Family Intervention With Caregivers of Children With Dental Needs
Phase: NA
Conditions: Dental Caries
Sponsor: Case Western Reserve University

 
 
 
 
 
Family Intervention with Caregivers of 
Children with Dental Needs 
Working Title: Family Access to Dentist Study (FADS) 
NIDCR Protocol Number: 14-060-E 
NIDCR Grant Number: U01DE024167-01 
Principal Investigator:  Suchitra S. Nelson 
NIDCR Program Official:  Melissa Riddle 
NIDCR Medical Monitor:  Jane Atkinson 
Version Number:  4.1 
25 July 2016
NCT02395120

FADS Protocol 
 
 
Tool Revision History: 
 
Version 
 
Number 
Date 
Summary of Revisions Made: 
  .1 
4/23/2013 
Initial draft 
  .2 
5/23/2013 
Major revisions: sections added 
  .3 
5/31/2013 
Minor revisions 
.4 
6/3/2013 
Submitted to NIDCR with grant application  
.5 
2/10/2014 
Resubmission to NIDCR with minor revisions: dates of major study 
events 
1.0 
2/25/2014 
Submitted Original IRB application  
1.1 
4/8/2014 
Resubmitted Original IRB application with revisions; Approved version 
2.0 
2/24/2015 
Submitted to IRB for Continuing Review: revisions to study design 
and new Washington sites; Approved version 
2.1 
4/7/15 
CROMS staff posted revised version to Rho website 
2.2 
6/2/2015 
NIDCR revised version posted to Rho website. NIDCR used the 
2/24/2015 approved IRB protocol to make revisions. 
3.0 
5/15/2015 
Submitted Addendum to IRB for addition of Spanish translations, 
final dental information (DIG), and Training and Calibration consent 
and assent forms; Approved version 
3.1 
6/30/2015  
Used 5/15/2015 current approved IRB approved protocol version 
and integrated NIDCR staff comments from the 2/24/2015 IRB 
approved Protocol version to post on CROMS website.  
3.2 
7/06/2015 
CROMS staff posted revised protocol version to Rho website 
4.0 
7/15/2015 
Final Version of Protocol after incorporating NIDCR requested 
changes-Submitted IRB Addendum 
4.1 
7/25/16 
Submitted Addendum to IRB for addition of Bedford City School 
District in the Ohio site. 

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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 and Clinical Site Investigator: 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signed: 
 
Date: 
 
 
Name: Suchitra S. Nelson 
 
 
 
Title: Professor 
 
 
 
 
 
Signed: 
 
 
 
 
 
Date: 
 
 
Name: Peter Milgrom 
 
Title: Professor 
 
 

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STATEMENT OF COMPLIANCE .................................................................................................................... i 
SIGNATURE PAGE........................................................................................................................................... ii 
LIST OF ABBREVIATIONS ........................................................................................................................... .vi 
PROTOCOL SUMMARY…….....................................................................................................................vii 
SCHEMATIC OF STUDY DESIGN………………………………………………………..…..viii 
1 
KEY ROLES AND CONTACT INFORMATION ................................................................................ 9 
2 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ......... 14 
2.1 
Background Information ............................................................................................................ 13 
2.2 
Rationale ..................................................................................................................................... 15 
2.3 
Potential Risks and Benefits ..................................................................................................... 165 
2.3.1 
Potential Risks ........................................................................................................................ 165 
2.3.2 
Potential Benefits ................................................................................................................... 165 
3 
OBJECTIVES ........................................................................................................................................ 176 
3.1 
Study Objectives ....................................................................................................................... 176 
3.2 
Study Outcome Measures ......................................................................................................... 176 
3.2.1 
Primary Outcome Measures................................................................................................. 176 
3.2.2 
Secondary Outcome Measures ............................................................................................ 176 
4 
STUDY DESIGN .................................................................................................................................. 198 
4.1 
Study Participants ..................................................................................................................... 198 
4.2 
Model and Design ..................................................................................................................... 198 
5 
STUDY ENROLLMENT AND WITHDRAWAL ............................................................................. 243 
5.1 
Subject Inclusion Criteria for enrollment ................................................................................. 243 
5.2 
Subject Exclusion Criteria .......................................................................................................... 23 
5.3 
Strategies for Recruitment and Retention ................................................................................ 243 
5.4 
Treatment Assignment Procedures .......................................................................................... 254 
5.4.1 
Randomization Procedures .................................................................................................. 254 
5.4.2 
Masking Procedures .............................................................................................................. 265 
5.5 
Subject Withdrawal ................................................................................................................... 265 
5.5.1 
Reasons for Withdrawal ........................................................................................................ 265 
5.5.2 
Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention ............................................................................................................................ 265 
5.6 
Premature Termination or Suspension of Study ...................................................................... 276 
6 
STUDY INTERVENTION .................................................................................................................. 287 
6.1 
Study Behavioral or Social Intervention(s) Description ........................................................... 287 
6.2 
Administration of Intervention .................................................................................................. 30 
6.3 
Procedures for Training Interventionists and Monitoring Intervention Fidelity ....................... 29 
6.4 
Assessment of Subject Compliance with Study Intervention .................................................. 310 
7 
STUDY SCHEDULE ............................................................................................................................ 321 
7.1 
Screening Recruitment/Enrollment ......................................................................................... 321 
7.2 
Baseline Dental Screening ........................................................................................................ 321 
7.3 
Follow-up Visit ......................................................................................................................... 332 

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7.4 
Final Study Visit ........................................................................................................................ 332 
7.5 
Withdrawal Visit ....................................................................................................................... 333 
8 
STUDY PROCEDURES/EVALUATIONS ......................................................................................... 34 
9 
ASSESMENT OF SAFTEY .................................................................................................................... 35 
9.1 
Specification of Safety Parameters ................................... Error! Bookmark not defined. 
9.1.1 
Unanticipated Problems ....................................................................................................... 365 
9.1.2 
Adverse Events ...................................................................................................................... 365 
9.1.3 
Serious Adverse Events ........................................................................................................ 365 
9.2 
Time Period and Frequency for Event Assessment and Follow-Up ....................................... 376 
9.3 
Characteristics of an Adverse Event ........................................................................................ 376 
9.3.1 
Relationship to Study Intervention ..................................................................................... 376 
9.3.2 
Expectedness of SAEs .......................................................................................................... 376 
9.3.3 
Severity of Event ................................................................................................................... 387 
9.4 
Reporting Procedures ............................................................................................................... 387 
9.4.1 
Unanticipated Problem Reporting to IRBs and NIDCR ................................................ 387 
9.4.2 
Serious Adverse Event Reporting to NIDCR .................................................................. 398 
9.5 
Halting Rules............................................................................................................................... 38 
10 
 STUDY OVERSIGHT ........................................................................................................................... 39 
11 
 CLINICAL SITE MONITORING ..................................................................................................... 410 
12 
 STATISTICAL CONSIDERATIONS ................................................................................................ 421 
12.1 
Study Hypotheses ..................................................................................................................... 421 
12.2 
Sample Size Considerations ...................................................................................................... 421 
12.3 
Planned Interim Analysis ............................................................................................................ 42 
12.4 
Final Analysis Plan ...................................................................................................................... 42 
13 
 SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ......................... 476 
14 
QUALITY CONTROL AND QUALITY ASSURANCE ................................................................... 487 
14.1 
Definitions: ............................................................................................................................... 487 
14.2 
Study Intervention and Study Questionnaires .......................................................................... 487 
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 
Subject Confidentiality .............................................................................................................. 510 
16 
DATA HANDLING AND RECORD KEEPING ............................................................................. 521 
16.1 
Data Management Responsibilities .......................................................................................... 521 
16.2 
Data Capture Methods ......................................................................................................................... 521 
16.3 
Types of Data ........................................................................................................................................ 521 
16.4 
Schedule and Content of Reports ...................................................................................................... 521 
16.5 
Study Records Retention ..................................................................................................................... 532 
16.6 
Protocol Deviations ............................................................................................................................. 532 
17 
 PUBLICATION POLICY ................................................................................................................................. 54 

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18 
LITERATURE REFERENCES ...................................................................................................................... 566 
SUPPLEMENTAL MATERIALS ................................................................................................................................ 61 
APPENDIX A: SCHEDULE OF EVENTS ............................................................................................. 62 
APPENDIX B: CONSENT FORMS .......................................................................................................... 63 
APPENDIX C: IPQ-RD AND CAREGIVER QUESTIONNAIRE ................................................... 93 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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LIST OF ABBREVIATIONS 
AE 
Adverse Event/Adverse Experience 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DMFS 
Decayed, missing, and filled tooth surfaces 
DMFT 
Decayed, missing, and filled teeth 
eCRF 
Electronic Case Report Form 
FFR 
Federal Financial Report 
FWA 
Federal wide Assurance 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
IRB 
Institutional Review Board 
MOP 
Manual of Procedures 
N 
Number (typically refers to subjects) 
NIDCR 
National Institute of Dental and Craniofacial Research, NIH, DHHS 
NIH 
National Institutes of Health 
OCTOM 
Office of Clinical Trials Operations and Management, NIDCR, NIH 
OHRP 
Office for Human Research Protections 
PHI 
Protected Health Information 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
WHO 
World Health Organization 
 
 
 
 

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PROTOCOL SUMMARY 
Title: 
Family Intervention With Caregivers Of Children With Dental Needs  
Précis: 
The study is a multi-site, double blind, parallel arm, community-based 
randomized controlled trial (phase III RCT) to evaluate the effectiveness of 
new referral approaches to increase receipt of dental care among inner-city 
urban and rural elementary school children who were screened at school and 
have restorative treatment needs. The study has 5 arms: The experimental 
intervention is the use of a theoretically driven CSM referral letter alone, the 
CSM letter plus a Dental Information Guide, a reduced CSM referral letter 
alone, or a reduced CSM referral letter plus a reduced Dental Information 
Guide. The control strategy is the use of a modified standard referral letter. All 
RCT participating K–4 grade children will receive a screening at the beginning 
of the school year and at the study end point 7 months later to determine if the 
child received dental care. 
Objective 
Primary: To evaluate the effectiveness of experimental (new) versus 
standard referral approaches given to parents/caregivers in increasing 
receipt of dental care among their children in grades K-4.  
 
Secondary: 
To 
assess 
changes 
in 
parent/caregiver 
illness 
representation/perception and behavioral intention between enrollment 
(beginning of school year), 2-week  and 7-month follow-up (end of 
school year) to understand the underlying mechanisms of the new vs. 
standard referral approach that result in receipt of dental care. 
Population: 
Population information: sample size=660 caregivers to be randomized; children 
will be both male and female, grades K-4; inner city African Americans 
(Bedford and E Cleveland, OH) and rural Whites and Hispanics (Cowlitz and 
Lewis counties, Washington State).   
Phase: 
III 
Number of Sites: 
 (1) East Cleveland City School District (ECCSD, Cleveland, OH), and 
Bedford City School District (BCSD, Bedford, OH). 
 (2) Cowlitz County (CCSD, WA), and Lewis County (LCSD, WA).   
Description of  
Intervention: 
The experimental intervention is the use of a theoretically driven CSM referral 
letter alone or the letter plus a dental information guide. The control strategy is 
the use of a modified standard referral letter. 
Study Duration: 
10  months 
Subject Participation 
Duration: 
1 year 

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Estimated Time to 
Complete Enrollment: 
3 months 
SCHEMATIC OF STUDY DESIGN 
Prior to  
Randomization 
 
 
 
 
 
Time Point  
Study Visit 1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Time Point  
Study Visit 2 
 
 
 
 
 
 
Time Point 
Study Visit Final 
 
 
Total N = 2217:   
 
Obtain informed consent/assent from caregivers and children.  
 
Gather baseline questionnaires (Illness Perception Questionnaire – 
Revised for Dental (IPQ-RD), Caregiver Questionnaire).  
 
Screen children for inclusion and exclusion criteria with a dental 
examination at beginning of school year. 
 
Randomize n=660 caregivers based on screening information 
 
Send referral letters (intervention and control) to caregivers of children who 
need restorative treatment based on the dental examination results. 
Final Assessments (7 months 
after dental examination) 
Dental Examinations 
Questionnaires (IPQ-RD) 
                 Randomize caregivers 
 
2 week follow-up from dental examination screening- administer questionnaires 
(IPQ-RD, Caregiver Questionnaire) N=660 
Arm 2 
CSM referral 
letter + DIG 
N=204 
Arm 1 
CSM referral 
letter alone 
N=204 
Arm 3 
Reduced  
CSM referral 
letter alone 
N=24 
Arm 5 
Modified 
Standard 
letter 
N=204 
Arm 4 
Reduced  
CSM referral 
letter + DIG 
N=24 

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1 
KEY ROLES AND CONTACT INFORMATION 
Principal Investigator 
Suchitra S. Nelson, PhD 
Professor of Community Dentistry,  
Case School of Dental Medicine 
2124 Cornell Road 
Cleveland, OH 44106-4905 
Telephone: (216) 368-3469 
Fax: (216) 368-3204 
Email: sxn15@case.edu 
Medical Monitor 
Jane Atkinson, DDS 
Director, Center for Clinical Research 
Division of Extramural Research 
National Institute of Dental and Craniofacial Research 
6701 Democracy Blvd 
Bethesda, Maryland  20892 
Telephone: (301) 435-7908 
Email: jatkinso@mail.nih.gov 
NIDCR Program Official 
Melissa Riddle, PhD 
Chief, Behavioral & Social Sciences Research Branch 
Division of Extramural Research 
National Institute of Dental and Craniofacial Research 
6701 Democracy Blvd 
Bethesda, Maryland  20892 
Telephone: (301) 451-3888 
Email: riddleme@mail.nih.gov 
Clinical Site Investigator 
and Principal Investigator 
(Subcontract): 
Peter Milgrom, DDS 
Professor 
Joana Cunha-Cruz, DDS, PhD 
Research Assistant Professor 
University of Washington 
Oral Health Sciences 
Box 357475, Suite B509, HSB, 1959 NE Pacific St. 
Seattle, WA 98195-7475 
Telephone: 206-685-4183 
FAX: 206-685-4258 
Email: dfrc@u.washington.edu 
Email: silvajcc@u.washington.edu 
 
 

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Institutions 
Case School of Dental Medicine 
2124 Cornell Rd 
Cleveland, OH 44106-4905 
Contact: Suchitra Nelson, PhD 
Telephone: (216) 368-3469 
Fax: (216) 368-3204 
 
University of Washington 
Box 357475 
Seattle, WA 98195-7475 
Contact: Peter Milgrom, DDS 
Telephone: (206) 685-4183 
Fax: (206) 685-4258 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Institutions Continued 
Cuyahoga County 
Bedford City School District 
Central Primary School 
799 Washington St. 
Bedford, OH 44146  
Contact: Monique Winston, Principal 
Telephone: (440) 439-4225 
 
Glendale Primary School 
400 W. Glendale Ave. 
Bedford, OH 44146 
Contact: Nora Beach, Principal 
Telephone: (440) 439-4227 
 
Carylwood Intermediate School 
1387 Caryl Dr. 
Bedford, OH 44146 
Contact: Kenneth Elder, Principal 
Telephone: (440) 439-4509 
 
Columbus Intermediate School 
23600 Columbus Rd. 
Bedford Heights, OH 44146 
Contact: Kimberly Sterlekar, Principal 
Telephone: (440) 786-3322  
 
 

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Institutions Continued 
Cuyahoga County 
East Cleveland City School District 
                        Caledonia Elementary School 
                        914 Caledonia Road 
                        Cleveland Heights, OH 44112 
                        Contact: Mary Fitzgerald, Principal 
                        Telephone: 216-268-6690 
 
                        Chambers Elementary School 
                        14305 Shaw Avenue 
                        E. Cleveland, OH 44112 
                        Contact: Crystal Cash, Principal 
                        Telephone: 216-268-6640 
 
                         Mayfair Elementary School 
                         13916 Mayfair Road 
                         East Cleveland, OH 44112 
                         Contact: Carol Godbold 
                         Telephone: 216-268-6651 
 
                         Prospect Elementary School 
                         1843 Stanwood Road 
                         East Cleveland, OH 44112 
                         Contact: Charles McCants 
                         Telephone: 216-268-6630 
 
                         Superior Elementary School 
                         1865 Garfield Avenue 
                         East Cleveland, OH 44112 
                         Contact: Shawna LeSure 
                         Telephone: 216-268-6670 
 
 
 
 
 
 
 
 
 
 

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Institutions Continued 
Cowlitz County School Districts 
Kelso School District 
Catlin Elementary School 
404 Long Ave 
Kelso, WA 98626  
Contact: Holly Budge, Principal 
Telephone: (360) 501-1550 
 
Wallace Elementary School 
402 Elm Street 
Kelso, WA 98626 
Contact: Jill Steele, Principal 
Telephone: (360) 501-1650 
 
Longview School District 
Kessler Elementary School 
1902 Kessler Blvd 
Longview, WA 98632 
Contact: Debbie Morgan, Principal 
Telephone: (360) 575-7580 
 
St. Helens Elementary School 
431 27th Ave. 
Longview, WA 98632 
Contact: Nikki Reese, Principal 
Telephone: (360) 575-7362  
 
Lewis County School Districts 
Centralia School District 
Jefferson Lincoln Elementary School 
400 W Summa 
Centralia, WA 98531 
Contact: David Eacker, Principal 
Telephone: (360) 330-7636 
Winlock School District 
Winlock Miller Elementary School 
405 NW Benton Street 
Winlock, WA 
Contact: Boyd Calder, Principal 
Telephone: (360) 785-3516 

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2. INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC 
RATIONALE 
2.1 Background Information 
The impetus for the proposed behavioral intervention trial comes from a community-based caries 
prevention trial among low-income minority kindergarten children followed until 2nd grade. During 
baseline exams, referrals were given for needed restorative and urgent care to the children’s 
caregivers, but on a subsequent dental exam only 19% of the children had received care (Nelson et 
al. 2012). Standard letters and follow-up phone calls were not effective in improving dental 
attendance. Recent studies in the U.K. have also concluded that school screening is ineffective in 
stimulating subsequent dental visits (Milsom et al. 2006a, b). Thus, indications are that caregiver-
level engagement or action is necessary to take care of their child’s further dental needs without 
which the benefits of child-level screening or interventions at schools are not realized.  
The experimental intervention will be based upon the Common Sense Model of Self-Regulation 
(CSM: Leventhal et al. 2003) to address parent/caregiver illness perception and navigation of 
resources to increase receipt of dental care during a 7-month follow-up period for children with 
restorative dental needs. In this five arm study the new CSM theory-driven referral letter alone or 
the new CSM referral letter and dental information guide (facts about dental caries, hints for getting 
dental care, making appointments and Medicaid access, transportation and dentists availability 
resources) will each be compared to a modified standard referral letter (based on November 2007 
guidelines for Oral Health Screening in Ohio Schools) to increase receipt of dental care among 
inner-city urban African American, and rural Hispanic and White elementary school children.  
The literature is clear that most low-income caregivers do not initiate and maintain the self-
management strategies necessary for their children’s oral health when the children are screened and 
referred from school. Most see dental diseases as acute, to be responded to only when there is pain 
or visible decay (Hooley et al. 2012). One approach used in self-management of chronic medical 
conditions is the Common Sense Model of Self-Regulation (CSM: Leventhal et al. 1997; Leventhal et 
al. 2003). This approach has never been used in dentistry. The CSM has been used to develop 
interventions for diabetes (Keogh et al. 2007; McAndrew et al. 2008), asthma (McAndrew et al. 
2008), attendance for cardiac rehab (Mosleh et al. 2009), and primary care (Phillips, Leventhal & 
Leventhal 2012). The CSM proposes that in response to a health threat, people form a cognitive and 
emotional representation (perception) of their illness that guides coping and action planning, 
followed by an appraisal of the coping strategy. Five key constructs guiding the illness representation 
or perception are: Identity, the patient/caregiver labeling of disease and its symptoms; Cause, the 
individual’s perception of the underlying cause of their illness; Consequence, the belief about the 
impact of the illness physically and socially; Timeline, the personal beliefs about the illness being 
acute, chronic, or cyclical in nature; and Cure or controllability, the belief whether the illness can be 
cured or kept under control by the individual or others. The importance of these concepts is that 
they are readily alterable, as opposed to many other factors in the system. The Illness Perception 
Questionnaire (IPQ: Weinman et al. 1996; Moss-Morris et al. 2002) has been used to identify these 
five dimensions of illness representation, together with coherence and emotional representation. A 

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CSM theory-based letter and information leaflet have been successfully shown to improve cardiac 
rehab attendance (Mosleh et al. 2009; Sniehotta et al. 2010). Other approaches such as motivational 
interviewing (MI) have been successful in reducing caries and influence positive behavior change 
among caregivers (Weinstein et al. 2006) but include multiple counseling sessions that are difficult 
and expensive when working with low-income populations and are likely not sustainable. 
Dental caries is the leading chronic childhood disease (US DHHS 2000). Its prevalence is steadily 
increasing, with poor and minority children bearing the brunt. Among 2-11 year-olds, 64% of 
African American children, 60% of Mexican American children, and 50% of White children had 
untreated tooth decay (Dye et al. 2007).  Nevertheless, despite availability of Medicaid, median 
dental utilization of low-income children is only 33-37% among the states (Hakim et al. 2012; GAO-
08-1121, 2008). This trend highlights why so many children require extensive treatment und   er 
general anesthesia (Savage et al. 2004). Untreated primary teeth are a strong predictor of future caries 
indicating the chronicity of the disease (Birkeland et al. 1976; Bader et al. 1986; Van Palenstein et al. 
2001; Motohashi et al. 2006). Untreated decay can lead to serious infections and pain, interference 
with eating/speaking, overuse of EDs, and lost school time (Edmunds et al. 1998). Early preventive 
care has been shown to reduce later downstream costs (Savage et al. 2004). Poorer oral health-
related quality of life was found among preschoolers with ECC (Leal et al. 2012; Martins-Junior et al. 
2012; Kramer et al. 2013) and among school children from low-income households (Locker 2007). 
Twelve states mandate dental screening of school children.  But, the laws do not require tracking 
and evaluation of children who receive referrals (ASTDD 2008). School screening has also been 
endorsed by W.H.O. (2003). This is seen as an antidote to prevalent parental views about lack of 
need for preventive care or treatment of children’s decayed but asymptomatic teeth (Milgrom et al. 
1998; Riedy et al. 2001; Tickle et al. 2003; Hilton et al. 2007). Recently, Nelson et al. (2012) found 
19% dental utilization after school screening, referral, and parental reminders. Studies in the U.K. 
have also failed to demonstrate the effectiveness of screening (Milsom et al. 2006a,b).  A related 
qualitative study by the same group found the school examination process was acceptable to parents 
and staff, but the procedure for follow-up was judged inadequate (Tickle et al. 2006). In contrast, 
other studies with follow-up (Zarod & Lennon 1992; Donaldson & Kinirons 2001; Hebbal & 
Nagarajappa 2005) reported increases in dental attendance. However, the rate was low even when 
the care was free; complex factors were involved in the receipt of follow-up care (Hebbal & 
Nagarajappa 2005). AAPD (2012) policy on school entrance oral examination states such exams are 
insufficient without follow-up. 
2.2 
Rationale 
First, the new intervention letter addresses two core issues: (a) importance of caries-free primary 
teeth for protection of permanent teeth and, (b) viewing dental caries as a chronic disease rather 
than acute or episodic. The current scientific evidence is clear that low-income caregivers do not 
know the importance of taking care of primary teeth and have the belief that dental caries is present 
only when the child has pain or symptoms. National surveys also indicate that untreated cavities are 
disproportionately higher and dental access is lower among Medicaid-eligible children. Therefore, 
caregivers require an accurate perception of dental caries for them to self-manage their child’s 
cavities and to adopt and maintain healthy behaviors. Hence our rationale for the use of the 
Common Sense Model of Self-Regulation (CSM) in attempting to change cognitive representation of 
the 2 core caregiver issues. The text of the intervention letter from the identity construct to timeline 

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construct is a chain of reasoning aimed at giving information and helping caregivers understand 
children’s dental disease. Second, the new intervention letter also addresses a third core issue, 
resources to self-manage their child’s cavities. For the resources component, the Dental Information 
Guide (DIG) will address the need for adequate knowledge of resources.   
The difficulty that all dental screening programs face, and the one we propose to address, is that few 
low-income caregivers take their children who have been screened to the dentist for follow-up 
restorative care.  
2.3 
Potential Risks and Benefits 
2.3.1 
Potential Risks 
There is no known risk with being in this study.  However, some people may feel uncomfortable answering 
personal questions for research.  We will try to make them feel as comfortable as possible and allow them to 
skip any questions that they choose not to answer.  Confidentiality risks may exist if information is 
misplaced. We will take every precaution to protect participant information and keep it confidential. The 
child may still receive medical and dental care if the caregiver or the child decides not to be in this study.  
The dental exam is commonly done in a dental office.  
2.3.2 
Potential Benefits 
The child may benefit if the caregiver learns about his/her tooth problems.  If the child has tooth decay, we 
will give the caregiver a referral to a dentist or dental clinic for dental care.  The child may also benefit by 
learning how to take care of his/her teeth.     

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3 OBJECTIVES 
3.1 
Study Objectives 
The aim of this study is to evaluate the effectiveness of new referral approaches to increase receipt 
of dental care among inner-city urban and rural elementary school children who were screened at 
school and have restorative treatment needs. The primary outcome is the assessment of dental care 
receipt through dental exams. The secondary outcomes are change in caregiver illness perception, 
measured through the IPQ-RD, and behavioral intention measured through items in the caregiver 
questionnaire.   
3.2 
Study Outcome Measures 
Table 3.2.1 shows a summary of the study outcome measures, their sources, and timeline. 
3.2.1 
Primary Outcome Measures 
The primary outcome will be receipt of dental care based on a change determined by clinical 
examination between baseline and follow-up at study exit (7 months after baseline). Please see MOP 
Section 5.2 for details of dental exam and criteria.  
In addition, other proximal surrogate outcomes from the caregiver questionnaire will also be 
assessed. These questions include: whether the child visited the dentist after the dental screening, the 
name of the dentist/dental clinic, whether an appointment was made or not, whether the child 
completed the needed dental treatment, the number of visits that were made to complete dental 
treatment, and if they did not complete the treatment the reasons why they did not complete the 
treatment. 
Examiner Training and Calibration: Exams will be conducted in a portable dental chair in the 
schools by a trained/calibrated examiner. Dr. Hafsteinn Eggertsson will train/calibrate the 
examiners in the ICDAS protocol in a 4-day central training session. Detailed caries assessment and 
examiner training, calibration and reproducibility protocols are in the MOP (Section 5.2). Examiners 
will not utilize dental radiographs. At follow-up, the examiner will not have access to the results of 
the first examination to avoid detection bias. 
3.2.2 
Secondary Outcome Measures 
The first secondary outcome (mediator) will be change in the overall Illness Perception 
Questionnaire-Revised for Dental (IPQ-RD), cognitive (identity, consequences, timeline, cause, 
cure/controllability) representation subscale scores (Weinman et al. 1996; Barrowclough & Lobban 
2001; Moss-Morris et al. 2002; Bonetti et al. 2010).   
The other secondary outcome (mediator) will be a change in behavioral intention (Luzzi & Spencer, 
2008; Ajzen, 1991, 2002).  Behavioral intention will be assessed using a caregiver questionnaire and 
is measured by the summative score of 2 items (e.g., “I want to take my child to the dentist“, and “I 
plan to take my child to the dentist” on a 5 point scale (Luzzi & Spencer, 2008). The use of these 
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our conceptual model. The change in IPQ-RD and behavioral intention scores will be calculated 
between baseline, two week, and final follow-up. A decrease in IPQ-RD scores (i.e. lower score) 
indicates better illness representation/perception, while increase in behavioral intention scores 
indicate a higher intention to take the child to dentist for follow-up care.  
 Table 3.2.1 Summary of measures, timeline, and source 
Variable Type 
Measure 
Timeline1 
Source 
Exposure  
(Intervention 
Study Arms) 
 CSM referral letter alone 
 CSM referral letter + DIG 
 Reduced CSM referral letter 
alone 
 Reduced CSM referral letter + 
DIG 
 Modified Standard letter 
At randomization 
 
 
Mosleh et al. 2009 
Ohio Department of Health 
Bureau 2007 
Primary 
Outcome 
Dental exams 
 Child’s receipt of dental care 
Beginning and 
end of school year 
ICDAS (Pitts 2004) 
Secondary 
Outcomes 
(Mediators) 
IPQ-RD 
 Caregiver illness perception 
Caregiver Questionnaire 
 Behavioral intention  
Baseline, 
Two-week, and 
Exit  
Barrowclough et al. 2001  
Ajzen 2002; Conner & 
Armitage 1998 
Moderators 
Caregiver Questionnaire  
 Caregiver literacy 
 Caregiver self-efficacy2 
 Caregiver dental fear 
 Caregiver perceived stress 
 Subjective norm2 
 Dental insurance status 
Site (urban/rural) 
Baseline 
Bennett et al. 2003 
Finlayson et al. 2005 
Humphris et al. 1995 
Cohen & Williamson 1988 
NHANES IV 
Ohio, Washington 
Confounders 
Child’s age, race, dental visit 
Caregiver socio-demographics 
(age, race, SES, education, 
marital status) 
Baseline 
NHANES IV 
Subject 
compliance with 
Intervention 
 Whether the referral letter (and 
DIG) was received (generic 
code) 
 Whether the referral letter (and 
DIG) was read/understood 
(Postcard)  
Within 2 days after 
Baseline dental 
exam 
 
1. Baseline: prior to screening dental exam; At randomization: after baseline dental screening exam; 
Two-weeks: Two weeks after randomization; Exit: two weeks before end of school year dental exam 
2. Caregiver self-efficacy and subjective norms will also be considered as potential mediators in the additional 
mediational analyses, and will be measured at the Exit in addition to Baseline. 

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4 STUDY DESIGN 
This section describes the model and design of the intervention study.  The study will utilize a multi-
site, double-blind, parallel arm, community-based randomized trial design (Phase 3).   
4.1 
Study Participants 
Subjects will be parents/caregivers and their children in grades K-4 in one of three Counties: 
Cuyahoga County (East Cleveland City School District (ECCSD, Cleveland, OH) and Bedford City 
School District (BCSD, Bedford, OH)); Cowlitz County (CC, WA); and Lewis County  (LC, WA); 
(See Table 4.1.1 below).  The study will be offered to all caregivers and their children including those 
children with special health care needs.  Parent/caregivers and children will be enrolled in the study 
upon signing the consent/assent form and completing the recruitment and contact form. All 
enrolled children will receive a dental screening at the beginning of the school year. Following the 
screening, only parent/caregivers whose child has a tooth with an International Caries Detection 
and Assessment System (ICDAS) active lesion score of 2 or greater will be randomized and continue 
further participation in the trial.  Caregivers with multiple children in K-4 will receive the same 
intervention assignment.  
Table 4.1.1 School District Information 
County 
School District 
Elementary Schools 
K-4 
Enrollment 
Cuyahoga Co. East Cleveland 
City SD 
Caledonia, Chambers, Mayfair, 
Superior 
889 
 
Bedford City SD 
Central, Glendale, Columbus, 
Carylwood 
1274 
Cowlitz Co. 
Kelso SD. 
Catlin,  Wallace 
1122 
 
Longview SD. 
Kessler, St. Helens 
 
Lewis Co. 
Central SD. 
Jefferson Lincoln 
586 
 
Winlock SD. 
Winlock Miller 
 
 
4.2 
Model and Design 
Figure 4.2.1 shows the study model for the intervention. The experimental intervention will be based 
upon the Common Sense Model of Self-Regulation (CSM: Leventhal et al. 2003) to address 
parent/caregiver illness perception and navigation of resources to increase receipt of dental care 
during a 7-month follow-up period for children with restorative dental needs. In this five arm study 
a CSM referral letter alone, a CSM referral letter plus Dental Information Guide (DIG), a reduced 
CSM referral letter alone, and a reduced CSM referral letter plus DIG will each be compared to a 
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Ohio Schools) to increase receipt of dental care among inner-city urban African American, and rural 
Hispanic and White elementary school children.  
 
 
 
Figure 4.2.1 illustrates the pathway through which the referral approaches (CSM referral letter alone, 
CSM referral letter + DIG, reduced CSM referral letter alone, reduced CSM referral letter + DIG, 
and modified standard letter) are intended to result in action by the caregiver. The child’s receipt of 
care will be mediated by changes in caregiver’s illness perception and behavioral intention, which 
will result from the interventions. The first mediator, caregiver’s illness perception is comprised of 
five constructs such as identity, cause, consequences, timeline, and controllability. The second 
mediator is caregiver’s behavioral intention (Azjen, 1991), i.e. their motivation or intention for taking 
their child to the dentist. Intention to initiate an action is also the first step in action planning. The 
moderating variables in the model are caregiver’s literacy, self-efficacy, dental fear, perceived stress, 
and dental insurance status. Additionally, to test other causal explanations for the effect of the 
intervention letters on receipt of dental care, measures from the health belief model (HBM: caregiver 
beliefs and attitudes, self-efficacy) and theory of planned behavior (TPB: subjective norms) theories 
will also be considered as mediators in this conceptual model. Additional mediational analysis will be 
conducted to explore alternative causal explanations. 
A description of the five study arms is as follows: 
Arm 1 (N=204): The first arm is the CSM referral letter alone. The letter text includes the cognitive 
dimensions of the CSM (identity, cause, consequences, timeline, and controllability). The letter has 
been tested for readability and clarity with caregivers of K-2 children. The referral letter will be given 
to the caregivers in their preferred language (English or Spanish).  
 
Arm 2 (N=204): The second arm is the CSM referral letter plus DIG to reinforce/change illness 
perception, knowledge about dental caries, and resources to seek care. The DIG is a brochure with 
Figure 4.2.1 Conceptual model describing the pathway mechanisms of the proposed new 
interventions 

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illustrations which provides myths and facts about dental caries, hints for getting dental care, making 
appointments and Medicaid access, transportation and dentist availability resources. While the 
general information on dental caries is similar for both sites, other resource information on how to 
seek care and a list of dentists is adapted to the specific site.  
 
