 
NIDCR Grant Number: UH3DE025483 
Principal Investigator: Molly A Martin 
NIDCR Program Official: Dena Fischer 
NIDCR Medical Monitor: Kevin McBryde 
Version Number:  2.0 
19 March 2018 
 

COordinated Oral Health Promotion (CO-OP) Chicago Trial 
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STATEMENT OF COMPLIANCE 
The study will be conducted in accordance with the International Conference on 
Harmonisation guidelines for Good Clinical Practice (ICH E6), the Code of Federal 
Regulations on the Protection of Human Subjects (45 CFR Part 46), and the NIDCR 
Clinical Terms of Award. All personnel involved in the conduct of this study have 
completed human subjects protection training. 

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SIGNATURE PAGE 
The signature below constitutes the approval of this protocol and the attachments, and 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and 
according to local legal and regulatory requirements and applicable US federal 
regulations and ICH guidelines. 
Principal Investigator or Clinical Site Investigator: 
Signed: 
 
Date:  
 
Name: Molly A Martin, MD, MAPP 
 
Title: Associate Professor 

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TABLE OF CONTENTS 
PAGE 
STATEMENT OF COMPLIANCE .................................................................................................. I 
SIGNATURE PAGE ...................................................................................................................... II 
TABLE OF CONTENTS ............................................................................................................... III 
LIST OF ABBREVIATIONS ......................................................................................................... VI 
PROTOCOL SUMMARY ........................................................................................................... VIII 
1 
KEY ROLES AND CONTACT INFORMATION .................................................................. 11 
2 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ....... 15 
2.1 
Background Information ......................................................................................... 15 
2.2 
Rationale ................................................................................................................ 15 
2.3 
Potential Risks and Benefits ................................................................................... 16 
2.3.1 
Potential Risks ............................................................................................ 16 
2.3.2 
Potential Benefits ........................................................................................ 17 
3 
OBJECTIVES ..................................................................................................................... 18 
3.1 
Study Objectives .................................................................................................... 18 
3.2 
Study Outcome Measures ...................................................................................... 18 
3.2.1 
Primary ....................................................................................................... 18 
3.2.2 
Secondary .................................................................................................. 18 
4 
STUDY DESIGN ................................................................................................................ 20 
5 
STUDY ENROLLMENT AND WITHDRAWAL ................................................................... 22 
5.1 
Subject Inclusion Criteria ........................................................................................ 22 
5.2 
Subject Exclusion Criteria ...................................................................................... 22 
5.3 
Strategies for Recruitment and Retention .............................................................. 22 
5.4 
Treatment Assignment Procedures ........................................................................ 23 
5.4.1 
Randomization Procedures ........................................................................ 23 
5.4.2 
Masking Procedures ................................................................................... 24 
5.5 
Subject Withdrawal ................................................................................................. 24 
5.5.1 
Reasons for Withdrawal ............................................................................. 24 
5.5.2 
Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention ................................................................................................. 25 
5.6 
Premature Termination or Suspension of Study .................................................... 25 
6 
STUDY INTERVENTION ................................................................................................... 26 
6.1 
Study Behavioral or Social Intervention(s) Description .......................................... 26 
6.2 
Administration of Intervention ................................................................................. 27 
6.3 
Procedures for Training Interventionists and Monitoring Intervention Fidelity ........ 27 
6.4 
Assessment of Subject Compliance with Study Intervention ................................. 30 
7 
STUDY SCHEDULE .......................................................................................................... 32 
7.1 
Screening ............................................................................................................... 32 
7.2 
Enrollment/Baseline Visit (Visit 1, prior to Randomization) .................................... 32 
7.3 
Randomization, Day 0 ............................................................................................ 33 
7.4 
6-Month Visit, Day 180 (- 14 days, + 60 days) ....................................................... 33 

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7.5 
Final Study Visit, Day 365 (+ 90 days) ................................................................... 33 
7.6 
Withdrawal Visit ...................................................................................................... 34 
7.7 
Intervention in-person visits for CHW-sites only, start Day 1 and complete by 
Day 365 .................................................................... Error! Bookmark not defined. 
7.8 
Intervention telephone follow-ups for CHW-sites only, start Day 2 and complete 
by Day 365 ............................................................... Error! Bookmark not defined. 
7.9 
Intervention in-person visits for usual care-sites only, start Day 1 after final day 
collection and complete end of study ....................... Error! Bookmark not defined. 
8 
STUDY PROCEDURES /EVALUATIONS ......................................................................... 35 
8.1 
Study Procedures/Evaluations ............................................................................... 35 
9 
ASSESSMENT OF SAFETY .............................................................................................. 37 
9.1 
Specification of Safety Parameters ........................................................................ 37 
9.1.1 
Unanticipated Problems ............................................................................. 37 
9.1.2 
Adverse Events .......................................................................................... 37 
9.1.3 
Serious Adverse Events ............................................................................. 37 
9.2 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 38 
9.3 
Characteristics of an Adverse Event ...................................................................... 38 
9.3.1 
Relationship to Study Intervention .............................................................. 38 
9.3.2 
Expectedness of SAEs ............................................................................... 38 
9.3.3 
Severity of Event ........................................................................................ 39 
9.4 
Reporting Procedures ............................................................................................ 39 
9.4.1 
Unanticipated Problem Reporting to IRB and NIDCR ................................ 39 
9.4.2 
Serious Adverse Event Reporting to NIDCR Error! Bookmark not defined. 
9.4.3 
Reporting of SAEs and AEs to FDA ............. Error! Bookmark not defined. 
9.4.4 
Events of Special Interest (if applicable) ...... Error! Bookmark not defined. 
9.4.5 
Reporting of Pregnancy ................................ Error! Bookmark not defined. 
9.5 
Halting Rules ............................................................ Error! Bookmark not defined. 
10 
STUDY OVERSIGHT ......................................................................................................... 41 
11 
CLINICAL SITE MONITORING .......................................................................................... 42 
12 
STATISTICAL CONSIDERATIONS ................................................................................... 43 
12.1 
Study Hypotheses .................................................................................................. 43 
12.2 
Sample Size Considerations .................................................................................. 43 
12.3 
Planned Interim Analyses (if applicable) .................. Error! Bookmark not defined. 
12.3.1 Safety Review ............................................... Error! Bookmark not defined. 
12.3.2 Efficacy Review ............................................ Error! Bookmark not defined. 
12.4 
Final Analysis Plan ................................................................................................. 45 
13 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS .................. 47 
14 
QUALITY CONTROL AND QUALITY ASSURANCE ......................................................... 48 
15 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................. 49 
15.1 
Ethical Standard ..................................................................................................... 49 
15.2 
Institutional Review Board ...................................................................................... 49 
15.3 
Informed Consent Process ..................................................................................... 49 
15.4 
Exclusion of Women, Minorities, and Children (Special Populations) .................... 50 

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15.5 
Subject Confidentiality ............................................................................................ 50 
15.6 
Future Use of Stored Specimens and Other Identifiable Data ............................... 51 
16 
DATA HANDLING AND RECORD KEEPING .................................................................... 52 
16.1 
Data Management Responsibilities ........................................................................ 52 
16.2 
Data Capture Methods ........................................................................................... 52 
16.3 
Types of Data ......................................................................................................... 52 
16.4 
Schedule and Content of Reports .......................................................................... 52 
16.5 
Study Records Retention ....................................................................................... 53 
16.6 
Protocol Deviations ................................................................................................ 53 
17 
PUBLICATION/DATA SHARING POLICY ......................................................................... 54 
18 
LITERATURE REFERENCES ........................................................................................... 55 
SUPPLEMENTAL MATERIALS .................................................................................................. 60 
APPENDICES ............................................................................................................................. 61 
APPENDIX A: SCHEDULE OF EVENTS ................................................................................... 62 
APPENDIX B: Survey Question Sources and Citations…………………………………………….64 
APPENDIX C: Plaque Protocol………………………………………………………………………..69 
APPENDIX D: Contact Attempt and Window Protocol……………………………………………...71 
APPENDIX E: CHW Action Plan………………………………………………………………………73 
APPENDIX F: Caries Risk Assessment………………………………………………………………74 
APPENDIX G: Core Curriculum Delivery Guide……………………………………………………..75 
APPENDIX H: CHW Encounter Tracking Form……………………………………………………...84 
APPENDIX I: CHW Fidelity Assessment Form……………………………………………………...90 
APPENDIX J: Trial Consent Form English………………………………………………………….. 92 
19 
REMEMBER ...................................................................................................................... 95 
 

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LIST OF ABBREVIATIONS 
 
AA 
African American 
ADL 
Activities of Daily Living 
AE 
Adverse Event 
CC 
Coordinating Center 
CDPH 
Chicago Department of Public Health 
CEDA 
Community and Economic Development Association of Cook County, Inc 
CHAOS 
Confusion, Hubbub, and Order Scale  
CHECK 
Coordinated Healthcare for Complex Kids 
CHWs 
Community Health Workers 
CI 
Confidence Interval 
CMP 
Clinical Monitoring Plan 
CRF 
Case Report Form 
CROMS 
Clinical Research Operations Management Support 
DSMB 
Data and Safety Monitoring Board 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice Guidelines 
HIPAA 
Health Insurance Portability and Accountability Act  
ICC 
Intra-class correlation 
ICER 
Incremental cost-effectiveness ratio 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
ISM 
Independent Safety Monitor 
IRB 
Institutional Review Board 
ITT 
Intention-to-treat 
MAR 
Missing at Random 
MRC 
Methodology Research Core 
N 
Number (typically refers to participants) 
NIDCR 
National Institute of Dental and Craniofacial Research, NIH, DHHS 
NIH 
National Institutes of Health 
OCTOM 
Office of Clinical Trials Operations and Management 
OHI-MIS 
Simplified Oral Hygiene Index – Maxillary Incisor 

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OHRP 
Office for Human Research Protections 
PHI 
Personal Health Information 
PI 
Principal Investigator 
PROMIS 
Patient-Reported Outcomes Measurement Information System 
RA 
Research Assistant 
SAE 
Serious Adverse Event 
TOST 
Two One Sided Tests 
UCSF 
University of California at San Francisco 
UIC 
University of Illinois at Chicago 
US 
United States 
WIC 
Supplemental Nutrition Program for Women, Infants, and Children 
 

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PROTOCOL SUMMARY 
Title: 
COordinated Oral health Promotion (CO-OP) Chicago 
Randomized Controlled Trial 
Précis: 
COordinated Oral health Promotion (CO-OP) Chicago will 
bring together a team of clinical pediatricians and dentists, 
researchers, health psychologists, and policy experts to 
rigorously test the ability of an oral health promotion 
intervention to improve tooth brushing behaviors for children 
under the age of 3 years old. The primary intervention will be 
family-focused oral health education and support from 
community health workers (CHWs) delivered to families over 
one year. Participating study families will be recruited from 
pediatric primary care medical clinics and community social 
service centers (Women Infant and Children [WIC] Centers). 
Sites will be cluster randomized to intervention (CHW services) 
or usual care. Data on self-reported brushing frequency, 
plaque score, and other oral health behaviors will be collected 
at baseline, 6-months, and 12-months. The primary analysis 
will assess for differences in brushing frequency and plaque 
score between the two arms at 12-months. 
Objectives: 
 
The primary study objective is to evaluate the efficacy of a one-
year oral health CHW intervention, compared to usual care, to 
improve self-reported brushing frequency and observed plaque 
score in low income urban children under the age of 3 years 
old. This is achieved by offering CHW intervention to half of 
participating families and comparing them to families receiving 
usual care. 
Outcomes: frequency of brushing child’s teeth, amount 
of plaque on child’s teeth (plaque score) 
The first exploratory objective is to determine if child tooth 
brushing behaviors are different in families whose oral health 
CHW is clinic-based compared to community-based. This is 
achieved by recruiting families from both primary care medical 
clinics and WIC centers. Sites are randomized to oral health 
CHW intervention (on the site level) or usual care to allow for 
an equal distribution of families receiving intervention and 
usual care in clinics and WIC centers. 
Outcomes: frequency of brushing child’s teeth, amount 
of plaque on child’s teeth (plaque score) 

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The second exploratory objective is to determine the cost 
effectiveness of the CHW intervention compared to usual care. 
Outcomes: System-level (program) costs  
Population: 
Participants are caregiver/child dyads in Cook County, IL. We 
anticipate enrolling 420 caregiver/child dyads (18-23 from each 
site). To qualify, children must be aged 6-36 months with a 
minimum of two central maxillary incisors at least 50% erupted. 
Caregivers will be mostly female. Children will be equally 
male/female. Families will be almost entirely of African-
American race and Hispanic ethnicity.  
Phase: 
II 
Number of Sites: 
20 sites: 10 primary care medical clinics and 10 WIC centers. 
Description of  
Intervention: 
CHWs trained in oral health will be assigned to half of the sites. 
Participants in these sites will be offered four in-person visits 
and follow-up phone calls over 12-months. These visits can 
occur at the location of the family’s preference (recruitment 
site, home, or mutually-agreed upon other location). A core 
curriculum of oral health topics will be covered during visits, 
with an emphasis on developing and sustaining healthy oral 
health management routines for the entire family. 
Study Duration: 
34 months 
Subject 
Participation 
Duration: 
12 + 3 months.  
Estimated Time to 
Complete 
Enrollment: 
12 months 

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Schematic of Study Design: 
 

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1 KEY ROLES AND CONTACT INFORMATION 
 
Principal 
Investigator:   
Molly Martin, MD, MAPP 
Associate Professor of Pediatrics 
University of Illinois at Chicago, Institute for Health Research 
and Policy 
1747 West Roosevelt Road, Room 558 
Chicago, IL 60608 
Phone Number: 312-996-2363 
Fax Number: 312-413-0474 
mollyma@uic.edu 
Medical Monitor: 
Kevin McBryde, MD 
National Institute of Dental and Craniofacial Research/NIH 
6701 Democracy Blvd, Room 638 
Bethesda, MD 20892 
Phone Number: 301-594-0170 
Fax Number: 301-480-8319 
mcbrydekd@nidcr.nih.gov   
NIDCR Program 
Official:   
Dena Fischer, DDS, MSD, MS 
Program Director, Clinical Research and Epidemiology 
Program 
National Institute of Dental and Craniofacial Research 
6701 Democracy Boulevard 
MSC 4878 
Bethesda, MD 20892-4878 
Bethesda, MD 20817 (overnight mail or courier service) 
Phone Number: 301-594-4876 
Fax Number: 301-480-8322 
dena.fischer@nih.gov 
Clinical Site 
Investigators: 
David Avenetti, DDS, MSD, MPH 
Clinical Assistant Professor and Post-Graduate Program 
Director 
University of Illinois at Chicago, Department of Pediatric 
Dentistry 
801 South Paulina Street (MC 850) 
Chicago, IL 60612 
Phone Number: 312- 996-2046  
Fax: 312-996-1981 
avenetti@uic.edu 
 

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Michael Berbaum, PhD 
Director, Design and Analysis Core 
Center for Clinical and Translational Science and Cancer 
Center 
Director, Methodology Research Core 
University of Illinois at Chicago, Institute for Health Research 
and Policy 
1747 West Roosevelt Road, Room 558 
Chicago, IL 60608 
Phone Number: 312-413-0476 
Fax Number: 312-996-2703 
mberbaum@uic.edu 
 
Marcio A. da Fonseca, DDS, MS 
Associate Professor and Head 
University of Illinois at Chicago, Department of Pediatric 
Dentistry 
801 South Paulina Street, (MC 850) 
Chicago, IL 60612 
Phone Number: 312-996-1993 
Fax Number: 312-996-1981 
marcio@uic.edu 
 
William Frese, M.D., MPH 
Asst. Professor, General Pediatrics 
University of Illinois Hospital & Health Sciences System 
840 S. Wood St. (MC 856) 
Chicago, IL 60612 
Phone Number: 312-413-1884 
Fax Number: 312-413-0243 
wfrese1@uic.edu 
 
Mark Minier, M.D. 
Asst. Professor, General Pediatrics 
University of Illinois Hospital & Health Sciences System 
840 S. Wood St. (MC 856) 
Chicago, IL 60612 
Phone Number: 312-996-0358 
Fax Number: 312-413-0243 
mminier@uic.edu 
 
Jennie Pinkwater, MNM 
Executive Director (Interim) 
Associate Executive Director 

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Illinois Chapter, American Academy of Pediatrics (ICAAP) 
1400 W. Hubbard, Suite 100 
Chicago, IL 60642 
Phone Number: 312-733-1026 
Fax: 312-733-1791 
jpinkwater@illinoisaap.com 
 
Oksana Pugach, MS, PhD 
Biostatistician 
University of Illinois at Chicago, Institute for Health Research 
and Policy 
1747 West Roosevelt Road, Room 558 
Chicago, IL 60608 
Phone Number: 312-413-9397 
Fax Number: 312-413-1221 
opugach@uic.edu 
 
Sheela Raja, PhD 
Assistant Professor and Director Clinical Behavioral Sciences 
University of Illinois at Chicago, Department of Pediatric 
Dentistry 
801 South Paulina Street (MC 850) 
Chicago, IL 60612 
Phone Number: 312- 413-0559  
Fax: 312-413-1638 
sraja1@uic.edu 
 
Institutions: 
University of Illinois at Chicago 
Primary study site 
Molly A Martin, MD, MAPP 
1747 West Roosevelt Road, Room 558 
Chicago, IL 60608 
Phone Number: 312-996-2363 
Fax Number: 312-413-0474 
mollyma@uic.edu 
 
University of California, San Francisco 
NIDCR Health Disparities Data Coordinating Center 
Stuart Gansky, DrPH 
3333 California St, Ste 495 
Box #1361 
San Francisco, CA 94143 
(couriers: 94118) 

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Phone Number:  415-502-8094 
Fax Number: 415-502-8447 
stuart.gansky@ucsf.edu 
Other Key 
Personnel: 
Anna Sandoval, MPH 
Project Manager 
University of Illinois at Chicago, Institute for Health Research 
and Policy 
1747 West Roosevelt Road, Room 558 
Chicago, IL 60608 
Phone Number: 312-355-2388 
Fax Number: 312-413-0474 
asando1@uic.edu 

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2 INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE  
2.1 
Background Information 
Almost half of children 11 years old and younger suffer from dental caries, making 
caries one of the most common chronic diseases of childhood.1 Low income and 
minority children bear a disproportionate portion of this burden and its associated 
morbidity.2-5 Caries prevalence in Illinois and Chicago exceeds national figures, and 
Chicago area children have a high prevalence of untreated caries.6 Factors that 
contribute to caries in children include insufficient fluoride exposure, unhealthy diets, 
and poor oral hygiene.7-8  
Community health workers (CHWs) are frontline public health workers who serve as 
liaisons between health and social services and community residents to facilitate access 
to services and improve the quality and cultural competence of service delivery.9 CHWs 
typically provide health education, information, assistance with services, and build 
individual and community capacity for health.10 CHWs have been a part of health 
promotion and disease prevention efforts in US communities for several decades. CHW 
programs aim to address the health needs of under-served populations by training 
community members to be health educators who can reach their friends and neighbors 
effectively.11-13 The basic rationale for this approach with underserved and hard-to-
reach populations is that CHWs live in the same communities and have struggled with 
many of the same issues as their neighbors and thus share with the target population a 
similar base of knowledge and experiences.12-13 CHWs utilize a model that empowers 
community members to identify their own needs and implement their own solutions with 
support from medical providers, which leads to improved community and personal self-
efficacy.14-16 There has been tremendous national interest in CHW interventions. This 
interest in part comes from an increasing number of studies supporting a role for CHW 
interventions in the improvement of health outcomes.17-20  However there are limited 
data to support CHW intervention efficacy upon child oral health outcomes or 
associated family behaviors.21-25  
COordinated Oral health Promotion (CO-OP) Chicago will test the efficacy of a family-
focused CHW oral health intervention to improve tooth brushing behaviors for young 
children. CHWs will be based out of two settings: a clinical setting and a community 
setting. The results of this study will inform the need for and design of future research 
and programs that include oral health specific CHWs. 
2.2 
Rationale 
The primary hypothesis this study tests is as follows: Participants receiving the oral 
health CHW intervention will have improved oral health behaviors, as measured using 
self-reported brushing frequency and observed plaque score, at 12-months compared to 
participants receiving usual care. 
Caregiver directed oral health education has been shown to have a positive effect on 
knowledge, intended behavioral change (including snacking and sugar intake), and 

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caries prevalence.21, 26-27 CHWs deliver education, social support and navigation 
services, which are important for low income families, but it remains unclear if oral 
health CHWs can influence knowledge and behaviors.13,28  
The primary goal of CO-OP Chicago is to use a rigorous study design to determine the 
ability of a CHW-delivered oral health intervention to improve oral health behaviors, 
specifically tooth brushing, in high risk low income families. If the outcomes of this study 
indicate a potential utility for the CHW intervention, future research will investigate the 
impact of the intervention on caries development. This study’s exploratory aim also will 
determine if future CHW studies need to further investigate setting of CHW intervention 
delivery.  
CHWs typically work out of either a clinical location or a community agency. Therefore 
CO-OP Chicago places CHWs in both types of location as their primary base. Ten 
pediatric primary care clinics that serve low income families were recruited, as well as 
10 Women Infant and Children (WIC) centers which are social service centers where 
families receive free formula and food. CHWs can meet with families in their clinic/WIC 
center, participant homes, or a mutually-agreed upon location. The CHW intervention 
will be delivered over four in-person visits within one year; this “dosage” was chosen in 
order to align with well child medical checks and WIC center appointments (typically 
every 3 months). Four visits per year has also been found in other disease areas to be 
both acceptable to families and associated with cost savings.29 The one-year duration 
was chosen because completing dental clinic visits or making behavioral changes can 
take months. In addition, the CHWs often need to spend entire visits on social issues 
such as communication or access. These are important time investments because they 
allow the families to gain resources and skills to make changes related to oral health. 
Another advantage to a year-long intervention is that it allows for reinforcement after 
mastering a behavior (such as brushing daily) in order to maintain that behavior long 
term. 
The study population was chosen for several reasons. While caries can be treated, the 
ultimate goal in pediatrics is primary prevention. Families with children under the age of 
3 years old were chosen in order to establish healthy behaviors for a lifetime.30 The 
recruitment sites serve low income, predominantly minority families whose rates of 
caries development are higher than the general population.31-32    
2.3 
Potential Risks and Benefits 
There are no known benefits to this research. The risks are mainly related to discomfort 
and confidentiality, as described in Section 2.3.1.  
2.3.1 
Potential Risks 
Caregivers and children who participate in this study may experience discomfort with 
responding to questions, having their home and brushing observed, and having their 
children’s teeth examined. They may not be comfortable with research staff or CHWs in 
their home. Staff will assure families that individual responses to study questionnaires 

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and individual oral exam and behavioral observation data collected for the study will not 
be shared with social service agencies, organizations, and people outside the study.   
There is a risk of loss of confidentiality for all study participants. Precautions will be in 
place to minimize this risk, such as collecting only minimal identifying information and 
storing data collection documents in locked cabinets (located in locked offices), using 
unique study codes for participants, using encrypted computers, and maintaining 
electronic data files on a password-protected computer drive. Individual identifier 
numbers that are linked to participant contact information will be stored separately from 
the data. Compliance with all IRB regulations concerning data collection, data analysis, 
data storage, and data destruction will be strictly observed.  
2.3.2 
Potential Benefits 
All study participants will be offered oral health CHW services either during the study or 
after its completion; however, it has not been demonstrated to date if this is a beneficial 
intervention. Therefore there are no known direct benefits to study participants. This 
study is intended to determine the efficacy of a CHW-delivered oral health intervention, 
which may add to the body of knowledge about interventions that improve children’s 
oral health.  

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3 OBJECTIVES 
3.1 
Study Objectives 
The primary study objective is to evaluate the efficacy of a one-year oral health CHW 
intervention, compared to usual care, to improve self-reported brushing frequency and 
observed plaque score in low income urban children under the age of 3 years old. 
The study’s first exploratory aim is to determine if the oral health CHW intervention 
impact on child tooth brushing behaviors varies when the CHWs are based out of a 
medical clinic compared to a community WIC center. 
The second exploratory aim is to determine the cost effectiveness of the CHW 
intervention compared to usual care at the system-level. 
3.2 
Study Outcome Measures 
Outcome measures will be collected by research assistants at baseline, 6 months and 
12 months. Outcomes are a mixture of self-report, clinical assessment, observations of 
behaviors and the home environment, and cost data. These are described in detail in 
Appendix B.  
3.2.1 
Primary 
This study has two primary assessment measures of tooth brushing behavior. 
(1) Caregiver self-report of child tooth brushing frequency: This is an ordinal variable (<1 
time/day, 1 time/day, 2 or more times/day). The goal of the intervention is to 
increase the frequency of participants reporting “2 or more times/day”.   
(2) Dental plaque: See Appendix C for the full plaque score protocol. Using disclosing 
solution, plaque will be observed on the buccal surfaces of teeth #D, E, F and G. 
Amount of plaque is reported using the Oral health Index  - Maxillary Incisor 
Score (OHI-MIS) which is a continuous variable, range 0 to 3.  
3.2.2 
Secondary 
The secondary measures (shown in detail in Appendix B) are organized into several 
domains.  
Oral health behaviors include duration of brushing and caregiver assistance with 
brushing, age started brushing, amount of toothpaste, and type of toothpaste (fluoride or 
no fluoride.) Whenever possible, self-reported behaviors will also be observed. Child 
access to appropriate timely dental care will also be assessed. CHWs will target all 
these behaviors in the intervention. In analyses, these variables will represent additional 
components of healthy daily oral care behaviors for children. 

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CHWs work by improving knowledge, self-efficacy, and building self-management skills 
and supports.14-16 Therefore we will measure caregiver knowledge, self-efficacy, and 
child and caregiver oral health quality of life. We will also measure caregiver 
psychological functioning, social support, and family functioning using the NIH PROMIS 
measures and the CHAOS scale.33-36 These variables will be used in analyses to 
understand changes, or lack of, in the primary outcomes. 
A range of risk factors for caries and associated oral health behaviors will be measured 
as covariates. These include exposure to sugar sweetened beverages, weaning 
behaviors, prior caries experience, sibling severe caries experience, and caregiver oral 
health behaviors and access. Medical risk factors such as child co-morbidities, 
medications, and weight will be assessed.  
Data will also be collected on the CHW intervention, both to inform intervention fidelity 
and generate cost estimates. Cost estimates are only relevant for the CHW intervention 
arm, because the usual care arm has no additional costs. Cost estimates will only be 
collected on the system-level. While individuals may ultimately incur some costs, the 
intervention is designed to minimize these. (Visits in clinics and WICs will be aligned 
with visits they already plan to attend for healthcare or WIC services. Home visits will be 
arranged around work schedules and require no travel for participants.)  
System-level costs: CHW time for visit set-up, travel, and delivery will be 
determined. Duration of CHW visits will be recorded (using case report forms), as 
well as the time needed for scheduling (weekly estimates with supervisor) and for 
transportation to home visits (mileage logs). This will be multiplied by CHW 
salary/benefits. The mileage costs will be recorded from mileage logs. CHW 
supplies and equipment (educational materials, phones, computers, and any 
other items) will be obtained through expense reports.   
 

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4 STUDY DESIGN 
• CO-OP Chicago is a two-arm cluster randomized controlled trial with repeated 
measurements. The comparison arm receives usual care. (After completion of 
the trial, the usual care arm will be offered limited CHW intervention.) The nature 
of the intervention allows for a single blind design in which data collection will be 
performed by research assistants.  
• The trial targets healthy, low income, predominantly minority children under the 
age of 3 years old, and their families in Cook County, Illinois.  
• This is a multi-center trial with two arms and 20 sites (clusters). 
• We will recruit between 18-23 families from each site for a total sample size of 
420. Sites are in two strata: medical clinic and WIC. These are combined for the 
primary analysis but will be compared to each other in the exploratory analysis.  
• Study enrollment is scheduled to be completed in approximately 12 months. The 
primary recruitment will occur in the first 10 months, and the last two months will 
allow for unexpected delays. 
• Participants will undergo study procedures for 12 months (+ 3 months). 
• Participants will be recruited from each of the 20 study sites. Once recruitment at 
a site is completed, the site will be randomized and participants will be informed 
of the arm allocation. Participants assigned to the CHW arm will then be offered 
four CHW in-person visits and four follow-up phone calls over 12 months. The 
expectation is that in-person visits will align with well-child checks/WIC 
appointments every 3 months, so two visits in the first six months and two visits 
in the second six months, although the schedule is flexible. Telephone follow-up 
calls will follow in-person visits at a time determined meaningful by the CHW and 
family. Participants assigned to the usual care arm will be offered a CHW visit 
after they complete the final data collection at 12 months. 
• Screening will occur at the study sites during the recruitment phase. Initial 
screening will be conducted verbally. Caregivers who are interested in 
participating will have an enrollment data collection visit scheduled. The study 
staff (two RAs) will conduct this visit in the family’s home, at the recruitment site, 
or at another mutually agreed upon location. First, consent will be obtained. Then 
the staff will obtain survey responses by verbally asking questions about 
demographics, brushing, general health, social support, access to care, and 
health behaviors. Child dental plaque measurements will be obtained: disclosing 
solution will be applied to the child’s teeth and the teeth will be photographed. If 
the data collection is occurring in the home, families will be asked to demonstrate 
tooth brushing and the technique and equipment will be documented. Data will 
be collected again by RAs at 6 months and 12 months. 

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• After sufficient participants have been enrolled from a site, the site will undergo 
randomization procedures. If the site is randomized to CHW services, all 
participants enrolled at that site will be offered the CHW intervention.  
• Outcomes will be collected via self-report, clinical assessment, and observation 
of behaviors and equipment. This is described in detail in Section 3.2. Plaque will 
be captured via photographs in the field which will then be scored by a calibrated 
clinician at UIC.   
 

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5 STUDY ENROLLMENT AND WITHDRAWAL 
  
5.1 
Subject Inclusion Criteria 
To be eligible to participate in these study activities, the caregiver/child dyad must meet 
the following criteria: 
Caregiver: 
• Provide a signed and dated informed consent form 
• Age 18 or older 
• Be the primary caregiver of a child age 6-36 months old. The primary caregiver is 
defined for this study as the person (or one of the people) who is consistently 
responsible for the child’s daily routines and who is a legal guardian. 
• If a child lives in multiple households, the caregiver must live with the child at 
least 5 days of the week. 
• The child must be an active patient/client in the clinic/center where recruited. 
• Speak English or Spanish 
• Willing to comply with all study procedures and be available for the duration of 
the study  
Child: 
• Age 6-36 months old  
• An active patient/client in the clinic/center where recruited 
• A minimum of two fully erupted central maxillary incisors  
5.2 
Subject Exclusion Criteria 
A caregiver/child dyad who meets any of the following criteria will be excluded from 
participation in this study: 
• Child with medical condition that limits his or her ability to conduct the study 
activities (such as severe developmental or cognitive delay, ventilator or oxygen 
dependence, oral aversion, severe facial deformities) 
• Anything that would place the individual at increased risk or preclude the 
individual’s full compliance with or completion of the study 
• Anything that would place the research or intervention staff at increased risk 
   
5.3 
Strategies for Recruitment and Retention 
This trial will recruit a total of 420 caregiver/child dyads, 18-23 dyads from each of the 
20 sites. In the CO-OP Chicago Pilot, 123 caregivers were approached, 58 agreed to 
participate, and 20 completed the enrollment. This suggests a screening to enrollment 
ratio of 6:1. Patient/client volumes vary by site, but the 20 sites together comprise at 
least 2400 potentially eligible subjects. Similar to the pilot, the RAs will approach 

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caregivers of young children who seem to be under the age of 3 in the waiting area of 
the clinic/center. The RA will assess the caregiver interest in the study and review 
inclusion/exclusion criteria. If the caregiver expresses a willingness and interest in study 
procedures, the RA will obtain caregiver’s contact information and schedule an 
enrollment appointment. It took RAs about 3 hours of screening time for each enrolled 
family in the pilot. Families are given small incentives like toothbrushes for completing 
the screening. 
Consent procedures will be conducted at the beginning of the enrollment visit, and the 
visit should last no more than 60 minutes. At the completion of the visit, participants will 
be offered $40 and a flyer describing basic oral health tips (https://www.nidcr.nih.gov/ 
oralhealth/Topics/ToothDecay/Documents/healthy-mouth-for-your-baby-factsheet.pdf.)  
Once enrolled, participants will be contacted again by RAs at 6 months and 12 months 
for data collection. Payment will be the same at those visits ($40). In total, families that 
complete all data collections will receive $120.  
The contact procedures are detailed in Appendix D.  Retention for all participants will be 
achieved by: 
- 
Careful vetting of all research materials through a community advisory board to 
ensure participants feel connected to the trial; 
- 
Using field staff who are engaging, respectful, and non-threatening; 
- 
Collecting multiple types of contact information for participants including primary 
phone, back up phone, emails, address, back up address, and an alternative 
contact person’s phone and address. RAs will clarify at each contact timepoint how 
participants prefer to be contacted (text, email, phone call) and when are the best 
times to reach them; 
- 
Remuneration for data collection; 
- 
Maintaining strong partnerships with the participant’s clinic/WIC center. 
Participants might experience a delay between enrollment and randomization while 
waiting for site to reach sufficient enrollment numbers. While waiting for randomization, 
research staff will call the family to verify contact information and reassure them about 
the study every 4 weeks.  
5.4 
Treatment Assignment Procedures 
Participant treatment assignments are determined by their site of enrollment. Sites will 
be cluster randomized to CHW or usual care. This process is described in Section 5.4.1. 
5.4.1 
Randomization Procedures  
Clinic and WIC sites will be randomized on the site level once enrollment has reached 
approximately 90% of goal (18-23 families) at each site. Simple cluster randomization 
with relatively small numbers of clusters is susceptible to baseline imbalance with 

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respect to cluster and participant characteristics between the intervention and 
comparison conditions. Thus, restricted randomization of clusters is commonly 
employed to enforce greater balance, which both eliminates potential bias and 
enhances power. We are using terminology from the review paper by Noah Ivers et al. 
where minimization and covariate-constrained randomization are special cases of a 
more general category of restricted randomization.37 We will employ a stratified by 
clinic/WIC minimization method  to ensure baseline characteristic balance at both 
cluster and participant level. Randomizing sites after approximately 90% of the 
enrollment goal will ensure blinding of RAs, site staff, and participants until most 
participants from each site are enrolled. (The last 10% of participants are often the 
slowest to recruit and this small number should not influence the participant-level 
covariate balance.) Cluster-level summary statistics regarding race and ethnicity 
characteristics of the site population (African American, Latino, or mixed) and site size 
(high, medium, low) will be used as cluster-level covariates for minimization. Cluster-
level randomization will be done by the UCSF Coordinating Center (CC). Once a site is 
randomized, the CC will inform the UIC project manager who will inform the site 
leadership of the site assignment via email and/or phone call. The UIC project manager 
will assign a CHW if randomized to that arm. The project manager will then inform the 
CHW of his/her participants and provide access to their contact information. UIC will 
send letters via mail to participants informing them of their site’s assignment, and their 
CHW’s information if applicable.  
5.4.2 
Masking Procedures  
Although double blinding in a behavioral randomized clinical trial is not feasible, blinding 
will be maximized by utilizing independent outcomes assessors (research assistants) 
who will be blinded to study arm, and by reminding staff and partners about equipoise. 
Participants will be reminded at every contact to not disclose their study arm or any 
intervention they are or are not receiving. Investigators who supervise the CHWs and 
the project manager will be unblinded to treatment arm because they will need to work 
with the CHWs and monitor intervention fidelity and data accuracy. The USCF CC will 
also be unblinded to treatment arm. Study staff and investigators will not have access to 
interim outcomes data. Unmasking procedures are described in more detail in the 
Manual of Procedures. 
5.5 
Subject Withdrawal 
Subjects may voluntarily withdraw their consent from the study.  
5.5.1 
Reasons for Withdrawal 
Subjects are free to withdraw from participation in the study at any time upon request.   

