Pilot Study of Collaborative and Multidimensional Tools to Improve Care and Quality of Life in Children with Autism Spectrum Disorder Aged 0 to 11 in Real-World Clinical Settings

What this Trial Is About

Researchers are studying children with Autism Spectrum Disorders ASD aged 0 to 11 years to evaluate the impact of ongoing real-life treatments provided in three different National Health Service settings. This observational study aims to explore multidimensional and comprehensive outcome measures that reflect global functioning, quality of life, and shared decision making. The study addresses the need for more integrated and long-term evaluation tools in ASD care, following Italian national guidelines. Participants will continue their usual treatments in line with national autism guidelines at different health facilities, representing diverse service organizations. New outcome tools, including the Child and Adolescent Needs and Strengths CANS scale, the Developmental Disabilities-Child Global Assessment Scale DD-CGAS, and the Pediatric Quality of Life Inventory PedsQL, will be used to assess changes pre- and post-intervention. The study will investigate correlations between these tools and identify clusters related to needs and strengths. During the study, children will undergo assessments using these scales from March 2025 to August 2026 to measure global functioning, quality of life, and evolving needs. Researchers will evaluate the acceptability and usefulness of the outcome tools for clinicians, patients, and families, as well as their sustainability in daily practice. The primary outcome focuses on identifying specific CANS item clusters that differentiate user profiles at baseline, with several secondary outcomes measuring changes over time.

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.