Arm 3 (N=24): The third arm is the reduced (removing text corresponding to “timeline”) CSM  
referral letter alone. The referral letter will be given to the caregivers in their preferred language 
(English or Spanish). The letter includes the remaining cognitive dimensions of the CSM (identity, 
cause, consequences, and controllability). While the last line (timeline construct) reinforces the core 
issues (baby teeth’s impact on adult teeth and the disease’s chronic nature), the text and constructs 
leading up to the last line is equally important. We think that this final message is fundamental to the 
intervention letter and this version will allow an estimate of the effect of the “timeline” text itself.  
 
Arm 4 (N=24): The fourth arm is the reduced CSM referral letter plus DIG to reinforce/change 
illness perception, knowledge about dental caries, and resources to seek care. The reduced DIG is a 
brochure with illustrations that provides myths and facts about dental caries, hints for getting dental 
care, making appointments and Medicaid access, transportation and dentist availability resources. As 
with the reduced letter, text and illustrations related to the “timeline” construct have been removed 
in the reduced dental information guide. This version will allow for an estimate of the effect of the 
“timeline” text and illustrations. While the general information on dental caries is similar for both 
sites, other resource information on how to seek care and a list of dentists is adapted to the specific 
site.  
 
Arm 5 (N=204): The fifth arm (control) is the modified standard letter (based on November 2007 
guidelines for Oral Health Screening in Ohio Schools). This letter is consistent with others used 
across the country and will be used in both the Ohio and Washington sites. 
 
All letters will be sent home with the child on the day of the screening and mailed to the caregiver’s 
address within 24 hours. The address will be obtained during recruitment and verified with the 
school secretary.  
A description of the recruitment, enrollment, randomization, and follow-up is below: 
Caregivers will be recruited at the beginning of the school year and complete baseline forms 
(consent form, Illness Perception Questionnaire-Revised for Dental (IPQ-RD) questionnaire, and 
caregiver questionnaire) prior to dental screening and randomization (Figure 4.2.2). Children in K-4 
whose parents have consented/assented will receive a screening exam in early October 2015. 
Caregivers whose children have no cavities or who have emergent needs will not participate further 
in the clinical trial.  The baseline data from discontinued child and caregiver participants will be used 
only for baseline descriptive comparisons.  
At the same time following screening exams eligible caregivers of children with restorative referrals 
will be randomized. Caregivers will be followed at 2 time points: 2 weeks after the receipt of the 
intervention letter and 2 weeks prior to the final (exit) study visit examinations in May 2016 
(approximately 7 months after the initial dental exam). At both time points caregivers will complete 
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sampled from arms 1, 2 and 5 (20 per arm), to complete the IPQ-RD 1 month after enrollment for 
reliability purposes. All questionnaires will be mailed to the home address and asked to be returned 
to the class-room teacher or the outreach staff. Further, outreach staff will ensure that the caregivers 
received and returned the materials through follow-up calls. The schedule and scripts for the call are 
contained in the MOP (Table 6.1 and Appendix 6). Children will have a follow-up dental exam in 
May 2016.  
 
 

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Figure 4.2.2 Flowchart for Recruitment, Enrollment, and Randomization 

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5 STUDY ENROLLMENT AND WITHDRAWAL 
5.1 
Subject Inclusion Criteria for Enrollment 
Inclusion Criteria: Inclusion criteria for Parents/Caregivers and their children for enrollment:  
 
Provide signed and dated consent form (also assent form for children 7 and older) 
  
 
Willing to comply with all study procedures and be available for the duration of the study 
 
 
Male or female child, grades K-4  
 
 
Child in good general health as evidenced by parent report (including children with special 
health care needs). Caregivers will indicate on the Recruitment and Contact Form if their 
child has any major medical problems or any cognitive or developmental disorders that 
would preclude them from participating in the dental exam.  
Additional Subject Inclusion Criteria for study continuation and randomization: 
 Caregivers will be randomized if their child has tooth with an International Caries Detection 
and Assessment System (ICDAS) active lesion score of ≥ 2. Caregivers with multiple 
children in K-4 will receive the same intervention assignment.  
5.2 
Subject Exclusion Criteria 
Exclusion Criteria: Exclusion criteria for Parents/Caregivers:  
 
Illiterate 
 
 
Under 18 years of age 
5.3 
Strategies for Recruitment and Retention 
Subjects will be recruited in Ohio or Washington States and will be volunteers.   
Ohio Site:  The recruitment follows a 2-stage process (See Section 4.2, Figure 4.2.2): (1) all caregivers 
of K-4 children enrolled in ECCSD and BCSD will be invited to have their children participate in 
the dental screening; (2) consented parent/caregivers and assented children will be screened and 
those who fulfill the inclusion criteria for study continuation and randomization will be randomized. 
We will follow recruitment strategies that were previously successful working with this minority 
school-based population (Nelson & Milgrom 2012). The venues for recruitment will include parent-
teacher meetings, open house, curriculum nights, health fairs, and at prearranged convenient times 
during school drop off /pick up of the child. Teacher support will be gained for sending 
introductory letters and consent forms home to increase recruitment. Outreach Workers will be 
hired from the local community to assist with recruitment at the schools. Candidates will be parent-
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among caregivers. Based on a previously cited study (Nelson & Milgrom 2012), we expect to recruit 
765/889 (86% recruitment rate) from ECCSD. Also based on the previous study, we expect 
428/765 recruited children (56% caries rate) will be screened positive for dental caries. Out of the 
428, 5% are expected to have acute urgent care needs and be excluded. Further, 10% will be 
caregivers with multiple children in K-4 and thus will receive the same intervention. A pool of 366 
caregivers will be eligible for randomization.  
Washington Sites: These sites will use the same recruitment approach as ECCSD.  The study intends 
to recruit 1452/1708 K-4 children (85%). In a recent screening with a similar rural population 
(Jefferson and Morrow Counties, OR), 85% of families agreed to participate with only a single 
notice home and no personal contact or follow-up. In an earlier study with a similar rural 
population, UW investigators recruited 76% of eligible families (Weinstein, Spiekerman & Milgrom 
2009). Based on 28% caries rate, we expect that 407/1452 recruited children will be screened 
positive for untreated caries. 5% of the children who are positive will be excluded because of 
emergent needs. Further 10% will be caregivers with multiple children. Thus, an available pool of 
348 caregivers will be eligible for randomization.  
Due to lower than expected enrollment in both the Ohio and Washington sites, we plan a second 
year of recruitment to include Bedford School District and East Cleveland School District (only KG 
and perhaps other grades if they did not enroll in the first year). For the  Bedford School District, 
1274 KG-4th grade children were enrolled during 2015-2016 school year in four elementary schools; 
80% Black; 67% economically disadvantaged eligible for free/reduced cost school lunch program. 
Bedford is quite similar to East Cleveland. Using our experience from the first year of recruitment 
we expect that out of the 1274 Bedford school children, about 764 will receive baseline screening 
(60% participation rate). Of 764 children, about 267 caregivers will be randomized (taking into 
account 30% multiple children and 50% caries rate). Similarly we expect about 50 caregivers will be 
randomized in East Cleveland. Between Bedford and East Cleveland School Districts, we expect to 
screen about 950 children in 2016-2017 school year. Of the 950 screened we expect to randomize 
317 caregivers. So we can meet our recruitment goal of 258 caregivers that is necessary to complete 
the study. 
5.4 
Treatment Assignment Procedures 
5.4.1 
Randomization Procedures 
Sequence Generation:  The study Biostatistician will generate the randomization sequence, which 
will be loaded into REDCap for allocation. REDCap is a secure, web-based application designed to 
support remote data capture for research studies, providing: 1) an intuitive interface for validated 
data entry, 2) audit trails for tracking data manipulation and export procedures, 3) automated export 
procedures for seamless data downloads to common statistical packages, and 4) procedures for 
importing data from external sources. Caregivers will be randomly assigned to one of the five study 
arms in the 17:17:2:2:17 ratio; randomization of caregivers will be stratified by their child’s grade 
level and school. The caregivers with multiple children will receive the same treatment based upon 
the grade level and school of one of their children, selected at random. Permuted blocks will be used 
to ensure the allocation of treatment assignments within strata as planned. Only the Biostatistician 
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Allocation Process: Caregivers will be allocated to study arms using the randomization module 
provided in REDCap. REDCap uses previously-generated randomization sequences to assign 
records to study arms, and can support up to 14 stratifying variables. Each unique caregiver ID will 
be linked to one or more unique child IDs in a one-to-many relationship. As each child record is 
examined, the corresponding caregiver’s study arm assignment will be displayed. If no allocation is 
found, the study staff will be directed to the randomization form to allocate that caregiver to the 
correct arm. REDCap will assign each caregiver to a specific study arm in accordance with the pre-
determined randomization sequence and the stratifying variables. To assist study staff in quickly 
processing randomizations, stratifying variables (as well as other basic data) will be prepopulated into 
REDCap by the Project Coordinators, using information gathered prior to the dental screening and 
randomization process. REDCap is secured using TLS/SSL, enabling study staff to use it from 
laptops using public or private wireless connections. 
5.4.2 
Masking Procedures 
All personnel who have contact with the child and caregiver will be blinded to participant group 
assignment except for personnel on the Data & Statistics Team. In order to maintain blinding, the 
dental examiners will not have access to study arm allocation. 
5.5 
Subject Withdrawal 
5.5.1 
Reasons for Withdrawal 
Subjects are free to withdraw from participation in the study at any time upon request. 
Subjects who drop out (or withdraw) from the study by their own choice will be considered 
dropouts/withdraws.   
An investigator may terminate a study subject’s participation in the study if: 
 Any medical condition or situation occurs such that continued participation in the study 
would not be in the best interest of the subject. 
 The child transfers out of the school district) that precludes further study participation. 
5.5.2 
Participants who are discontinued from the study by one of the study personnel will be considered a 
discontinuer.  Handling of Subject Withdrawals or Subject Discontinuation of 
Study Intervention 
All reasons for dropout/withdrawal or discontinuation of the study intervention will be documented 
in the tracking database and reviewed by the study team and reported to the NIDCR Medical 
Monitor. For gathering information on discontinuation, Outreach Workers will be contacting 
subjects at the 2 follow-up time points (2 weeks after initial dental screening and 2 weeks before the 
last dental screening).   
In the event of a subject telling the Outreach Worker that he/she is dropping out of the study, the 
Outreach Worker should gather the following information as much as the subject allows. 

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 
Record the reason for dropping out of the study. 
 
 
Record any event reported by subjects that the PI determines to be an unanticipated 
problem. 
 
 
Debrief about the intervention. 
 
 
Complete the appropriate questionnaire nearest the drop out time point. 
If it is determined by study personnel that a participant should be discontinued from the study, the 
decision to withdraw a participant must be discussed and confirmed by the PI and Clinical Site 
Investigator.  If both agree that a subject should be withdrawn from the study, the date of 
withdrawal and reason(s) for withdrawal should be recorded in the tracking database.  
5.6 
Premature Termination or Suspension of Study 
Termination of the study normally would occur at the end of subject accrual and completion of all 
study procedures.  For various reasons a study may terminate prematurely.  Written notification, 
documenting the reason for study suspension or termination, will be provided by the suspending or 
terminating party to the Principal Investigator (PI) , Medical Monitor, or NIDCR.  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 which 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 
The new referral intervention letters (Arms 1 to 4) have been based on the CSM theory. Expert 
input was sought from both CSM experts and other Health Behavior Theory (HBT) experts to 
assess the consistency of the letter text to the CSM theory. All experts agreed that the new referral 
text is consistent with the CSM theory. But, the text may not be specific and other theories especially 
the Health Belief Model (HBM) and Theory of Planned Behavior (TPB) could also be mapping to 
the letter text. Two ways in which we propose to address this in our study: is to include additional 
theory-based measures as potential mediators (caregiver beliefs and attitudes, self-efficacy, subjective 
norms) of the intervention’s effects; another way is to report the results of this study where other 
alternative theories are discussed. The modified standard letter (control) does not map to any HBT 
constructs.  
 
Arm 1: The intervention is the CSM referral letter alone (English and Spanish; MOP Appendices 
section 6). The letter text includes the cognitive dimensions of the CSM (identity, cause, timeline, 
consequences and controllability). Table 6.1.1 gives the letter text and the CSM cognitive constructs 
that the text maps to. The letter has been tested for readability and clarity with caregivers of K-2 
children. The Spanish translation was done by a native Mexican Spanish speaker and back translated 
by a second individual to ensure comparability.  Both versions were written at a 6th grade level or 
lower. The letter will be sent home with the child on the day of screening and mailed to the 
caregiver address within 24 hours. School District records include information on the primary 
language spoken at home. The address will be obtained during recruitment and verified with the 
school secretary.  
 
Arm 2: The intervention is the CSM referral letter + the dental information guide (DIG; MOP 
Appendices Section 6) to reinforce/change illness perception, knowledge about dental caries, and 
resources to seek care. The dental information guide is a brochure with illustrations which provides 
myths and facts about dental caries, hints for getting dental care, making appointments and Medicaid 
access, transportation and dentist availability resources. The information guide was pilot-tested and 
modified based on caregivers and community leaders input. While the general information on dental 
caries is similar for both sites, other resource information on how to seek care and a list of dentists is 
adapted to the specific site (see MOP Appendices Section 6 for site-specific DIG). As with the other 
arms, the letter will be sent home with the child on the day of the screening and mailed to the 
caregiver’s address within 24 hours.  
 
Arm 3: The intervention is the reduced (removing text corresponding to “timeline”) CSM referral 
letter alone (English and Spanish; MOP Appendices Section 6). The letter includes the remaining 
cognitive dimensions of the CSM (identity, cause, consequences and controllability). While the last 
line (timeline construct) reinforces the core issues (baby teeth’s impact on adult teeth and the 
disease’s chronic nature), the text and constructs leading up to the last line is equally important. We 
think that this final message is fundamental to the intervention letter and this version will allow an 
estimate of the effect of the “timeline” text itself. The letter has been tested for readability and 
clarity with caregivers of K-2 children. The Spanish translation was done by a native Mexican 

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Spanish speaker and back translated by a second individual to ensure comparability.  Both versions 
were written at a 6th grade level or lower. 
 
Arm 4: The intervention is the reduced CSM referral letter + reduced dental information guide 
(Reduced DIG; MOP Appendices Section 6) to reinforce/change illness perception, knowledge 
about dental caries, and resources to seek care. The reduced dental information guide is a brochure 
with illustrations that provides myths and facts about dental caries, hints for getting dental care, 
making appointments and Medicaid access, transportation and dentist availability resources. As with 
the reduced letter, text and illustrations related to the “timeline” construct have been removed in the 
reduced dental information guide. This version will allow for an estimate of the effect of the 
“timeline” text and illustrations. While the general information on dental caries is similar for both 
sites, other resource information on how to seek care and a list of dentists is adapted to the specific 
site (see MOP Appendices Section 6 for site-specific DIG). The letter will be sent home with the 
child on the day of the screening and mailed to the caregiver’s address within 24 hours.  
 
Arm 5: The control is the modified standard referral letter (based on November 2007 guidelines for 
Oral Health Screening in Ohio Schools. MOP Appendices Section 6). This letter is consistent with 
others used across the country. Both Ohio and Washington sites will use the same standard letter. 
As with Arms 1, 2, 3 and 4, the letter will be sent home with the child on the day of the screening 
and mailed to the caregiver’s address within 24 hours.  
 
 
Table 6.1.1 Text of intervention letter and associated CSM constructs 
Intervention letter text 
CSM construct 
Cavities are the #1 childhood health problem. Children may have 
cavities even if they do not have pain. Cavities should be treated 
when found. 
Identity 
Cavities can be serious in baby teeth. Cavities can affect children’s 
learning and how they look and feel about themselves. 
Consequences 
Other health problems may not be under your control. But, you can 
prevent cavities by taking your child to the dentist at least once a 
year. Your child will benefit from this greatly. 
Controllability 
Cavities do not just happen. Bacteria cause cavities. A dentist 
can clear up the bacteria.   
Causes 
If cavities are not treated, the bacteria in baby teeth can affect 
adult teeth. 
Timeline 
 
 

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6.2 
Administration of Intervention 
The referral letter (and dental information guide for Arms 2 and 4) will be sent home with the child 
on the day of screening and mailed to the caregiver’s address within 24 hours. School District 
records include information on the primary language spoken at home. The address will be obtained 
during recruitment and verified with the school secretary.  
Procedures will be in place to make certain that the referral letters are received. In the R34 pilot 
study, caregivers preferred to have it mailed. But when the letter was sent home both with the child 
and also mailed to the caregiver, 75% received the letter either through child or mail or both, while 
25% reported they did not receive the letter. To maximize the chance the referral letter and/or 
information guide are received, a trained Outreach Worker will call the caregiver within 2 days to 
clarify the receipt: 5 attempts will be made at various times during the day and evening. If the letter 
was not received, the worker will verify the address and another packet will be sent. The training 
procedure for the Outreach Workers is in the next section and a more detailed account is in the 
MOP (Refer to Section 6).  In Washington some Outreach workers will be bi-lingual.  
 
6.3 
Procedures for Training Interventionists and Monitoring Intervention Fidelity 
The Project Coordinator in Cleveland and Washington will be responsible for facilitating the 
caregiver participants’ access to the interventions.  Given that the nature of the interventions (i.e., 
referral letters), are structured, the Project Coordinator will primarily be responsible for assuring 
that the letters are sent. Outreach workers will be responsible for assuring that letters are received 
by the caregiver. They will not be personally delivering the intervention information.  This makes 
training and fidelity assessment less complicated. This section generally describes the procedures for 
training the Outreach Workers and monitoring compliance with study procedures (See MOP 
Section 5.2 for a detailed description).  
Project Coordinators will supervise the Outreach Workers at their respective sites. Staff training 
for Project Coordinators (Ohio and Washington), and Outreach Workers (Ohio only), will be 
centrally conducted at Case Western Reserve University (CWRU).  The Washington Project 
Coordinator will receive training at CWRU and in turn will train the outreach staff at Washington. 
While the curriculum varies depending on the staff member’s role in the project, at a minimum all 
staff will be trained in the topics of Human Subject Protection, Good Clinical Practice (GCP), 
and Protocol training.  
Intervention fidelity ensures that the intervention was conducted as planned, i.e., follows the study 
protocol. The importance of adhering to the study protocol (e.g., when to send out referral letters, 
when to make phone calls and following the phone call scripts) will be emphasized during the 
Outreach Worker training as well as following the MOP. One aspect of Outreach Workers’ duties 
will require them to make phone calls to caregiver participants confirming receipt of the letters. To 
ensure that Outreach Workers make a similar number of phone calls and provide the same 
information to each participant the calls will be recorded.  The Project Coordinator in each 
respective site will listen to each of the first 10 calls (reminder calls to return the questionnaire).  
Outreach Workers will receive additional training if there are deviations from the script; then. 

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Then, the first ten (10) of the following remaining type of calls will be recorded and reviewed for 
each Outreach Worker (confirmation of receipt of referral letters-call #2, and reminders to return 
completed questionnaires-calls #4 and #6) to assure continued fidelity.  Furthermore, all contacts 
with caregivers will be entered into the tracking database and reviewed to ensure that Outreach 
Workers are following the protocol/MOP. 
 
6.4 
Assessment of Subject Compliance with Study Intervention 
Procedures will be in place to make certain that the referral letters (and DIG) are 
received/read/understood. .  
The following procedures will maximize the chance that caregivers receive the referral letter (and 
DIG for Arms 2 and 4): 
 Include the same generic code (ex. 1001) at the bottom of all referral letters.  
 A trained Outreach worker (OW) will call the caregiver within 48 hours of the dental 
screening to confirm receipt of the referral letter: 5 attempts will be made at various times 
during the day and evening.  
 When calling to confirm receipt of the referral letter, the Outreach worker will ask the 
caregiver to read the code at the bottom of the letter. 
 If the referral letter was not received, the Outreach worker will verify the caregiver’s address 
and send another one with her/his child or by mail, depending on the caregiver’s preference.  
 The training procedures for the Outreach workers are described in the next section and a 
more detailed account can be found in the MOP (Refer to Section 6).  In Washington some 
Outreach workers will be bi-lingual  
In addition, to ensure that caregivers read and understood the referral letter, a self-addressed 
stamped postcard will be enclosed with the referral letter. There will be two questions on the 
postcard: (a) I have read and understood the letter (yes/no); (b) I understand that my child’s dental 
screening in the school was not a complete dental exam (yes/no). Caregivers will be able to answer 
question (b) if they read the letter because this sentence is in both the standard and CSM referral 
letters. Outreach workers will remind caregivers to answer the questions and return the postcard. 
 
 

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7 STUDY SCHEDULE 
Refer to Appendix A for the Schedule of Events. 
 
7.1 
Screening 
Recruitment/Enrollment (Day -56 to -1)  
 
Recruit potential caregiver participants using an in person approach at several venues 
including parent-teacher meetings, open house, curriculum nights, health fairs, and at 
prearranged convenient times during school drop off /pick up of the child. An additional 
approach is to send home a recruitment packet containing a recruitment flyer and consent 
forms to increase recruitment. 
 
Review inclusion/exclusion criteria to determine eligibility (Refer to Sections 5.1, 5.2). 
 
Review the written consent form (Refer to Section 15.3) with the potential participant; 
study staff signs the consent form acknowledging that informed consent was reviewed and 
caregiver signs acknowledging consent was obtained. 
 
Obtain (in person or by mail) demographic and contact information and responses to the 
following questionnaires: Baseline Illness Perception Questionnaire – Revised for Dental 
(IPQ-RD) and Baseline Caregiver Questionnaire. 
 
Telephone contact with caregiver if baseline questionnaires are not filled out and returned 2 
days after receipt. 
 
7.2 
Baseline Dental Screening 
Baseline Dental Screening Visit (Visit 1, Day 0-5) 
 
Obtain assent of child prior to dental screening examination.  
 
Perform initial child dental screening examination at child’s respective elementary school. 
 
Record results of dental screening examination. 
 
Randomize caregivers of children with restorative referral outcome on screening to 1 of 5 
study arms. 
 
Send referral letter packets to caregiver with child and by mail. 
 
Telephone contact with caregivers (within 48 hours of screening examination) to confirm 
receipt of referral letter packet. 

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 
Resend referral letter packets to caregivers as necessary. 
 
Follow-up telephone contact with caregivers to confirm receipt of secondary letter. 
 
7.3 
Follow-up Visit 
Follow-up Visit (Visit 2: 2 weeks after initial dental examination) 
 
Telephone contact with caregivers (2 days before questionnaires sent) to confirm contact 
information and let them know the questionnaires will be sent to them. 
 
Mail 2-week follow-up questionnaires (IPQ-RD and Caregiver) to caregivers. 
 
Telephone contact with caregivers (7 days after questionnaires are received) to remind them 
to return questionnaires. 
 
Additional telephone contacts (1-2 reminders), and then ask for assistance from the teacher. 
 
Record unanticipated problems or adverse events as reported by subject or observed by 
investigator. 
 
7.4 
Final Study Visit 
Final Study Visit (Final Visit: approximately 7 months after initial dental examination) 
 Telephone contact with caregivers (2 days before questionnaires sent) to confirm contact 
information and let them know the questionnaires will be sent to them. 
 Mail Final follow-up questionnaires (IPQ-RD and Caregiver) to caregivers. 
 Telephone contact with caregivers (7 days after questionnaires are received) to remind them 
to return questionnaires. 
 Perform final child dental screening examination at child’s respective elementary school. 
 Record results of dental screening examination. 
 Record unanticipated problems or adverse events as reported by subject or observed by 
investigator. 
7.5 
Withdrawal Visit 
Early Withdrawal or Termination Visit (any time investigator withdraws participant or participant 
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 
In-person contact  
 
Record any event reported by participants that the PI determines to be an unanticipated 
problem. 
 
Debrief about the intervention. 
 
Obtain responses to the nearest study questionnaires (IPQ-RD, caregiver) 
 

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8 STUDY PROCEDURES/EVALUATIONS 
The following are the various study procedures and evaluations that will be done during the study: 
Administration of questionnaires (IPQ-RD and caregiver questionnaires including demographic 
information) for caregiver and child information (See Section 3.2, Table 3.2.1; see Appendix C): 
Caregivers will be asked to complete questionnaires at three time points (baseline prior to screening, 
2 weeks after the dental screening examination, and at the end of the school year). 
Dental examinations for baseline caries status and primary study outcome: Exams will be performed 
on the children whose caregivers have consented to their participation.  The dental examinations will 
be done according to the standard caries detection and assessment system termed ICDAS 
(International Caries Detection and Assessment System). The initial examination (approximately 2 
months after the beginning of the school year) will determine a child’s need for restorative care 
which is an inclusion/exclusion criterion for study continuation and randomization.  The final 
examination (approximately 1 month prior to the end of the school year) will be used for the 
primary study outcome for children enrolled in the RCT. 
Administration of the intervention (referral letters) (See Section 6 – Study Intervention): The letter 
will be sent home with the child and mailed to the caregiver.  Confirmation that the letter was 
received will be obtained through telephone contacts. 
 

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9 
ASSESSMENT OF SAFETY 
9.1 
Specification of Safety Parameters 
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. 
Per the definition, only a subset of adverse events would be characterized as unanticipated problems. 
There are other types of incidents, experiences, and outcomes that are not considered adverse 
events, but are characterized as unanticipated problems (e.g., breach of confidentiality or other 
incidents involving social or economic harm). 
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 
Serious adverse events (SAEs) are a subset of all 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 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, AEs and SAEs will be recorded in the data collection system throughout 
the study.  
Given the nature of the intervention (a referral letter and dental information guide), it is unlikely that 
intervention-related SAEs or AEs will occur. However, throughout the study, if a caregiver or 
teacher reports an event to any study staff; it will be communicated to the PI immediately. The PI 
will record all reportable events occurring any time after informed consent is obtained until the last 
day of study participation.  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 
Given the nature of the intervention (a referral letter), it is unlikely that SAEs or AEs will occur 
which are related to the intervention/study.  The NIDCR Medical Monitor and the Study PI will be 
responsible for determining whether an SAE/AE is expected or unexpected.  An adverse event will 
be considered unexpected if the nature, severity, or frequency of the event is not consistent with the 
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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 IRBs and NIDCR 
Incidents or events that meet the OHRP criteria for unanticipated problems require the creation and 
completion of an unanticipated problem report form.  The following information will be included 
when reporting an adverse event, or any other incident, experience, or outcome as an unanticipated 
problem to the University Hospitals Case Medical Center (UHCMC) 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 UHCMC IRB 
and to NIDCR (Medical Monitor and Program Official) within 1 week of the study staff/PI 
becoming aware of the event.  
 Any other unanticipated problem will be reported to the UHCMC IRB and to NIDCR 
(Medical Monitor and Program Official) within 2 weeks of the study staff/PI becoming 
aware of the problem.  
All unanticipated problems will be reported to NIDCR’s centralized reporting system via Rho 
Product Safety: 
 Product Safety Fax Line (US):  1-888-746-3293 

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 Product Safety Email:  rho_productsafety@rhoworld.com  
General questions about SAE reporting will be directed to the Rho Product Safety Help Line 
(available 8:00AM – 5:00PM Eastern Time):   
 US:  1-888-746-7231 
9.4.2 
Serious Adverse Event Reporting to NIDCR 
Any AE meeting the specified Serious Adverse Event criteria will be submitted (by fax or email) on 
an SAE form to NIDCR’s centralized safety system via Rho Product Safety. Once submitted, Rho 
Product Safety will send a confirmation email to the investigator within 1 business day. The 
investigator will contact Rho Product Safety if this confirmation is not received. This process applies 
to both initial and follow-up SAE reports. 
SAE Reporting Contact Information:    
 Product Safety Fax Line (US):  1-888-746-3293 
 Product Safety Email:  rho_productsafety@rhoworld.com  
General questions about SAE reporting will be directed to the Rho Product Safety Help Line 
(available 8:00AM – 5:00PM Eastern Time):   
 US:  1-888-746-7231 
The PI will complete a Serious Adverse Event Form and submit via fax or email within the 
following timelines:   
 All deaths and immediately life-threatening events, whether related or unrelated, will be 
recorded on the Serious Adverse Event Form and submitted to Product Safety within 24 
hours of site awareness.  
 Serious adverse events other than death and immediately life-threatening events, regardless 
of relationship, will be reported by fax within 72 hours of site awareness.  
All SAEs will be followed until resolution or stabilization.  
9.5 
Halting Rules 
Discontinuation of the study will be determined by standard NIH policies and procedures. Given 
that the study procedures are deemed “minimal risk”, it is unlikely that the trial would need to be 
discontinued early because of concern for human subjects. The PI and NIDCR will share 
responsibility in monitoring progress on this study, including progress toward meeting the 
recruitment and retention goals, data quality and integrity, and protections of human subjects.  
 

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10  
STUDY OVERSIGHT 
In addition to the PI’s responsibility for oversight, study oversight will be under the direction of the 
NIDCR Medical Monitor. The PI will submit a report every 6 months to the NIDCR Medical 
Monitor for review. This report will include data regarding enrollment and retention, unanticipated 
problems and protocol deviations, disposition of biospecimens, outcome measures, quality 
management findings and other relevant parameters. If necessary, additional steps may be taken to 
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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. 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 
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12  
STATISTICAL CONSIDERATIONS 
12.1 
Study Hypotheses 
We hypothesize that the CSM-based interventions will increase receipt of dental care compared to 
the modified standard referral letter. 
12.2 
Sample Size Considerations 
The primary aims are to compare dental care receipt among the five intervention groups, overall and 
separately for each study site (Ohio and Washington).  
The five intervention groups are:  
Arm 1: CSM referral letter alone (N=204)  
Arm 2: CSM referral letter + DIG (N=204)  
Arm 3: Reduced CSM referral letter alone (N=24)  
Arm 4: Reduced CSM referral letter + DIG (N=24)  
Arm 5: Modified Standard letter (N=204)  
The utilization will be defined as evidence of dental care through restorations or extractions at the 
final study visit exam that was previously not found during the baseline exam. All changes will be 
recorded on a tooth level using ICDAS criteria and then dichotomized at the caregiver level as 
having obtained or not obtained dental care for their child/children.  
There are three treatment comparisons to assess the overall CSM referral letter and DIG: CSM 
referral letter alone versus standard letter (Arm 1 vs Arm 5), CSM referral letter plus DIG versus 
standard letter (Arm 2 vs Arm 5), and CSM referral letter alone versus CSM referral letter plus DIG 
(Arm 1 vs Arm 2). As described below we address the issue of multiple testing, both multiple 
comparisons and multiple sites, using a gatekeeper approach. By specifying a sequence of tests, this 
approach will allow for the use of a nominal 0.05 alpha level for each test while maintaining a 0.05 
family-wise alpha level for the six tests (three at each study site).  
An additional comparison will be conducted to assess the effect of the targeted component (e.g., the 
‘timeline’ text): CSM referral letter with and without DIG versus reduced CSM referral letter with 
and without DIG (Arm 1, 2 vs Arm 3, 4).     
The sample size was calculated with the following assumptions for the overall effect of the 
intervention letter: 19% utilization rate for standard letter (Nelson et al. 2012), 37% rate for CSM 
referral letter alone (based on Medicaid utilization among children: GAO-08-1121, 2008), 57% rate 
for CSM referral letter + DIG (based on 57% who reported that they took their child to the dentist 
or had an appointment after receiving the CSM referral letter + DIG in the R34 study). Then, using 
a two-sided test for equal proportions (namely, a Z test with pooled variance), we find that a sample 
size of 102 per intervention group per site (thus, 306 subjects per site) will provide 80% power to 
detect rate differences of 19% versus 37% (as expected for Arm 5 vs Arm 1) or 37% versus 57% (as 
expected for Arm 1 vs Arm 2) for each site, and 98% power for each of these comparisons using the 

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combined sample. As siblings (with the same caregiver) may be included in the study, a conservative 
approach will be to consider the required sample sizes as referring to the number of caregivers. 
Somewhat greater power will be expected if within-caregiver correlation is less than 1. 
For the Ohio site with a total of 889 potential children, we expect 86% to participate (Nelson & 
Milgrom 2012), with 56% receiving a referral and 5% excluded for emergent needs. From previous 
Dr. Nelson’s study in ECCSD elementary schools we expect 10% of caregivers to have multiple 
(usually two) children. Thus, an estimated total of 366 caregivers will be available for randomization 
to the five groups. For the Washington sites, with a total of 1704 potential children, we expect 85% 
participation (based on 2013 screenings in both districts), with 28% receiving a referral, 5% 
exclusions for emergent needs, and a 10% reduction in the corresponding number of caregivers due 
to inclusion of siblings. A total of 347 caregivers will be available for randomization. Even with 5% 
out of school transfers, the available sample will be adequate for testing the proposed hypothesis. 
Thus, we expect to randomize 330 caregivers/site to the five study arms to account for any drop-
outs at randomization and maintain the required power for the trial. 
With regard to our secondary endpoint, the overall IPQ-RD score, we note that our expected 
sample size will provide for each site 80% power to detect an 10 point decrease in the mean score 
(e.g., from an expected mean of 127 for the standard letter to 117 for the CSM referral letter) 
assuming a common standard deviation of 27 (estimated from previous data). A decrease in IPQ-
RD scores indicates better illness representation/perception of caregiver. Since the IPQ-RD has 
never been utilized previously, we refer to a popular rule of thumb (Cohen, 1988) which considers 
the above standardized effect size of 0.37 (10/27) as a medium, and thus plausible, effect size. 
The statistical test of the effect of the targeted component (timeline) will involve a comparison of 
408 (Arm 1, 2) versus 48 (Arm 3, 4) subjects. This test may have low power, particularly if the effect 
of the targeted text is not large. However, including these arms will allow this effect to be estimated 
and thus provide some idea of its relative contribution in this exploratory analysis, as well as allow us 
to detect a large effect (if the component is responsible for a large proportion of the CSM referral 
letter effect).  
12.3 
Planned Interim Analysis 
No interim analysis is planned. 
12.4 
Final Analysis Plan 
Primary Statistical Analysis: Descriptive statistics will include frequencies (categorical variables) and 
means (continuous variables) of baseline covariates among the five intervention groups. Chi-square 
tests (for categorical variables) and t-tests (for continuous variables) will be performed to test for 
group differences (by site and overall). In our primary analysis, we will fit multivariate generalized 
linear (specifically, logistic regression) models with dental care receipt as the (binary) outcome and 
the child as the unit of analysis (as receipt of dental care will be determined for each child). A 
generalized estimating equations (GEE) approach (with an exchangeable working correlation 
structure) will be used to allow for correlations among multiple children for a given caregiver. 
Separate models will be fit for each site as well as overall. The models will include two indicator 
variables representing the three interventions. Each model will include an a priori selected set of 

