About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Parallel
Treatments tested in this trial
Behavioral Treatment
BehavioralPROTECT (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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
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
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.
Sponsors and contacts
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University of Illinois at Chicago
Lead sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator