I-TOPS With Patients With Genetic Syndrome SYN-TOPS
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 an
| Condition(s) | Genetic Syndrome |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. This 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 |
| Who can participate | Inclusion Criteria: * Diagnosis of genetic syndrome * Age: 11 to 39 years and 11 months * Ownership of a personal computer and access to the Internet at home; * Basic computer literacy of the patient and/or family, sufficient to manage email, browse the Internet, use websites and conduct video-calls; * Presence of at least one parent, caregiver or guardian living with the patient who is available to participate in the intervention. Exclusion Criteria: * Presence of severe or profound intellectual disability; * Autism Spectrum Disorder, Level 3 (requiring very substantial support) based on DSM-5; * Presence of an acute psychiatric disorder. |
| Ages | 11 Years to 39 Years |
| Sex | All |
| Lead sponsor | IRCCS Eugenio Medea |
| Locations | Bosisio Parini, Lecco, Italy |
| Start date | 2026-02-18 |
| NCT ID | NCT07563218 |
| Official listing | https://clinicaltrials.gov/study/NCT07563218 |