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Study identifier: NCT07563218 Synced from ClinicalTrials.gov · July 28, 2026
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I-TOPS With Patients With Genetic Syndrome SYN-TOPS

Condition: Genetic Syndrome  ·  Sponsor: IRCCS Eugenio Medea

PhaseNA
Planned participants42
Who can joinAll sexes, 11 Years to 39 Years
Healthy volunteersNo

About this study

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 behavio…

This description comes directly from the study's public registry record.

Talk to the study team

Claudia Corti, PsyD; PhD  ·  +39031877111  ·  claudia.corti@lanostrafamiglia.it

Always discuss trial participation with your own doctor first.

Locations (1)

Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, ItalyBosisio Parini, Lecco, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT07563218