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5.5.2 
Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention 
If a participant requests to be withdrawn from the study, the following must happen for 
official withdrawal: 
- 
Principal Investigator (PI) calls and/or emails to explain instructions for withdrawal 
- 
Mail/email them a copy of their signed consent along with letter from the PI and 
stamped envelope addressed to UIC/IHRP that includes instructions on how to 
withdraw 
o If no response in 2 weeks, repeat mailing 
- 
Instructions 
o Participant caregiver to write “I am withdrawing from this study” 
somewhere on the consent form and send it back in the envelope 
provided. 
- 
If no response or returned consent form, participant remains in study. Continue to 
repeat procedure if participant continues to request withdrawal. 
- 
Once a participant is withdrawn, a note should be placed in their clinic/WIC records 
stating this. 
Families that withdraw will not be replaced. 
 
5.6 
Premature Termination or Suspension of Study 
This study may be suspended or prematurely terminated if there is sufficient reasonable 
cause.  Written notification, documenting the reason for study suspension or 
termination, will be provided by the suspending or terminating party to Dr. Molly Martin, 
funding agency, and regulatory authorities.  If the study is prematurely terminated or 
suspended, the PI will promptly inform the IRB and will provide the reason(s) for the 
termination or suspension.  
Circumstances that may warrant termination include, but are not limited to: 
• Determination of unexpected, significant, or unacceptable risk to subjects. 
• Insufficient adherence to protocol requirements. 
• Data that are not sufficiently complete and/or evaluable.  
• Determination of futility. 

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6 STUDY INTERVENTION 
6.1 
Study Behavioral or Social Intervention(s) Description 
This study will test an oral health CHW intervention. 
6.1.1. CHW Intervention Pedagogy 
CHWs use social cognitive theory to help families shape and maintain behaviors.38 The 
CO-OP Chicago Oral Health CHW intervention will apply formal self-management skills 
(problem solving, decision making, resource utilization, patient/doctor partnership, and 
taking action),39-442 in addition to the oral health core curriculum. CHWs will use Action 
Plans as a tool to teach these skills and take action. Action Plans are small goals for a 
specific change over a designated time period (Appendix E). The CHWs will start by 
providing education from the oral health core curriculum, but when they note a barrier in 
the delivery of the education, they will incorporate a relevant self-management skill and 
create an action. For example, a CHW may suspect the family is not brushing the child’s 
teeth regularly but instead of just saying that, the CHW will have the family track how 
often the child is brushing over a one week period.  The family will “self-discover” they 
do not brush as often as recommended. Then the CHW will have the family brainstorm 
as to why that might be (bathroom organization, parent work schedules, behavioral 
issues, etc.). Once they have a list of the problems, the family will create an Action Plan 
for one problem they want to work on. On subsequent CHW visits and follow-up 
telephone calls, CHWs revisit past Action Plans, revise them, and make new ones.   
6.1.2. CHW Core Curriculum 
1. Oral health basics 
a. What is caries 
b. Causes of caries 
c. Importance of caries prevention 
2. Tooth brushing 
a. When to start 
b. Frequency 
c. Technique 
d. Equipment 
e. Toothpaste 
3. Fluoride 
a. Water  
b. Other sources 
4. Weaning 
a. When to transition from bottle 
b. Sippy cup recommendations 
c. Nighttime feeding 
5. Nutrition 
a. Sugar-sweetened beverages  
b. Juice 
c. Healthy foods 
6. Seeing the dentist 
a. When to start 
b. What to expect 
c. Frequency 
d. Role of the pediatrician 

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6.2 
Administration of Intervention 
Families will be offered 4 in-person visits and 4 phone call follow-ups over 12 months. 
The expectation is that two visits will occur in the first six months and two visits will 
occur in the second six months. The expectation for phone call follow-ups is that they 
will occur after the in–person visits, on a schedule that is determined by the family and 
CHW.  Visits can occur at any location of the family’s choosing. This could be the home, 
clinic, WIC, or other location.  
At in-person visits, CHWs will spend 1-2 hours with the family. The first 15 minutes are 
spent in social engagement (getting to know the people in the family and the family’s 
interests, as well as the family getting to know the CHW, or catching up socially if 
families are already known). CHWs will try to engage all family members in the visits if 
possible. At the first visit, the CHW will then administer the Caries-risk Assessment 
Tool43 (Appendix F) for all family members present. CHWs will follow this with tailored 
education based upon the risk assessment results using a variety of live demonstration, 
pictorial, video, and written resources. The oral health topics are drawn from the Core 
Curriculum (Section 6.1.2, Appendix G). CHWs will generally apply popular education 
methods44, meaning they will rarely use written materials. Instead they will engage the 
family in discussion using questions, stories, videos, and demonstrations. These are the 
same techniques and methods used in the CHW training. For equipment, CHWs will 
have computers with Wi-Fi access (via hotspots) to view videos. CHWs will have 
models for demonstrating tooth brushing and they will practice with families. CHWs will 
also facilitate family-wide dental care access by identifying accepting providers, 
providing families with provider contact information, and assisting to make appointments 
as needed. CHWs will have access to Purple Binder which is an online community 
resources search service (www.purplebinder.com). For the last 15 minutes of the visit, 
families will make Action Plans (Appendix E).  At the start of all subsequent visits, 
Action Plans from the previous visit will be reviewed and discussed. CHWs will aim to 
address all the core curriculum topics over the one year intervention. After each visit, 
CHWs will call or text the caregiver during the subsequent month to follow-up on actions 
and reinforce concepts from the previous visit. The detailed core curriculum protocol 
and materials are included in Appendix G. CHWs will document topics covered and 
materials used immediately after each visit. (Form in Appendix H). Follow-up telephone 
calls will be conducted to review information and plans, address questions, and provide 
social support. (Appendix G) 
6.3 
Procedures for Training Interventionists and Monitoring Intervention 
Fidelity 
6.3.1. CHW Training and Hiring 
Because limited formal certification or licensing programs for CHWs exist nationally or 
locally,45 training curriculums are developed for individual programs and are not 
standardized for any disease area. CHWs require training in disease-specific content, 

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building relationships, self-advocacy, teamwork and conflict resolution, crisis and 
emergency management, and home visitation before going into the field.13,45  
Phase I: Pre-Hire Training 
Potential candidates for the CHW positions will be recruited through existing UIC 
programs, participating medical clinics and WIC sites, community list-serves, and word 
of mouth. Preference will be given to candidates who have already worked as CHWs 
and who have experience with the participating clinics or WIC centers. We plan to hold 
one training session on the west side and another on the south side of Chicago. Notices 
for the training will be distributed through the partner sites, UIC, and local CHW 
listserves. A cohort of 12-15 candidates will be selected from those who express 
interest to attend each pre-hire training. Pre-hire training serves several purposes: 1) 
The training builds community capacity and skills around oral health, 2) It allows 
investigators to determine the best candidates for the position, and 3) It provides a pool 
of back-up candidates for the future. In the pilot phase of this project, the CO-OP 
Chicago team built and tested a comprehensive oral health CHW training curriculum.28 
The manual is available at website (http://go.uic.edu/COOPChicago) and in the Manual 
of Procedures. This 4.5 hour training will be conducted by Dr. Martin and either Dr. 
Avenetti or the hygienist in English. The training concludes with standardized role plays 
to evaluate skills attainment and content delivery. Once both trainings are completed, 
the CHW positions will be posted, and trainees will be invited to apply. The training role 
play scores and observations will be compared. The best candidates will be interviewed 
and hired. Additional pre-hire trainings will be conducted if needed until the CHWs are 
hired. 
Phase 2: Post-Hire Training 
Three to four CHWs (3.0 FTE) will be hired. Once hired, CHWs will undergo additional 
training. If the CHWs have not previously worked or been trained as CHWs, they will 
undergo the UIC Coordinated Healthcare for Complex Kids (CHECK, 
https://www.mycheck.uic.edu/  basic CHW training which was designed by Dr. Martin 
and is supervised currently by Dr. Minier: 
CHECK Basic CHW Training Program 
Topics 
Duration 
CHECK Overview: Medicare and Medicaid overview, CMS innovations awards, 
Inappropriate healthcare use, Goals and activities of CHECK 
1 hour 30 minutes 
Health and Disease Overview: Diabetes type 1, Prematurity, Sickle cell disease, Asthma 
1 hour 
Building Relationships and Motivational Interviewing: Trust, Communication, Coping 
and support, Respect and patient-centeredness  
1 hour 
Self-Advocacy: Advocating for yourself, teaching patients to self-advocate  
30 minutes 
Teamwork and Conflict Resolution: Teamwork, Conflict resolution 
30 minutes  
Managing Transitions: Transitioning from adolescence to adulthood, Transitioning from 
pediatric to adult care, Hospital to home 
30 minutes 

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Home Visitation: Why home visits, Preparing for a home visit, Safety, Home visit 
etiquette, Building trust, Mandatory reporting 
1 hour 
Self-Management: Problem solving, Social support, Environmental rearrangement, Self-
monitoring, Action planning 
1 hour 
Operations: Office tour, Supplies (obtain laptop, office supplies, keys, office space, 
business cards, parking card), Building access, Job description, Job management 
(evaluations, monitoring, union, hours, scheduling, payroll, meetings, supervision) 
3 hours 
Teams and Protocols: Geographic zones/teams, Mobile van/dentistry, Phone protocols, 
Assessment protocols, Mental health specialists, disease specific teams (asthma, 
diabetes, sickle cell disease, prematurity), Hospital protocols, Tour 
4 hours 
Insurance: Medicaid managed care companies, Medical neighborhoods 
1 hour 
Community Outreach 
Basics of community outreach, Community-based medical neighborhood, Tour 
1 hour 30 minutes 
Medical Legal Issues: Medical legal team, Social Security, Education issues (504 plans 
and Individual Education Plans) 
1 hour 
Technology: Data access, use, and support; Purple binder; Compliance and HIPAA 
2 hours 
CHWs will be familiarized with the study protocol, clinic and WIC site policies, home 
visitation strategies, and documentation. CHWs will complete the 12-hour Mental Health 
First Aid course (www.mentalhealthfirstaid.org). Dr. Raja will then teach and practice 
basic motivational interviewing (4 hours). CHWs will shadow experienced CHWs on 
other projects at UIC for a minimum of three visits and they will shadow UIC dental 
clinicians for a minimum of 20 hours before being ready for field work. The first three 
CHW home visits will be conducted with the CHW supervisor. The CHW supervisor will 
score each visit using the CHW Fidelity Assessment Form (Appendix I). When the CHW 
scores at least 4 in each category on three visits, the CHW is ready to visit participants 
alone.  
Phase 3: Ongoing Training 
CHWs will receive continual education that includes monthly reviews of topics of interest 
to the CHWs, as well as participation in general CHW events conducted by the Chicago 
CHW Local Network (http://chwnetwork.wordpress.com/) and the CHECK Care 
Coordination team. Continual education includes oral health topics as needed (see 
Section 6.3.3.) 
6.3.2. CHW Supervision 
CHWs are not clinicians and they often struggle with many of the same issues as their 
clients in terms of health problems, children, housing, and poverty. This allows them to 
intimately understand the challenges their clients face and usually translates into strong 
bonds between CHWs and clients, but it sometimes transforms into a significant burden 
when clients struggle with serious issues. The CHWs also must deal with the stresses 
of home visitation (safety, cleanliness, hectic households, and poverty) and the 
pressures of executing a new non-clinical role in clinical and WIC settings. In order for 
CHWs to successfully perform their job, they require adequate supervision and support. 
Supervision is best conducted using a team approach with a group of CHWs to facilitate 

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self-discovery and group learning. In CO-OP Chicago, CHWs will report directly to the 
CHW supervisor (the CO-OP Chicago project manager) for day-to-day supervision and 
support. Dr. Minier and the project manager will ensure the CHW roles are properly 
explained to clinical staff and faculty in the participating clinics. Ms. Pinkwater will 
provide a similar role within the WIC sites. CHWs will meet with the CHW supervisor 
weekly. Every two weeks, CHWs will also meet with the CHW supervisor, Dr. Martin, Dr. 
Avenetti, and Dr. Martin/Ms. Pinkwater (rotating) for discussion of clinical issues, self-
management skills support, and for continuing education. Dr. Raja will meet with CHWs 
on an as-needed basis to discuss mental health issues related to participants or the 
CHW job and to generate strategies for resolution.   
6.3.3. Fidelity Monitoring 
CHWs will have a caseload of up to 70 patients, each of whom will receive 4 visits and 
follow-up calls over one year. CHWs will complete documentation after every encounter 
to record visit location, duration, oral health curriculum topics covered, resources 
utilized, issues encountered, and family members who participated. This form is in 
Appendix I. These data will be reviewed monthly by the CHW supervisor and 
investigators to ensure consistency and fidelity of the intervention content and also to 
inform the study team about areas of focus and challenge. Reports from these data will 
show core curriculum topics covered and pending per patient, resources used, and 
overall trends in topics. While the goal is to cover each of the core curriculum topics 
over the duration of the intervention with each family, CHWs may deviate due to family 
needs and resources. Deviations will be reviewed; if they are due to CHW issues (lack 
of comfort with a topic or poor organization), additional training will be provided either to 
the specific CHW alone or to the group as needed. These data will also be used in final 
analyses to determine “dose” of intervention and assess the influence of specific 
topics/skills on outcomes. 
The CHW supervisor will accompany each CHW on a minimum of one visit out of every 
30 (8% of total visits). The CHW supervisor will assess the CHW using the CHW Fidelity 
Assessment Form (Appendix I). If a CHW scores less than 4 on any category, additional 
training and support will be provided to the CHW. Depending on the specific issue, 
additional training/support could include extra sessions with the investigators, and/or 
more shadowing experience with more experienced CHWs and/or in the dental clinic. 
Additional visit supervision and fidelity scoring will be implemented until the CHW is 
consistently scoring 4 on all categories. 
6.4 
Assessment of Subject Compliance with Study Intervention 
Subject compliance is defined and measured in two ways. First, we will measure 
compliance with the CHW visit protocol, meaning how many of the four in-person visits 
and two follow-up phone calls are completed in the 12-month intervention period. This is 
assessed using the CHW documentation (number of visits/calls completed). Families 
that are not compliant will have less CHW encounters. Second, we will monitor 
participant compliance with goals. This is determined using the Action Plans (Appendix 

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E) that are completed at each in-person visit. The Action Plan documents record the 
goals and the CHW Encounter Tracking Form (Appendix H) records progress, or lack 
of, regarding these Action Plans (goal achieved, partially achieved, or not achieved at 
all).  
 
 

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7 STUDY SCHEDULE 
7.1 
Screening 
Screening Visit with RA (prior to Baseline Visit)  
• Obtain and document verbal consent from potential caregiver subject on 
screening consent document. 
• Ask the potential caregiver subject screening questions to determine eligibility. 
• Perform brief visual examination needed to determine eligibility of the child 
subject. 
• Describe the study procedures and show the recruitment video (if interested).  
• Schedule study enrollment visit for individuals who are eligible, interested, and 
available for the duration of the study.    
7.2 
Enrollment/Baseline Visit with RA (Visit 1, prior to Randomization) 
• Obtain and document consent from subject on study consent form. 
• Verify inclusion/exclusion criteria.   
• Obtain self-reported data via verbal questionnaire. This includes demographic 
information, oral health behaviors, oral health risk factors, medical history 
questions, and family psychosocial functioning. 
• Weigh child. 
• Apply disclosing solution to child’s teeth and obtain photographs for plaque 
assessment. 
• If conducted in home, observe child brushing teeth and brushing equipment. 
• Explain to family the randomization process and when intervention will start 
(Intervention will begin after randomization for families in sites that are 
randomized to receive CHW services. For families in sites that are randomized to 
not receive CHW services, they will be offered CHW services after study 
completion in one year.) 
• Verify contact information. 
• Thank family. Offer remuneration and give flyer on basic oral health 
recommendations. 

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7.3 
Randomization, Day 0 
Each site will be randomized to CHWs or usual care once recruitment is completed or 
near completion. See Section 5.4.1. for details.  
7.4 
Intervention in-person visits for CHW-sites only, start Day 1 and complete 
by Day 365  
Four in-person visits will be offered to families. See Appendix D for details. The first two 
visits will be delivered between days 1-179. The third and fourth visits will be delivered 
between days 180-364.  
7.5 
Intervention telephone follow-ups for CHW-sites only, start Day 2 and 
complete by Day 365  
Four follow-up telephone calls will be offered to families. The plan is for follow-up 
telephone calls to follow in-person visits. 
7.6 
6-Month Visit with RA, Day 180 (- 14 days, + 60 days)  
• Obtain self-reported data via verbal questionnaire. This includes demographic 
information, oral health behaviors, oral health risk factors, medical history 
questions, and family psychosocial functioning. 
• Weigh child. 
• Apply disclosing solution to child’s teeth and obtain photographs for plaque 
assessment. 
• If conducted in home, observe child brushing teeth and brushing equipment. 
• Record adverse events as reported by subject or observed by investigator. 
• Verify contact information. 
• Thank family. Offer remuneration. 
7.7 
Final Study Visit with RA, Day 365 (+ 90 days) 
• Obtain self-reported data via verbal questionnaire. This includes demographic 
information, oral health behaviors, oral health risk factors, medical history 
questions, and family psychosocial functioning. 
• Weigh child. 
• Apply disclosing solution to child’s teeth and obtain photographs for plaque 
assessment. 
• If conducted in home, observe child brushing teeth and brushing equipment. 

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• Record adverse events as reported by subject or observed by investigator. 
• Remind family that we will send families a copy of the study results at the end of 
the study. Results will also be posted on the study website and displayed at the 
clinic/WIC center. Remind families that if they are in the usual care arm, they will 
soon receive a phone call from a CHW offering them a visit. Remind them that 
we may contact them in the future for follow-up studies if they agreed to that at 
the time of consent. Verify contact information. 
• Thank family. Offer remuneration. 
7.8 
Intervention in-person visits for usual care-sites only, start Day 1 after 
final day collection and complete end of study 
Families that are in usual care sites will be offered one CHW visit after they complete 
the final data entry. This is a courtesy visit to assess family risks and refer them to 
existing resources. The window for completion of this visit will last as long as funding is 
available for the CHWs. 
7.9 
Withdrawal Visit 
If a subject withdraws from the trial or is administratively withdrawn, no more data 
collection will occur. 
 
 

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8 STUDY PROCEDURES /EVALUATIONS 
8.1 
Study Procedures/Evaluations 
Location  
Because data collection would ideally occur in the homes by RAs, the home will be 
presented to families as the preferred location. Families that agree to home data 
collection will be given first priority in enrollment. Some families may be uncomfortable 
with home data collection for a variety of reasons including trust, not being on the lease 
at the place they live, or feeling that the home is unclean or unsafe. Families that want 
to participate but cannot agree to a home visit will be scheduled for data collection in 
their site of recruitment (WIC or clinic) or another location where the plaque 
measurement can be performed. Once families have interacted with project staff and 
better understand the study, they may agree to future data collection and intervention 
visits in the home. For the 6- and 12-month data collection visits, home will again be the 
preferred location for data collection, though collection of the study primary outcomes is 
the most important factor regarding data collection location. 
Survey development 
Most survey questions were drawn from NHANES, NHIS, and the previous EC4 
consortium, or are published survey instruments. A few questions were developed by 
the CO-OP Steering Committee to capture variables of interest for this research. The 
questions and question sources are shown in Appendix B. Primary domains are 
brushing behaviors, oral health risk factors, and demographics. These questions were 
informed by the clinical expertise of the investigators as well as the investigators’ 
experience doing home environmental assessments for research purposes.46-47  
Data Collection 
All instruments will be in the preferred language of the caregiver. The RA will verbally 
ask study questions to the participants, using visual prompts to show response options. 
The RA will record answers on a portable laptop computer unless Wi-Fi is not available 
or the computer malfunctions, in which case paper forms will be used. An exception to 
this are the questions from the PROMIS scales. The RA will administer the PROMIS 
questions in the same way as the other questions with one exception; if the environment 
does not seem to offer sufficient privacy or the caregiver seems reluctant to verbally 
answer these questions, the RA will offer the caregiver the option of completing the 
questions on the computer (handing the computer to the participant to complete) or on a 
paper version with pen/pencil. The decision between computer or paper will be made 
based on the respondent’s comfort with computers. Our experiences in similar 
populations and in the pilot phase of this project have suggested that the reading ability 
of many adults is limited, and they usually are more comfortable when they are read the 
questions, even when the questions are sensitive. The PROMIS depression, anxiety, 

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and functioning scale is not a clinical tool and does not have a clinical cut point that 
requires action.35-36 RAs will offer a list of mental health resources to all participants at 
the conclusion of the PROMIS questions. 
Next, the following procedures will be performed:  
Plaque measurement: A RA will apply disclosing solution to the anterior maxillary 
incisors while another RA photographs the teeth. The images will be verified for 
accuracy. A dental hygienist or dentist will obtain a plaque score from the 
photographs, following the Simplified Oral Hygiene Index - Maxillary Incisor (OHI-
MIS) described by Greene and Vermillion.48 The detailed protocol is in Appendix 
C.  
Tooth brushing observation: The RA will observe the child’s tooth brushing, 
including any caregiver assistance with this activity and the equipment used for 
brushing. The RA will document the steps of brushing, caregiver involvement in 
the process, the time of active brushing, and equipment used.  
Data fidelity  
The UCSF Coordinating Center (CC) is developing a gold standard calibration protocol 
for examiners of plaque. This will include the specific requirements of images and will 
ensure scoring of images is consistent. (Also see Section 14). RAs will practice 
application of the disclosing solution and image obtainment under the supervision of 
study investigators until they demonstrate they can consistently collect quality images 
for scoring. They will then review the plaque measurement procedures monthly with 
investigators.  
RAs will practice collection of all questionnaire and behavior observation data, and then 
two RAs will simultaneously collect data (double data entry) from practice participants 
(and sometimes real participants) until 95% concordance between RA-collected data is 
observed. The RA field supervisor will then observe and double code one out of every 
30 data collections to ensure fidelity. If errors are noted or concordance is less than 
95%, the RA will be required to practice additional data collection under the supervision 
of the field supervisor until 95% concordance is achieved.  
 

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9 ASSESSMENT OF SAFETY 
9.1 
Specification of Safety Parameters 
Safety monitoring for this study will focus on unanticipated problems involving risks to 
participants, including unanticipated problems that meet the definition of a serious 
adverse event. 
9.1.1 
Unanticipated Problems 
The Office for Human Research Protections (OHRP) considers unanticipated problems 
involving risks to subjects or others to include, in general, any incident, experience, or 
outcome that meets all of the following criteria: 
• unexpected in terms of nature, severity, or frequency given (a) the research 
procedures that are described in the protocol-related documents, such as the 
IRB-approved research protocol and informed consent document; and (b) the 
characteristics of the subject population being studied; 
• related or possibly related to participation in the research (“possibly related” 
means there is a reasonable possibility that the incident, experience, or outcome 
may have been caused by the procedures involved in the research); and 
• suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized. 
 
9.1.2 
Adverse Events 
An adverse event is any untoward or unfavorable medical occurrence in a human 
subject, including any abnormal sign (for example, abnormal physical exam or 
laboratory finding), symptom, or disease, temporally associated with the subject’s 
participation in the research, whether or not considered related to the subject’s 
participation in the research. 
9.1.3 
Serious Adverse Events 
A serious adverse event (SAE) is one that meets one or more of the following criteria: 
• Results in death 
• Is life-threatening (places the subject at immediate risk of death from the event 
as it occurred) 
• Results in inpatient hospitalization or prolongation of existing hospitalization 

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• Results in a persistent or significant disability or incapacity 
• Results in a congenital anomaly or birth defect   
• An important medical event that may not result in death, be life threatening, or 
require hospitalization may be considered an SAE when, based upon appropriate 
medical judgment, the event may jeopardize the subject and may require medical 
or surgical intervention to prevent one of the outcomes listed in this definition. 
9.2 Time Period and Frequency for Event Assessment and Follow-Up 
Unanticipated problems will be recorded in the data collection system throughout the 
study.  
The PI will record all events with start dates occurring any time after informed consent is 
obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study 
participation.  At each study visit, the investigator will inquire about the occurrence of 
AE/SAEs since the last visit.  Events will be followed for outcome information until 
resolution or stabilization. 
9.3 Characteristics of an Adverse Event 
9.3.1 
Relationship to Study Intervention 
To assess relationship of an event to study intervention, the following guidelines are 
used: 
1. Related (Possible, Probable, Definite) 
a. The event is known to occur with the study intervention. 
b. There is a temporal relationship between the intervention and event onset. 
c. The event abates when the intervention is discontinued. 
d. The event reappears upon a re-challenge with the intervention. 
2. Not Related (Unlikely, Not Related) 
a. There is no temporal relationship between the intervention and event 
onset. 
b. An alternate etiology has been established. 
9.3.2 
Expectedness of SAEs 
The Study PI will be responsible for determining whether an SAE is expected or 
unexpected.  An adverse event will be considered unexpected if the nature, severity, or 

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frequency of the event is not consistent with the risk information previously described for 
the intervention.   
9.3.3 
Severity of Event 
The following scale will be used to grade adverse events: 
1. Mild: no intervention required; no impact on activities of daily living (ADL) 
2. Moderate: minimal, local, or non-invasive intervention indicated; moderate impact 
on ADL 
3. Severe: significant symptoms requiring invasive intervention; subject seeks 
medical attention, needs major assistance with ADL 
9.4 
Reporting Procedures 
9.4.1 
Unanticipated Problem Reporting to IRB and NIDCR 
Incidents or events that meet the OHRP criteria for unanticipated problems require the 
creation and completion of an unanticipated problem report form.  OHRP recommends 
that investigators include the following information when reporting an adverse event, or 
any other incident, experience, or outcome as an unanticipated problem to the IRB: 
• appropriate identifying information for the research protocol, such as the title, 
investigator’s name, and the IRB project number; 
• a detailed description of the adverse event, incident, experience, or outcome;  
• an explanation of the basis for determining that the adverse event, incident, 
experience, or outcome represents an unanticipated problem;  
• a description of any changes to the protocol or other corrective actions that have 
been taken or are proposed in response to the unanticipated problem. 
To satisfy the requirement for prompt reporting, unanticipated problems will be reported 
using the following timeline:   
• Unanticipated problems that are serious adverse events will be reported to the 
IRB and to NIDCR within 5 business days of the investigator becoming aware of 
the event.  
• Any other unanticipated problem will be reported to the IRB and to NIDCR within 
15 business days of the investigator becoming aware of the problem.  
• All unanticipated problems should be reported to appropriate institutional officials 
(as required by an institution’s written reporting procedures), the supporting 

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agency head (or designee), and OHRP within one month of the IRB’s receipt of 
the report of the problem from the investigator. 
All unanticipated problems, including unanticipated problems that are SAEs, will be 
reported to NIDCR through the Rho Product Safety centralized reporting system : 
• Product Safety Fax Line (US):  1-888-746-3293 
• Product Safety Fax Line (International):  919-287-3998 
• Product Safety Email:  rho_productsafety@rhoworld.com  
General questions about SAE reporting can be directed to the Rho Product Safety Help 
Line (available 8:00AM – 5:00PM Eastern Time):   
• US:  1-888-746-7231 
• International: 919-595-6486 
For any unanticipated problem meeting the SAE criteria, the study clinician will 
complete a Serious Adverse Event Form and will submit via fax or email within the 
timelines stated in Section 9.4.1. Once submitted, Rho Product Safety will send a 
confirmation email to the investigator within 1 business day. The investigator should 
contact Rho Product Safety if this confirmation is not received. This process applies to 
both initial and follow-up SAE reports. 
   
 
 

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10 STUDY OVERSIGHT 
In addition to the PI’s responsibility for oversight, study oversight will be under the 
direction of a Data and Safety Monitoring Board (DSMB) composed of members with 
appropriate clinical, statistical, scientific, and ethical expertise. The NIDCR will appoint 
the Board. The DSMB will meet annually to assess safety and efficacy data (if 
applicable), study progress, and data integrity for the study.  If concerns arise, more 
frequent meetings may be held. The DSMB will operate under the rules of an NIDCR-
approved charter that will be approved at the organizational meeting of the DSMB.  The 
DSMB will provide recommendations to the NIDCR.   
 
  

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11 CLINICAL SITE MONITORING 
Clinical site monitoring is conducted to ensure that the rights of human subjects are 
protected, that the study is implemented in accordance with the protocol and/or other 
operating procedures, and that the quality and integrity of study data and data collection 
methods are maintained.  Monitoring for this study will be performed by NIDCR’s 
Clinical Research Operations and Management Support (CROMS) contractor. The 
monitor will evaluate study processes and documentation based on NIDCR standards 
and the International Conference on Harmonisation (ICH), E6: Good Clinical Practice 
guidelines (GCP). 
Details of clinical site monitoring will be documented in a Clinical Monitoring Plan (CMP) 
developed by the CROMS contractor, in collaboration with the NIDCR Office of Clinical 
Trials and Operations Management (OCTOM) and the NIDCR Program Official/Project 
Scientist. The CMP will specify the frequency of monitoring, monitoring procedures, the 
level of clinical site monitoring activities (e.g., the percentage of subject data to be 
reviewed), and the distribution of monitoring reports.  Some monitoring activities may be 
performed remotely, while others will take place at the study site(s).  Staff from the 
CROMS contractor will conduct monitoring activities and provide reports of the findings 
and associated action items in accordance with the details described in the CMP.  
Documentation of monitoring activities and findings will be provided to the site study 
team, the study PIs, OCTOM, and the NIDCR. The NIDCR reserves the right to conduct 
independent audits as necessary. 
 

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12 STATISTICAL CONSIDERATIONS 
12.1 
Study Hypotheses 
The primary hypothesis this study tests is as follows: Participants receiving the oral 
health CHW intervention will have improved oral health behaviors, as measured using 
self-reported brushing frequency and observed plaque score, at 12 months compared to 
participants receiving usual care. 
12.2 
Sample Size Considerations 
Study design: 10 clinics and 10 WICs, cluster randomized allocation to two arms.  
 
Brushing frequency: Brushing frequency is an ordinal variable with three categories: <1 
a day, once a day, 2 or more times a day measured at baseline, 6 months, and 12 
months. The proportion of responses (from the pilot study) in the reference population is 
p0 = (0.16, 0.26, 0.58). We assume cross-time correlation due to repeated observations 
is 0.7, which is a reasonable assumption for behavioral outcomes. We assumed the 
interclass correlation (ICC) due to clustering in sites is 0.01. (Using CO-OP UH2 pilot 
data, the ICC was 0. When 
3 sites were added to these 
data, the ICC was still 0. 
This may simply reflect a 
small sample size. 
Alternatively the ICC due to 
site clustering may be so 
small as to be negligible. 
Therefore, we feel 0.01 is a 
conservative assumption.)  
We also assumed the effect 
size of 2 between arms at 
the study endpoint 
expressed as OR. This 
effect size translates to the 
following proportion of 
frequency of brushing in the 
intervention arm: p1 = (0.09, 
0.18, 0.73).  
The power calculation used Monte Carlo simulation based on 1000 datasets (see below 
for details). We used a proportional odds model in the power simulation. To achieve 
power of 80%, we will need to recruit 21 participants from each cluster (420participants 
total). The sample size calculation controls for multiplicity of having two outcomes 
measures by Bonferroni adjustment (Type 1 error = 0.025). The proposed sample size 
is a conservative estimate as the simulation does not take into account stratification due 
to clinics and WICs. The analysis will control for outcome imbalance between clinics 
and WICs via covariate adjustment and hence increase precision of the estimates.  

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Data Generating Model for Power Simulation 
We followed a mixed-effect ordinal logistic model motivated by an underlying latent 
variable.49 The three-level data structure was defined as follows. We assumed that 
there are 
1,...,
ij
k
n
=
 level-1 units that are nested within 
1,...,
i
j
n
=
 level-2 units that are, 
in turn, nested within 
1,...,
i
n
=
 level-3 units. In the case of our longitudinal cluster-
randomized trial, the level-1 observations are the measurement occasions, level-2 
corresponds to subjects, and level-3 corresponds to sites.  Assuming a logistic 
response function for outcome with 
1...,
c
C
=
 ordered categories, the three-level mixed 
effect model for the cumulative probability of a response is given by 
 
(
)
(
)
1
2
3
log
1
ijkc
c
i
ijk
i
ijk
ij
i
ijkc
P
G
T
GT
P






=
−
+
+
+
+
−
 
To identify the model, we set the intercept to zero and estimated 
1
C − threshold 
parameters. Here, 
(
)
Pr
ijkc
ijk
P
Y
c
=

 is the probability of a response falling within the c 
lower categories. With respect to the random effects, it was assumed that the level-2 
random intercept (i.e., subject-specific intercept) was normally distributed as 
(
)
2
2
~
0,
ij
N


 and the level-3 random intercept (i.e., cluster-specific intercept) was
(
)
2
3
~
0,
i
N


. The random components were assumed to be independent from each 
other. For the fixed effects the parameter 
1
 represents the intervention effect at 
baseline (set up at zero), and the parameter
2
 represents the slope associated with the 
time effect in the control group. Finally, the intervention-by-time parameter, 
3
, the 
effect of primary interest, represents the difference in slopes for the outcome between 
the intervention groups. 
 
Plaque score: Plaque score is described using the Simplified Oral Hygiene Index - 
Maxillary Incisor (OHI-MIS).  Our sample size calculation is based on a statistical 
calculation of power using an effect size = 0.40 for the two arm comparison at the end of 
study. Our estimates of baseline OHI-MIS scores from the pilot study (mean=1.2, 
SD=0.78) suggest this effect size corresponds to a change of 0.31 units between arms. 
In order to detect this "moderate" effect size, with two-sided Type I error α = 0.025 
(Bonferroni correction due to multiplicity) and Power = 0.80, each arm should have 141 
participants, for a total of 282. Calculations employed Rochon's 1998 GEE method, as 
implemented in the SAS GEESIZE v. 3.1 macro implemented by Dahmen, et al.50 We 
assumed 0.7 ICC due to repeated measures. To further account for the clustering effect 
due to site (ICC=0.01), the minimum needed sample size to recruit is 170 per arm or 
340 total.  
 
Both sample calculations assume 15% attrition at each follow-up (6- and 12-months).  

