Actively Recruiting

Age: 0Years - 11Years
All Genders
NCT07393152

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.

Led by Antonella Costantino · Updated on 2026-02-20

400

Participants Needed

3

Research Sites

85 weeks

Total Duration

On this page

Sponsors

A

Antonella Costantino

Lead Sponsor

I

IRCCS Eugenio Medea

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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.

Who Can Participate

Age: 0Years - 11Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Autism Spectrum Disorder according to the regional NFA network criteria
  • Participant is under 12 years old
  • Consent obtained from the person responsible for the participant's health decisions
Not Eligible

You will not qualify if you...

  • Participant is 12 years old or older at enrollment
  • No consent from the person responsible for the participant's health decisions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

IRCCS Eugenio Medea- U.O. di Neuropsichiatria infantile - Disturbi del Neurosviluppo

Bosisio Parini, (LC), Italy, 23842

Actively Recruiting

2

UOSD Disturbo Autistico nel ciclo della vita

Busto Arsizio, (VA), Italy, 21052

Actively Recruiting

3

SC Child and Adolescence Neuropsychiatric Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico , Milan, Italy

Milan, Michigan, Italy, 20122

Actively Recruiting

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Research Team

M

Maria Antonella Costantino

CONTACT

D

Debora Zanolla

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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