Oral Health Intervention for Caregivers of Children Presenting for Dental Surgery

NCT07220850 | Recruiting DMC

• 1 other identifier: UH3DE032003
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief 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. 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, they 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.

Conditions

Early Childhood Caries

Keywords

Early Childhood Caries; Behavioral Intervention; Community Health Workers

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  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)

  12 months: From baseline to post-surgical event; Assessments are at baseline, 6 months and 12 months.

• The Decayed, Missing, Filled Teeth Index (DMFT)

  12 months: From baseline to 12 months post-surgical event at baseline, 6 months and 12 months.

Study Arms (2)

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.

Behavioral: Behavioral Treatment

Interventions

Behavioral Treatment BEHAVIORAL

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.

PROTECT Arm: This is the behavioral intervention arm

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

College of Dentistry (MC 621)

Chicago, Illinois, 60612, United States

RECRUITING

Related Links

• This is our UIC Protect Website.

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Helen Lee, MD, MPH

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Lee, MD, MPH

CONTACT

312-996-4020; leehelen@uic.edu

Joanna Buscemi, PhD

CONTACT

773-325-2971; jbuscem2@depaul.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MPI

Study Record Dates

• First Submitted: October 21, 2025
• First Posted: October 24, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 24, 2025

Record last verified: 2025-10

Locations

US (1)