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baseline variables (listed below) and, for the overall model, an indicator variable for site. Secondarily, 
we will fit a model with a site by intervention group interaction, and the latter will be tested to 
formally assess possible intervention effect heterogeneity over sites. 
We will also consider working correlation structures (e.g., alternating logistic regressions) that allow 
for second-level clusters, namely schools (within which the first-level cluster, caregiver, is nested). 
We will determine final models based on the quasi-likelihood information criterion (QIC).  
Intervention (and other covariate) effects will be tested using generalized score statistics.  
Given the parameter estimates from the above models, we use a model-based standardization 
approach (Albert et al. 2011) to estimate relative risks (i.e., the ratio of the probabilities of dental 
usage for a given pair of interventions). A bootstrap approach will be used to obtain a 95% 
confidence interval for each relative risk.  Significance will be determined using a gatekeeper 
approach to hypothesis testing. Specifically, we will first test for a difference in dental care receipt 
rates for S vs CSM+DIG (at the 0.05 nominal alpha level). If (and only if) this test is significant, we 
will proceed to test S vs. CSM alone and CSM vs CSM+DIG (both at the 0.05 nominal alpha level). 
We will use a similar approach for testing for each site. We will start by testing (for a given treatment 
comparison) an overall effect (stratifying over sites) at the 0.05 nominal alpha level. If (and only if) 
this is significant, we will then test (for the same treatment comparison) the effect within each site 
(at the 0.05 nominal alpha level). A 0.05 family-wise error level is attained in this approach assuming 
that a (true) effect for S vs. CSM+DIG implies a (true) effect for either S vs. CSM or CSM vs. 
CSM+DIG (or both), and that an overall effect implies an effect in one or both sites (which is 
logically the case). 
To test the effect of the targeted component (timeline), we will fit the same multivariate generalized 
linear (specifically, logistic regression) models mentioned above with additional indicator 
representing reduced text.  
Adjustment for Baseline Characteristics:  Estimated intervention effects (described above) will be 
adjusted for the following baseline socio-demographic variables: child’s age, race, and caregiver SES, 
education, and marital status.  
Model Assumptions: We will assume that the probabilities of dental care receipt follow the selected 
logistic regression model (controlling for covariates) mentioned above. We assume that the 
outcomes for different caregivers (or different schools if a correlation structure for two cluster levels 
is used) are independent. 
Analysis of Secondary Outcomes (Questionnaire data): Summary statistics (including means and 
standard errors) for questionnaire responses for both the IPQ-RD and behavioral intention items 
within the caregiver questionnaire will be calculated by site and intervention group. This will be done 
for the overall questionnaire (IPQ-RD and behavioral intention), for each of the five IPQ-RD 
cognitive constructs, and the two behavioral intention questions. Analyses will be done by site and 
overall (controlling for site). A summary measure approach, based on the mean questionnaire 
response, will be used to compare questionnaire outcomes across intervention groups, for the 
overall questionnaire and by construct. Specifically, for each construct (or overall) a linear regression 
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indicators and selected baseline (control) covariates as independent variables. Inferences (that is, p-
values and confidence intervals) will be performed assuming summary measures are normally 
distributed. This assumption will be tested using the Shapiro-Wilk statistic and if violated a suitable 
transformation of the summary measure used or a nonparametric approach (e.g., using ranks of the 
summary measures) conducted.  
In the event of missing questionnaire responses, we will first assess whether the data are missing 
completely at random (MCAR), that is, whether missingness for a given item is dependent only on 
participant baseline characteristics and not further on any other item responses. This will be done 
using a generalized estimating equations (GEE) approach, that is, by fitting a multivariate 
generalized linear (e.g., logistic regression) model to missing data indicators for each item, including 
as explanatory variables selected baseline covariates and other item responses, and testing for an 
effect of the latter.  
If the MCAR assumption is deemed reasonable (no significant effect found), we will conduct the 
above regression analyses with mean outcomes based on available data. A weighted analysis (that is, 
regression with the use of the weighted least squares criterion) will be conducted to adjust for 
differential missingness (thus, non-homogeneous summary measure variances) among participants. 
If the MCAR assumption is found to be violated we will use a multiple imputation approach (in 
conjunction with the summary measure approach) using a suitable imputation model (i.e., using 
other item responses). For each construct (or overall) we will perform an F-test for a difference in 
the mean summary measure among the three intervention groups, and obtain nominal 95% 
confidence intervals for pairwise mean differences. If necessary, we will include a random effect for 
school.  
In addition to assessing the overall effects of the interventions, we will investigate the mechanisms 
(or paths) through which interventions impact dental care receipt. As represented in Figure 1, we 
hypothesize that a significant portion of the intervention effect will occur via a three-link path: 
intervention will affect caregiver illness representation which will in turn affect behavioral intention 
which will in turn affect dental care receipt. Initially, we will consider an overall average score for 
caregiver illness representation and for behavioral intention. We have previously developed a 
generalized causal mediation analysis methodology (Albert and Nelson, 2011) which we can use to 
estimate and test this specific path effect. It is possible that other paths may also be involved – 
namely, a direct path (possibly involving unidentified mediators) from intervention to dental care 
receipt, and paths through either caregiver illness representation or behavioral intention alone. We 
will therefore decompose the overall effect, and estimate the contribution of each of the four 
possible paths. For each (broadly defined) mediator, we may be interested in examining multiple 
components (e.g., summary scores or factors representing specific constructs for caregiver illness 
representation, and the two questions of behavioral intention). We may thus handle each mediator in 
our model as multidimensional (that is, a vector of latent or observed variables). In addition, we will 
consider a further refinement of the model, and decomposition of the intervention effect, by 
allowing separate paths through the individual components of each mediator. The 2-week 
measurement time for the mediators reflects the hypothesized time of maximum impact of the 
intervention. However, we will make use of the 7-month measurements of the mediators to assess 
any changes in the effect of the intervention over time, as well as the relationship between the 
mediators (at alternative times) and dental care receipt.  

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As a supplementary analysis, we will use measurements of self-efficacy (from the Caregiver 
Questionnaire given at 2 weeks and exit) to test the Health Belief Model as an alternative 
explanation for the effectiveness of the experimental intervention. Specifically, the mediation effect 
though self-efficacy will be assessed using a similar model and approach as described above. The 
relative contribution of the multiple hypothesized mediators will also be examined by including them 
together in a multiple mediator model. 
 

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13  
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
Each participating site will maintain appropriate 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.  Each site 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.   
Each intervention site (CWRU, UW) will maintain appropriate research records for this study. All 
records with identifiable information will be kept in secured locked storage units. Only local (e.g., 
Outreach Workers), and CWRU, UW study personnel, the NIDCR Medical Monitor, and NIDCR 
staff appointed to the trial will have access to the records. Access by the NIDCR Medical Monitor 
and NIDCR staff is for the purposes of quality assurance reviews, audits, and evaluation of the study 
safety and progress. 
 
Specific original documents and data records include, but are not limited to: 
 
Consent chart with all participant-identifying information: Includes signed 
consent/assent forms, consent documentation, caregiver recruitment and contact form, 
unanticipated problem or adverse event report forms, and reimbursement logs. These 
documents will contain the participant’s name and other confidential information (e.g. 
names of child/children and other family members). 
 
Case Report Forms (CRF): e.g., child baseline and final follow-up ICDAS dental caries 
assessment form; child baseline and final follow-up dental screening form; Caregiver and 
IPQ-RD baseline, 2-week follow-up, and final follow-up questionnaires (paper-based 
and electronic) 
 
Non-CRF forms: e.g., progress notes checklist (paper-based) 
 
Recorded audio tapes of Outreach Workers’ phone calls (electronic; audio tapes are kept 
for only 8 weeks) 
 
Tracking logs 
 
Memoranda (paper-based) 

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14 
QUALITY CONTROL AND QUALITY ASSURANCE 
14.1 
Definitions 
Quality Assurance (QA) 
The process to ensure the quality of the intervention meets the study design expectations. 
Quality Control (QC)  
A set of routine technical activities to measure and control the quality of the intervention and 
accuracy of data acquisition as the intervention is being implemented. 
14.2 
Study Intervention and Study Questionnaires 
Quality Assurance Procedures 
The Outreach Workers and study staff, who will facilitate the receipt of intervention letters and 
access to the study questionnaires, will attend a 2-day in person training on the conduct of the study 
protocol and logistics (See MOP Section 5). In-class training will incorporate the topics of human 
subject protection, Good Clinical Practice (GCP), and the study protocol. A segment of the training 
will emphasize how data management procedures promote high-quality data collection and reduce 
threats to fidelity.  Focus will be placed on following the procedures that have been outlined in the 
protocol, principles of data management, and forms administration procedures.  All types of 
documentation will be discussed including forms filled out by participants and study forms 
completed by staff.  For each, the purpose, instructions for completion and procedures to maintain 
accuracy will be addressed. As part of tracking and managing study records, staff members will learn 
how to document activities that occur with subjects, update study documentation, and use the 
tracking logs. As part of the training, the study staff will be certified in the topics presented to ensure 
their comprehension of the expectations.   
Fidelity of the Outreach Workers’ telephone contacts with caregivers will be assessed throughout 
the study to ensure that they have not provided additional information to the childrens’ caregivers 
that might influence the outcome. (Refer to MOP Section 5).   
For reliability purposes and to further assess the stability of the IPQ-RD presumably after visits to 
the dentists (between 2 and 4 weeks), we will randomly select a sub-sample of 60 caregivers (20 each 
in arms 1, 2, and 4) to respond to the IRQ-RD after 4 weeks. 
Quality Control Procedures 
The first ten (10) Outreach Workers telephone contacts (reminder calls to return the 
questionnaires) will be audio recorded in digital media and reviewed  Then, the first ten (10) of the 
following remaining type of call will be recorded and reviewed for each Outreach Worker 
(confirmation of receipt of referral letters-calls #2, and reminders to return completed 
questionnaires-calls #4 and #6).   At the beginning of the study, the Project Coordinators will 
review the first ten telephone contacts to ensure fidelity of the calls and accuracy of data recording.  

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Outreach Workers will be provided with feedback on their performance and conduct including but 
not limited to these specific areas; adherence to telephone script, adherence to protocol/MOP, 
adherence to good clinical practice.  Outreach Workers with a telephone contact with less than 
acceptable quality will receive a private training session focused on problematic areas.  This QC 
activity will take place until the first ten sessions have been completed after implementation of the 
study intervention.  This will ensure that any weaknesses in study protocol will be addressed early.   
All data entry of study forms and questionnaires will be the responsibility of the Project 
Coordinators at each site (CWRU and UW) with overall monitoring responsibility by the Data and 
Statistics Team at CWRU.  Outreach Workers will send completed forms/questionnaires to the 
CWRU/UW for data entry where they will be stored in secured/locked file cabinets.  Each form and 
questionnaire will be entered and verified by two separate individuals.  Any field that is unclear will 
be clarified with the Outreach Worker or caregiver who completed the document.  After each 
study visit, all study forms and questionnaires collected and entered into the database will be merged 
and cross checked for inconsistencies and range and assessed for missing data.  Any inconsistencies, 
outliers, or missing data observed will be compared to the paper document and appropriate 
corrective actions carried out. 

