Oral Health Intervention for Caregivers of Children Presenting for Dental Surgery
NCT07220850 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420
Last updated 2026-05-08
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, 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.
Conditions
- Early Childhood Caries
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.
Sponsors & Collaborators
-
National Institute of Dental and Craniofacial Research (NIDCR)
collaborator NIH -
University of Illinois at Chicago
lead OTHER
Principal Investigators
-
Helen Lee, MD, MPH · University of Illinois at Chicago
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Max Age
- 7 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-30
- Primary Completion
- 2027-09-30
- Completion
- 2028-09-30
Countries
- United States
Study Locations
More Related Trials
-
Preoperative Preparation for Children
NCT00205244 ·Status: COMPLETED ·Phase: NA
-
Reading Preoperatively to Reduce Anxiety in Day Surgery
NCT00338325 ·Status: COMPLETED ·Phase: PHASE2
-
Comfort Talk for Pediatric Cardiac Catheterization
NCT02347748 ·Status: COMPLETED ·Phase: NA
-
Efficacy of Tell-Show-Do Behavior-Management Technique During Local Anesthesia in Preschool Children
NCT02578160 ·Status: UNKNOWN ·Phase: NA
-
To Assess Breathing Exercise as a Relaxation Method
NCT06698523 ·Status: COMPLETED ·Phase: NA
-
The Effect of Two Distraction Strategies in Reducing Preoperative Anxiety in Children
NCT05285995 ·Status: COMPLETED ·Phase: NA
-
Effect of Preoperative Psychological Intervention on the Degree of Cooperation During Tracheal Catheter Extubation in Patients
NCT04918485 ·Status: COMPLETED ·Phase: NA
-
Caregiver Self-Management of Stress
NCT04337021 ·Status: COMPLETED ·Phase: NA
-
Reducing Work-related Screen Time in Health Care Workers During Leisure Time
NCT05106647 ·Status: COMPLETED ·Phase: NA
-
The Anxiety of Parents of Children Undergoing Cardiac Surgery
NCT01492452 ·Status: COMPLETED ·Phase: NA
-
Coaching Intervention for Caregivers of Persons With Stroke
NCT04535284 ·Status: UNKNOWN ·Phase: NA
-
A Stress Survey in Nurse Anesthetist Students
NCT03094338 ·Status: UNKNOWN
-
Qualitative and Systemic Assessment of a Nurse Intervention an Inpatient Child and His or Her Parents
NCT03977948 ·Status: COMPLETED
-
Exploring Stress and Coping Behaviors of the Major Carer Whose Children With Prader-Willi Syndrome
NCT00808548 ·Status: UNKNOWN
-
Art Therapy to Promote Wellbeing and Self-care in Resident Physicians.
NCT05654376 ·Status: UNKNOWN ·Phase: NA
-
Coaching Program to Address Burnout, Wellness and Professional Development in Early Career Pediatric Surgeons
NCT06193694 ·Status: COMPLETED ·Phase: NA
-
Efficacy of Spontaneous Laughter in the Postoperative Treatment of Children
NCT02563587 ·Status: UNKNOWN ·Phase: NA
-
The Impact of Meditation on Anxiety and Post-Operative Pain in Pediatric Patients Undergoing Urological Surgery
NCT06858267 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Aromatherapy Effect on Anxiety Prior to Ultrasound Guided Musculoskeletal Procedures
NCT05660486 ·Status: COMPLETED ·Phase: NA
-
RELAX Surgical: Effects of Environmental Design on Pre-surgical Relaxation
NCT02230644 ·Status: COMPLETED ·Phase: NA
-
Effects of Complementary Therapies Delivered Via Mobile Technologies
NCT02236455 ·Status: COMPLETED ·Phase: NA
-
Research on the Effect of Drama Workshop on Stress Management of Nursing Students Based on Social Interaction Theory
NCT05506345 ·Status: COMPLETED ·Phase: NA
-
Animation-Based Breathing Therapy for School-Age Children
NCT06988254 ·Status: COMPLETED ·Phase: NA
-
Personal Resilience Skills to Improve Surgery Training
NCT06139614 ·Status: COMPLETED ·Phase: NA
-
Impact of Regular Karate Practice on the Quality of Life and Health Outcomes of Students
NCT07116291 ·Status: RECRUITING ·Phase: NA