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NCT07393152Recruiting

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.

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.

Source: ClinicalTrials.gov · Last updated 20 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
400 (estimated)
First submitted
30 Jul 2025
Start date
13 Mar 2025
Primary completion date
31 Oct 2026
Lead sponsor
Antonella Costantino
Diseases
Autism
NCT number
NCT07393152

What you commit to

  • Study type: Observational
  • Planned participants: 400
  • From 13 Mar 2025 to the primary completion date, 31 Oct 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Subjects aged 12 years or older at the time of enrollment

Other

  • No consent from the person holding parental responsibility for health choices

Who the study is looking for

  • 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

Age in the registry: 0 years to 11 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS Eugenio Medea- U.O. di Neuropsichiatria infantile - Disturbi del Neurosviluppo
Coordinator of this site? Confirm its status
Bosisio PariniItalyRecruiting
UOSD Disturbo Autistico nel ciclo della vita
Coordinator of this site? Confirm its status
Busto ArsizioItalyRecruiting
SC Child and Adolescence Neuropsychiatric Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico , Milan, Italy
Coordinator of this site? Confirm its status
MilanItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.