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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.

Recruitingn/aAges 0 Years - 11 YearsAllAntonella Costantino
NCT07393152 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 f

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📋 Eligibility rules (as published)
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
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What it tests

  • DD-CGAS (Wagner et al. 2007)
  • Pediatric Quality of Life Inventory (PedsQL).
  • Child and Adolescent Needs and Strengths (CANS) (Lyons 2022)
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Where

3 sites
IRCCS Eugenio Medea- U.O. di Neuropsichiatria infantile - Disturbi del Neurosviluppo
Bosisio Parini, Italy
UOSD Disturbo Autistico nel ciclo della vita
Busto Arsizio, Italy
SC Child and Adolescence Neuropsychiatric Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico , Milan, Italy
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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