I-TOPS With Patients With Genetic Syndrome SYN-TOPS

Recruiting now · Not applicable

Conditions studied: Genetic Syndrome

In brief

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.

Key facts

Study ID

NCT07563218

Run by

IRCCS Eugenio Medea

People needed

42

Starts

2026-02-18

Expected to finish

2028-02-17

Last updated by the study team

2026-05-01

Who can join

Age: 11 and older, up to 39. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy — Bosisio Parini, Lecco, Italy (enrolling)

Full record on ClinicalTrials.gov

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