NCT07563218 I-TOPS With Patients With Genetic Syndrome SYN-TOPS
| NCT ID | NCT07563218 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Eugenio Medea |
| Condition | Genetic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2026-02-18 |
| Primary Completion | 2027-02-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2026-02-18 with a primary completion date of 2027-02-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 requires the participation of both the adolescent/young adult and at least one parent, caregiver or legal guardian, as it is a family-centered program. Participants 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/caregivers/guardians will also be evaluated. The study aims to provide evidence for an accessible, scalable telehealth intervention to improve cognitive and behavioral outcomes in this underserved population.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07563218 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 39 Years, studying Genetic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07563218 currently recruiting?
Yes, NCT07563218 is actively recruiting participants. Contact the research team at claudia.corti@lanostrafamiglia.it for enrollment information.
Where is the NCT07563218 trial being conducted?
This trial is being conducted at Bosisio Parini, Italy.
Who is sponsoring the NCT07563218 clinical trial?
NCT07563218 is sponsored by IRCCS Eugenio Medea. The trial plans to enroll 42 participants.