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.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-11
SponsorAntonella Costantino

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Subjects aged 12 years or older at the time of enrollment

No consent from the person holding parental responsibility for health choices

Trial design

Treatments tested in this trial

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

Treatment groups

400 Participants
are divided into 1 treatment group

Sponsors and collaborators

Antonella Costantino

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Sponsor institution

IRCCS Eugenio Medea

Collaborator

Azienda Socio Sanitaria Territoriale della Valle Olona

Collaborator