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12.3 
Final Analysis Plan 
The primary study objective is to evaluate the efficacy of a one-year oral health CHW 
intervention, compared to usual care, to improve self-reported brushing frequency and 
observed plaque index in low income urban children under the age of 3 years old. 
Modern best practice for multilevel data is generalized mixed-effect models with random 
parameters to account for repeated measurements and clustering in sites.50-52 For 
frequency of brushing, we will employ a random-effect ordinal regression model. The 
OHI-MIS will be analyzed as continuous outcome using a linear random-effect model. 
(Although each surface is scored ordinally, the Central Limit Theorem says that a mean 
- even of 4 within person measures - in a sample size of at least 25 follows the Normal 
[Gaussian] distribution.53) The model specification that follows pertains to both 
outcomes. The between-subjects factors – usual care or CHW, within-subjects 
occasions of measurement -- time, and their interaction will be in the model. The 
interaction term is the focus of the analysis. We will employ Bonferroni-Holm 
adjustments to control for multiplicity, which is a sequentially rejective procedure that 
provides a more powerful test than the Bonferroni correction.54 For this, the smallest of 
the two outcomes p-value will be compared to 0.025, and if rejected the second p-value 
will be compared to 0.05 to claim significance. Fixed effect indicators for clinic and WIC 
sites as well as all other variables used in restricted randomization will be included in all 
models. Guidance specific to cluster-randomized trials will be followed.55-57 The analysis 
will be carried out under intention-to-treat (ITT) principles, implying that respondents 
who are randomized must be represented in analysis and therefore have missing data 
imputed.58 We anticipate data missing at random (MAR)59,  but will be vigilant for data 
not MAR (NMAR) as well. Imputation methods adapted for cluster-randomized designs 
will also be employed.60-62  
Analysis of the exploratory aim with the hypothesis of no difference between sites will 
extend models described above with a three-way interaction: time by group by site. The 
analysis will follow standard mixed model approaches described in Hedeker & 
Gibbons.63 We will estimate the intervention effect (average change in the outcome) at 
the last follow up conditional on site type. The 95% confidence interval (CI) of site 
difference in the estimated means will be compared to a pre-specified acceptance 
criterion (scientifically justified maximum difference of no clinical significance). If the 
95% CI is contained within the acceptance criteria, the equivalence between sites can 
be declared (based on two one sided tests (TOST) approach).64  
The cost data will first be summed and presented on the system-level (program costs, 
separate for clinic and WIC sites). Cost effectiveness can also be determined by 
combining the mean total cost per participant with change in primary outcomes. We will 
calculate the incremental cost-effectiveness ratio (ICER) for the CHW home intervention 
compared to usual care, such that ICERt = (C1 – C0) / (E1t – E0t), where C is cost and E 
is effectiveness. Subscript 1 denotes CHW home intervention and subscript 0 denotes 
the comparison condition. t denotes the time period: 6 months and 12 months. 95% 
confidence intervals for the ICERs will be calculated to evaluate the uncertainty in these 

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results.65-67 One-way and multi-way sensitivity analyses can be conducted for the key 
parameters to evaluate whether the ICERs are sensitive to plausible changes in their 
values. The sensitivity analysis is a check on the robustness and will determine the key 
parameters impacting the ICERs. 
 
 

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13 SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
Study staff will maintain appropriate medical and research records for this study, in 
compliance with ICH E6, Section 4.9 and regulatory and institutional requirements for 
the protection of confidentiality of subjects.  Study staff will permit authorized 
representatives of NIDCR and regulatory agencies to examine (and when required by 
applicable law, to copy) research records for the purposes of quality assurance reviews, 
audits, and evaluation of the study safety, progress and data validity.   
Source documents include paper and electronic data collection documents and digital 
images. Survey answers will be recorded either in REDCap or on paper case report 
forms (CRFs). Data will be documented either directly into REDCap or on paper CRFs. 
Images will be recorded digitally and then transferred to the UIC secure network servers 
after collection.  
 
 
Three years after the end of the CO-OP Chicago research activity, data will be publicly 
released. Data sets will be stripped of all protected personal health information (PHI) to 
allow sharing of data without compromising participant confidentiality, privacy, and 
safety.  All identification covered under HIPAA will have been removed.  All remaining 
variables not covered under HIPAA will be evaluated in terms of the risk of deductive 
disclosure of identity, and appropriate measures will be taken to protect confidentiality. 
The stripped data will be maintained by the study team, in partnership with the 
community clinical partner. In order to ensure responsible usage of study data, user 
registration will be required to access or download data files.  Registered users will 
receive technical assistance with questions or problems from the Methodology 
Research Core (MRC) at the University of Illinois at Chicago’s Institute for Health 
Research and Policy or from the UCSF CC.  A data sharing agreement will be required 
that will describe the conditions and restrictions of their use; limited data access will be 
made available only to users who successfully complete a rigorous approval process by 
both the investigators and the community partners.  Data sets will be encrypted for 
transfer to approved investigators. 
 
 

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14 QUALITY CONTROL AND QUALITY ASSURANCE 
Refer to the UCSF Coordinating Center (CC) Clinical Data Management Plan for 
additional details on data security and management. CO-OP Chicago will develop a 
Data Validation Plan in partnership with the CC Clinical Research Specialist and Data 
Manager specific to this project. The REDCap database is stored on the UCSF server. 
Access is given to UCSF and UIC staff on an as needed basis, as determined by the 
CC.  
Data will be documented either directly into REDCap or on paper CRFs. Data collected 
on paper CRFs will be assessed for accuracy and completeness by research staff prior 
to data entry. Quality assurance checks will be implemented at the time data are 
entered into REDCap as an assurance of data accuracy for electronic data capture.  
Erroneous and/or inconsistent values will prompt generation of an entry to a query 
report that will be developed for this study.  Query reports will be generated routinely 
and distributed to study staff for resolution.  Once generated, a query will remain part of 
the report until it is resolved. The CC will generate standard and customized reports for 
data monitoring and quality assessment throughout the project. Additional reports can 
be generated if indicated. 
Images will be recorded digitally and then transferred to the UIC secure network servers 
after collection. Images will be reviewed immediately after upload by RAs to ensure 
successful upload and saved using the participant ID number in the image name.   
 
At the time the study database is constructed, the CC and CO-OP Chicago project 
manager will ensure that the electronic data capture system is in compliance with the 
approved NIDCR protocol and is in compliance with source documents. Ongoing 
adherence to the protocol and source documents is achieved by the reports described 
previously and by regular fidelity monitoring of RAs as described in Section 8.1. Source 
documents are described in Section 13. Quality assurance issues will be addressed at 
the site level and in partnership with the CC, depending on the issue. A more detailed 
plan will be developed with the CC before launching the trial.  
 
UCSF CC is preparing a calibration protocol for calibration of assessment of plaque 
images. Other staff training methods are described in Section 8.1. Training of staff will 
be monitored by the CO-OP Chicago project manager.  
 

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15 ETHICS/PROTECTION OF HUMAN SUBJECTS 
15.1 
Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with the 
principles set forth in The Belmont Report: Ethical Principles and Guidelines for the 
Protection of Human Subjects of Research, as drafted by the US National Commission 
for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 
1979) and codified in 45 CFR Part 46 and/or the ICH E6.  
15.2 
Institutional Review Board 
The protocol, informed consent form(s), recruitment materials, and all subject materials 
will be submitted to the IRB for review and approval.  Approval of both the protocol and 
the consent form must be obtained before any subject is enrolled.  Any amendment to 
the protocol will require review and approval by the IRB before the changes are 
implemented in the study.   
15.3 
Informed Consent Process 
Informed consent is a process that is initiated prior to the individual agreeing to 
participate in the study and continues throughout study participation.  Extensive 
discussion of risks and possible benefits of study participation will be provided to 
participants and their families, if applicable. The RA will obtain written informed consent 
and parental permission from the caregiver before the start of the data collection. If the 
caregiver participant is not the legal guardian of the child but is the primary caregiver 
agreeing to participate, separate consent forms will completed by the caregiver 
participant and legal guardian. (An example of this is that sometimes grandmothers do 
the majority of the day-to-day care of a child but the mother is the legal guardian. In this 
instance, we would ask the mother to sign the parental permission informed consent for 
the child and the grandmother to sign the informed consent for herself.) A consent form 
describing in detail the study procedures and risks will be given to the participant.  
Consent forms will be IRB-approved, and the participant is required to read and review 
the document or have the document read to him or her.  The RA will explain the 
research study to the participant and answer any questions that may arise. The 
participant will sign the informed consent document prior to conducting any study-
related assessments or procedures. Participants will be given the opportunity to discuss 
the study with their surrogates or think about it prior to agreeing to participate. They may 
withdraw consent at any time throughout the course of the study. A copy of the informed 
consent document will be given to participants for their records. The rights and welfare 
of the participants will be protected by emphasizing to them that the quality of their 
clinical care will not be adversely affected if they decline to participate in this study. 
The consent process will be documented in the clinical or research record.  

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All research staff, investigators, and clinical staff with access to data will undergo HIPAA 
and human subjects research training.  Training is provided at the University of Illinois at 
Chicago through the Citi Program (www.citiprogram.org). 
 
Consents for screening will be verbal, and written consent documents will be provided 
and signed when participants are enrolled in the trial. Note that assent is not used 
because all children will be under the age of 3 years old. 
 
15.4 
Exclusion of Women, Minorities, and Children (Special Populations) 
This study conforms to NIH policies on the inclusion of women and minorities. Based on 
results from the CO-OP Chicago pilot phase and formative work, we anticipate 95% of 
caregivers will be female. The children will be approximately 50/50 male/female. We 
expect approximately 60% of families will be Hispanic ethnicity and approximately 40% 
will be African-American.  This study includes children and conforms with NIH policy 
(Subpart D – Additional Protections for Children Involved as Subjects in Research, 45 
CFR Part 46.401-46.409.) 
15.5 
Subject Confidentiality 
Participant confidentiality is strictly held in trust by the investigators, study staff, and the 
sponsor(s) and their agents.  This confidentiality applies to any study information 
relating to participants. 
The study protocol, documentation, data, and all other information generated will be 
held in strict confidence.  No information concerning the study or the data will be 
released to any unauthorized third party without prior written approval of the sponsor. 
The study monitor or other authorized representatives of the sponsor may inspect all 
study documents and records required to be maintained by the investigator, including 
but not limited to, medical records (office, clinic, or hospital) for the study participants.  
The clinical study site will permit access to such records.   
All data and images will be kept confidential, and no subject will be identifiable from 
research records or published data. We will employ procedures used in other studies to 
maintain confidentiality of data. All case report forms (CRFs) will be coded with ID 
numbers only. Participant contact information will be stored separately from data files, 
and access to this information will be limited to the PI and research staff. The master list 
of ID code numbers and corresponding names will be kept in a locked file cabinet or in a 
password protected file on an internal server, with close scrutiny of access maintained 
by the PI. The master list is used only to coordinate data collection. Compliance with 
IRB and NIH regulations concerning data storage and destruction will be strictly 
observed. It is anticipated that research specialists, the database manager, and the 
project manager will have access to identifiable data. 

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15.6 
Future Use of Stored Specimens and Other Identifiable Data 
Not applicable. 
 

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16 DATA HANDLING AND RECORD KEEPING 
The investigators are responsible for ensuring the accuracy, completeness, legibility, 
and timeliness of the data reported.  All source documents should be completed in a 
neat, legible manner to ensure accurate interpretation of data.  The investigators will 
maintain adequate case histories of study participants, including accurate CRFs and 
other source documentation.   
16.1 
Data Management Responsibilities 
Data collection and accurate documentation are the responsibility of the study staff 
under the supervision of the investigator.  All source documents must be reviewed by 
the study team and data entry staff, who will ensure that they are accurate and 
complete.  Unanticipated problems and adverse events must be reviewed by the 
investigator or designee.   
16.2 
Data Capture Methods 
Data will be collected by research staff who will receive training on survey techniques 
and documenting data as well as tooth brushing technique and plaque index scoring.  
The data will be entered directly into REDCap or documented initially on CRFs and then 
entered into REDCap.  
Images will be collected for quality assessments and data collection. Images will be 
recorded using a mobile recording device and then will be uploaded to the secure UIC 
server as soon as a Wi-Fi connection is established. The goal is to upload these 
immediate after the completion of the home visit. Images will then be deleted from the 
mobile recording device after the quality check has been completed.  
CRFs will be transported to UIC and stored in locked file cabinets in a building that is 
accessible only with security identification. 
16.3 
Types of Data 
The types of data include: 
- 
Electronic data files on REDCap 
- 
Images 
- 
Paper CRFs 
- 
Safety data (unanticipated problems) 
16.4 
Schedule and Content of Reports 
Reports on recruitment and implementation for the study will be provided to the study 
team and NIDCR monthly. Data analysis and review will occur once data collection is 
complete.  

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16.5 
Study Records Retention 
Study records will be maintained for at least three years from the date that the grant 
final federal financial report (FFR) is submitted to the NIH.   
16.6 
Protocol Deviations 
A protocol deviation is any noncompliance with the clinical study protocol or Good 
Clinical Practice requirements.  The noncompliance may be on the part of the subject, 
the investigator, or study staff.  As a result of deviations, corrective actions may to be 
developed by the study staff and implemented promptly. 
These practices are consistent with investigator and sponsor obligations in ICH E6: 
• Compliance with Protocol, Sections 4.5.1, 4.5.2, 4.5.3, and 4.5.4. 
• Quality Assurance and Quality Control, Section 5.1.1 
• Noncompliance, Sections 5.20.1 and 5.20.2. 
All deviations from the protocol must be addressed in study subject source documents 
and reported to NIDCR and the local IRB, according to their requirements.   
 
 
 

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17 PUBLICATION/DATA SHARING POLICY 
This study will comply with the NIH Public Access Policy, which ensures that the public 
has access to the published results of NIH funded research. It requires scientists to 
submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital 
archive PubMed Central upon acceptance for publication. 
Data from this study will be shared in accordance with the NIH Data Sharing Policy. 
https://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm.  
The National Institutes of Health (NIH) has issued a policy to promote broad and 
responsible dissemination of information from NIH-funded clinical trials through 
ClinicalTrials.gov. The policy establishes the expectation that all investigators 
conducting clinical trials funded in whole or in part by the NIH will ensure that these 
trials are registered at ClinicalTrials.gov, and that results information of these trials is 
submitted to ClinicalTrials.gov. Please see 
https://www.federalregister.gov/documents/2016/09/21/22379/nih-policy-on-the-
dissemination-of-nih-funded-clinical-trial.information.  
 

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66. Tambour M, Zethraeus N. Bootstrap confidence intervals for cost effectiveness 
rations: Some simulation results. Health Economics. 1998;7:143-147.  
67. Briggs AH, Wonderling DE, Mooney CZ. Pulling cost-effectiveness analysis up by its 
bootstraps: A nonparametric approach to confidence interval estimation. Health 
Economics. 1997;6:327-340. 
 

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SUPPLEMENTAL MATERIALS 
 
 

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APPENDICES 
 
Appendix A: Schedule of Events  
Appendix B: Survey Question Sources and Citations  
Appendix C: Plaque Protocol 
Appendix D: Contact Attempt and Window Protocol 
Appendix E: CHW Action Plan 
Appendix F: Caries Risk Assessment 
Appendix G: Core Curriculum Delivery Guide 
Appendix H: CHW Encounter Tracking Form 
 Appendix I: CHW Fidelity Assessment Form 
Appendix J: Trial Consent Form English  
 

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APPENDIX A: SCHEDULE OF EVENTS 
Schedule of Events 
Procedures and 
Intervention 
Screening  
(prior to baseline) 
Enrollment/ Baseline  
Data Collection 
(prior to randomization) 
Randomization (Day 0) 
Intervention Visit 1 
(Day 30, -23, +149) 
Intervention Visit 2 
(Day 90, -76, +89) 
6-month Data Collection 
(Day 180, -14, +60) 
Intervention Visit 3 
(Day 240, -59, +124) 
Intervention Visit 4 
(Day 300, -199, +64) 
Final Data Collection/ 
Study Completion 
(Day 365, -0, +90) 
Premature 
Discontinuation* 
Verbal Consent Form 
X 
 
 
 
 
 
 
 
 
 
Signed Consent Form 
 
X 
 
 
 
 
 
 
 
 
Assessment of Eligibility 
Criteria 
X 
X 
 
 
 
 
 
 
 
 
Self-report questionnaire: 
demographics, beliefs, 
behaviors, risk factors 
 
X 
 
 
 
X 
 
 
X 
 
Review of Medical/Dental 
History 
 
X 
 
 
 
X 
 
 
X 
 
Review of Concomitant 
Medications  
 
X 
 
 
 
X 
 
 
X 
 
Plaque assessment 
(disclosing solution and 
image collection) 
 
X 
 
 
 
X 
 
 
X 
 
Tooth brushing observation 
(home only) 
 
X 
 
 
 
X 
 
 
X 
 
Physical 
Exam-
ination 
Number of 
teeth 
X 
X 
 
 
 
 
 
 
 
 
Weight 
 
X 
 
 
 
X 
 
 
X 
 
Study Intervention 
 
 
 
X 
X 
 
X 
X 
 
 
Assessment of Adverse 
Events 
 
X 
 
 
 
X 
 
 
X 
 
*Premature discontinuation is not applicable. Participants that withdraw/are withdrawn will have no further 
data collection or intervention. 
 
