I-TOPS: Italian online problem-solving program for young people with genetic syndromes
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 11 Years to 39 Years |
| Sex | All |
| Sponsor | IRCCS Eugenio Medea Academic / other |
| Locations | 1 site (Bosisio Parini, Lecco) |
| Trial ID | NCT07563218 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bosisio Parini, Lecco
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.