Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-25 @ 2:42 PM
Study NCT ID:
NCT07220850
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2025-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Health Intervention for Caregivers of Children Presenting for Dental Surgery
Sponsor:
University of Illinois at Chicago
Organization:
Study Overview
Official Title:
Testing a Multi-behavioral Intervention to Improve Oral Health Behaviors in the Pediatric Dental Surgery Population
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTECT
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.
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. Our team 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 we believe 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. We will identify barriers to recruitment, retention, intervention delivery, and outcome measurements. We 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. We 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. We 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. We 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, we will estimate a mediation model with positive parenting, self-efficacy and knowledge as mediators in the pathway to behavioral change. We 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.
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. Our team 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 we believe 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. We will identify barriers to recruitment, retention, intervention delivery, and outcome measurements. We 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. We 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. We 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. We 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, we will estimate a mediation model with positive parenting, self-efficacy and knowledge as mediators in the pathway to behavioral change. We 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UH3DE032003 | NIH | None | https://reporter.nih.gov/quic… | View |