Super: a Joint System in a Rehabilitation Educational Digital Platform

NCT ID: NCT05473754

Last Updated: 2022-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-09

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Autism Spectrum Disorder Telerehabilitation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental Group

Families, teachers, and clinicians use SUPER digital platform in addition to usual rehabilitative and educative interventions.

SUPER digital platform

Intervention Type BEHAVIORAL

SUPER digital platform was implemented to ensure synergy between ASD families, health services, and schools through different tools to share rehabilitative and educational objectives and strategies. It was designed following the ASD International Guidelines and the recommendations of the ICF-CY and was organized into two areas: General (to promote scientific knowledge on ASD) and Personalized (restricted virtual space for groups of users following an individual with ASD).

Control Group

Families, teachers, and clinicians perform usual rehabilitative and educative interventions.

No interventions assigned to this group

Interventions

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SUPER digital platform

SUPER digital platform was implemented to ensure synergy between ASD families, health services, and schools through different tools to share rehabilitative and educational objectives and strategies. It was designed following the ASD International Guidelines and the recommendations of the ICF-CY and was organized into two areas: General (to promote scientific knowledge on ASD) and Personalized (restricted virtual space for groups of users following an individual with ASD).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milano Bicocca

OTHER

Sponsor Role lead

Responsible Party

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Giulia Purpura

PhD, Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Renata Nacinovich, MD

Role: PRINCIPAL_INVESTIGATOR

University of Milano Bicocca

Locations

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ASST Monza, University of Milano Bicocca

Monza, , Italy

Site Status RECRUITING

Centro Riabilitativo Pompei

Pompei, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giulia Purpura, PhD

Role: CONTACT

+39 3381321252

Facility Contacts

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Giulia Purpura

Role: primary

Giovanna Gison

Role: primary

Other Identifiers

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SUPER

Identifier Type: -

Identifier Source: org_study_id

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