Pilot Study on Collaborative, Comprehensive, Multidimensional and Quality of Life Tools for Priority Definition, Shared Decision Making, Outcome Evaluation and Quality of Care Improvement in ASD Individuals and Programs in the Real World.
Recruiting now
Conditions studied: Autism Spectrum Disorders
In brief
ASD is a very complex and lifelong disorder. Patients' functioning is influenced by multiple factors, including treatments, inclusion and life contexts. Nonetheless, outcome measures are still point-specific and highly fragmented, rarely considering global or multidimensional functioning, development or long-term modifications, especially in the real world. The present study considers ongoing real-life treatments in three different NHS settings, in line with the Italian Guidelines. Two age classes will be considered, 0-5 and 6-11, adding new outcome tools pre-post intervention to those already used, to evaluate quality of life, global functioning, multidimensional needs and strengths and shared decision making. Correlations between the different outcome tools will be explored, and possible clusters will be investigated. Acceptability of the outcome tools for the operators, patients and families, as well as usefulness and sustainability in daily practice, will also be evaluated.
Key facts
- Study ID
- NCT07393152
- Run by
- Antonella Costantino
- People needed
- 400
- Starts
- 2025-03-13
- Expected to finish
- 2026-10-31
- Last updated by the study team
- 2026-02-20
Who can join
Age: any, up to 11. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Subjects aged 12 years or older at the time of enrollment
- No consent from the person holding parental responsibility for health choices
Where it is running
- IRCCS Eugenio Medea- U.O. di Neuropsichiatria infantile - Disturbi del Neurosviluppo — Bosisio Parini, (LC), Italy (enrolling)
- UOSD Disturbo Autistico nel ciclo della vita — Busto Arsizio, (VA), Italy (enrolling)
- SC Child and Adolescence Neuropsychiatric Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico , Milan, Italy — Milan, Michigan, Italy (enrolling)
Full record on ClinicalTrials.gov
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