NCT07220850 · University of Illinois at Chicago
Oral Health Intervention for Caregivers of Children Presenting for Dental Surgery
(PROTECT)
What this study is about
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 taken by mouth health disease and subsequent surgeries. Dr. Helen Lee, an anesthesiologist, and Dr.
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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.
Interventions
BEHAVIORAL
Behavioral Treatment
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where
- Chicago, Illinois
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 8, 2026 · Source of record for eligibility and locations