Early Childhood CariesPROTECTNCT07220850
Oral Health Intervention for Caregivers of Children Presenting for Dental Surgery
A study testing Behavioral Treatment in people with Early Childhood Caries, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Too many young children, particularly those living in poverty, present for dental surgery under anesthesia - an expensive, potentially dangerous, short-term fix that often results in recurring oral health disease and subsequent surgeries. Dr. Helen Lee, an anesthesiologist, and Dr. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- Behavioral Treatment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2025to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- caregivers of child patients who are in the same household greater than or equal to 50% of the week
- caregivers aged 18-90 years
- caregivers with access to a computer or a telephone
- child patients that are less than 96 months of age at the time of enrollment scheduled for DGA at the UIC clinic
Who cannot join
- surgical child is foster status
- families who are planning to move out of state within the six-month period
- children with systemic health issues as classified by American Society of Anesthesiology Classification of greater than or equal to 3, or a mental health condition such as autism/developmental delay, as medical complexity is associated with other issues that influence a child's health behaviors and caregiver-child interactions
- and adults unable to consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
College of Dentistry (MC 621)
Chicago, Illinois, 60612
David Avenetti, MD, 312.996.7555, avenetti@uic.edu
About this study
Official title: Testing a Multi-behavioral Intervention to Improve Oral Health Behaviors in the Pediatric Dental Surgery Population
Too many young children, particularly those living in poverty, present for dental surgery under anesthesia - an expensive, potentially dangerous, short-term fix that often results in recurring oral health disease and subsequent surgeries. Dr. Helen Lee, an anesthesiologist, and Dr. Joanna Buscemi, a clinical health psychologist, recognized that to decrease need for surgeries, caregivers need resources and support to build their skills and knowledge around managing their child's oral health. After 5 years of relationship-building, publishing preliminary qualitative work, and building a team with the appropriate skills and knowledge, investigators developed a grant application to develop and test a parenting intervention for caregivers of preschool- aged children presenting for dental surgery.
With support from the National Institute of Dental and Craniofacial Research (NIDCR) of the National Institutes of Health (NIH), the team created the PROTECT intervention with a focus on providing caregivers with parenting and behavioral tools to help improve tooth brushing and lower added sugar intake while simultaneously addressing social determinants of health that make behavior change more difficult. Community health workers will engage with caregivers for 6 months following the child's surgery to deliver PROTECT and support parents in behavioral change. A surgical event is a unique opportunity to change behaviors in systemically oppressed families that have manifested a need for behavior change. This intervention will meet caregivers needs at a critical time when risk disease recurrence intersects with a desire to change. This work has the potential to not only improve oral health of entire households but may also have a concomitant effect on parallel diseases, such as pediatric obesity.
Read the detailed description
Dental caries is the most common chronic disease of childhood, disproportionately affecting vulnerable children (ethnic/racial minority groups, low-income families, and those who live in rural areas). Young children who have poor oral health behaviors (e.g., inadequate tooth brushing, diet high in added sugar) are at risk for developing severe early childhood caries (S-ECC), which is an indication for dental surgery. Prevalence of S-ECC has declined and utilization of preventive dental care has increased over time. However, inequities in disease burden persist, and demand for dental surgery under general anesthesia (DGA) is increasing. The impact of S-ECC on a child's health ripples out across systemic and psychosocial well-being, with links to childhood obesity and oral health quality of life. Surgical events have inherent safety risks with the potential for iatrogenic errors or possible direct harm. Further, surgical intervention is expensive and ineffective in the long term. Because the intervention does not directly address the etiologic factors, which are largely behavioral, approximately 50% of children have recurrent disease within 12 months after DGA.
Given that parenting behaviors influence a child's oral health status, caregivers are an important catalyst for promoting child behavior changes. Positive parenting, such as appropriate monitoring of a child during tooth brushing or negotiating conflicts when children want sugary snacks, influences child health behaviors. The investigators conducted preliminary qualitative research with caregivers while their child was undergoing DGA. This preliminary work, as well as other supportive studies, identified barriers to changing oral health behaviors: parenting style, dental self-efficacy, and oral health knowledge. The objective of this study is to develop and test the initial efficacy of PROTECT (Preventing Recurrent Operations Targeting Early Childhood Caries Treatment), a 6-month behavioral parenting intervention for DGA families enrolled in Medicaid. Our primary outcomes (tooth brushing frequency and % total calories from added sugar) are associated with S-ECC and have been identified as predominant behavior challenges for surgical families. PROTECT, informed by Social Cognitive Theory (SCT), will be delivered by trained community health workers (CHWs) who have social proximity to our participants. PROTECT will be delivered over a six-month interval beginning at the surgical event. This time period coincides with when many parents report high motivation to change behaviors and improve oral health. Behavioral parenting interventions have been validated in mental health and childhood obesity, and the investigators believe this will impact S-ECC.
UG3 Specific Aim 1. Develop PROTECT, a 6-month behavioral parenting intervention to reduce S-ECC. The development of PROTECT will be informed by evidence-based behavioral parenting and dietary interventions for preschool children of low-income as well as stakeholder (caregiver, clinical provider, CHW) input.
UG3 Specific Aim 2. Assess the feasibility and accessibility of PROTECT during the perioperative period. The investigators will identify barriers to recruitment, retention, intervention delivery, and outcome measurements. The investigators will recruit 25 caregivers of preschool children scheduled for DGA to conduct a 6-month pilot study with the following goals: finalize study protocol; measure intervention adherence (dose delivered/dose intended); and determine how to optimize intervention via (1) total intervention duration; (2) frequency; and (3) intensity. The investigators will also assess feasibility and acceptability using validated measures.31 UH3 Specific Aim 1. Test the efficacy of PROTECT compared to Usual Care (UC), to improve behavioral oral health outcomes. The investigators will conduct a randomized clinical trial to test the efficacy of PROTECT (n = 210) compared to UC (n = 210) in the pediatric DGA population. Primary outcomes include tooth brushing frequency and % total calories derived from added sugars. the investigators hypothesize that participants in the PROTECT group will increase tooth brushing and decrease % added sugar intake to a greater degree than those in the UC group. Assessments will occur throughout the 6-month intervention and 6 months after intervention completion.
Aim 1a. Determine mechanistic role of behavioral change targets in influencing intervention effectiveness. Per SCT, the investigators will estimate a mediation model with positive parenting, self-efficacy and knowledge as mediators in the pathway to behavioral change. The investigators will also collect weekly remote assessment data (parenting and oral health behaviors), via a text messaging platform, to measure in-the-moment parental behaviors and barriers to adhering to study goals around child oral health behaviors.
A surgical event is a unique opportunity to change behaviors in systemically oppressed families that have manifested a need for behavior change. This proposal will meet caregivers needs at a critical time when risk disease recurrence intersects with a desire to change. This work has the potential to not only improve oral health of entire households but may also have a concomitant effect on parallel diseases, such as pediatric obesity.
- Conditions
- Early Childhood Caries
- Being tested
- Behavioral Treatment
- Keywords
- Early Childhood Caries, Behavioral Intervention, Community Health Workers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral TreatmentBehavioural
PROTECT (Preventing Recurrent Operations Targeting Early Childhood Caries Treatment) is a 6-month parenting program using evidence-based strategies to increase children's toothbrushing and reduce sugar intake. Sessions also address positive parenting, goal setting, stress management, and problem-solving. Community health workers (CHWs)-some bilingual in Spanish-will deliver 10 sessions (5 informational, 5 maintenance) to caregivers of children scheduled for dental surgery at UIC. Each 30-60-minute session focuses on applying skills to daily life and overcoming behavior-change challenges. CHWs can connect caregivers to social services or dental providers and refer concerns to a clinic social worker through a clinical psychologist. The program, developed from prior evidence and oral health/CHW curricula, covers oral health, nutrition, parenting, rewards, routines, problem-solving, monitoring, self-efficacy, and goal setting.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care: Control | No intervention | The control, or Usual Care (UC) group will receive usual clinical care, which consists of education during and immediately after surgery. Families randomized to the UC arm will receive the usual standard of care between the time they are identified as surgical candidates to the point when they are scheduled to have their post-surgical visit. Clinical education is provided by pediatric dental residents, and at least one pre-surgical visit is designed to allow families to discuss how their oral health behaviors contribute to caries and answer any questions regarding changing oral health behaviors. Families who are experiencing significant social issues which interfere with their ability to care for their child's teeth are identified by clinic staff and referred to a full-time social worker employed by the dental clinic. Similar to the intervention arm participants, RAs will be trained to report any potential social issues to the research team's clinical psychologist for referral. |
| PROTECT Arm: This is the behavioral intervention arm | Experimental | PROTECT (Preventing Recurrent Operations Targeting Early Childhood Caries Treatment) is a 6-month parenting program using evidence-based strategies to increase children's toothbrushing and reduce sugar intake. Sessions also address positive parenting, goal setting, stress management, and problem-solving. Community health workers (CHWs)-some bilingual in Spanish-will deliver 10 sessions (5 informational, 5 maintenance) to caregivers of children scheduled for dental surgery at UIC. Each 30-60-minute session focuses on applying skills to daily life and overcoming behavior-change challenges. CHWs can connect caregivers to social services or dental providers and refer concerns to a clinic social worker through a clinical psychologist. The program, developed from prior evidence and oral health/CHW curricula, covers oral health, nutrition, parenting, rewards, routines, problem-solving, monitoring, self-efficacy, and goal setting. Receives: Behavioral: Behavioral Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basic Research Factors Questionnaire (BRFQ)
Child and caregiver brushing behaviors (11 items) are included in the Basic Research Factors Questionnaire (BRFQ). The BRFQ is a validated questionnaire to assess dental knowledge, attitudes, and behaviors of caregivers with young children. We will also assess frequency of brushing, assistance with brushing, and use of fluoridated toothpaste. The BRFQ is validated in English and has been translated into Spanish (not yet validated) by members of the research team. Higher scores indicating greater risk for ECC. Parental oral health behaviors (12 items) possible score range 0-100% of items answered with "adherent" response . Parental oral health knowledge, (15 items) possible score range 0-100% of items answered correctly. Parental dental self-efficacy (11 items) with score range 1-5 per item with higher scores indicating caregivers were more confident in engaging in recommended oral health behaviors for their children.
Measured: 12 months; from baseline to 12 months post-surgical event (assessments at baseline, 6 months and 12 months)
Child's dietary intake from the previous day (12:00A - 11:59P) will be captured in-person/telephone/zoom using Nutrition Data System for Research (NDSR) data capture and analysis software
The software uses interview prompts to conduct a standardized multiple pass 24-hour dietary recall. The multi-pass approach enables respondents to recall foods and beverages consumed with greater accuracy. The parent/caregiver will be asked to use the food amounts booklet to aid the diet interview. A bilingual team member will use the Spanish interviewer prompts provided as an option in the NDSR system for all recalls that are conducted in Spanish. Data collection staff will be trained to conduct dietary recalls. Dietary recall data will be used to calculate nutrient intake (e.g., kcal, fat, protein, carbohydrate) and % kcal from total sugars and added sugars. NDSR is housed on the IHRP network drive which is password protected. Data will be downloaded from the NDSR software package and uploaded to REDCap. The dietary recall interview is validated in both English and Spanish.
Measured: 12 months: from baseline to 12 months post-surgical event. Assessments are at baseline, 6 months and 12 months.
Secondary outcomes (3)
The Self-Efficacy Scale for Maternal Oral Care (SESMO)
The Self-Efficacy Scale for Maternal Oral Care (SESMO) was designed for mothers of children up to 8 years old. It consists of 12 items (on a 4-point Likert scale), divided into two self-efficacy domains (subscales): (i) self-efficacy for tooth brushing and (ii) self-efficacy for dietary habits. This measure has been validated in English and Spanish. sed a 5-point Likert scale (1 = not confident to 5 =completely confident), with total scores ranging from 16 to 80. Higher scores indicate greater maternal self-efficacy in managing their child's oral health.
Measured: 12 months: From baseline to 12 months post-surgical event. Assessments are at baseline, 6 months and 12 months.
The Multidimensional Assessment of Parenting Scale (MAPS)
The Multidimensional Assessment of Parenting Scale (MAPS) measures parenting practices and includes measures of positive and negative dimensions of warmth/hostility and behavioral control. It includes 34 items on a 5-point Likert scale and has been validated in English and translated into Spanish (not yet validated) by members of the research team. The Likert-scale scoring system indicates participants rating their parenting behaviors across multiple dimensions. Each survey question is rated on a scale of 1- 5. With 1 being "Never", 2 being "Almost Never", 3 being "Sometimes", 4 being "Often" and 5 being "Always". Higher scores in positive domains indicate supportive parenting, while higher scores in negative domains reflect more problematic behaviors. Summary Score: lowest possible score: 34 highest possible score: 170
Measured: 12 months: From baseline to post-surgical event; Assessments are at baseline, 6 months and 12 months.
The Decayed, Missing, Filled Teeth Index (DMFT)
Clinical Outcomes: The Decayed, Missing, Filled Teeth Index (DMFT) will be used to assess disease severity for primary and any permanent teeth. Scores range from 1-20 if in the primary dentition. Receipt of urgent/emergent dental care or sedation or caries will also be documented. Select members of the research team will extract data from electronic dental records after a child has a preventive dental visit (UIC or MileSquare) and enter into REDCap. We will use this data to calculate the DMFT score, which will be stored in REDCap.
Measured: 12 months: From baseline to 12 months post-surgical event at baseline, 6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start30 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood CariesStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Helen Lee, University of Illinois Chicago
- Investigators
- Helen Lee, MD, MPH, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220850
- Sponsor's protocol ID
- UH3DE032003
- Other IDs
- UH3DE032003
- Acronym
- PROTECT
- Status last verified
- May 2026
- First submitted
- 21 Oct 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Multi-behavioral Intervention to Improve Oral Health Behaviors in the Pediatric Dental Surgery Population
- ClinicalTrials.gov ID
- NCT07220850
- Acronym / sponsor ID
- PROTECT / UH3DE032003
- Conditions
- Early Childhood Caries
- Keywords
- Early Childhood Caries, Behavioral Intervention, Community Health Workers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 24 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Too many young children, particularly those living in poverty, present for dental surgery under anesthesia - an expensive, potentially dangerous, short-term fix that often results in recurring oral health disease and subsequent surgeries. Dr. Helen Lee, an anesthesiologist, and Dr. Joanna Buscemi, a clinical health psychologist, recognized that to decrease need for surgeries, caregivers need resources and support to build their skills and knowledge around managing their child's oral health. After 5 years of relationship-building, publishing preliminary qualitative work, and building a team with the appropriate skills and knowledge, investigators developed a grant application to develop and test a parenting intervention for caregivers of preschool- aged children presenting for dental surgery.
With support from the National Institute of Dental and Craniofacial Research (NIDCR) of the National Institutes of Health (NIH), the team created the PROTECT intervention with a focus on providing caregivers with parenting and behavioral tools to help improve tooth brushing and lower added sugar intake while simultaneously addressing social determinants of health that make behavior change more difficult. Community health workers will engage with caregivers for 6 months following the child's surgery to deliver PROTECT and support parents in behavioral change. A surgical event is a unique opportunity to change behaviors in systemically oppressed families that have manifested a need for behavior change. This intervention will meet caregivers needs at a critical time when risk disease recurrence intersects with a desire to change. This work has the potential to not only improve oral health of entire households but may also have a concomitant effect on parallel diseases, such as pediatric obesity.
Detailed description
Dental caries is the most common chronic disease of childhood, disproportionately affecting vulnerable children (ethnic/racial minority groups, low-income families, and those who live in rural areas). Young children who have poor oral health behaviors (e.g., inadequate tooth brushing, diet high in added sugar) are at risk for developing severe early childhood caries (S-ECC), which is an indication for dental surgery. Prevalence of S-ECC has declined and utilization of preventive dental care has increased over time. However, inequities in disease burden persist, and demand for dental surgery under general anesthesia (DGA) is increasing. The impact of S-ECC on a child's health ripples out across systemic and psychosocial well-being, with links to childhood obesity and oral health quality of life. Surgical events have inherent safety risks with the potential for iatrogenic errors or possible direct harm. Further, surgical intervention is expensive and ineffective in the long term. Because the intervention does not directly address the etiologic factors, which are largely behavioral, approximately 50% of children have recurrent disease within 12 months after DGA.
Given that parenting behaviors influence a child's oral health status, caregivers are an important catalyst for promoting child behavior changes. Positive parenting, such as appropriate monitoring of a child during tooth brushing or negotiating conflicts when children want sugary snacks, influences child health behaviors. The investigators conducted preliminary qualitative research with caregivers while their child was undergoing DGA. This preliminary work, as well as other supportive studies, identified barriers to changing oral health behaviors: parenting style, dental self-efficacy, and oral health knowledge. The objective of this study is to develop and test the initial efficacy of PROTECT (Preventing Recurrent Operations Targeting Early Childhood Caries Treatment), a 6-month behavioral parenting intervention for DGA families enrolled in Medicaid. Our primary outcomes (tooth brushing frequency and % total calories from added sugar) are associated with S-ECC and have been identified as predominant behavior challenges for surgical families. PROTECT, informed by Social Cognitive Theory (SCT), will be delivered by trained community health workers (CHWs) who have social proximity to our participants. PROTECT will be delivered over a six-month interval beginning at the surgical event. This time period coincides with when many parents report high motivation to change behaviors and improve oral health. Behavioral parenting interventions have been validated in mental health and childhood obesity, and the investigators believe this will impact S-ECC.
UG3 Specific Aim 1. Develop PROTECT, a 6-month behavioral parenting intervention to reduce S-ECC. The development of PROTECT will be informed by evidence-based behavioral parenting and dietary interventions for preschool children of low-income as well as stakeholder (caregiver, clinical provider, CHW) input.
UG3 Specific Aim 2. Assess the feasibility and accessibility of PROTECT during the perioperative period. The investigators will identify barriers to recruitment, retention, intervention delivery, and outcome measurements. The investigators will recruit 25 caregivers of preschool children scheduled for DGA to conduct a 6-month pilot study with the following goals: finalize study protocol; measure intervention adherence (dose delivered/dose intended); and determine how to optimize intervention via (1) total intervention duration; (2) frequency; and (3) intensity. The investigators will also assess feasibility and acceptability using validated measures.31 UH3 Specific Aim 1. Test the efficacy of PROTECT compared to Usual Care (UC), to improve behavioral oral health outcomes. The investigators will conduct a randomized clinical trial to test the efficacy of PROTECT (n = 210) compared to UC (n = 210) in the pediatric DGA population. Primary outcomes include tooth brushing frequency and % total calories derived from added sugars. the investigators hypothesize that participants in the PROTECT group will increase tooth brushing and decrease % added sugar intake to a greater degree than those in the UC group. Assessments will occur throughout the 6-month intervention and 6 months after intervention completion.
Aim 1a. Determine mechanistic role of behavioral change targets in influencing intervention effectiveness. Per SCT, the investigators will estimate a mediation model with positive parenting, self-efficacy and knowledge as mediators in the pathway to behavioral change. The investigators will also collect weekly remote assessment data (parenting and oral health behaviors), via a text messaging platform, to measure in-the-moment parental behaviors and barriers to adhering to study goals around child oral health behaviors.
A surgical event is a unique opportunity to change behaviors in systemically oppressed families that have manifested a need for behavior change. This proposal will meet caregivers needs at a critical time when risk disease recurrence intersects with a desire to change. This work has the potential to not only improve oral health of entire households but may also have a concomitant effect on parallel diseases, such as pediatric obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care: Control | No intervention | –The control, or Usual Care (UC) group will receive usual clinical care, which consists of education during and immediately after surgery. Families randomized to the UC arm will receive the usual standard of care between the time they are identified as surgical candidates to the point when they are scheduled to have their post-surgical visit. Clinical education is provided by pediatric dental residents, and at least one pre-surgical visit is designed to allow families to discuss how their oral health behaviors contribute to caries and answer any questions regarding changing oral health behaviors. Families who are experiencing significant social issues which interfere with their ability to care for their child's teeth are identified by clinic staff and referred to a full-time social worker employed by the dental clinic. Similar to the intervention arm participants, RAs will be trained to report any potential social issues to the research team's clinical psychologist for referral. |
| PROTECT Arm: This is the behavioral intervention arm | Experimental | Behavioral: Behavioral TreatmentPROTECT (Preventing Recurrent Operations Targeting Early Childhood Caries Treatment) is a 6-month parenting program using evidence-based strategies to increase children's toothbrushing and reduce sugar intake. Sessions also address positive parenting, goal setting, stress management, and problem-solving. Community health workers (CHWs)-some bilingual in Spanish-will deliver 10 sessions (5 informational, 5 maintenance) to caregivers of children scheduled for dental surgery at UIC. Each 30-60-minute session focuses on applying skills to daily life and overcoming behavior-change challenges. CHWs can connect caregivers to social services or dental providers and refer concerns to a clinic social worker through a clinical psychologist. The program, developed from prior evidence and oral health/CHW curricula, covers oral health, nutrition, parenting, rewards, routines, problem-solving, monitoring, self-efficacy, and goal setting. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- caregivers of child patients who are in the same household greater than or equal to 50% of the week
- caregivers aged 18-90 years
- caregivers with access to a computer or a telephone
- child patients that are less than 96 months of age at the time of enrollment scheduled for DGA at the UIC clinic
Key exclusion criteria (4 listed)
- surgical child is foster status
- families who are planning to move out of state within the six-month period
- children with systemic health issues as classified by American Society of Anesthesiology Classification of greater than or equal to 3, or a mental health condition such as autism/developmental delay, as medical complexity is associated with other issues that influence a child's health behaviors and caregiver-child interactions
- and adults unable to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral TreatmentPROTECT (Preventing Recurrent Operations Targeting Early Childhood Caries Treatment) is a 6-month parenting program using evidence-based strategies to increase children's toothbrushing and reduce sugar intake. Sessions also address positive parenting, goal setting, stress management, and problem-solving. Community health workers (CHWs)-some bilingual in Spanish-will deliver 10 sessions (5 informational, 5 maintenance) to caregivers of children scheduled for dental surgery at UIC. Each 30-60-minute session focuses on applying skills to daily life and overcoming behavior-change challenges. CHWs can connect caregivers to social services or dental providers and refer concerns to a clinic social worker through a clinical psychologist. The program, developed from prior evidence and oral health/CHW curricula, covers oral health, nutrition, parenting, rewards, routines, problem-solving, monitoring, self-efficacy, and goal setting. | Behavioural | PROTECT Arm: This is the behavioral intervention arm |
Primary outcome
Basic Research Factors Questionnaire (BRFQ)
Time frame: 12 months; from baseline to 12 months post-surgical event (assessments at baseline, 6 months and 12 months)
Child and caregiver brushing behaviors (11 items) are included in the Basic Research Factors Questionnaire (BRFQ). The BRFQ is a validated questionnaire to assess dental knowledge, attitudes, and behaviors of caregivers with young children. We will also assess frequency of brushing, assistance with brushing, and use of fluoridated toothpaste. The BRFQ is validated in English and has been translated into Spanish (not yet validated) by members of the research team. Higher scores indicating greater risk for ECC. Parental oral health behaviors (12 items) possible score range 0-100% of items answered with "adherent" response . Parental oral health knowledge, (15 items) possible score range 0-100% of items answered correctly. Parental dental self-efficacy (11 items) with score range 1-5 per item with higher scores indicating caregivers were more confident in engaging in recommended oral health behaviors for their children.
Child's dietary intake from the previous day (12:00A - 11:59P) will be captured in-person/telephone/zoom using Nutrition Data System for Research (NDSR) data capture and analysis software
Time frame: 12 months: from baseline to 12 months post-surgical event. Assessments are at baseline, 6 months and 12 months.
The software uses interview prompts to conduct a standardized multiple pass 24-hour dietary recall. The multi-pass approach enables respondents to recall foods and beverages consumed with greater accuracy. The parent/caregiver will be asked to use the food amounts booklet to aid the diet interview. A bilingual team member will use the Spanish interviewer prompts provided as an option in the NDSR system for all recalls that are conducted in Spanish. Data collection staff will be trained to conduct dietary recalls. Dietary recall data will be used to calculate nutrient intake (e.g., kcal, fat, protein, carbohydrate) and % kcal from total sugars and added sugars. NDSR is housed on the IHRP network drive which is password protected. Data will be downloaded from the NDSR software package and uploaded to REDCap. The dietary recall interview is validated in both English and Spanish.
3 secondary outcomes
The Self-Efficacy Scale for Maternal Oral Care (SESMO)
Time frame: 12 months: From baseline to 12 months post-surgical event. Assessments are at baseline, 6 months and 12 months.
The Multidimensional Assessment of Parenting Scale (MAPS)
Time frame: 12 months: From baseline to post-surgical event; Assessments are at baseline, 6 months and 12 months.
The Decayed, Missing, Filled Teeth Index (DMFT)
Time frame: 12 months: From baseline to 12 months post-surgical event at baseline, 6 months and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- This is our UIC Protect Website.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helen Lee, MD, MPH principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Treatment in people with Early Childhood Caries, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helen Lee, MD, MPH (312-996-4020, leehelen@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Basic Research Factors Questionnaire (BRFQ) (time frame: 12 months; from baseline to 12 months post-surgical event (assessments at baseline, 6 months and 12 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.