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15 
ETHICS/PROTECTION OF HUMAN SUBJECTS 
15.1 
Ethical Standard 
The investigators 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; 62 Federal Regulations 25691 (1997).  
15.2 
Institutional Review Board 
University Hospitals Case Medical Center Institutional Review Board will serve as the IRB of record, 
with University of Washington IRB being the reliant IRB.  The University of Washington study sites 
will utilize the University Hospitals Case Medical Center IRB approved consent and assent forms. 
The protocol, informed consent form(s), recruitment materials, and all subject materials will be 
submitted to the University Hospitals Case Medical Center (FWA#: 00004428)  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/Assent 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 subjects and their families, if applicable.  A 
consent form describing in detail the study procedures and risks will be given to the subject.  
Consent forms will be IRB-approved, and the subject is required to read and review the document 
or have the document read to him or her.  The investigator or designee will explain the research 
study to the subject and answer any questions that may arise.  The subject will sign the informed 
consent document prior to any study-related assessments or procedures.  Subjects 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 signed informed consent document will be given to subjects for their records.  The rights and 
welfare of the subjects 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 research record.   
Informed consent is acquired once at the start of the academic school year from the 
parent(s)/caregiver(s) who choose to participate in the study.  The informed consent process begins 
prior to the parent(s)/caregiver(s) agreeing to be in the study and continues for the entire time 
he/she is in the study. Informed consent must be acquired in order to allow K-4th grade children to 
undergo the screening exam, and prior to the parent/caregiver’s completion of the baseline IPQ-RD 
and Parent Questionnaire and randomization into the trial.  Additionally, assent will be obtained 
from children in 3rd and 4th grades who are  7 years of age or older. Site-specific written informed 
consent and assent will be obtained from all study participants using only the stamped approved 

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forms (See Appendix B). Consent/Assent from the participant will be obtained by the project staff 
prior to enrollment and the participant can withdraw consent at any time during the study. The 
project staff will briefly explain the research study and answer any questions. The project staff will 
discuss the possible benefits and risks related to taking part in the study. The rights and welfare of 
the children will be protected by emphasizing to them that the quality of their care will not be 
adversely affected in the event that the parent(s)/caregiver(s) do not want to be contacted to 
participate in the clinical trial phase of the project. If the parent(s)/caregiver(s) are unsure about 
participating he/she may take the study information and flyer home to discuss with his/her family 
or to think about it prior to agreeing. Once informed consent is obtained via the University 
Hospitals Case Medical Center consent form, consent continues for the entire time the 
parent/guardian is in the study. The study participants will receive a copy of the signed and dated 
consent/assent document. The study personnel will maintain the documentation of consent/assent 
in the consent documentation form (see MOP; Appendices Section  3).  
15.4 
Subject Confidentiality 
Subject confidentiality is strictly held in trust by the PI and Clinical Site Investigator, their staff, 
representatives for University Hospitals Case Medical Center Institutional Review Board, and the 
representatives of the study sponsor (NIDCR). This confidentiality is extended to cover mental 
status in addition to the clinical information relating to participating subjects. 
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 documents 
and records required to be maintained by the investigator. The intervention site will permit access to 
such records. 

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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 
subjects, including accurate case report forms (CRFs), and source documentation. (See MOP Section 
10) 
16.1 
Data Management Responsibilities 
Data collection and accurate documentation are the responsibility of the Outreach Workers and 
Project Coordinators under the supervision of the PI and Clinical Site 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 PI.   
16.2 
Data Capture Methods 
Data for this study are captured using examinations, forms, questionnaires, and audio recordings.  
Study data will be collected and stored using the REDCap platform. REDCap is a secure, web-based 
application designed to support remote data capture for research studies, providing: 1) an intuitive 
interface for validated data entry, 2) audit trails for tracking data manipulation and export 
procedures, 3) automated export procedures for seamless data downloads to common statistical 
packages, and 4) procedures for importing data from external sources. 
Study forms will be completed by study personnel on paper, and subsequently entered into REDCap 
by study staff. Because randomization is contingent upon the computer, no paper randomization 
forms will be completed. Paper forms will be securely stored in a locked file cabinet at both sites 
when they are not in use. Completed paper forms will be transferred between sites via courier or 
other secure document service. Similarly, questionnaires used in the study (IPQ-RD, Caregiver 
Questionnaire) will be completed by subjects on paper sheets and returned to Outreach Workers in 
each school. Study staff will enter the information into the secure web-based REDCap system.  
Recorded audios will be stored in secured/locked cabinets in one of the Project Coordinators’ 
offices.  
16.3 
Types of Data 
Data for this study will include: (1) dental examination data; and (2) study questionnaires.  
Additionally, audio tapes will be used for fidelity monitoring.  Form revisions should be minimal, 
however, should they occur, changes will be submitted to the study team for updating and 
dissemination to Outreach Workers. 
16.4 
Schedule and Content of Reports 
Dental examination and study questionnaire data will be reviewed for accuracy and completeness 
after each study visit.  The Outreach Workers will review the questionnaires after the participants 
have completed them, and the Project Coordinators and the Data and Statistics Team will do a 
final review after the documents have been transmitted.  An annual report (or as requested by the 

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NIDCR Medical Monitor or NIDCR Program Official) will also be generated for sharing progress 
of the study. 
The Data & Statistics Team will generate regular reports showing enrollment and potential 
data anomalies, which will be sent to PIs, Project Coordinators, and other relevant study staff. The 
Data Manager will work with the PIs at each site to resolve any data anomalies that arise during 
recruitment. The Data & Statistics Team will also respond to data queries generated by the PIs, 
Project Coordinators, or other study staff. 
Statistical analyses and summary reports will be generated by the study Biostatistician during 
the course of the study. At the end of the study, the study Biostatistician will conduct analyses of the 
data and assist in preparation of study publications and presentations. The Data Manager will 
provide technical and data support for the Biostatistician throughout the study. 
16.5 
Study Records Retention 
Study documents should be retained for 6 years after the completion of the study. These documents 
may be retained for a longer period, however, if required by local regulations or determined 
necessary by the NIDCR Medical Monitor, NIDCR PO, or UHCMC IRB.  No records will be 
destroyed without the written approval of the NIDCR.   
16.6 
Protocol Deviations 
A protocol deviation is any noncompliance with the clinical study protocol, Good Clinical Practice, 
or Manual of Procedures requirements.  The noncompliance may be on the part of the subject, the 
investigator, or study staff (e.g., Project Coordinators, Outreach Workers).  As a result of deviations, 
corrective actions are to be developed by the PI and/or Project Coordinator, 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 promptly 
reported to NIDCR and the UHCMC and/or UW IRBs, according to their requirements.   
 
 

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17  
PUBLICATION 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. The Executive Committee will be responsible for developing publication 
procedures, resolving authorship issues, and informing the NIDCR Program Official regarding 
potential publications or presentations.  
The International Committee of Medical Journal Editors (ICMJE) member journals have adopted a 
clinical trials registration policy as a condition for publication.  The ICMJE defines a clinical trial as 
any research project that prospectively assigns human subjects to intervention or concurrent 
comparison or control groups to study the cause-and-effect relationship between a medical 
intervention and a health outcome.  Medical interventions include drugs, surgical procedures, 
devices, behavioral treatments, process-of-care changes, and the like.  Health outcomes include any 
biomedical or health-related measures obtained in patients or participants, including 
pharmacokinetic measures and adverse events. The ICMJE policy requires that all clinical trials be 
registered in a public trials registry such as ClinicalTrials.gov, which is sponsored by the National 
Library of Medicine.  Other biomedical journals are considering adopting similar policies. For 
interventional clinical trials performed under NIDCR grants and cooperative agreements, it is the 
grantee’s responsibility to register the trial in an acceptable registry, so the research results may be 
considered for publication in ICMJE member journals.  The ICMJE does not review specific studies 
to determine whether registration is necessary; instead, the committee recommends that researchers 
who have questions about the need to register err on the side of registration or consult the editorial 
office of the journal in which they wish to publish. 
U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007 or FDAAA), 
Title VIII, Section 801 mandates that a "responsible party" (i.e., the sponsor or designated principal 
investigator) register and report results of certain "applicable clinical trials:" NIH grantees must take 
specific steps to ensure compliance with NIH implementation of FDAAA. 
Additionally, we will follow the publication policies outlined in the Cooperative Agreement Terms 
and Conditions from NIDCR as excerpted below: 
Each publication, press release or other document that cites results from NIH grant-supported 
research must include an acknowledgment of NIH grant support and disclaimer such as “The 
project described was supported by Award Number TBD from the National Institute of Dental & Craniofacial Research. The 
content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of 
Dental & Craniofacial Research or the National Institutes of Health.” 
*Journal Citation: 
 

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De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the 
International Committee of Medical Journal Editors. N Engl J Med. 2004;351:1250-1. 
 

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18 
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SUPPLEMENTAL MATERIALS 
These documents are relevant to the protocol, but they are not considered part of the 
protocol.  They are stored and modified separately. As such, modifications to these 
documents do not require protocol amendments. 
 Manual of Procedures 
 Case report forms 
 Statistical Analysis Plan 
 
 
 
 
 

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APPENDIX A:  Schedule of Events 
 
 
 
Screening 
 
Study Visit 1 
/
 
Study Visit 2 
 
Study Visit Final (7-8 
months after initial 
 
Premature 
Signed Consent/Assent Form 
 
 
 
 
 
Assessment of Eligibility 
Criteria 
X 
X 
 
 
 
Study Intervention – Referral 
Letters 
 
X 
 
 
 
Questionnaires (IPQ-RD, 
Caregiver), demographic info 
 
X 
X 
X 
X 
School dental examinations 
 
 
 
 
 
Person contact 
X 
X 
 
 
 
Telephone contact 
X 
X 
X 
X 
(X) 
Mail contact 
 
 
X 
X 
(X) 
Assessment of Adverse Events 
 
 
(X) 
(X) 
(X) 
 
(X) – As indicated/appropriate 
 
 
 
 
 

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APPENDIX B:  Consent forms 
 
1. UHCMC Consent form 
2. UHCMC Assent form 
3.  UHCMC Consent form (examiner training) 
4.  UHCMC Assent form (examiner training) 
5. UHCMC Consent form (Spanish) 
6. UHCMC Assent form (Spanish) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX C:  IPQ-RD and Caregiver Questionnaire 
 
In English: 
1. Baseline IPQ-RD  
2. Baseline Caregiver Questionnaire  
3. 2-week Follow-up IPQ-RD  
4. 2-week Follow-up Caregiver Questionnaire  
5. Final Follow-up IPQ-RD  
6. Final Follow-up Caregiver Questionnaire  
 
In Spanish:  
1. Baseline IPQ-RD  
2. Baseline Caregiver Questionnaire  
3. 2-week Follow-up IPQ-RD  
4. 2-week Follow-up Caregiver Questionnaire  
5. Final Follow-up IPQ-RD  
6. Final Follow-up Caregiver Questionnaire 
 
 
 
 
 

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