Collaborative tools to set priorities, support shared decisions, and track quality of life for children with autism
Official title: Studio Pilota su Strumenti Collaborativi, Globali, Multidimensionali e di qualità Della Vita Per la Definizione Delle priorità, lo Sviluppo di Processi Decisionali Condivisi, la Valutazione Degli Esiti e il Miglioramento Della qualità Delle Cure Per le Persone Con Disturbi Dello Spettro Autistico (ASD) Nella Pratica Clinica Quotidiana.
Run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · NCT07393152 · Data updated 2026-11-12
This pilot will try combining new and existing questionnaires to track quality of life, overall functioning, and needs in children with autism under 12 who are receiving usual care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Years to 11 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 3 sites (Bosisio Parini, (LC) and 2 other locations) |
| Status | Recruiting |
| Started | March 13, 2025 |
| Main results expected | October 31, 2026 |
| Study ends | October 31, 2026 |
| Registry record updated | February 20, 2026 |
| Trial ID | NCT07393152 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children under 12 with an autism diagnosis according to the regional network criteria whose parent or guardian provides consent and who receive care at a participating center.
✕Probably not a fit
Children aged 12 or older, those without parental consent, and children who do not attend the participating centers are not eligible and therefore will not benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational pilot collects real-world data from three NHS settings in Italy, following routine treatments aligned with regional guidelines. Children are grouped into ages 0–5 and 6–11 and given additional outcome tools before and after planned interventions alongside measures already in use. The project uses instruments such as DD-CGAS, PedsQL, and CANS to measure global and multidimensional functioning, quality of life, and needs/strengths. Analyses will look for correlations and clusters across tools and will assess acceptability and sustainability for clinicians, patients, and families in everyday practice.
Why it matters
Potential benefit: If successful, this approach could give clinicians and families clearer, multidimensional information to guide personalized care and shared decision making.
How similar studies have gone: Individual tools like the PedsQL, DD-CGAS, and CANS are validated in pediatric and mental health settings, but combining them into a real-world, multidimensional outcome package and testing acceptability in routine services is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASD diagnosis according to the criteria shared by the regional NFA network * Age under 12 * Consent from the person holding parental responsibility for health choices Exclusion Criteria: * Subjects aged 12 years or older at the time of enrollment * No consent from the person holding parental responsibility for health choices
Where it's running
-
IRCCS Eugenio Medea- U.O. di Neuropsichiatria infantile - Disturbi del Neurosviluppo
Bosisio Parini, (Lc), Italy Recruiting -
UOSD Disturbo Autistico nel ciclo della vita
Busto Arsizio, (VA), Italy Recruiting -
SC Child and Adolescence Neuropsychiatric Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico , Milan, Italy
Milan, Michigan, Italy Recruiting
Study contacts
- Study coordinator: Maria Antonella Costantino
- Email: antonella.costantino@policlinico.mi.it
- Phone: +39 02 5503.4400
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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.