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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 400
- Locations
- 3
- Primary Endpoint
- Specific clusters of CANS items that differentiate the profiles of needs and strengths of users at T0.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 0 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Children aged 0-11 with ASD diagnosis
Patients will be enrolled in ongoing treatments in the real context as long as they are in line with the national guidelines for autism, in at least three different national health facilities (SSN) in Lombardy, to represent the variability of the possible organizations of services and interventions, adding new outcome tools.
Intervention: DD-CGAS (Wagner et al. 2007) (Other)
Children aged 0-11 with ASD diagnosis
Patients will be enrolled in ongoing treatments in the real context as long as they are in line with the national guidelines for autism, in at least three different national health facilities (SSN) in Lombardy, to represent the variability of the possible organizations of services and interventions, adding new outcome tools.
Intervention: Pediatric Quality of Life Inventory (PedsQL). (Other)
Children aged 0-11 with ASD diagnosis
Patients will be enrolled in ongoing treatments in the real context as long as they are in line with the national guidelines for autism, in at least three different national health facilities (SSN) in Lombardy, to represent the variability of the possible organizations of services and interventions, adding new outcome tools.
Intervention: Child and Adolescent Needs and Strengths (CANS) (Lyons 2022) (Other)
Outcomes
Primary Outcomes
Specific clusters of CANS items that differentiate the profiles of needs and strengths of users at T0.
Time Frame: From March 2025 to August 2026
The primary objective of the study is to identify specific clusters of CANS items that differentiate the profiles of needs and strengths of users at T0.
Secondary Outcomes
- Correlations between CANS assessment and participants' global functioning (DD-CGAS)(From March 2025 to August 2026)
- Correlations between CANS assessment and participants' quality of life (PEDSQL)(From March 2025 to August 2026)
- Evaluation of changes in children's needs over time based on CANS actionable items.(march 2025 to august 2026)
- Evaluation of changes in children's Quality of Life over time.(from march 2025 to august 2026)
- Evaluation of changes in children's global functioning(from march 2025 to august 2026)
Investigators
Antonella Costantino
Director Child and Adolescence Neuropsychiatric Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico , Milan, Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico