[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548403":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":42,"responsibleParty":67,"collaborators":70,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":18,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":45,"whyStopped":18,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Universidad de los Andes, Chile","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","The whole intervention has 24 sessions. Children will play with the game two times a week, each lasting 15 minutes, over a period of 12 weeks. Each session stimulates two skills (one cognitive and one non-cognitive skills) and has eight activities with increasing levels of difficulty.",[13],"Behavioral: JAPI: Cognitive, Emotional and Social Stimulation for Preschool Children",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","The control group receives standard school curricula, which is not a manualized intervention. The standard curriculum is provided by the Ministry of Education with a guideline called \"Curricular Bases for Kindergarten Education\" which includes pre-kindergarten directions to Early Year Educators regarding emotion regulation and planification to implement in class.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","JAPI: Cognitive, Emotional and Social Stimulation for Preschool Children","Those children in the intervention group will play with the gaming platform \"Japi\" using a tablet device in a designated time given from schools' authorities. Early Year Educators will be present to help with the discipline and motivation of the students and Research Assistants will be there as well to provide technical support for the use of the equipment.\n\nThe intervention has 24 sessions, and the dosage will be two sessions of 15 minutes each per week for 12 weeks. Sessions number 1 to number 8 are focused on emotional regulation and inhibitory control. Sessions number 9 to 16 work on working memory and problem-solving. Sessions number 17 to 24 promote empathy and planification skills. Each session will have eight activities with increasing levels of difficulty.",[9],[26],"JAPI",[28],{"name":29,"affiliation":30,"role":31},"Jorge Gaete, MD, PhD","Universidad de Los Andes","PRINCIPAL_INVESTIGATOR",[33,38],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","+56226181000","2277","jgaete@uandes.cl",{"name":39,"role":34,"phone":40,"phoneExt":18,"email":41},"Natalia Ríos, BA","+56978783002","nmrios@miuandes.cl",[43,60],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Universidad de los Andes","RECRUITING","Santiago","Santiago Metropolitan","7620086","Chile","CL",{"type":52,"coordinates":53},"Point",[54,55],-70.64827,-33.45694,{"lat":55,"lon":54},[58],{"name":59,"role":34,"phone":35,"phoneExt":36,"email":37},"Jorge Gaete, Md, Phd",{"facility":44,"status":45,"city":46,"state":47,"zip":18,"country":49,"countryCode":50,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},{"type":52,"coordinates":62},[54,55],{"lat":55,"lon":54},[65],{"name":66,"role":34,"phone":35,"phoneExt":36,"email":37},"Jorge Gaete, Md, PhD",{"type":31,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Jorge Gaete","Principal Investigator",[71],{"name":72,"class":6},"University of Talca","100548403","japi-cognitive-emotional-and-social-stimulation-for-preschool-children-100548403",false,"NCT06420544","Japi: Cognitive, Emotional and Social Stimulation for Preschool Children","Japi","For schools:\n\nInclusion criteria:\n\n1. Schools located in Santiago (Chile).\n2. Schools with Preschool Education.\n3. Mixed-sex schools.\n4. Schools with vulnerability (≥75%), measured with the School Vulnerability Index - National System of Equality Allocation (IVE-SINAE). This index is the proportion of students in a given school with high vulnerability. This index considers the following socioeconomic variables to group the schools: mother's educational level, father's educational level, and total monthly household income, among others.\n\nExclusion criteria:\n\n1. Three or more classes in Preschool. This criterion was considered for economic and practical reasons.\n2. Implementing a manualized program to promote cognitive or social-emotional skills.\n3. Participating in a similar study.\n\nFor students:\n\nInclusion criteria:\n\n1\\) Children attending pre-kindergarten\n\nExclusion criteria:\n\n1. Children with intellectual disability\n2. Children unable to understand and speak Spanish",true,"ALL","3 Years","5 Years",{"count":85,"type":86},120,"ESTIMATED","INTERVENTIONAL",[89],"NA","Mental health disorders are one of the leading causes of illness globally, and their relevance is expected to increase. Low and Middle Income Countries (LMIC), already facing psychological and behavioral issues due to chronic adversity, were further impacted during the COVID-19 pandemic. A study showed that symptoms of depression and anxiety in youth doubled during the first year of the pandemic compared to the pre-pandemic period.\n\nA study in China found that the prevalence of the total difficulties was (8.2%), with conduct problems (7.0%), peer problems (6.6%), and hyperactivity-inattention (6.3%) among the most prevalent. In this study emotional problems reached 4.7%. Finally, recent evidence has revealed that students' psychosocial and behavioral problems have increased in the early stage of schools reopened. Several international agencies have calls on governments, and public and private sector partners, to commit, communicate and act to promote mental health for all children, protect those in need of help, and care for the most vulnerable.\n\nThe importance of psychosocial skills acquired in early childhood, such as emotional regulation and social problem-solving, for preventing mental disorders was highlighted. Studies indicate that the development of executive functions and non-cognitive skills in early childhood has a positive impact on long-term health and economic productivity.\n\nHowever, the treatment gap for mental disorders in LMIC is significant, with only one in ten affected receiving treatment. Preventive interventions are needed, particularly in early childhood, to improve cognitive and socio-emotional skills.\n\nObjective: The research proposal aims to develop a gaming platform aiming to improve cognitive and non-cognitive skills in early childhood at schools with high socio-economic vulnerability, supported by Early Years Educators and Parents using a dashboard integrated in a whole system housed in local server, and to evaluate the acceptability and feasibility of this gaming platform and dashboards, with the ultimate goal of reducing behavioral problems, and improving functional and performance outcomes later in life.\n\nOutcomes: Acceptability; Feasibility; Cognitive and non-cognitive skills; Working Memory; Inhibitory control; Emotion recognition; Social competence; Behavioral problems and psychological assessment.",[92],"Behavioral Problem of Child",[94,95,96,97,98,99],"Executive Functions","Behavioral Problem","Children","Videogame","Non-cognitive skills","Cognitive skills","2024-06-12",{"date":102,"type":103},"2024-06-14","ACTUAL",{"date":105,"type":103},"2024-06-01",{"date":107,"type":86},"2024-12-31",{"name":5,"class":6},2]