I-TOPS: Italian online problem-solving program for young people with genetic syndromes
Official title: 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
Run by IRCCS Eugenio Medea · NCT07563218 · Data updated 2026-11-12
This project will test whether an Italian-adapted, web-based problem-solving program (I-TOPS) with parent participation can help adolescents and young adults (ages 11–39) with genetic syndromes improve planning, self-regulation, and communication in daily life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 11 Years to 39 Years |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | IRCCS Eugenio Medea Academic / other |
| Locations | 1 site (Bosisio Parini, Lecco) |
| Status | Recruiting |
| Started | February 18, 2026 |
| Main results expected | February 17, 2027 |
| Study ends | February 17, 2028 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT07563218 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adolescents and young adults (11 to 39 years) with a diagnosed genetic syndrome involving the central nervous system who have basic computer skills, home Internet and a personal computer, and at least one caregiver living with them who can participate.
✕Probably not a fit
Patients with severe or profound intellectual disability, Autism Spectrum Disorder Level 3, acute psychiatric disorders, no reliable home Internet/computer access, or no available caregiver are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, web-delivered intervention adapts the Teen Online Problem-Solving (TOPS) program for adolescents and young adults with genetic syndromes affecting the central nervous system. Participants and at least one parent or caregiver complete structured online modules and video sessions focused on problem-solving, self-regulation, and communication skills. The program is family-centered and delivered via a dedicated platform, with outcomes measured for executive function, social and adaptive skills, and feasibility of remote delivery. Exclusion criteria include severe/profound intellectual disability, ASD Level 3, and acute psychiatric disorder.
Why it matters
Potential benefit: If successful, I-TOPS could improve everyday executive, social, and adaptive functioning and expand access to a scalable, home-delivered rehabilitation option.
How similar studies have gone: Web-delivered TOPS programs have shown benefits in youth with traumatic brain injury and other neurological conditions, but adapting TOPS specifically for genetic syndromes is a novel application.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy
Bosisio Parini, Lecco, Italy Recruiting
Study contacts
- Study coordinator: Claudia Corti, PsyD; PhD
- Email: claudia.corti@lanostrafamiglia.it
- Phone: +39031877111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.