Clinical trial NCT05473754: Super: a Joint System in a Rehabilitation Educational Digital Platform
Official title: Feasibility Study About Super Digital Platform: a Joint System for Rehabilitation and Educational Projects for Children With Autism Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism Spectrum Disorder
Telerehabilitation
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with Autism Spectrum Disorders that perform rehabilitative programs

Brief summary: Due to its complexity and variability, Autism Spectrum Disorder (ASD) requires multidisciplinary and multidimensional interventions. SUPER (in Italian: Sistema Unitario in una Piattaforma Riabilitativa ed Educativa) is an Italian digital platform, implemented to facilitate collaboration between families, health services, and schools and to promote personalized intervention for children with ASD. The research protocol, aimed to test SUPER's feasibility and usability, foresees the enrollment of 12 ASD children in the Experimental Group (EG) and 12 ASD children for the Control Group. All families, teachers, and clinicians will perform usual rehabilitative and educative interventions, but the EG will use SUPER, in addition to ordinary programs. The feasibility and acceptability of SUPER will be assessed through usability scales and questionnaires realized ad hoc for the purpose. At baseline and established endpoints, ASD patients will be evaluated with different assessment tools.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Autism Spectrum Disorder
* Access to Child Neuropsychiatry or Pediatric Rehabilitation services participating in the study
* Age of patients from 3 to 7,11 years
* Informed consent freely acquired before the start of the study by the patient's parents

Exclusion Criteria:

* Patients with severe genetic degenerative diseases
* Patients with severe sensory disabilities
* Patients with severe medical complications

Primary outcomes:
measure: Change from baseline at 3 months in a specific questionnaire that evaluates perception of taking charge
timeFrame: T0 (baseline) and T1 (after 3 months)
measure: Acceptability of SUPER Digital Platform
timeFrame: T1 (after 3 months of use of SUPER by parents, clinicians and teachers)
measure: Usability of SUPER Digital Platform via System Usability Scale
timeFrame: T1 (after 3 months of use of SUPER by parents, clinicians and teachers)
measure: Change from baseline at 3 months in the Parent Stress Index-Short Form (PSI-SF)
timeFrame: T0 (baseline) and T1 (after 3 months)
Secondary outcomes:
measure: Efficacy of SUPER Digital Platform to support rehabilitation about adaptive behaviour in children with ASD by VABS-2
timeFrame: T0 (baseline), T2 (after 6 months)
measure: Efficacy of SUPER Digital Platform to support rehabilitation about behaviour of ASD children by CBCL
timeFrame: T0 (baseline), T1 (after 3 months); T2 (after 6 months)
measure: Efficacy of SUPER Digital Platform to support the improvement of autistic symptoms in ASD children by CARS-2
timeFrame: T0 (baseline), T2 (after 6 months)
measure: Efficacy of SUPER Digital Platform to support the improvement of social communication ASD children by SCQ
timeFrame: T0 (baseline), T1 (after 3 months), T2 (after 6 months)
Other outcomes:
Locations:
city: Monza
country: Italy
facility: ASST Monza, University of Milano Bicocca
city: Pompei
country: Italy
facility: Centro Riabilitativo Pompei
Study officials:
affiliation: University of Milano Bicocca
name: Renata Nacinovich, MD
role: PRINCIPAL_INVESTIGATOR
References: