protocolSection identificationModule nctId: NCT06278168, orgStudyIdInfo id: CNR-IRIB-PRO-2024-002, briefTitle: Awareness Training in Children With Autism Spectrum Disorder., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-12, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2025-05-08, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Istituto per la Ricerca e l'Innovazione Biomedica, class: OTHER, collaborators name: Messina, Italy, descriptionModule briefSummary: The proposed protocol aims to facilitate awareness and understanding of autism spectrum disorder among children aged 8 to 14 with an IQ between 85 and 115. Conducted once a week for 60 minutes, the protocol encompasses two initial group sessions followed by 5 group meetings, introducing activities to foster self-awareness, cognitive understanding, and an inclusive environment. Subsequently, the protocol advances to 12 individual sessions focused on emotional well-being and self-awareness, integrating Oculus technology and chest sensors for heart rate monitoring. Initiating the intervention, individual family meetings are scheduled to outline intervention goals and phases. The initial group sessions focus on social bonding, cognitive understanding, and creating an accepting atmosphere among participants. Utilizing activities addressing neurodiversity awareness and technological tools like tablets, the sessions encourage discussions on individual differences and sensitivities. The subsequent individual sessions are structured to explore personal values, identify inner critical voices, and develop emotional awareness through exercises exploring emotions and physical sensations. Progressively, the intervention introduces mindfulness, guiding participants to acknowledge emotions as normal and encouraging alignment of daily actions with personal values. Following this, sessions center on building observational skills, recognizing past behaviors, and fostering strengths tied to values. Participants are encouraged to distinguish between their critical "consultant" and the value-driven "explorer," fostering personal growth and reflection. The protocol's later stages delve into identifying personal strengths linked to core values and exploring value-driven goals. Visual exercises, metaphors, and flexible self-views are emphasized, promoting adaptability and self-evolution. The protocol concludes by advocating a flexible self-view, embracing change, and connecting oneself to ever-evolving metaphors like "a cup with changing contents" or "the ever-changing sky." These sessions culminate with visual relaxation facilitated through Oculus technology while simultaneously monitoring participants' heart rates using chest sensors. This comprehensive approach integrates technological tools with emotional and cognitive exercises, providing a multifaceted framework to enhance self-awareness and promote acceptance within the context of neurodiversity., conditionsModule conditions: Autism, conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Awareness training with using Oculus., interventions name: Awareness training without using Oculus, outcomesModule primaryOutcomes measure: Wechsler Intelligence Scale for Children Fourth edition (WISC-IV), primaryOutcomes measure: Multidimensional Anxiety Scale for Children-Second Edition (MASC 2), primaryOutcomes measure: Screen for Child Anxiety Related Disorders (SCARED), eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR), status: RECRUITING, city: Messina, zip: 98164, country: Italy, contacts name: Flavia Marino, role: CONTACT, phone: +393395798263, email: flavia.marino@irib.cnr.it, contacts name: Maria Valeria Maiorana, role: CONTACT, phone: +393285856656, email: mariavaleria.maiorana@irib.cnr.it, contacts name: Flavia Marino, role: PRINCIPAL_INVESTIGATOR, contacts name: Germana Doria, role: SUB_INVESTIGATOR, contacts name: Chiara Failla, role: SUB_INVESTIGATOR, contacts name: Noemi Vetrano, role: SUB_INVESTIGATOR, contacts name: Ileana Scarcella, role: SUB_INVESTIGATOR, contacts name: Roberta Minutoli, role: SUB_INVESTIGATOR, contacts name: Paola Chilà, role: SUB_INVESTIGATOR, contacts name: Giovanni Pioggia, role: SUB_INVESTIGATOR, contacts name: Gennaro Tartarisco, role: SUB_INVESTIGATOR, geoPoint lat: 38.19394, lon: 15.55256, hasResults: False