[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609920":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":57,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":12,"maxAge":73,"enrollmentInfo":74,"targetDuration":12,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":40,"whyStopped":12,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Illinois at Chicago","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"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\u002FCHW curricula, covers oral health, nutrition, parenting, rewards, routines, problem-solving, monitoring, self-efficacy, and goal setting.",[18],"Behavioral: Behavioral Treatment",[20],{"type":21,"name":22,"description":16,"armGroupLabels":23,"otherNames":12},"BEHAVIORAL","Behavioral Treatment",[14],[25],{"name":26,"affiliation":5,"role":27},"Helen Lee, MD, MPH","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":12,"email":32},"CONTACT","312-996-4020","leehelen@uic.edu",{"name":34,"role":30,"phone":35,"phoneExt":12,"email":36},"Joanna Buscemi, PhD","773-325-2971","jbuscem2@depaul.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"College of Dentistry (MC 621)","RECRUITING","Chicago","Illinois","60612","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-87.65005,41.85003,{"lat":50,"lon":49},[53],{"name":54,"role":30,"phone":55,"phoneExt":12,"email":56},"David Avenetti, MD","312.996.7555","avenetti@uic.edu",{"type":27,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Helen Lee","Principal investigator",[61],{"name":62,"class":63},"National Institute of Dental and Craniofacial Research (NIDCR)","NIH","100609920","oral-health-intervention-for-caregivers-of-children-presenting-for-dental-surgery-100609920",false,"NCT07220850","Oral Health Intervention for Caregivers of Children Presenting for Dental Surgery","Testing a Multi-behavioral Intervention to Improve Oral Health Behaviors in the Pediatric Dental Surgery Population","PROTECT","Inclusion Criteria:\n\n* caregivers of child patients who are in the same household greater than or equal to 50% of the week\n* caregivers aged 18-90 years\n* caregivers with access to a computer or a telephone\n* child patients that are less than 96 months of age at the time of enrollment scheduled for DGA at the UIC clinic\n\nExclusion Criteria:\n\n* surgical child is foster status\n* families who are planning to move out of state within the six-month period\n* 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\u002Fdevelopmental delay, as medical complexity is associated with other issues that influence a child's health behaviors and caregiver-child interactions\n* and adults unable to consent.","ALL","7 Years",{"count":75,"type":76},420,"ESTIMATED","INTERVENTIONAL",[79],"NA","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.\n\nWith 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.",[82],"Early Childhood Caries",[82,84,85],"Behavioral Intervention","Community Health Workers","2026-05-07",{"date":88,"type":89},"2026-05-08","ACTUAL",{"date":91,"type":89},"2025-09-30",{"date":93,"type":76},"2028-09",{"name":5,"class":6},1]