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. (ASD Outcome)

February 18, 2026 updated by: Antonella Costantino

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • (LC)
      • Bosisio Parini, (LC), Italy, 23842
        • Recruiting
        • IRCCS Eugenio Medea- U.O. di Neuropsichiatria infantile - Disturbi del Neurosviluppo
        • Contact:
    • (VA)
      • Busto Arsizio, (VA), Italy, 21052
        • Recruiting
        • UOSD Disturbo Autistico nel ciclo della vita
        • Contact:
        • Principal Investigator:
          • Mariarosa Ferrario
    • Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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.
Other: 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).
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From March 2025 to August 2026

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlations between CANS assessment and participants' global functioning (DD-CGAS)
Time Frame: From March 2025 to August 2026
The outcome measure TAI measured with CANS and expressed as the sum of the actionable items (see section "Groups and Intervention") will be correlated will be correlated with outcome measure quality of life, measured with DD-CGAS expressed as 1-100 score con 1 che rappresenta la maggiore compromissione del funzionamento e 100 il miglior funzionamento
From March 2025 to August 2026
Correlations between CANS assessment and participants' quality of life (PEDSQL)
Time Frame: From March 2025 to August 2026
The outcome measure TAI measured with CANS and expressed as the sum of the actionable items (see section "Groups and Intervention") will be correlated will be correlated with outcome measure quality of life, measured with DD-CGAS expressed as 0-100 score with higher scores on the PedsQL indicating better perceptions of health-related quality of life.
From March 2025 to August 2026
Evaluation of changes in children's needs over time based on CANS actionable items.
Time Frame: march 2025 to august 2026
Differences between T0 and T1 TAI measeured with CANS and expressed as the sum of the actionable items (see section "Groups and Interventions") will be evaluated using a paired sample t test.
march 2025 to august 2026
Evaluation of changes in children's Quality of Life over time.
Time Frame: from march 2025 to august 2026
Differences between T0 and T1 PedsQL scores (range 0-100, where 0 represents the lowest quality of life and 100 represents the highest quality of life ) will be evaluated using a paired sample t test.
from march 2025 to august 2026
Evaluation of changes in children's global functioning
Time Frame: from march 2025 to august 2026
DESCRIPTION Differences between T0 and T1 DD-CGAS scores (range 1-100, where 1 represents the lowest level of global functioning and 100 represents the highest level of global functioning) will be evaluated using a paired sample t test.
from march 2025 to august 2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antonella Costantino

Collaborators

IRCCS Eugenio Medea
Azienda Socio Sanitaria Territoriale della Valle Olona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

July 30, 2025

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 573_12.03.2025_P_bis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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