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.
About This Trial
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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
DD-CGAS (Wagner et al. 2007)
The DD-CGAS is a clinician-completed scale that provides a global rating of the child's functioning. The score refers to the subject's typical functioning during a specified period of time, usually the week prior to the assessment. It is a global assessment based on all available sources of information and all domains of functioning, including self-sufficiency, communication, social behavior, and academic/school functioning. The score should not be influenced by the specific diagnosis, the perceived cause of dysfunction (e.g., cognitive or physical limitation, environmental constraints, behavioral disturbance), or the type and severity of symptoms. The DD-CGAS is a dimensional scale with scores ranging from 1 to 100, with 1 representing the greatest impairment in functioning and 100 representing the best functioning. Each decile (e.g., 1-10, 11-20) has a specific description. The instrument has excellent replicability between raters and temporal stability.
Pediatric Quality of Life Inventory (PedsQL).
The PedsQL is designed for children and adolescents between the ages of 2 and 18 years and takes approximately 5 minutes to complete. It is administered as a self-report instrument or via proxy interview. The proxy interview version corresponds to the age of the child (e.g., 2-4 years, 5-7 years, 8-12 years, and 13-18 years). The PedsQL consists of 23 items that assess 4 broad scales, including: physical functioning, emotional functioning, social functioning, and academic functioning. Items are rated using a 5-point Likert scale (0 = never; 4 = almost always), with the total score calculated as the sum of all items considered. PedsQL item scores are inverted and linearly transformed to a 0 to 100 scale, with higher scores indicating a better perception of health-related quality of life. It is important to note that the PedsQL has been validated in children with autism, including parents of children with autism (Vasilopoulou et al. 2016; Perry, N. et al. 2024).
Child and Adolescent Needs and Strengths (CANS) (Lyons 2022)
The Child and Adolescent Needs and Strengths scale (CANS) (Lyons 2022) is an open source tool widely used to assess the needs and strengths of children, adolescents, and their families, in clinical, educational and social services settings. It is organized into multiple domains that cover various aspects of a child's life. Common domains include life functioning, behavioral/emotional needs, risk behaviors, strengths, caregiver needs and strengths. Additional modules as trauma can be used.The tool uses a scoring system that reflects the level of need or strength in each area. Typically, needs are rated on a scale from 0 to 3, where 0: No evidence of problems; 1: Watchful waiting, preventive action needed; 2: Action or intervention is required; 3: Immediate or intensive action required. Strengths are rated similarly, with higher scores reflecting greater need for action to support the development of each specific strength.