[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608873":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":60,"collaborators":31,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":31,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":31,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":88,"whyStopped":31,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"IRCCS Fondazione Stella Maris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PEERS","EXPERIMENTAL","Twenty subjects will be carry out PEERS intervention",[13],"Behavioral: PEERS",{"label":15,"type":16,"description":17,"interventionNames":18},"CONTROLS","ACTIVE_COMPARATOR","Twenty subjects will be carry out Treatment As Usual",[19],"Behavioral: Control",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","The Program for the Education and Enrichment of Relational Skills (PEERS®) is world-renowned for providing evidence-based social skills treatment to adolescents with autism spectrum disorder (ASD), attention-deficit\u002Fhyperactivity disorder (ADHD), anxiety, depression, and other socio-emotional problems.",[9],[26],"TAU (TREATMENT AS USUAL)",{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Control","This group will also consist of children diagnosed with high-functioning ASD. However, these children will not receive PEERS therapy. Instead, they will continue their usual treatments in their local settings without participating in the PEERS therapy sessions. This group\\'s outcomes will be compared with the experimental group to assess the effectiveness of PEERS therapy.",[15],null,[33],{"name":34,"affiliation":35,"role":36},"Antonio Narzisi, PhD","IRCCS Stella Maris Foundation, Pisa (Calambrone), Italy","PRINCIPAL_INVESTIGATOR",[38,42],{"name":34,"role":39,"phone":40,"phoneExt":40,"email":41},"CONTACT","00393205690832","antonio.narzisi@fsm.unipi.it",{"name":43,"role":39,"phone":44,"phoneExt":31,"email":45},"Annarita Milone, MD","00393389339732","annarita.milone@fsm.unipi.it",[47],{"facility":48,"status":31,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":31},"IRCCS Stella Maris","Calambrone","Pisa","56018","Italy","IT",{"type":55,"coordinates":56},"Point",[57,58],10.3,43.58333,{"lat":58,"lon":57},{"type":36,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Antonio Narzisi","Principal Investigator","100608873","social-adaptation-and-validation-of-the-in-person-peers-program-for-adolescents-with-autism-100608873",false,"NCT07207213","SOCIAL: Adaptation and Validation of the In-person PEERS® Program for Adolescents With Autism.","Italian Adaptation and Validation of the In-person UCLA-PEERS® Model for Adolescents With Autistic Spectrum Disorder","Inclusion Criteria:\n\n* (a) age between 10 and 14 years;\n* clinical diagnosis of Autism Spectrum Disorder according to ICD-10 (WHO, 1992);\n* absence of intellectual disability (IQ over 85);\n* absence of a concomitant major psychiatric disorder (e.g., schizophrenia, bipolar disorder, psychiatric illness);\n* absence of oppositional\u002Faggressive behavior (outside the family context);\n* difficulty developing and\u002For maintaining peer relationships;\n* self-motivation to participate in the treatment of both the adolescent and the family;\n* availability of a caregiver to regularly attend sessions with parents and to support the participant during the program;\n* consent of the parents and the adolescent to participate in all evaluations and to be recorded during treatment sessions\n\nExclusion Criteria:\n\n* Full IQ below 85;\n* concomitant major psychiatric disorders","ALL","10 Years","14 Years",{"count":74,"type":75},36,"ESTIMATED","INTERVENTIONAL",[78],"NA","Autism Spectrum Disorder (ASD) falls under the category of high complexity disorders which, in most cases, accompany individuals throughout their entire life with significant impacts and costs for individuals, their families, and society at large. Adolescence is a time of increasing challenge for teenagers with ASD and their families, as it is a time to lay the foundations for the transition to adulthood but at the same time, it is a period of clear mismatch between the abilities and interests of teenagers with ASD and the expectations of their peers. It becomes increasingly difficult to initiate and maintain friendships that require social skills, communicate through social media, or make appropriate use of humor. It is in peer relationships that recognizing and applying implicit social norms is more difficult, and social errors can lead to a bad reputation, exclusion, and being bullied.\n\nThis creates the need for concrete responses through evidence-based treatment programs adapted to the Italian context. In this scenario, the Program for the Education and Enrichment of Relational Skills (PEERS®) fits in, a psychosocial intervention that falls under the category of Social Skill Training (SST) conducted in a group context, evidence-based, originating from the United States for adolescents with ASD that involves structured teaching of knowledge and skills related to social relationships.\n\nSOCIAL has three main objectives: clinical, scientific, and social. The clinical objective is articulated in the study of the effectiveness of the in-person PEERS® program on an Italian population of adolescents with ASD (aged between 10 and 14) to respond to the evident need for a psychosocial intervention adapted to the Italian context. The scientific objective aims to identify an electroencephalographic biomarker that acts as a predictor of the efficacy of PEERS® and is specific to a particular individual profile. Finally, the social objective intends to extend the support network of adolescents with ASD through meetings with schools to train Teachers, thus parallelizing the treatment for generalization of the skills acquired during clinical treatment and also to the school context where peers play a key role.\n\nSOCIAL aims to respond to a gap that exists in Italy for a critical age group involving teenagers with ASD, proposing an evidence-based treatment that extends to family and school contexts.",[81],"Autism Spectrum Disorder",[83,84,85,86,87],"Autism","Adolescents","UCLA-PEERS","Social Skills","Intervention","NOT_YET_RECRUITING","2025-10-02",{"date":91,"type":92},"2025-10-03","ACTUAL",{"date":94,"type":75},"2026-01-01",{"date":96,"type":75},"2027-09-30",{"name":5,"class":6},1]