[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561646":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":18,"responsibleParty":40,"collaborators":44,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":18,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":18,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":75,"whyStopped":18,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":18},{"fullName":5,"class":6},"National Health Promotion Associates, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LifeSkills for Elementary School (Intervention)","EXPERIMENTAL","Approximately 1500 students in the 3rd grade (100 students per school) will complete pre-tests, post-tests, and 12- and 24-month follow-ups. Students whose school is randomized to the intervention condition (15 schools) will receive the LifeSkills Training standard curriculum plus bullying\u002Fcyberbullying classroom and serious game.",[13],"Behavioral: Bullying prevention",{"label":15,"type":16,"description":17,"interventionNames":18},"LifeSkills for Elementary School (Control)","NO_INTERVENTION","Approximately 1500 students in the 3rd grade (100 students per school) will complete pre-tests, post-tests, and 12- and 24-month follow-ups. Students whose school is randomized to the control condition (12 schools) will not receive the LifeSkills Training intervention, but will receive the health education content normally provided by their schools.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Bullying prevention","The intervention utilizes a serious (educational) videogame and teacher-led, interactive class sessions. Students exposed to the intervention will learn to respond to in-person and online bullying from the perspectives of perpetrator, victim, and bystander. The intervention enhances personal self-management skills, social skills, refusal skills, and other life skills needed to successfully navigate developmental tasks, increase resilience, and facilitate healthy psychosocial development.",[9],[26],{"name":27,"affiliation":28,"role":29},"Christopher Williams, PhD, MPH","National Health Promotion Associates","PRINCIPAL_INVESTIGATOR",[31,36],{"name":27,"role":32,"phone":33,"phoneExt":34,"email":35},"CONTACT","914-421-2525","204","cwilliams@nhpamail.com",{"name":37,"role":32,"phone":33,"phoneExt":38,"email":39},"Nina Daley, BS","217","ndaley@nhpamail.com",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Christopher Williams","Senior Vice President",[45],{"name":46,"class":47},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100561646","using-digital-health-technology-to-prevent-bullying-and-cyberbullying-among-elementary-school-students-100561646",false,"NCT06592872","Using Digital Health Technology to Prevent Bullying and Cyberbullying Among Elementary School Students","Inclusion Criteria: All students are eligible to participate in the intervention and complete the surveys.\n\nExclusion Criteria: All students are eligible to participate in the intervention and complete the surveys. Survey data will be excluded from the analysis for participants with significant cognitive impairment or severe learning disabilities, as designated by school personnel.\n\n\\-",true,"ALL","7 Years","11 Years",{"count":59,"type":60},3000,"ESTIMATED","INTERVENTIONAL",[63],"NA","This project is designed to address the urgent need for an effective primary prevention approach to the problem of bullying and cyberbullying among elementary school students. The project involves developing, feasibility testing, and testing for the effectiveness an innovative new approach to the primary prevention of bullying utilizing both a serious (educational) videogame and facilitator-led, interactive class sessions. Using a cluster randomized controlled trial, the intervention will teach students how to respond to in-person and online bullying from the perspectives of perpetrator, victim, and bystander. The intervention enhances personal self-management skills, social skills, refusal skills, and other life skills needed to successfully navigate developmental tasks, increase resilience, and facilitate healthy psychosocial development. At the end of the initial intervention period, and at one- and two-year follow-ups, we will compare outcomes of students in the intervention and control groups with respect to changes in behaviors, norms, attitudes, and knowledge regarding bullying, cyberbullying, and substance use behavior.",[66,67,68],"Bullying","Cyberbullying","Smoking",[70,71,72,73,74],"bullying","cyberbullying","elementary school","videogame","educational games","NOT_YET_RECRUITING","2025-08-29",{"date":78,"type":79},"2025-09-08","ACTUAL",{"date":81,"type":60},"2025-10",{"date":83,"type":60},"2027-12",{"name":42,"class":6}]