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.

NCT07393152 | Recruiting

• 1 other identifier: 573_12.03.2025_P_bis
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 3

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.

Conditions

Autism Spectrum Disorders

Keywords

Global functioning; Quality of life; Child and adolescent need and strenght; autism spectrum disorders; Outcome evaluation tools

Outcome Measures

Primary Outcomes (1)

• Specific clusters of CANS items that differentiate the profiles of needs and strengths of users at T0.

  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.

  From March 2025 to August 2026

Secondary Outcomes (5)

• 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

Study Arms (1)

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.

Other: DD-CGAS (Wagner et al. 2007); Other: Pediatric Quality of Life Inventory (PedsQL).; Other: Child and Adolescent Needs and Strengths (CANS) (Lyons 2022)

Interventions

DD-CGAS (Wagner et al. 2007) OTHER

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.

Children aged 0-11 with ASD diagnosis

Pediatric Quality of Life Inventory (PedsQL). OTHER

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).

Children aged 0-11 with ASD diagnosis

Child and Adolescent Needs and Strengths (CANS) (Lyons 2022) OTHER

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.

Children aged 0-11 with ASD diagnosis

Eligibility Criteria

• Age: 0 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children diagnosed with ASD enrolled in one of the intervention programs in line with the national guidelines, within the partner institutions or other NPIA/rehabilitation services for developmental age of the Lombardy Region are eligible. The overall expected sample is 400 male and female children, under 12 years of age, 200 children aged 0-5 years at T0 and 200 children aged 6-11 years at T0.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Antonella Costantino: lead
• IRCCS Eugenio Medea: collaborator
• Azienda Socio Sanitaria Territoriale della Valle Olona: collaborator

Study Sites (3)

IRCCS Eugenio Medea- U.O. di Neuropsichiatria infantile - Disturbi del Neurosviluppo

Bosisio Parini, (LC), 23842, Italy

RECRUITING

UOSD Disturbo Autistico nel ciclo della vita

Busto Arsizio, (VA), 21052, Italy

RECRUITING

SC Child and Adolescence Neuropsychiatric Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico , Milan, Italy

Milan, Michigan, 20122, Italy

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Jolliffe, I. T. (2002). Principal Component Analysis (2nd ed.). Springer.

  BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Benzoni, S. et al. (2020). Partecipazione e valutazione di esito nella salute mentale in età evolutiva: gli strumenti della famiglia CANS nell'esperienza italiana. Erickson

  BACKGROUND

• Babamoradi H, van den Berg F, Rinnan A. Confidence limits for contribution plots in multivariate statistical process control using bootstrap estimates. Anal Chim Acta. 2016 Feb 18;908:75-84. doi: 10.1016/j.aca.2016.01.002. Epub 2016 Jan 7.

  PMID: 26826689 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Maria Antonella Costantino

CONTACT

+39 02 5503.4400; antonella.costantino@policlinico.mi.it

Debora Zanolla

CONTACT

debora.zanolla@policlinico.mi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Child and Adolescence Neuropsychiatric Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico , Milan, Italy

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: February 6, 2026
• Study Start: March 13, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: February 20, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)