 
 

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APPENDIX B: STUDY INSTRUMENTS AND SOURCES 
 
Question 
number 
Question 
Type of 
Variable 
Domain 
Purpose 
Source 
Collection 
method 
A2 
Child frequency of 
brushing 
Primary 
Brushing 
behavior 
Determine 
behavior 
EC4/BRFQ 
Self-report 
A1 
Child age started 
brushing 
Secondary 
Brushing 
behavior 
Determine 
behavior 
NHANES 
Self-report 
A5 
Child age started 
using toothpaste 
Secondary 
Brushing 
behavior 
Determine 
behavior 
NHANES 
Self-report 
A3 
Caregiver 
assistance with 
brushing 
Secondary 
Brushing 
behavior 
Determine 
behavior 
EC4/BRFQ 
Self-report 
A6-A7 
Child type of 
toothpaste 
Secondary 
Brushing 
behavior 
Determine 
behavior 
CO-OP pilot 
Self-report 
A4 
Child duration of 
brushing 
Secondary 
Brushing 
behavior 
Determine 
behavior 
CO-OP pilot 
Self-report 
A8 
Child amount of 
toothpaste 
Secondary 
Brushing 
behavior 
Determine 
behavior 
NHANES 
Self-report 
A9a-o 
Caregiver self-
efficacy 
Covariate 
Self-efficacy 
Predict/explain 
behavior 
EC4/BRFQ 
Self-report 
A10-A15 
Child oral health 
quality of life 
Covariate 
Quality of life 
Assess if 
associated with 
child behaviors 
ECOHIS 
Self-report 
A16a-j 
Caregiver oral 
health quality of life 
Covariate 
Quality of life 
Assess if 
associated with 
child behaviors 
Oral Health 
Impact Profile 
Self-report 
A17 
Caregiver sources 
of support for 
brushing 
Covariate 
Brushing risk 
factor 
Identify caregiver 
supports 
CO-OP pilot 
Self-report 
A18 
Caregiver barriers 
to brushing 
Covariate 
Brushing risk 
factor 
Identify barriers 
CO-OP pilot 
Self-report 
A19 
Child type of 
drinking water 
Covariate 
Oral health 
behavior 
Identify sources of 
fluoride 
EC4/BRFQ 
Self-report 
A20-A21 
 
Child dental care 
utilization 
Covariate 
Oral health 
behavior 
Determine rate, 
identify source of 
education and 
service receipt 
NHANES 
Self-report 
A22 
Last time child had 
teeth professionally 
cleaned 
Covariate 
Oral health 
behavior 
Interpret plaque 
score 
Modified from 
BRFSS 
Self-report 
A23-A24 
Child barriers to 
dental care 
Covariate 
Oral health 
behavior 
Identify barriers 
NHANES 
Self-report 
A25-A26 
Sugar sweetened 
beverages 
Covariate 
Oral health 
behavior 
Identify risk 
factors 
EC4/BRFQ 
Self-report 
A27-A28 
Child type of 
cup/bottle 
Covariate 
Oral health 
behavior 
Identify risk 
factors 
EC4/BRFQ 
Self-report 
A29 
Child cup/bottle at 
night 
Covariate 
Oral health 
behavior 
Identify risk 
factors 
EC4/BRFQ 
Self-report 

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A30 
Child caries history 
Covariate 
Oral health risk 
factor 
Determine caries 
rate 
CO-OP pilot 
Self-report 
A31 
Child history of 
general anesthesia 
for dental 
Covariate 
Oral health risk 
factor 
Assess risk for 
severe caries 
CO-OP pilot 
Self-report 
A32 
Sibling history of 
general anesthesia 
for dental 
Covariate 
Oral health risk 
factor 
Assess risk for 
severe caries 
CO-OP pilot 
Self-report 
A33a-e 
Caregiver 
knowledge and 
attitudes on oral 
health 
Covariate 
Oral health 
beliefs 
Assess if 
associated with 
child behaviors 
EC4/BRFQ 
Self-report 
A34 
Caregiver general 
oral health 
assessment 
Covariate 
Oral health risk 
factor 
Assess if 
associated with 
child behaviors 
NHIS 
Self-report 
A35 
Caregiver brushing 
frequency 
Covariate 
Oral health risk 
factor 
Assess if 
associated with 
child behaviors 
EC4/BRFQ 
Self-report 
A36 
Caregiver dental 
care utilization 
Covariate 
Oral health risk 
factor 
Assess if 
associated with 
child behaviors 
NHANES 
Self-report 
A37 
Caregiver reason 
for last dental visit 
Covariate 
Oral health risk 
factor 
Assess if 
associated with 
child behaviors 
NHANES 
Self-report 
A38-A39 
Caregiver barriers 
to dental care 
Covariate 
Oral health risk 
factor 
Assess if 
associated with 
child behaviors 
NHANES 
Self-report 
B1-B7 
Child plaque: Oral 
Hygiene Index – 
Maxillary Incisor 
Simplified 
Primary 
Brushing 
behavior 
Determine 
behavior 
CO-OP and 
UCSF pilots 
Observed 
C1 
Caregiver 
assistance with 
brushing 
Secondary 
Brushing 
behavior 
Determine 
behavior 
CO-OP pilot 
Observed 
C2 
Type of toothpaste 
Secondary 
Brushing 
behavior 
Determine 
behavior 
CO-OP pilot 
Observed 
C3a-b 
Duration of 
brushing, entire 
activity and actual 
brushing 
Secondary 
Brushing 
behavior 
Determine 
behavior 
CO-OP pilot 
Observed 
C4 
Amount of 
toothpaste 
Secondary 
Brushing 
behavior 
Determine 
behavior 
CO-OP pilot 
Observed 
C5-C6 
Mouth rinsed 
Secondary 
Brushing 
behavior 
Determine 
behavior 
CO-OP pilot 
Observed 
C7 
Type of toothbrush 
Secondary 
Brushing 
behavior 
Determine 
behavior 
CO-OP pilot 
Observed 
C8a-l 
Parenting during 
brushing 
Covariate 
Oral health risk 
factor 
Assess if 
associated with 
child behaviors 
Toothbrushing 
Observation 
System scale 
Observed 
D1-D26 
Demographics 
Covariate 
Demographics 
Describe 
participants 
multiple 
Self-report 

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D27 
Weight  
Covariate 
Medical risk 
factor 
Identify risk 
factors 
CO-OP pilot 
Measurement 
D28a-e 
Child medical 
history and 
medications 
Covariate 
Medical risk 
factor 
Identify risk 
factors 
Clinical 
practice 
Self-report 
D29 
Caregiver general 
health 
Covariate 
Psychosocial 
risk factor 
Identify risk 
factors 
NHIS 
Self-report 
E1-E3 
Caregiver 
psychological 
functioning 
Covariate 
Psychosocial 
risk factor 
Identify risk 
factors 
PROMIS 
anxiety, 
depression, 
functioning 
Self-report 
E4-E6 
Caregiver social 
support 
Covariate 
Psychosocial 
risk factor 
Identify risk 
factors 
PROMIS 
Social 
Support 
Survey 
Self-report 
E7-12 
Family functioning 
Covariate 
Psychosocial 
risk factor 
Identify risk 
factors 
CHAOS scale 
Self-report 
 
CHW intervention 
delivery costs 
Secondary 
Cost 
Assess cost 
effectiveness 
Mileage logs, 
phone logs, 
expense 
reports 
Mileage logs, 
phone logs, 
expense 
reports 
 
CHAOS 
The CHAOS scale was originally developed as a 15-item instrument that could be answered only as yes/no. (1) 
Matheny A, Wachs T, Ludwig J, Phillips K. Bringing order out of chaos: psychometric characteristics of Confusion, 
Hubbub and Order Scale. J Appl Dev Psychol. 1995;16:429-444. (2) Haach LM, Gerdes AC, Schneider BW, Hurtado 
GD. Advancing our knowledge of ADHD in Latino children: Psychometric and cultural properties of Spanish-versions 
of parental/family functioning measures. J Abnorm Child Psychol. 2011;39.1:33-43.  
 
A subsequent study has used a modified 6-item version that allows a range of responses. (1) Coldwell J, Pike A, 
Dunn J. Household chaos--links with parenting and child behaviour. J Child Psychol Psychiatry. 2006 
Nov;47(11):1116-22. (2) Deater-Deckard K, Mullineaux P, Beckman C, Petrill S, Schatschneider C, Thompson L. 
Conduct problems, IQ, and household chaos: a longitudinal multi-informant study. J Child Psychol Psychiatry. 
2009;50(10):1301-1308.  Both versions have been used in Chicago populations of caregivers; the 6-item scale is 
easier for families to understand and answer. Therefore that is what the study will use. 
 
 
CO-OP Pilot  
These questions were developed by the CO-OP Steering Committee with input from NIDCR Project Scientists and 
the Data Coordinating Center. All questions were tested in the pilot phase of the project. 
 
Demographics 
Gender, age, insurance, relationship, education level: Developed by CO-OP, tailored to our population and survey 
needs. 
Employment: From EC4, original source Cancer Biomedical Informatics Grid (caBIG) 2003074(4). 
Ethnicity: 2010 US Census. https://www.census.gov/schools/pdf/2010form_info.pdf  
Time in the US, race, caregiver relationship status, people in the home: From previous Chicago studies in Hispanic, 
mixed-race populations. Martin MA, Mosnaim GS, Olson D, Swider S, Karavolos K, Rothschild S. Results from a 
community-based trial testing a community health worker asthma intervention in Puerto Rican youth in Chicago. J 
Asthma. 2015 Feb;52(1):59-70. 

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EC4/BRFQ 
Items addressing oral health behavior were developed by the Knowledge and Behavior Workgroup of the EC4, which 
included faculty from each of the three Collaborating Centers:  Judith Albino (UCD), Angela Brega (UCD), Kristin 
Hoeft (UCSF), Clemencia Vargas (BU), and Peggy Walsh (UCSF).  Initial steps in item development involved 
identifying existing items.  Items were then heavily adapted or newly developed to address the 12 key counseling 
messages expected to be communicated across all projects. The cross-center Behavioral Intervention Workgroup 
identified the key counseling messages, which then served to guide development of survey items related to 
knowledge and behavior. Members of the Behavioral Intervention Workgroup included the following:  Belinda Borrelli 
(BU), Tracy Finlayson (UCSF), Karen Fehringer (UCD), Barbara Heckman (UCSF), Michelle Henshaw (BU), Carol 
Kaufman (UCD), Nancy Kressin (BU), Ruth Nowjack-Raymer (NIDCR), Melissa Riddle (NIDCR), Paul Spicer (UCD), 
and Peggy Walsh (UCSF).  
Citation:  (1) Wilson A, Brega AG, Batliner TS, Henderson W, Campagna E, Fehringer K, Gallegos J, Daniels D, 
Albino J.  Assessment of parental oral health knowledge and behaviors among American Indians of a Northern Plains 
tribe.  Journal of Public Health Dentistry.  J Public Health Dent. 2014 Spring;74(2):159-67. (2) Albino J, Tiwari T, 
Gansky SA, Henshaw MM, Barker JC, Brega AG, Gregorich SE, Heaton B, Batliner TS, Borrelli B, Geltman P, 
Kressin NR, Weintraub JA, Finlayson TL, Garcia RI, and the Early Childhood Caries Collaborating Centers. The 
basic research factors questionnaire for studying early childhood caries. Manuscript under review. 
 
NHANES 
For amount of toothpaste self-report, the caregiver will also be shown a picture demonstrating the response options; 
this modification originated from the NIDCR Project Scientists and the Data Coordinating Center. 
Citation: Centers for Disease Control and Prevention (CDC). National Center for Health Statistics (NCHS). National 
Health and Nutrition Examination Survey Questionnaire (or Examination Protocol, or Laboratory Protocol). 
Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, [2013-
2014][www.cdc.gov/nchs/nhanes]. 
 
NHIS 
Citation: Centers for Disease Control and Prevention (CDC). National Center for Health Statistics (NCHS). National 
Health Interview Survey (NHIS). Hyattsville, MD: U.S. Department of Health and Human Services, Centers for 
Disease Control and Prevention, 2008. [www.cdc.gov/nchs/nhis] 
 
Oral Health Impact Scale 
Citations: (1) Slade GD, Nuttall N, Sanders AE, Steele JG, Allen PF, Lahti S. Impacts of oral disorders in the United 
Kingdom and Australia. Br Dent J. 2005 Apr 23;198(8):489-93. (2) Slade GD. Derivation and validation of a short-
form oral health impact profile. Community Dentistry & Oral Epidemiology 1997; 25:284-90. (3) Slade GD, Spencer 
AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health,1994;11:3–11. 
 
Oral Hygiene Index – Maxillary Incisor Simplified 
This instrument was modified from the Simplified Oral Health Index (Greene JC, Vermillion JR. The simplified oral 
hygiene index. J Amer Dent Assoc 1964; 68: 7-13.) and pilot tested by CO-OP Chicago and UCSF during the pilot 
phase of the project.  
 
ECOHIS 
Citation: Pahel BT, Rozier RG, Slade GD. Parental perception of children’s oral health: The Early Childhood Oral 
Health Impact Scale (ECOHIS). Health and Quality of Life Outcomes 2007;5:6-17. 
 
PROMIS Instruments 
Citations:  

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− 
Patient-Reported Outcomes Measurement Information System. Available at 
http://www.nihpromis.org/measures/translations. Accessed 9/24/14, 
− 
Patient-Reported Outcomes Measurement Information System. Available at 
http://www.assessmentcenter.net/documents/PROMIS%20Scoring%20Manual-
%20CATs,%20Profiles,%20Short%20Forms.pdf. Accessed 5/8/14. 
− 
Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for 
measuring emotional distress from the Patient-Reported Outcomes Measurement Information System 
(PROMIS®): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. 
− 
Hahn EA, Dewalt DA, Bode RK, Garcia SF, Devellis RF, Correia H, Cella D. New English and Spanish social 
health measures will facilitate evaluating health determinants. Health Psychology. 2014;epub ahead of print. 
 
Toothbrushing Observation System 
We used the parent items (12) from the Toothbrushing Observation System.  
Citation: Collett BR, Huebner CE, Seminario AL, Wallace E, Gray KE, Speltz ML. Observed child and parent 
toothbrushing behaviors and child oral health. Int J Paediatr Dent. 2016 May;26(3):184-92. 
 
 
 

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APPENDIX C: PLAQUE PROTOCOL 
 
CO-OP Chicago Plaque Protocol 
 
This protocol was developed jointly between the CO-OP Chicago and UCSF 
investigators. The UCSF Coordinating Center is developing a calibration protocol 
for this measure for the Oral Health Disparities in Children Consortium (OHDC). 
 
Background 
 
Dental plaque is a biofilm that contains varying levels of cariogenic bacteria based on inherent 
microbiota and plaque age. The accumulation of dental plaque has been widely described in the 
literature as a significant risk factor for caries. Dental plaque on primary incisors is strongly 
predictive of future caries.1 Most preventive behaviors emphasize removal of dental plaque to 
disrupt the cariogenic microbiota in the oral environment.  
 
Many plaque scoring systems have been described in the literature, but none are specific to 
pediatric patients.2 Plaque systems explored for this study include the Oral Hygiene Index, 
Silness-Löe Index, Simplified Oral Hygiene Index (OHI-S) and the Quigley-Hein Index with 
Turesky Modification.3 Due to age, cooperation potential, and the eruption status of primary 
teeth, traditional scoring systems which include permanent teeth are not applicable to the 0 to 3-
year-old population and require modifications before epidemiologic use.  
 
Simplified Oral Hygiene Index – Maxillary Incisor Scale (OHI-MIS) 
 
The Simplified Oral Hygiene Index (OHI-S)4 will be modified for use in young children with 
primary teeth, to assess the status of current oral hygiene, based on the amount of debris 
(plaque) present. The original Oral Hygiene Index (1960) scored 12 tooth surfaces with two 
components, a debris index and calculus index, to create a numerical determination of the 
overall oral hygiene. The Simplified index uses the same criteria to assign scores of 6 tooth 
surfaces (labial) instead of 12.4  
 
Because this index is meant for adults, the OHDC modification of the OHI-S for young children 
scores 4 buccal (facial) tooth surfaces of the primary maxillary incisors, (d, e, f, and g also 
known as 52, 51, 61, 62 in the international tooth numbering system), denoted OHI-MIS.  The 
OHI-MIS score will be determined after using plaque disclosing liquid which tints the plaque red 
making it visible.  Then an extra-oral photographic image of the buccal (facial) surfaces will be 
taken to allow asynchronous scoring. 
 
The criteria for classifying each surface for OHI-MIS will be the same as OHI-S. 
Scores 
Criteria 
0 
No debris or stain present 
1  
Soft debris covering not more than one-third of the tooth surface, or presence of 
extrinsic stains without other debris regardless of surface area covered 
2 
Soft debris covering more than one-third, but not more than two-thirds, of the 
exposed tooth surface 
3 
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At least two of the four possible surfaces must be examined for an individual score to be 
calculated. Partially erupted teeth should not be scored. The OHI-MIS debris index = (buccal 
(facial) incisor scores d+e+f+g) / (Total number of examined surfaces). With this 
calculation, the score will range from 0 (best) to 3 (worst). To evaluate such systems for clinical 
relevance, Wei & Lang suggest “oral cleanliness is considered: ’good’ if the score is between 
0.3-0.6; ’fair’ when it is 0.7-1.8; or ’poor’ when the score is between 1.9-3.0.”4 
 
Procedures 
 
Depending on the age and cooperation of the child, subjects will be reclined in a knee-to-knee 
position or seated upright. A research assistant will apply two drops of plaque disclosing 
solution to maxillary incisors with a disposable micro applicator brush with care not to disrupt the 
plaque biofilm. Plaque disclosing solution will be used per manufacturer's instructions. The 
specific product for use in this study is 2Tone (Young Dental). Instructions for use can be found 
on the following site: http://www.youngdental.com/product/2tone-disclosing-solution/#  If 
needed, the child’s mouth will be held open with a mouth prop. 
 
The second research assistant will have a portable overhead light and a mobile phone camera 
(iPhone 7). After completing the disclosing steps and waiting approximately 15 seconds, the 
second research assistant will take a series of photographs of the teeth at a distance of 
approximately 18” above the subject. The second research assistant will verify appropriate 
capture of images. If images do not clearly capture all maxillary incisors with sufficient clarity 
and light, the images will be repeated. 
 
