Trial Outcomes & Findings for Family Access to Dentist Study (NCT NCT02395120)

Last Updated: 2022-06-16

Results Overview

The primary outcome was receipt of dental care based on a change in the child's oral health status, as determined by clinical examinations between baseline screening (beginning of schoolyear) and follow-up at study exit (end of school year). A child was classified as having received dental care if she or he had any tooth at follow-up with an ICDAS sealant code (1 or 2),restoration code (3 to 8), or extraction code (X), previously identified at baseline via an active ICDAS lesion code ≥2.

Recruitment status

COMPLETED

Study phase

Target enrollment

1305 participants

Primary outcome timeframe

Between baseline and follow-up (7 months after baseline)

Results posted on

2022-06-16

Participant Flow

Children in grades K-4 and their caregivers were recruited from six school districts in Ohio and Washington (14 schools) in school years 2015/2016 and 2016/2017 to participate in the baseline dental screening at the beginning of the year (phase 1). Those with untreated cavities were eligible to participate in the clinical trial phase of the study (phase 2).

Out of 1,584 children screened, 694 had untreated cavities that needed restorative care. Caregivers were randomized if their child had any tooth with an International Caries Detection and Assessment System (ICDAS) active lesion score ≥2. The caregivers (n=611) and their children (694) were randomized to the 5 arms of the study. 97children transferred or were absent for the baseline dental exam days.

Participant milestones

Participant milestones
Measure	Intervention Letter The CSM-based referral letter alone will be sent to caregivers Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control).	Intervention Letter+DIG The CSM-based referral letter with the dental information guide will be sent to caregivers. Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control). DIG: Dental information guide (DIG) to reinforce/change illness perception, knowledge about dental caries, and resources to seek care. DIG 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.	Reduced Intervention Letter The reduced (removing text corresponding to "timeline") CSM-based referral letter alone will be sent to caregivers. Reduced intervention letter: Reduced (removing text corresponding to "timeline") CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control).	Reduced Intervention Letter+Reduced DIG The reduced CSM-based referral letter with the reduced dental information guide will be sent to caregivers. Reduced intervention letter: Reduced (removing text corresponding to "timeline") CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control). Reduced DIG: Text and illustrations related to the "timeline" construct of the CSM have been removed in the reduced dental information guide.	Standard Letter Modified standard letter will be sent to caregivers. Standard letter: Standard referral letter according to Ohio Department of Health Bureau guidelines. This letter is consistent with others used across the country.
Overall Study STARTED	400	398	43	63	401
Overall Study Started-Caregivers	188	188	20	28	187
Overall Study Started-Children	212	210	23	35	214
Overall Study Completed-Caregivers	161	159	17	25	164
Overall Study Completed-Children	182	177	20	32	186
Overall Study COMPLETED	343	336	37	57	350
Overall Study NOT COMPLETED	57	62	6	6	51

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Letter The CSM-based referral letter alone will be sent to caregivers Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control).	Intervention Letter+DIG The CSM-based referral letter with the dental information guide will be sent to caregivers. Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control). DIG: Dental information guide (DIG) to reinforce/change illness perception, knowledge about dental caries, and resources to seek care. DIG 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.	Reduced Intervention Letter The reduced (removing text corresponding to "timeline") CSM-based referral letter alone will be sent to caregivers. Reduced intervention letter: Reduced (removing text corresponding to "timeline") CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control).	Reduced Intervention Letter+Reduced DIG The reduced CSM-based referral letter with the reduced dental information guide will be sent to caregivers. Reduced intervention letter: Reduced (removing text corresponding to "timeline") CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control). Reduced DIG: Text and illustrations related to the "timeline" construct of the CSM have been removed in the reduced dental information guide.	Standard Letter Modified standard letter will be sent to caregivers. Standard letter: Standard referral letter according to Ohio Department of Health Bureau guidelines. This letter is consistent with others used across the country.
Overall Study Missed follow-up dental exam	57	62	6	6	51

