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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Specific clusters of CANS items that differentiate the profiles of needs and strengths of users at T0.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Subjects aged 12 years or older at the time of enrollment
- •No consent from the person holding parental responsibility for health choices
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
干预措施: Child and Adolescent Needs and Strengths (CANS) (Lyons 2022) (Other)
结局指标
主要结局
Specific clusters of CANS items that differentiate the profiles of needs and strengths of users at T0.
时间窗: 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.
次要结局
- 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)
研究者
Antonella Costantino
Director Child and Adolescence Neuropsychiatric Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico , Milan, Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico