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.

Официальное название

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.

Обзор

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.

Вмешательства

• Другое 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 perce
• Другое 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
• Другое 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 too

Первичные конечные точки

• Specific clusters of CANS items that differentiate the profiles of needs and strengths of users at T0. [Срок оценки: From March 2025 to August 2026]

Вторичные конечные точки (5)

• Correlations between CANS assessment and participants' global functioning (DD-CGAS) [Срок оценки: From March 2025 to August 2026]
• Correlations between CANS assessment and participants' quality of life (PEDSQL) [Срок оценки: From March 2025 to August 2026]
• Evaluation of changes in children's needs over time based on CANS actionable items. [Срок оценки: march 2025 to august 2026]
• Evaluation of changes in children's Quality of Life over time. [Срок оценки: from march 2025 to august 2026]
• Evaluation of changes in children's global functioning [Срок оценки: from march 2025 to august 2026]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Subjects aged 12 years or older at the time of enrollment
• No consent from the person holding parental responsibility for health choices

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 3 центра

• IRCCS Eugenio Medea- U.O. di Neuropsichiatria infantile - Disturbi del Neurosviluppo — Bosisio Parini
• UOSD Disturbo Autistico nel ciclo della vita — Busto Arsizio
• SC Child and Adolescence Neuropsychiatric Unit, Fondazione IRCCS Cà Granda Ospedale Maggio — Milan

Публикации

• Sandbank M, Pustejovsky JE, Bottema-Beutel K, Caldwell N, Feldman JI, Crowley LaPoint S, Woynaroski T. Determining Associations Between Intervention Amount and Outcomes for Young Autistic Children: A Meta-Analysis. JAMA Pediatr. 2024 Aug 1;178(8):763-773. doi: 10.1001/jamapediatrics.2024.1832. PMID 38913359
• Provenzani U, Fusar-Poli L, Brondino N, Damiani S, Vercesi M, Meyer N, Rocchetti M, Politi P. What are we targeting when we treat autism spectrum disorder? A systematic review of 406 clinical trials. Autism. 2020 Feb;24(2):274-284. doi: 10.1177/1362361319854641. Epub 2019 Jul 3. PMID 31269800
• Perry N, Boulton KA, Hodge A, Ong N, Phillips N, Howard K, Raghunandan R, Silove N, Guastella AJ. A psychometric investigation of health-related quality of life measures for paediatric neurodevelopment assessment: Reliability and concurrent validity of the PEDS-QL, CHU-9D, and the EQ-5D-Y. Autism Res. 2024 May;17(5):972-988. doi: 10.1002/aur.3127. Epub 2024 Apr 10. PMID 38597587
• Ne'eman A. When Disability Is Defined by Behavior, Outcome Measures Should Not Promote "Passing". AMA J Ethics. 2021 Jul 1;23(7):E569-575. doi: 10.1001/amajethics.2021.569. PMID 34351268
• Jolliffe, I. T. (2002). Principal Component Analysis (2nd ed.). Springer.
• Godoy PBG, Sumiya FM, Seda L, Shephard E. A systematic review of observational, naturalistic, and neurophysiological outcome measures of nonpharmacological interventions for autism. Braz J Psychiatry. 2022 Nov 5;44(5):532-547. doi: 10.47626/1516-4446-2021-2222. Epub 2022 Jun 24. PMID 35751600
• Cordell, K. D. et al. (2016). Patterns and priorities of service need identified through the Child and Adolescent Needs and Strengths (CANS) assessment. Children and Youth Services Review, 60, 129-135.
• Brown, C. C., Wang, E. W., & Goad, C. (2022). A review of the psychometric properties of the child and adolescent needs and strengths (CANS): Perspectives on the present state of the literature and future directions. Residential Treatment for Children & Youth, 39(3), 331-346.

Идентификаторы

NCT: NCT07393152 · 573_12.03.2025_P_bis

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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