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Taking people in ItalyNo phase

Testing new ways to measure quality of life and needs in children with autism

Tries new outcome tools in children with autism spectrum disorder receiving usual care.

Plain-language title generated from the registry record
Registry title: 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.

Key facts

Where
Bosisio Parini, Busto Arsizio, and Milan, ItalySee the 3 sites

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 0 and 11 years old?

Source: NCT07393152, who can take part

Where in Italy

  • IRCCS Eugenio Medea- U.O. di Neuropsichiatria infantile - Disturbi del NeurosviluppoBosisio Parini, ItalyTaking people
  • UOSD Disturbo Autistico nel ciclo della vitaBusto Arsizio, ItalyTaking people
  • SC Child and Adolescence Neuropsychiatric Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico , Milan, ItalyMilan, ItalyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Antonella Costantino
Trial code
NCT07393152
Record updated
20 February 2026
Original description
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.Read full original descriptionShow less

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.

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.

Inclusion: 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: Subjects aged 12 years or older at the time of enrollment; No consent from the person holding parental responsibility for health choices.

ClinicalTrials.gov NCT07393152