[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636248":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":52,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":35,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"IRCCS Eugenio Medea","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment-first","EXPERIMENTAL","Participants assigned to this arm will receive the I-TOPS intervention, a combined web-based and telehealth program. The intervention includes two integrated components: (1) a digital platform through which patients independently complete structured psychoeducational activities (e.g., informational materials on neurological conditions and video-based problem-solving strategies for everyday situations), and (2) scheduled telemedicine sessions delivered by a psychologist trained in cognitive-behavioral therapy and experienced in neuropsychological rehabilitation. These sessions provide clinical guidance, monitor adherence, and support the application of learned strategies to daily life. The intervention is designed to integrate psychoeducation with cognitive-behavioral and neuropsychological rehabilitation principles.\n\nParticipants will undergo assessments at three time points: T0 (baseline, prior to treatment), T1 (immediately post-treatment) and T2 (six-month post-treatment follow-up).",[13],"Behavioral: Italian Tailored Online Problem-Solving (I-TOPS)",{"label":15,"type":16,"description":17,"interventionNames":18},"Waiting-list-first","ACTIVE_COMPARATOR","Participants assigned to this arm will receive the I-TOPS intervention after a waiting-list period corresponding to the treatment period of Group 1 (experimental group). Participants will undergo assessments at three time points: T0 (baseline, prior to the waiting-list period), T1 (immediately after the waiting-list period), and T2 (immediately post-treatment).",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Italian Tailored Online Problem-Solving (I-TOPS)","The I-TOPS web-based platform is structured into 10 core sessions aimed at providing patients, on the one hand, with information about the effects of their neurological condition and, on the other, with support in learning and applying strategies for planning and organization, enhancement of social skills, and emotion regulation. The combination of patients' independent work on the platform and the online support sessions conducted by the therapist ensures that the intervention goes beyond the mere delivery of informational content and includes practical activities to be carried out in daily life. These activities are based on specific cognitive-behavioral strategies proposed by both the program and the therapist, with personalized support tailored to the patient's real-life context by the clinician (contextualization process).",[9,15],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Claudia Corti, PsyD; PhD","CONTACT","+39031877111","claudia.corti@lanostrafamiglia.it",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy","RECRUITING","Bosisio Parini","Lecco","23842","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],9.29,45.80075,{"lat":45,"lon":44},[48,49],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},{"name":50,"role":29,"phone":30,"phoneExt":25,"email":51},"Sandra Strazzer, MD","sandra.strazzer@lanostrafamiglia.it",{"type":53,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[55],{"name":56,"class":57},"IRCCS Fondazione Don Carlo Gnocchi, Milano","UNKNOWN","100636248","i-tops-with-patients-with-genetic-syndrome-syn-tops-100636248",false,"NCT07563218","I-TOPS With Patients With Genetic Syndrome SYN-TOPS","SYN-TOPS: A Multicenter Randomized Clinical Trial on the Use of the I-TOPS Intervention to Improve Adaptive Skills in Adolescents and Young Adults With Genetic Syndromes","SYN-TOPS","Inclusion Criteria:\n\n* Diagnosis of genetic syndrome\n* Age: 11 to 39 years and 11 months\n* Ownership of a personal computer and access to the Internet at home;\n* Basic computer literacy of the patient and\u002For family, sufficient to manage email, browse the Internet, use websites and conduct video-calls;\n* Presence of at least one parent, caregiver or guardian living with the patient who is available to participate in the intervention.\n\nExclusion Criteria:\n\n* Presence of severe or profound intellectual disability;\n* Autism Spectrum Disorder, Level 3 (requiring very substantial support) based on DSM-5;\n* Presence of an acute psychiatric disorder.","ALL","11 Years","39 Years",{"count":70,"type":71},42,"ESTIMATED","INTERVENTIONAL",[74],"NA","Genetic syndromes involving the central nervous system are often associated with cognitive, behavioral and communication difficulties that negatively impact adaptive functioning and quality of life. Despite advances in digital health, there remains a lack of evidence-based interventions targeting executive functions and psychosocial outcomes in this population.\n\nThis multicenter study aims to evaluate the feasibility and efficacy of an adapted version of the Teen Online Problem-Solving (TOPS) program, a web-based intervention designed to enhance problem-solving, self-regulation and communication skills in everyday contexts. The adapted intervention (I-TOPS) will be tailored for adolescents and young adults with genetic syndromes involving the central nervous system. The I-TOPS intervention requires the participation of both the adolescent\u002Fyoung adult and at least one parent, caregiver or legal guardian, as it is a family-centered program.\n\nParticipants will complete online modules at home, supported by bimonthly videoconference sessions with a cognitive-behavioral psychologist. Outcomes will be assessed through pre- and post-intervention measures of executive functioning, adaptive behavior and psychological well-being, reported by both participants and caregivers. Psychological well-being of participating parents\u002Fcaregivers\u002Fguardians will also be evaluated.\n\nThe study aims to provide evidence for an accessible, scalable telehealth intervention to improve cognitive and behavioral outcomes in this underserved population.",[77],"Genetic Syndrome",[79,80,81,82,83],"executive functions","social skills","adaptive skills","telerehabilitation","rehabilitation","2026-04-24",{"date":86,"type":87},"2026-05-01","ACTUAL",{"date":89,"type":87},"2026-02-18",{"date":91,"type":71},"2028-02-17",{"name":5,"class":6},1]