protocolSection identificationModule nctId: NCT06331429, orgStudyIdInfo id: EmoTiCare, briefTitle: Emoticare: Serious Game for the Adaptation to the Disease of Adolescents With Type 1 Diabetes Mellitus., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University of Valencia, class: OTHER, collaborators name: Universitat Politècnica de València, descriptionModule briefSummary: The intervention program targets adolescents with chronic Type 1 Diabetes Mellitus. Given the critical developmental stage and life transitions, necessitating robust personal resources, psychological support becomes imperative. To foster socioemotional skills and overall well-being, particularly crucial for averting future emotional issues and promoting a healthier, more fulfilling life, this support is especially vital for those dealing with chronic illnesses. Such conditions pose a risk for psychological problems, potentially complicating treatment and prognosis. Presently, digital and technological platforms are integrating psychological interventions for patients with chronic diseases, showcasing an innovative approach to address psychological challenges.The platform integrates new technologies for assessment and intervention. Ecological Momentary Assessment enables real-time evaluation, with data transferred to the technological platform. Artificial intelligence personalizes interventions based on participants' socio-demographic characteristics and assessment results. Ecological Momentary Intervention is employed for in-context treatments in participants' daily lives and natural environments. A serious game method, proven effective in various interventions, is used to engage adolescents and young people intrinsically. The game encompasses six main areas aligning with theoretical models, facilitating the development of socio-emotional competencies, and promoting physical and psychological health. It addresses different aspects of psychological and subjective well-being, reinforcing resources needed to navigate vital changes in these developmental stages, especially when living with a chronic illness., conditionsModule conditions: Type 1 Diabetes, conditions: Adolescent Development, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: EmoTiCare, outcomesModule primaryOutcomes measure: Change Quality of Life (Baseline-Pre-Post), primaryOutcomes measure: Change Emotional and Behavioral Problems (Baseline-Pre-Post), primaryOutcomes measure: Change Emotional Competences (Baseline-Pre-Post), primaryOutcomes measure: Change Self-concept (Baseline-Pre-Post), primaryOutcomes measure: Change Coping (Baseline-Pre-Post), primaryOutcomes measure: Change Social Skills (Baseline-Pre-Post), secondaryOutcomes measure: Change Threat of disease(Baseline-Pre-Post), secondaryOutcomes measure: Change Psychoeducation Diabetes, secondaryOutcomes measure: Change Resilience (Baseline-Pre-Post), otherOutcomes measure: Glycaemic control (Baseline-Pre-Post), eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Universitat de València, city: Valencia, country: Spain, contacts name: Marián Pérez-Marín, PhD, role: CONTACT, phone: 963983392, email: marian.perez@uv.es, contacts name: Selene Valero Moreno, PhD, role: SUB_INVESTIGATOR, contacts name: Inmaculada Montoya-Castilla, PhD, role: SUB_INVESTIGATOR, contacts name: Javier Martín Ávila, MsC, role: SUB_INVESTIGATOR, contacts name: Esther Rodríguez-Jiménez, MsC, role: SUB_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False