References 
 
1. Alaluusua S, Malmivirta R. Early plaque accumulation—a sign for caries risk in young 
children. Community dentistry and oral epidemiology. 1994; 22.5PT1: 273-276. 
2. Wei SH, Lang NP. Periodontal epidemiological indices for children and adolescents: II. 
Evaluation of oral hygiene; III. Clinical applications. Pediatric dentistry. 1981;3(4):353-60. 
3. Greene JC, Vermillion JR. The oral hygiene index: a method for classifying oral hygiene 
status. Journal of the American Dental Association. 1960; 61: 29-35.  
4. Greene, JG, Vermillion JR. The simplified oral hygiene index. Journal of the American 
Dental Association. 1964; 68.1: 7-13. 
 
 

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APPENDIX D: CONTACT ATTEMPT AND WINDOW PROTOCOL 
 
CO-OP Chicago 
 
CONTACT ATTEMPT AND WINDOW PROTOCOL 
 
Research Specialist: Data Collection 
 
Windows 
Type of Visit 
Earliest start 
Latest acceptable 
Baseline 
NA 
NA 
6-month 
14 days before 
60 days after 
12-month 
Date due 
90 days after 
Clock starts when randomized. 
12-month due date does not change regardless of when 6-month data collection visit 
completed. 
 
Attempts 
- 
For main outcomes visit: 12-month 
o These are primary outcomes, need to try to get at all costs. 
o Contact every 2-4 days at varying times of day and varying types of mediums for 
first 2 weeks. Consider then reducing frequency of attempts but do not give up until 
window closed. 
o If phone not working, or no answer after 5 attempts, stop by home up to 2 times. If 
can talk with family, great. If not, then drop off letter. 
o If cannot drop off letter or no response to dropped off letter after 1 week, send 
certified letter.  
o If no response to anything, at minimum try to call once a week until window closed. 
o If ultimately family cannot do in person, do via telephone if feasible for family. 
o If phone not working/no answer, attempt to verify address and phone number at the 
subject’s clinic/WIC.  
o If no answer from all phone numbers and letters, attempt to see if any scheduled 
appointments at subject’s clinic/WIC. If yes, try to be at that appointment to talk with 
family before/after.  
o Track for each attempt 
▪ 
Date 
▪ 
Day of week 
▪ 
Time of day 
▪ 
Medium (phone call, text, email, letter, stopped at home) and 
number/address used 
▪ 
Comment section (note if family answered but can’t talk now, family stood 
you up, talked with other family member and told to call back, etc) 
- 
For 6-month 
o Same as 12-month but shorter window.  
 
 
 

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CHWs 
 
Windows 
4 visits over 12 months, preferred in person at home or other location face-to-face. Goal is 2 
visits in first 6 months, 2 visits in second 6 months. Follow-up phone calls should be conducted 
after visits (total of 4). 
- 
Additional contacts acceptable but not encouraged. 
- 
CHW can call family to schedule as soon as randomization completed.  
- 
Goal is one visit every 2-3 months 
- 
No more than 2 in-person visits before the six month mark; no more than 2 in-person visits 
after the six month mark 
- 
In-person visits cannot be closer than 30 days. 
 
Attempts 
- 
Contact every 2-4 days at varying times of day and varying types of mediums for first 2 
weeks. Consider then reducing frequency of attempts to weekly for 4 weeks, then monthly. 
- 
If phone not working, or no answer after 5 attempts, stop by home up to 2 times. If can talk 
with family, great. If not, then drop off letter. 
- 
If phone not working/no answer, can verify address and phone number in subject’s 
clinic/WIC.  
- 
If no answer from all phone numbers and letters, look if any scheduled appointments at the 
clinic/WIC. If yes, try to be at that appointment to talk with family before/after.  
- 
If no answer from all phone numbers and letters and has an identified provider, talk to 
providers and/or staff at the clinic/WIC to see if they know better way to contact the subject. 
Ask them to help in process.  
- 
Send certified letter 
- 
Track for each attempt 
▪ 
Date 
▪ 
Day of week 
▪ 
Time of day 
▪ 
Medium (phone call, text, email, letter, stopped at home) and 
number/address used 
▪ 
Comment section (note if family answered by can’t talk now, family stood you 
up, talked with other family member and told to call back, etc) 
 
 
 

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APPENDIX E: CHW ACTION PLAN 
 
 
 
ACTION PLAN /  PLAN DE ACCIÓN 
 
Date: 
Fecha: 
 
In the next ____________, we are going to:  what 
En las próximas ____________, vamos a:  
_____________________________________________________________________________________
___________________________________________________________________________________ 
 
We will do this:  when  
Vamos a hacerlo: cuando 
_____________________________________________________________________________________
___________________________________________________________________________________ 
 
The following things may get in the way of our plan: 
Es posible que las siguientes cosas puedan interferir en nuestro plan: 
_____________________________________________________________________________________
___________________________________________________________________________________ 
 
We will try to get past these barriers by: 
Vamos a tratar de superar estos obstáculos: 
_____________________________________________________________________________________
___________________________________________________________________________________ 
 
Level of confidence/Nivel de seguridad: 
 
1            2            3            4            5            6            7            8            9            10 
Not very sure 
 
 
 
 
 
 
 
 
Very sure 
No estamos seguros 
 
 
 
 
 
         Estamos muy seguros  
 
 
 
 
 
 
 
 
 
 
Signature of participant  
 
                         Signature of CHW 
 Firma de participante    
                                      Firma de promotora/e 
 
 

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APPENDIX F: CARIES RISK ASSESSMENT 
 
Caries Risk Assessment 
American Academy of Pediatric Dentistry. Guideline on caries-risk assessment and management for 
infants, children, and adolescents. Pediatric Dentistry. 2013 Sep-Oct;35(5):E157-64. 
 
Complete for each person present if family agrees. 
 
Children ages 0-5 years old 
 
Date: 
CHW: 
Child ID number (or initials and age if not index child):  
 
 
High 
Risk 
Low 
Risk 
Biological 
 
 
Mother/primary caregiver has active caries 
Yes 
 
Family is low income 
Yes 
 
Child has more than 3 between meal snacks or beverages that 
contain sugar per day 
Yes 
 
Child is put to bed with a bottle containing natural or added sugar 
Yes 
 
Child has special healthcare needs 
Yes 
 
Child is a recent immigrant 
Yes 
 
Protective 
 
 
Child receives fluoridated drinking water or fluoride supplements 
 
Yes 
Child has teeth brushed daily with fluoride toothpaste 
 
Yes 
Child receives topical fluoride from health professional 
 
Yes 
Child has dental home/regular dental care 
 
Yes 
Clinical Findings* 
 
 
Child has white spot lesions or enamel defects 
Yes 
 
Child has visible cavities or fillings 
Yes 
 
Child has plaque on teeth 
Yes 
 
* CHWs should only do what they feel comfortable with and what family is comfortable with, can 
skip this section 
 
 

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APPENDIX G: CORE CURRICULUM DELIVERY GUIDE 
 
 
CO-OP CHICAGO CHW HOME VISIT 
Core Curriculum Delivery Guide 
 
 
 
 
FIRST VISIT 
 
Goals:  
- 
Get to know the family 
- 
Find out what they want to get out of the project or work on first 
- 
Make a plan for the next 3 visits 
- 
Begin or complete one core curriculum module 
 
What to bring: 
- 
CHW Training Manual (with ppt slides) 
- 
Caries Risk Assessment forms 
- 
Action plans 
- 
Laptop/tablet with hotspot 
 
1. Introduce yourself and tell a little about yourself. 
2. Ask about them: general and then why they joined program 
a. What do they want to work on the most in the next year? 
b. What are the biggest oral health concerns they have? 
3. Caries Risk Assessment for all family members participating 
a. Discuss scores 
4. Get an idea about what they know, where they are at 
a. Oral health basics module  
5. Make a plan for the next several visits about what content areas you will cover.   
a. Talk about what we have to offer 
b. Match what they are interested in with the content areas 
c. Outline plan for next 3 visits 
6. Introduce action plans 
a. What they are, how they work, why we do them 
b. What does family want to change before next visit? 
c. Help family make action plan 
d. Give copy to participant 
7. Plan for next visit  
a. Work with family to decide on a time for next visit 
 
 
 
 
 

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SUBSEQUENT HOME VISIT PROTOCOL   
 
1. Greetings – 5 minutes 
2. Review action plan – 10 minutes 
a. Discuss if action plan achieved.  If yes, how.  If no, why not and speculate on 
ways to achieve the plan in the future. 
b. Discuss belief in ability to change behaviors 
3. Core Curriculum – 30 minutes 
4. Action plan – 10 minutes 
a. What does family want to change? 
b. Help family make action plan 
5. Plan for next visit – 5 minutes 
a. Work with family to decide on a time for next visit 
 
 
TELEPHONE FOLLOW-UP VISITS 
 
1. Greetings – 1 minute 
2. Ask if any questions since last visit, discuss – up to 15 minutes 
3. Review action plan, revise if needed – up to 10 minutes 
4. Remind about next visit, confirm date, time, place – up to 5 minutes 
 
 
 
 

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Content Areas 
 
 
 
 
 
 
 
 
 
 
Materials list 
• 
CHW Training Manual (with ppt slides) 
• 
A Pediatric Guide to Children’s Oral Health Flip Chart and Reference Guide 
• 
NIDCR one-pager “A Healthy Mouth For Your Baby” 
• 
Mouth with teeth Model 
• 
Toothbrushes 
• 
Floss 
• 
Toothpaste 
• 
Sippy cups 
• 
Dental referral list 
• 
Laptop/tablet with hotspot 
• 
Business cards 
• 
Project info and contact sheet 
• 
Optional: food and drink containers 
 
 
 
Depending on the content area, use the following pages as a guide. 
 
 
Core Curriculum 
1. Oral health basics 
2. Tooth brushing 
3. Fluoride 
4. Weaning 
5. Nutrition 
6. Seeing the dentist 

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Oral Health Basics 
 
i. Goals:  
1. To define dental caries 
2. To describe causes of caries. 
3. To discuss importance of caries prevention. 
 
ii. What you need: 
1. CHW Training Manual (with ppt slides) 
2. A Pediatric Guide to Children’s Oral Health Flip Chart and Reference 
Guide 
3. Mouth with teeth model  
4. Handout: NIDCR one pager “A Healthy Mouth For Your Baby”  
 
 
A. Topic areas 
a. Present normal infant tooth development: “A Pediatric Guide to Children’s Oral Health 
Flip Chart and Reference Guide” pages 2-3, mouth with teeth model 
b. If family interested, can present normal tooth anatomy: CHW Training ppt slide 10-11 
c. Ask caregiver to list causes of caries.   
i. Define caries: “A Pediatric Guide to Children’s Oral Health Flip Chart and 
Reference Guide” page 5 
d. Ask caregiver to identify behaviors that could cause caries.  
i. Discuss all behaviors: “A Pediatric Guide to Children’s Oral Health Flip Chart and 
Reference Guide” pages 6-9.  
ii. Make sure discuss  
1. Vertical transmission (caregiver to child from utensils, pacifiers, sharing 
food) 
2. Family history of caries 
3. Frequency foods/drinks without enough breaks 
4. Sleeping with a bottle or cup 
5. Sugary foods/drinks 
6. Gummy foods 
7. Some medical conditions (that impair child’s saliva, ability to participate 
in brushing, or require special medicines) 
iii. If family interested, can discuss bacteria and how bacteria interact with sugar to 
form caries 
e. Describe different stages of tooth decay (i.e. white spots, brown spots) 
i. Show pictures: “A Pediatric Guide to Children’s Oral Health Flip Chart and 
Reference Guide” page 6, CHW Training ppt slide 12, 19, 24-26 
f. 
Discuss importance of caries prevention, emphasize they can prevent caries from 
happening and stop those that have already started (CHW will explain how) 
i. Give handout “A Healthy Mouth For Your Baby” 
 
 
 

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2. Brushing Basics 
 
i. Goals: 
1. Describe when to start brushing teeth (or wiping gum line) 
2. Describe how and when to brush teeth 
3. Describe types of toothbrushes 
4. Describe types and amount of toothpaste  
5. Explain how to floss   
 
ii. What you need: 
1. CHW Training Manual (with ppt slides) 
2. Mouth with teeth model and toothbrush 
3. Toothpaste (for demonstration of quantity) 
4. Laptop/tablet with hotspot 
 
A. Topic areas 
a. Discuss when caregiver should start wiping gum line or brushing child’s teeth 
b. Discuss how often to brush 
i. If needed, discuss strategies to remember 
c. Show caregiver on model teeth how to brush 
i. Discuss brushing technique 
ii. Discuss brushing duration 
iii. If needed, discuss strategies to help (timers, songs, etc) 
d. Show caregiver photo on how much toothpaste to use (CHW Training Manual ppt slide 
45). Could also show on real toothbrushes. 
e. Show video on tooth brushing based on child’s age (i.e. baby vs toddler) 
i. Baby:  
1. https://www.youtube.com/watch?v=kyJo7vUpbT8 
2. https://www.youtube.com/watch?v=KB8mwBfcrXw 
ii. Child: 
http://www.colgate.com/en/us/oc/oral-health/basics/brushing-and-
flossing/video/No-More-Nasties-Brushing-for-Kids 
iii. Adult: 
https://www.youtube.com/watch?v=lmmFRJjadOI&index=3&list=PLEbUg8bEgm
RWGhvM1KgvX9bA_FkbG9WEM 
f. 
Discuss different types of toothbrushes  
g. Discuss roll of spitting 
h. Show caregiver how to floss teeth and when to start 
i. 
Talk about how to store toothbrushes 
j. 
Practice brushing (and flossing if family wants) 
 
 
 

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3. Fluoride 
i. Goals: 
1. To know what fluoride is and how it prevents cavities 
2. Understand fluoride recommendations for toothpaste 
3. To know benefits of fluoridated water (tap water) as opposed to 
bottle water 
4. To know why fluoride varnish is applied  
5. Dispel fluoride myths 
 
ii. What to bring: 
1. CHW Training Manual (with ppt slides) 
2. Different kinds of toothpaste (infant, child, adult regular, no fluoride 
adult) 
 
 
A. Topic areas 
a. Ask if caregiver knows what fluoride is   
i. Discuss what it is and why it is important. 
1. Makes teeth stronger to resist caries 
2. Can rebuild teeth when some damage 
3. Has some anti-bacterial properties 
b. Identify day-to-day activities that provide teeth with fluoride  
i. Toothpaste 
1. Ask what kind of toothpaste they use for themselves and children, and 
why 
2. Explain recommendation for fluoride toothpaste 
3. Practice reading labels to identify fluoride 
ii. Water 
1. Ask if they know about fluoride in water 
2. Discuss types of water they drink (bottled, filtered, tap) 
a. Explain amount of fluoride in those 
b. If no fluoride in source of water, explain how to fix that (change 
type of water or add fluoride) 
c. Ask if families have received fluoride varnish  
i. Show picture (CHW Training manual ppt slide 40) or show demo varnish kit 
ii. Discuss where and when to get (i.e. dentist and/or pediatric office) 
d. Discuss concerns for too much fluoride, provide reassurance 
 
 

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4. Weaning 
i. Goals:  
1. To identify age when child should transition from bottle to cup 
2. To identify sippy cup recommendations 
3. To discuss effects of nighttime feeding 
 
ii. What to bring: 
1. CHW Training Manual (with ppt slides) 
2. A Pediatric Guide to Children’s Oral Health Flip Chart and Reference 
Guide 
3. Consider bringing different kinds of sippy cups (hard top, soft tops) 
 
 
A. Topic areas 
a. Ask about sleeping with the bottle or cup 
i. Discuss recommendations: never allow sleeping with bottle/cup 
ii. Remind families consequences, review baby bottle caries if needed 
iii. Discuss challenges encountered and strategies 
b. Ask caregiver to state the age in which a child should transition to a cup 
i. Discuss recommendations: Change over to sippy cup/regular cup at 1 
ii. Remind families consequences, review baby bottle caries if needed 
iii. Discuss challenges encountered and strategies 
c. Discuss types of sippy cups 
i. Explain why hard top cups preferred 
 
 
 

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5. Nutrition 
i. Goals:  
1. To identify foods that contribute to caries 
2. To identify beverages, including juice, that affect oral health 
3. To identify effects of frequent snacking 
4. To identify healthy foods 
 
ii. What to bring: 
1. Consider bringing some juice containers, fruit snacks, gummy 
vitamins, soda containers to read labels and compare 
 
 
A. Topic areas 
a. Ask caregiver what food or beverage items can cause caries. In discussion: 
i. Emphasize sugar-sweetened beverages (avoid) 
1. Sodas also have acid which hurts teeth 
ii. Discuss juice (sugar in natural pure juice is still sugar, don’t recommend) 
iii. Gummies, fruit snacks, and sticky foods (avoid) 
iv. Candy (avoid) 
v. Discuss milk and breastfeeding (sugar in milk too, need to clean teeth 
afterwards) 
b. Discuss caregiver about frequent snacking and how it contributes to caries 
i. Frequent foods but more likely frequent drinking (includes milk/breastmilk) 
ii. Emphasize breaks in feeding 
c. Discuss strategies for limiting sugar-sweetened beverages, unhealthy snacks, and 
frequency 
i. Kids want to do what their parents do… 
ii. Engage family in discussion, 
d. Inform caregiver what food items are healthy for child 
i. Foods that clean the teeth while eating them 
1. Fresh fruits and vegetables 
2. Crunchy foods (apples, pears, carrots, salads, etc) 
ii. Variety 
 
 
 

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6. Seeing the Dentist 
 
i. Goals:  
1. To know when a child should see a dentist 
2. What to expect at first dental visit 
3. How often should child go to dentist 
4. To know the responsibility of a medical provider in oral health 
 
 
ii. What to bring: 
1. Dental referral list 
 
 
 
A. Topic areas 
a. Discuss when a child should start going to the dentist and why 
i. At 1 year of age or within 6 months of getting first tooth 
ii. Why: Start fluoride, receive education, identify any problems, get child used to 
the dentist 
b. Identify/list what will happen at first dental visit 
i. Teeth examined 
ii. Fluoride applied 
c. Discuss how often child should go to dentist 
i. Every 6 months 
d. Discuss challenges to bring child to dentist, and problem solve 
i. Insurance (Medicaid covers dental for children but not all dentist accept it) 
ii. Finding dentist that will take babies 
1. Dental referral list 
iii. Scheduling 
iv. Transportation 
v. Child resistance or fear 
vi. Children with special needs 
e. Discuss the role a pediatrician or family doctor has regarding oral health 
i. Should be screening and can often apply varnish 
f. 
Ask caregiver if he/she receives dental care and if he/she would like assistance 
i. Dental referral list 
ii. Insurance assistance 
 
 
 
 
 
 

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APPENDIX H: CHW ENCOUNTER TRACKING FORM  
 
 
 
 
 
 
         Participant ID _____________ 
 
 
 
 
 
 
 
 
 
 
 
CHW __________________ 
ENCOUNTER DOCUMENTATION  
 
Participant Name_________________________________ 
 
 
 
Time Encounter Began 
_____________________________ 
Accompanied by:  1□ no one   2□ someone (name:  __________________) 
 
Time Encounter Ended 
_____________________________  
 
Encounter Number (circle one):    1      2      3      4     Follow-up call 1    Follow-up call 2    Follow-up call 3     Follow-up call 4   
other_________________ 
 
Encounter Location: 1□ clinic (specify__________________)   2□ WIC (specify__________________) 3□ home   4□ other 
(specify___________________) 
Date of Encounter: ________________________________ 
 
 
 
 
CARIES RISK ASSESSMENT 
□ Completed 
    □ Not completed because already done at past visit □ Not completed for other reason (describe):____________________ 
 
 
 
 
 
 
 
 
 

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CORE CURRICULUM   
 
 
 
 
 
 
 
 
 
 
                            
TOPIC         
     Check one                        SUBTOPICS 
 
                    MATERIALS USED 
 
Details and Comments 
1.  Oral health 
basics 
□ Major topic of visit→ 
□ Minor topic of visit→ 
□ Not covered 
□ Normal tooth development  
□ Tooth anatomy  
□ What are caries 
□ Causes of caries         
□ Importance of caries prevention        
□ Other (specify):  
□ CHW Training Manual  
□ A Pediatric Guide to 
Children’s Oral Health Flip 
Chart and Reference Guide 
□ Mouth with teeth model  
□ A Healthy Mouth For Your 
Baby handout 
□ Other (specify): 
 
  
2.  Tooth 
brushing  
□ Major topic of visit→ 
□ Minor topic of visit→ 
□ Not covered 
□ When to start              
□ Frequency                                          
□ Technique     
□ Duration   
□ Equipment 
□ Toothpaste amount 
□ Spitting 
□ Flossing 
□ Other (specify): 
□ CHW Training Manual  
□ Mouth with teeth model  
□ Toothbrushes given 
□ Floss given 
□ Tooth brushing videos 
□ Other (specify): 
 
 
3.  Fluoride 
□ Major topic of visit→ 
□ Minor topic of visit→ 
□ Not covered 
□ Define fluoride and roles 
□ Toothpaste 
□ Water                             
□  CHW Training Manual 
□  Toothpaste 
□ Other (specify): 
 

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□ Varnish 
□ Fluoride risks/myths   
□ Other (specify): 
 
4.  Weaning 
□ Major topic of visit→ 
□ Minor topic of visit→ 
□ Not covered 
□ When to transition from bottle 
□ Sippy cup recommendations 
□ Nighttime feeding 
□ Other (specify): 
□  CHW Training Manual 
□  Sippy cups 
□ Other (specify): 
 
 
5.  Nutrition  
□ Major topic of visit→ 
□ Minor topic of visit→ 
□ Not covered 
□ Sugar-sweetened beverages 
□ Juice 
□ Sticky foods, candy, etc  
□ Frequency of foods/drinks  
□ Healthy foods  
□ Other (specify): 
□ Other (specify): 
 
 
6.  Seeing the 
dentist 
□ Major topic of visit→ 
□ Minor topic of visit→ 
□ Not covered 
□ When to start 
□ What to expect 
□ Frequency 
□ Role of the pediatrician 
□ Other (specify): 
 
□ Dental referral list 
□ Other (specify): 
 
 
7.  Other topics □ Major topic of visit→ 
□ Minor topic of visit→ 
Describe: 
 
 

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□ Not covered 
 
ACTION PLAN  
Did family accomplish their Action Plan from the last visit? 
□ Yes  (exactly as they had planned)    
□ No, not even close.  Why? 
__________________________________________________________________________________________________________________
_____ 
 
□ Some but not all.  Why? 
__________________________________________________________________________________________________________________
______ 
 
 
ENCOUNTER PARTICIPATION 
Did the target child participate?   1□ Yes    2□ No       If yes, how much did they participate?    1□ A lot       2□ A little       3□ Not at all 
 
List each other person who participate in the visit and the amount they participated: 
Person 1:  First name: ________________________   Relationship to child: ___________________________  Participated:  1□ A lot     
2□ A little       3□ Not at all 
Person 2:  First name: ________________________   Relationship to child: ___________________________  Participated:  1□ A lot     
2□ A little       3□ Not at all Person 3:  First name: ________________________   Relationship to child: 
___________________________  Participated:  1□ A lot       2□ A little       3□ Not at all Person 4:  First name: 
________________________   Relationship to child: ___________________________  Participated:  1□ A lot       2□ A little       3□ 
Not at all Person 5:  First name: ________________________   Relationship to child: ___________________________  Participated:  
1□ A lot       2□ A little       3□ Not at all Person 6:  First name: ________________________   Relationship to child: 

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___________________________  Participated:  1□ A lot       2□ A little       3□ Not at all Person 7:  First name: 
________________________   Relationship to child: ___________________________  Participated:  1□ A lot       2□ A little       3□ 
Not at all Person 8:  First name: ________________________   Relationship to child: ___________________________  Participated:  
1□ A lot       2□ A little       3□ Not at all 
 
SELF EVALUATION 
Self-Evaluation – How did I (the CHW) do today? 
   
    1              2                     3                     4                  5 
Poor       Mediocre      Satisfactory       Good          Excellent 
How much progress do I feel was made on this visit? 
 
          1                     2                               3                    4 
       None             Some                        Good              Great 

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List anything else that happened or seems important here: 
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________ 
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________ 
 
 

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APPENDIX I: CHW FIDELITY ASSESSMENT FORM 
CHW Fidelity Assessment Form 
 
Date: 
 
Time: 
 
CHW:  
 
 
 
 
 
 
Supervisor: 
 
Directions: For items, 1-9, assess the CHW on a scale from 1 – 5.  Calculate the average rating at the bottom of the 
page. 
 
1 
Needs review of content and additional practice in this area 
 
2 
Demonstrates a basic understanding of the skill and is ready to practice a more complicated skill 
3 
Demonstrates an adequate understanding of a complicated skill, but needs more practice before starting on a 
clinical trial 
4 
Demonstrates an adequate understanding of the skill and is ready for entering the field on a clinical trial 
5 
Demonstrates a sophisticated understanding of the skill and could likely be role model for his/her peers. 
N/E 
Not evaluated: This role play scenario did not allow opportunity to evaluate this skill 
 
 
SKILL 
RATING 
COMMENTS/SUGGESTIONS 
1 
ACCURACY OF CONTENT:  CHW demonstrates 
knowledge of oral health information or self-
management skill. 
 
 
 
2 
CLARITY OF CONTENT: Communicates content in 
lay person’s language, keeps the level of detail simple, 
and limits amount of material covered so it’s likely to 
be retained, and not overwhelm the participant. 
 
 
 
3 
OPENNESS TO QUESTIONS:  Responds to questions 
from participant.  If CHW does not know the answer, 
talks about how participant could pursue the answer or 
assures participant that they will learn what they can 
and get back to them at the next meeting.     
 
 
 
4 
INDIVIDUALIZING the CONTENT and PROCESS:  
Shows an ability to find out what is most relevant to 
this participant and tailors the protocol to maximize 
acceptance of material.   
 
 
 
5 
MODEL & GUIDE: CHW used modeling and 
experiential learning.  Used conversational and 
problem-solving approaches (rather than lecture or 
debate) to promote guided discovery and learning, 
helping participants to draw their own conclusions.  
 
 
 
6 
CHECK FOR PARTICIPANT UNDERSTANDING of 
MATERIAL: CHW checks for participant 
understanding by asking the participant to answer open-
 
 

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ended questions, to put presented material into their 
own words, and/ or to demonstrate knowledge by 
practicing the skill within the session.  
 
7 
ACTION: Discussed an action plan for weekly practice 
of skills.  Encouraged participant to tie the content of 
material to their daily lives by developing a plan to take 
some action or to practice a skill in the time before their 
next meeting. 
 
 
 
8 
ASKED FOR FEEDBACK: CHW asked participant for 
feedback on how this meeting and the overall process in 
the study is going.   
 
 
 
9 
INTERPERSONAL EFFECTIVENESS: CHW 
displayed optimal levels of warmth, concern, 
confidence, genuineness, professionalism, and 
maintained appropriate boundaries.   
 
 
 
 
 
AVERAGE RATING (Calculated) 
 
 
 
 
 
 
 Average score of <4 requires evaluation and possible remediation. 
 
 

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APPENDIX J: TRIAL CONSENT FORM ENGLISH 
 
 
 
 
 
 
 
 
 
 
 
 
You are being asked to participate in a research study.  Researchers are required to 
provide a consent form such as this one to tell you about the research, to explain that 
taking part is voluntary, to describe the risks and benefits of participation, and to help 
you to make an informed decision.  You should feel free to ask the researchers any 
questions you may have. 
 
Principal Investigator Name and Title: Dr. Molly Martin  
Department and Institution: University of Illinois at Chicago Department of Pediatrics 
Address and Contact Information: 1747 West Roosevelt Road, Room 547, M/C 275, 
Chicago, IL 60608 
Sponsor: National Institute of Dental and Craniofacial Research at the National 
Institutes of Health 
 
Why am I being asked?  
 
 
 
You are being asked to be a subject in a research study that is trying to better 
understand dental cavities in children.  You have been asked to participate in the 
research because you are a parent or guardian of a child who is at risk for dental 
cavities. Your participation in this research is voluntary.  Your decision whether or not to 
participate will not affect your current or future dealings with the University of Illinois at 
Chicago, with your clinic, and with your Women, Infant, and Children (WIC) center.  If 
you decide to participate, you are free to withdraw at any time without affecting 
these relationships.  
 
Approximately 420 subjects may be involved in this research at UIC.  
 
What is the purpose of this research?  
 
 
The purpose of this study is to better understand how to help parents take care of their 
children’s teeth and prevent cavities. 
 
What procedures are involved?  
 
 
If you and your child participate in the study, you agree to participate for about one year. 
During the year, you and/or your child will be expected to participate in up to 7 in-person 
Leave box empty - For office use only 
University of Illinois at Chicago Consent for 
Participation in Research 
Protocol Title: COordinated Oral health 
Promotion (CO-OP) Chicago – Pilot Study 
 
Principal Investigator: Molly Martin, MD 
Phone Number: 312-996-2363 
Email: mollyma@uic.edu 

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visits that will last about one hour each, and 4 follow-up telephone calls or text 
messages that each require a few minutes of your time. Some people will be in a group 
that requires all 7 visits, and some people will be in a group that has only 4 study visits. 
 
The first thing that happens is we collect information from you. To do this, we ask that 
you allow two University of Illinois research specialists to go to your home, or a location 
of your choice, and ask you some questions about you, your family, and about dental 
care in your family.  During this visit, we will ask you to: 
1) Answer questions about your family’s beliefs about how to take care of teeth and 
what you do to take care of your family’s teeth; 
2) Answer questions about your health and your child’s health; 
3) Allow us to put a gel on your child’s teeth that shows us where plaque is. Then 
we will look at your child’s teeth and take pictures of the teeth; A dental 
professional will look at the pictures for your child’s teeth to understand how 
much plaque is on your child’s teeth. 
4) Allow us to look at the space where your child’s teeth are brushed; 
5) Demonstrate for us how your child's teeth are brushed. 
This visit will take about one hour. We will contact you 6 months later to repeat these 
questions. We will contact you one year after you started the program to repeat these 
questions one last time. 
 
After enough people from your clinic or WIC center have signed up for the study, your 
clinic or WIC center will be randomly assigned either to have a community health worker 
(CHW) available for patients or clients or to continue with usual care. Randomization is 
like the flip of a coin. This means about half of clinics and WIC centers will have CHW 
services and half will not. If you are a patient or client at one of the clinics or WIC 
centers that gets a CHW, then you will be offered CHW services during the study. If you 
are a patient or client at one of the clinics or WIC centers that does not get a CHW, you 
will be offered one CHW visit at the end of the study after the final data collection.  
 
If you are in a clinic or WIC that has CHW services, you will receive a letter with your 
CHW’s information in it a few weeks after your data are collected. The CHW will meet 
with you four times over one year, about every three months. These visits can be in 
your home, the clinic, the WIC, or wherever you choose. During these visits, the CHW 
will talk with you and your family about how to care for your family’s teeth. CHW visits 
will last about one hour each. After each visit, the CHW will call or text you to see how 
you are and ask if you have questions.  
 
If you are in a clinic or WIC that does not have CHW services, you will be contacted by 
a CHW several weeks after your one year data collection visit. The CHW will offer to 
meet with you and your family at a location of your choosing for 1-2 hours for education 
and support.  
 
We will let your clinic or WIC center know that you are enrolled in this study. 
 

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How long will I be in the study?   
You will be in this study for approximately one year. 
 
What are the potential risks and discomforts? 
A risk of this research is loss of privacy (revealing to others that you are taking part in 
this study) or confidentiality (revealing information about you to others whom you have 
not given permission to see this information). It is possible that you or your child may 
feel uncomfortable and experience distress during the time we are asking you to answer 
questions and demonstrate tooth brushing behaviors, or while we are examining your 
child’s teeth for plaque. If the study activities seem unacceptable to you or your family, 
you are free to not participate in the study. If information is revealed about child abuse 
or neglect, the law requires that this information be reported to the proper authorities. 
 
Are there benefits to taking part in the research?   
You will not directly benefit from participation in the research. The study results will be 
used to design future programs to help children and their families. 
 
What other options are there? 
You have the option to not participate in this study.  
 
What about privacy and confidentiality? 
The people who will know that you are a research subject are members of the research 
team, CHWs, and your clinic or WIC center. No information about you, or provided by 
you, during the research, will be disclosed to others without your written permission, 
except if necessary to protect your rights or welfare or if required by law.  
 
Study information which identifies you and the consent form signed by you may be 
looked at and/or copied for examining the research by the National Institutes of Health, 
the UIC Office for the Protection of Research Subjects, the University of California San 
Francisco, or the State of Illinois Auditors. 
 
When the results of the research are published or discussed in conferences, no 
information will be included that would reveal your identity.   
 
Confidentiality will be maintained by keeping research records in locked file drawers 
within a locked office. Each participant will be given an identification number to ensure 
confidentiality of the data files. The information linking participants’ names and 
identification number will be kept in a locked room in locked file cabinets. Once 
collected, your data will not be available to anyone other than the investigators involved 
in this project. Data that identifies you will be destroyed one year after the completion of 
the study.  
 
How will your health information be protected? 
The researchers agree to protect your health information and will only share this 
information as described within this research consent form. 

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What are the costs for participating in this research?   
 
There are no costs to you for participating in this research.  
 
Will I be reimbursed for any of my expenses or paid for my participation in this 
research? 
You will receive $40 in cash upon completion of each data collection. There are three 
data collections, so at the end of the study you may have received a total of $120.  
 
Can I withdraw or be removed from the study?  
If you decide to participate, you are free to withdraw your consent and discontinue 
participation at any time. All you need to do is contact the principal investigator at the 
phone number on this form. The researchers also have the right to stop your 
participation in this study without your consent if they believe it is in your best interests.  
 
Who should I contact if I have questions?  
Contact Dr. Molly Martin (principal investigator) at 312-996-2363, email 
mollyma@uic.edu.  
• if you have any questions about this study or your part in it,   
• if you have questions, concerns or complaints about the research. 
 
What are my rights as a research subject? 
If you feel you have not been treated according to the descriptions in this form, or if you 
have any questions about your rights as a research subject, including questions, 
concerns, complaints, or to offer input, you may call the Office for the Protection of 
Research Subjects (OPRS) at 312-996-1711 or 1-866-789-6215 (toll-free) or e-mail 
OPRS at uicirb@uic.edu. 
 

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REMEMBER 
Your participation in this research is voluntary. Your decision whether or not to 
participate will not affect your current or future relations with the University of Illinois at 
Chicago, with your clinic, and with your WIC center. If you decide to participate, you are 
free to withdraw at any time without affecting that relationship. 
 
Signature of Participant  
You have read (or someone has read to you) the above information. You have 
discussed the procedures, risks and benefits of the study with the researchers. You 
have been given an opportunity to ask questions and your questions have been 
answered to your satisfaction. You agree to participate in this research.  You will be 
given a copy of this signed form for your information and to keep for your records.  The 
original copy will be stored in the research file at the University of Illinois at Chicago.   
 
 
Please check one 
□   Yes, you can contact me about future research studies   _____ (Initials of 
Participant) 
□   No, do not contact me about future research studies 
 
 
 
 
 
 
 
 
 
 
 
Signature 
 
 
 
 
Date 
 
 
 
 
 
 
 
Printed Name 
 
 
 
 
I have discussed the above research study, including the purpose, risks, and benefits, 
with the subject. I encouraged questions and answered all questions that were asked. 
The subject is aware that he/she does not have to participate in the research and may 
later withdraw their consent. 
 
 
 
 
 
 
 
 
 
 
 
 
  ___________ 
 
Signature of Person obtaining consent Date  
 
Printed Name 
 
 
 
 
 
 
(Same as Subject’s)