Baseline Characteristics

The analysis population differs from the overall population due to missing data and including only the age of the caregivers. The age of the children was not collected as inclusion criteria was based on the grade of the child (K-4), not on age.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Letter n=400 Participants The CSM-based referral letter alone will be sent to caregivers Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control).	Intervention Letter+DIG n=398 Participants The CSM-based referral letter with the dental information guide will be sent to caregivers. Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control). DIG: Dental information guide (DIG) to reinforce/change illness perception, knowledge about dental caries, and resources to seek care. DIG 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.	Reduced Intervention Letter n=43 Participants The reduced (removing text corresponding to "timeline") CSM-based referral letter alone will be sent to caregivers. Reduced intervention letter: Reduced (removing text corresponding to "timeline") CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control).	Reduced Intervention Letter+Reduced DIG n=63 Participants The reduced CSM-based referral letter with the reduced dental information guide will be sent to caregivers. Reduced intervention letter: Reduced (removing text corresponding to "timeline") CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control). Reduced DIG: Text and illustrations related to the "timeline" construct of the CSM have been removed in the reduced dental information guide.	Standard Letter n=401 Participants Modified standard letter will be sent to caregivers. Standard letter: Standard referral letter according to Ohio Department of Health Bureau guidelines. This letter is consistent with others used across the country.	Total n=1305 Participants Total of all reporting groups
Age, Continuous Caregiver Age	34.06 years STANDARD_DEVIATION 7.09 • n=161 Participants • The analysis population differs from the overall population due to missing data and including only the age of the caregivers. The age of the children was not collected as inclusion criteria was based on the grade of the child (K-4), not on age.	34.63 years STANDARD_DEVIATION 9.78 • n=159 Participants • The analysis population differs from the overall population due to missing data and including only the age of the caregivers. The age of the children was not collected as inclusion criteria was based on the grade of the child (K-4), not on age.	31.46 years STANDARD_DEVIATION 3.5 • n=17 Participants • The analysis population differs from the overall population due to missing data and including only the age of the caregivers. The age of the children was not collected as inclusion criteria was based on the grade of the child (K-4), not on age.	34.22 years STANDARD_DEVIATION 8.16 • n=25 Participants • The analysis population differs from the overall population due to missing data and including only the age of the caregivers. The age of the children was not collected as inclusion criteria was based on the grade of the child (K-4), not on age.	32.55 years STANDARD_DEVIATION 8.15 • n=164 Participants • The analysis population differs from the overall population due to missing data and including only the age of the caregivers. The age of the children was not collected as inclusion criteria was based on the grade of the child (K-4), not on age.	33.7 years STANDARD_DEVIATION 8.4 • n=526 Participants • The analysis population differs from the overall population due to missing data and including only the age of the caregivers. The age of the children was not collected as inclusion criteria was based on the grade of the child (K-4), not on age.
Sex: Female, Male Caregiver Sex · Female	165 Participants n=179 Participants • The analysis population differs from the overall population due to missing data for some participants.	166 Participants n=180 Participants • The analysis population differs from the overall population due to missing data for some participants.	16 Participants n=17 Participants • The analysis population differs from the overall population due to missing data for some participants.	21 Participants n=23 Participants • The analysis population differs from the overall population due to missing data for some participants.	166 Participants n=179 Participants • The analysis population differs from the overall population due to missing data for some participants.	534 Participants n=578 Participants • The analysis population differs from the overall population due to missing data for some participants.
Sex: Female, Male Caregiver Sex · Male	14 Participants n=179 Participants • The analysis population differs from the overall population due to missing data for some participants.	14 Participants n=180 Participants • The analysis population differs from the overall population due to missing data for some participants.	1 Participants n=17 Participants • The analysis population differs from the overall population due to missing data for some participants.	2 Participants n=23 Participants • The analysis population differs from the overall population due to missing data for some participants.	13 Participants n=179 Participants • The analysis population differs from the overall population due to missing data for some participants.	44 Participants n=578 Participants • The analysis population differs from the overall population due to missing data for some participants.
Sex: Female, Male Children Sex · Female	110 Participants n=196 Participants • The analysis population differs from the overall population due to missing data for some participants.	121 Participants n=202 Participants • The analysis population differs from the overall population due to missing data for some participants.	11 Participants n=20 Participants • The analysis population differs from the overall population due to missing data for some participants.	12 Participants n=26 Participants • The analysis population differs from the overall population due to missing data for some participants.	107 Participants n=202 Participants • The analysis population differs from the overall population due to missing data for some participants.	361 Participants n=646 Participants • The analysis population differs from the overall population due to missing data for some participants.
