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.

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 0 to 11 years
• All sexes
• No healthy volunteers
• Child

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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: 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.

Conditions

Autism Spectrum Disorders

Being tested

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

Keywords

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

Medical subject headings

Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• 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.

• 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).

• 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: From March 2025 to August 2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Feb 2026
2. Study start13 Mar 2025
3. Primary completion31 Oct 2026 (estimated)
4. Study completion31 Oct 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (10)Papers the sponsor has linked to this study.
• Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.