Sex: Female, Male Children Sex · Male	86 Participants n=196 Participants • The analysis population differs from the overall population due to missing data for some participants.	81 Participants n=202 Participants • The analysis population differs from the overall population due to missing data for some participants.	9 Participants n=20 Participants • The analysis population differs from the overall population due to missing data for some participants.	14 Participants n=26 Participants • The analysis population differs from the overall population due to missing data for some participants.	95 Participants n=202 Participants • The analysis population differs from the overall population due to missing data for some participants.	285 Participants n=646 Participants • The analysis population differs from the overall population due to missing data for some participants.
Ethnicity (NIH/OMB) Caregiver Ethnicity · Hispanic or Latino	21 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	16 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	2 Participants n=20 Participants • The analysis population is reported separately for caregivers and children.	2 Participants n=28 Participants • The analysis population is reported separately for caregivers and children.	11 Participants n=187 Participants • The analysis population is reported separately for caregivers and children.	52 Participants n=611 Participants • The analysis population is reported separately for caregivers and children.
Ethnicity (NIH/OMB) Caregiver Ethnicity · Not Hispanic or Latino	79 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	83 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	8 Participants n=20 Participants • The analysis population is reported separately for caregivers and children.	12 Participants n=28 Participants • The analysis population is reported separately for caregivers and children.	85 Participants n=187 Participants • The analysis population is reported separately for caregivers and children.	267 Participants n=611 Participants • The analysis population is reported separately for caregivers and children.
Ethnicity (NIH/OMB) Caregiver Ethnicity · Unknown or Not Reported	88 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	89 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	10 Participants n=20 Participants • The analysis population is reported separately for caregivers and children.	14 Participants n=28 Participants • The analysis population is reported separately for caregivers and children.	91 Participants n=187 Participants • The analysis population is reported separately for caregivers and children.	292 Participants n=611 Participants • The analysis population is reported separately for caregivers and children.
Ethnicity (NIH/OMB) Children Ethnicity · Hispanic or Latino	23 Participants n=212 Participants • The analysis population is reported separately for caregivers and children.	19 Participants n=210 Participants • The analysis population is reported separately for caregivers and children.	4 Participants n=23 Participants • The analysis population is reported separately for caregivers and children.	4 Participants n=35 Participants • The analysis population is reported separately for caregivers and children.	25 Participants n=214 Participants • The analysis population is reported separately for caregivers and children.	75 Participants n=694 Participants • The analysis population is reported separately for caregivers and children.
Ethnicity (NIH/OMB) Children Ethnicity · Not Hispanic or Latino	89 Participants n=212 Participants • The analysis population is reported separately for caregivers and children.	89 Participants n=210 Participants • The analysis population is reported separately for caregivers and children.	8 Participants n=23 Participants • The analysis population is reported separately for caregivers and children.	15 Participants n=35 Participants • The analysis population is reported separately for caregivers and children.	88 Participants n=214 Participants • The analysis population is reported separately for caregivers and children.	289 Participants n=694 Participants • The analysis population is reported separately for caregivers and children.
Ethnicity (NIH/OMB) Children Ethnicity · Unknown or Not Reported	100 Participants n=212 Participants • The analysis population is reported separately for caregivers and children.	102 Participants n=210 Participants • The analysis population is reported separately for caregivers and children.	11 Participants n=23 Participants • The analysis population is reported separately for caregivers and children.	16 Participants n=35 Participants • The analysis population is reported separately for caregivers and children.	101 Participants n=214 Participants • The analysis population is reported separately for caregivers and children.	330 Participants n=694 Participants • The analysis population is reported separately for caregivers and children.
Race (NIH/OMB) Caregiver Race · American Indian or Alaska Native	1 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	0 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	0 Participants n=20 Participants • The analysis population is reported separately for caregivers and children.	0 Participants n=28 Participants • The analysis population is reported separately for caregivers and children.	0 Participants n=187 Participants • The analysis population is reported separately for caregivers and children.	1 Participants n=611 Participants • The analysis population is reported separately for caregivers and children.
Race (NIH/OMB) Caregiver Race · Asian	1 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	1 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	0 Participants n=20 Participants • The analysis population is reported separately for caregivers and children.	0 Participants n=28 Participants • The analysis population is reported separately for caregivers and children.	0 Participants n=187 Participants • The analysis population is reported separately for caregivers and children.	2 Participants n=611 Participants • The analysis population is reported separately for caregivers and children.
Race (NIH/OMB) Caregiver Race · Native Hawaiian or Other Pacific Islander	0 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	2 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	0 Participants n=20 Participants • The analysis population is reported separately for caregivers and children.	0 Participants n=28 Participants • The analysis population is reported separately for caregivers and children.	2 Participants n=187 Participants • The analysis population is reported separately for caregivers and children.	4 Participants n=611 Participants • The analysis population is reported separately for caregivers and children.
Race (NIH/OMB) Caregiver Race · Black or African American	90 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	88 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	9 Participants n=20 Participants • The analysis population is reported separately for caregivers and children.	11 Participants n=28 Participants • The analysis population is reported separately for caregivers and children.	92 Participants n=187 Participants • The analysis population is reported separately for caregivers and children.	290 Participants n=611 Participants • The analysis population is reported separately for caregivers and children.
Race (NIH/OMB) Caregiver Race · White	47 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	54 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	6 Participants n=20 Participants • The analysis population is reported separately for caregivers and children.	7 Participants n=28 Participants • The analysis population is reported separately for caregivers and children.	56 Participants n=187 Participants • The analysis population is reported separately for caregivers and children.	170 Participants n=611 Participants • The analysis population is reported separately for caregivers and children.
Race (NIH/OMB) Caregiver Race · More than one race	5 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	8 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	1 Participants n=20 Participants • The analysis population is reported separately for caregivers and children.	2 Participants n=28 Participants • The analysis population is reported separately for caregivers and children.	7 Participants n=187 Participants • The analysis population is reported separately for caregivers and children.	23 Participants n=611 Participants • The analysis population is reported separately for caregivers and children.
Race (NIH/OMB) Caregiver Race · Unknown or Not Reported	44 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	35 Participants n=188 Participants • The analysis population is reported separately for caregivers and children.	4 Participants n=20 Participants • The analysis population is reported separately for caregivers and children.	8 Participants n=28 Participants • The analysis population is reported separately for caregivers and children.	30 Participants n=187 Participants • The analysis population is reported separately for caregivers and children.	121 Participants n=611 Participants • The analysis population is reported separately for caregivers and children.
Race (NIH/OMB) Children Race · American Indian or Alaska Native	1 Participants n=202 Participants • The analysis population is reported separately for caregivers and children.	0 Participants n=200 Participants • The analysis population is reported separately for caregivers and children.	0 Participants n=20 Participants • The analysis population is reported separately for caregivers and children.	0 Participants n=26 Participants • The analysis population is reported separately for caregivers and children.	0 Participants n=198 Participants • The analysis population is reported separately for caregivers and children.	1 Participants n=646 Participants • The analysis population is reported separately for caregivers and children.
Race (NIH/OMB) Children Race · Asian	1 Participants n=202 Participants • The analysis population is reported separately for caregivers and children.	1 Participants n=200 Participants • The analysis population is reported separately for caregivers and children.	0 Participants n=20 Participants • The analysis population is reported separately for caregivers and children.	0 Participants n=26 Participants • The analysis population is reported separately for caregivers and children.	0 Participants n=198 Participants • The analysis population is reported separately for caregivers and children.	2 Participants n=646 Participants • The analysis population is reported separately for caregivers and children.
Race (NIH/OMB) Children Race · Native Hawaiian or Other Pacific Islander	0 Participants n=202 Participants • The analysis population is reported separately for caregivers and children.	2 Participants n=200 Participants • The analysis population is reported separately for caregivers and children.	0 Participants n=20 Participants • The analysis population is reported separately for caregivers and children.	0 Participants n=26 Participants • The analysis population is reported separately for caregivers and children.	2 Participants n=198 Participants • The analysis population is reported separately for caregivers and children.	4 Participants n=646 Participants • The analysis population is reported separately for caregivers and children.
Race (NIH/OMB) Children Race · Black or African American	97 Participants n=202 Participants • The analysis population is reported separately for caregivers and children.	90 Participants n=200 Participants • The analysis population is reported separately for caregivers and children.	11 Participants n=20 Participants • The analysis population is reported separately for caregivers and children.	13 Participants n=26 Participants • The analysis population is reported separately for caregivers and children.	82 Participants n=198 Participants • The analysis population is reported separately for caregivers and children.	293 Participants n=646 Participants • The analysis population is reported separately for caregivers and children.
Race (NIH/OMB) Children Race · White	51 Participants n=202 Participants • The analysis population is reported separately for caregivers and children.	50 Participants n=200 Participants • The analysis population is reported separately for caregivers and children.	5 Participants n=20 Participants • The analysis population is reported separately for caregivers and children.	8 Participants n=26 Participants • The analysis population is reported separately for caregivers and children.	48 Participants n=198 Participants • The analysis population is reported separately for caregivers and children.	162 Participants n=646 Participants • The analysis population is reported separately for caregivers and children.
Race (NIH/OMB) Children Race · More than one race	5 Participants n=202 Participants • The analysis population is reported separately for caregivers and children.	11 Participants n=200 Participants • The analysis population is reported separately for caregivers and children.	2 Participants n=20 Participants • The analysis population is reported separately for caregivers and children.	0 Participants n=26 Participants • The analysis population is reported separately for caregivers and children.	8 Participants n=198 Participants • The analysis population is reported separately for caregivers and children.	26 Participants n=646 Participants • The analysis population is reported separately for caregivers and children.
Race (NIH/OMB) Children Race · Unknown or Not Reported	47 Participants n=202 Participants • The analysis population is reported separately for caregivers and children.	46 Participants n=200 Participants • The analysis population is reported separately for caregivers and children.	2 Participants n=20 Participants • The analysis population is reported separately for caregivers and children.	5 Participants n=26 Participants • The analysis population is reported separately for caregivers and children.	58 Participants n=198 Participants • The analysis population is reported separately for caregivers and children.	158 Participants n=646 Participants • The analysis population is reported separately for caregivers and children.
Education Greater than high school	82 Participants n=155 Participants • Data is provided for caregivers. Children were all in grades K-4. The analysis population differs from the overall population due to missing data for some participants.	89 Participants n=166 Participants • Data is provided for caregivers. Children were all in grades K-4. The analysis population differs from the overall population due to missing data for some participants.	8 Participants n=15 Participants • Data is provided for caregivers. Children were all in grades K-4. The analysis population differs from the overall population due to missing data for some participants.	9 Participants n=16 Participants • Data is provided for caregivers. Children were all in grades K-4. The analysis population differs from the overall population due to missing data for some participants.	75 Participants n=161 Participants • Data is provided for caregivers. Children were all in grades K-4. The analysis population differs from the overall population due to missing data for some participants.	263 Participants n=513 Participants • Data is provided for caregivers. Children were all in grades K-4. The analysis population differs from the overall population due to missing data for some participants.
Education Less than or equal to high school	73 Participants n=155 Participants • Data is provided for caregivers. Children were all in grades K-4. The analysis population differs from the overall population due to missing data for some participants.	77 Participants n=166 Participants • Data is provided for caregivers. Children were all in grades K-4. The analysis population differs from the overall population due to missing data for some participants.	7 Participants n=15 Participants • Data is provided for caregivers. Children were all in grades K-4. The analysis population differs from the overall population due to missing data for some participants.	7 Participants n=16 Participants • Data is provided for caregivers. Children were all in grades K-4. The analysis population differs from the overall population due to missing data for some participants.	86 Participants n=161 Participants • Data is provided for caregivers. Children were all in grades K-4. The analysis population differs from the overall population due to missing data for some participants.	250 Participants n=513 Participants • Data is provided for caregivers. Children were all in grades K-4. The analysis population differs from the overall population due to missing data for some participants.
Marital Status Married	50 Participants n=156 Participants • Data is provided for caregivers. The Analysis population also differs from the overall population due to missing data for some participants.	42 Participants n=167 Participants • Data is provided for caregivers. The Analysis population also differs from the overall population due to missing data for some participants.	5 Participants n=15 Participants • Data is provided for caregivers. The Analysis population also differs from the overall population due to missing data for some participants.	4 Participants n=16 Participants • Data is provided for caregivers. The Analysis population also differs from the overall population due to missing data for some participants.	45 Participants n=163 Participants • Data is provided for caregivers. The Analysis population also differs from the overall population due to missing data for some participants.	146 Participants n=517 Participants • Data is provided for caregivers. The Analysis population also differs from the overall population due to missing data for some participants.
Marital Status Other	106 Participants n=156 Participants • Data is provided for caregivers. The Analysis population also differs from the overall population due to missing data for some participants.	125 Participants n=167 Participants • Data is provided for caregivers. The Analysis population also differs from the overall population due to missing data for some participants.	10 Participants n=15 Participants • Data is provided for caregivers. The Analysis population also differs from the overall population due to missing data for some participants.	12 Participants n=16 Participants • Data is provided for caregivers. The Analysis population also differs from the overall population due to missing data for some participants.	118 Participants n=163 Participants • Data is provided for caregivers. The Analysis population also differs from the overall population due to missing data for some participants.	371 Participants n=517 Participants • Data is provided for caregivers. The Analysis population also differs from the overall population due to missing data for some participants.

PRIMARY outcome

Timeframe: Between baseline and follow-up (7 months after baseline)

Population: Participants analyzed for the primary outcome are children.

Outcome measures

Outcome measures
Measure	Intervention Letter n=182 Participants The CSM-based referral letter alone will be sent to caregivers Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control).	Intervention Letter+DIG n=177 Participants The CSM-based referral letter with the dental information guide will be sent to caregivers. Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control). DIG: Dental information guide (DIG) to reinforce/change illness perception, knowledge about dental caries, and resources to seek care. DIG 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.	Reduced Intervention Letter n=20 Participants The reduced (removing text corresponding to "timeline") CSM-based referral letter alone will be sent to caregivers. Reduced intervention letter: Reduced (removing text corresponding to "timeline") CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control).	Reduced Intervention Letter+Reduced DIG n=32 Participants The reduced CSM-based referral letter with the reduced dental information guide will be sent to caregivers. Reduced intervention letter: Reduced (removing text corresponding to "timeline") CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control). Reduced DIG: Text and illustrations related to the "timeline" construct of the CSM have been removed in the reduced dental information guide.	Standard Letter n=186 Participants Modified standard letter will be sent to caregivers. Standard letter: Standard referral letter according to Ohio Department of Health Bureau guidelines. This letter is consistent with others used across the country.
Number of Participants With Receipt of Dental Care-restoration or Extraction of at Least One Tooth at Final Exam	68 Participants	76 Participants	8 Participants	14 Participants	71 Participants

SECONDARY outcome

Timeframe: Between baseline and final follow-up

Population: Analysis was completed for caregivers who completed the final follow-up IPQ-RD Questionnaire.

Change in the overall Illness Perception Questionnaire-Revised for Dental (IPQ-RD) mean score from baseline to the final data collection timepoint. The IPQ-RD is a 32 item instrument with scale responses going from 1 to 5 (strongly agree to strongly disagree) with strongly agree and agree being an accurate response. This was converted to an accurate (1,2) and inaccurate (3,4,5) dichotomous variable for each IPQ-RD item. A proportion of accurate responses was calculated for each participant (i.e. number of accurate responses divided by the total number of IPQ-RD items). The mean proportion of accurate responses was calculated as the average for the total number of participants who completed the IPQ-RD instrument. Since a lower score on the IPQ-RD is an accurate response, the difference of baseline minus final follow-up results in a negative score meaning an improved score from baseline.

Outcome measures

Outcome measures
Measure	Intervention Letter n=86 Participants The CSM-based referral letter alone will be sent to caregivers Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control).	Intervention Letter+DIG n=94 Participants The CSM-based referral letter with the dental information guide will be sent to caregivers. Intervention letter: Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control). DIG: Dental information guide (DIG) to reinforce/change illness perception, knowledge about dental caries, and resources to seek care. DIG 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.	Reduced Intervention Letter n=13 Participants The reduced (removing text corresponding to "timeline") CSM-based referral letter alone will be sent to caregivers. Reduced intervention letter: Reduced (removing text corresponding to "timeline") CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control).	Reduced Intervention Letter+Reduced DIG n=12 Participants The reduced CSM-based referral letter with the reduced dental information guide will be sent to caregivers. Reduced intervention letter: Reduced (removing text corresponding to "timeline") CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control). Reduced DIG: Text and illustrations related to the "timeline" construct of the CSM have been removed in the reduced dental information guide.	Standard Letter n=98 Participants Modified standard letter will be sent to caregivers. Standard letter: Standard referral letter according to Ohio Department of Health Bureau guidelines. This letter is consistent with others used across the country.
Change in Illness Perception Assessed by IPQ-RD	-2.65 mean proportion of accurate responses Standard Deviation 18.24	-2.79 mean proportion of accurate responses Standard Deviation 19.09	-1.96 mean proportion of accurate responses Standard Deviation 18.80	1.96 mean proportion of accurate responses Standard Deviation 25.62	-1.10 mean proportion of accurate responses Standard Deviation 19.51

SECONDARY outcome

Timeframe: Final follow-up (7 months)

Population: Analysis was done for caregivers completing the question at the final timepoint.

Behavioral intention is measured by the percent of "yes" responses to the item "I want to take my child to the dentist" and "I plan to take my child to the dentist". Caregivers who have taken the child to the dentist will skip this question at follow-up.