Super: a Joint System in a Rehabilitation Educational Digital Platform

NCT05473754 | Unknown DMC

• 1 other identifier: SUPER
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorder; Telerehabilitation

Outcome Measures

Primary Outcomes (4)

• Change from baseline at 3 months in a specific questionnaire that evaluates perception of taking charge

  Questionnaire created ad hoc for taking charge: it is a parent-report instrument with 22 items based on a 5-points Likert Scale. Higher scores (maximum 110) mean a better perception of taking charge, while lower scores (minimum 22) mean a worse perception about taking charge.

  T0 (baseline) and T1 (after 3 months)

• Acceptability of SUPER Digital Platform

  SUPER Questionnaire is an instrument created ad hoc to evaluate the acceptability of SUPER platform for parents, clinicians and teachers of children with ASD. It is composed by 38 items based on a 5-points Likert Scale. Higher scores (maximum 190) mean optimal acceptability of SUPER within the rehabilitative taking charge, while lower scores (minimum 38) mean a worse level of acceptability.

  T1 (after 3 months of use of SUPER by parents, clinicians and teachers)

• Usability of SUPER Digital Platform via System Usability Scale

  SUS (System Usability Scale) is a standardized tool for measuring the perceived usability of an interactive system, such as websites, user interfaces, and web applications. It consists of 10 items that are scored on a Likert scale, from 1 (strongly disagree) to 5 (strongly agree). The SUS scores below 68 reveal usability issues with the system, while scores higher than 68 indicate acceptable levels of usability. More specifically, scores over 80 suggest an "excellent" usable system, scores between 68 and 80 can be considered "good", scores between 51 and 68 indicate "fair" results, scores below 51 are "poor", and scores below 36 reflect "unusable" systems.

  T1 (after 3 months of use of SUPER by parents, clinicians and teachers)

• Change from baseline at 3 months in the Parent Stress Index-Short Form (PSI-SF)

  The Parenting Stress Index-Short Form (PSI-SF) is one of the most commonly used measures of parenting stress both in clinical and research contexts. The PSI-SF is a 36-item, self-report measure with three subscales: Parental Distress (PD), Parent-Child Dysfunctional Interaction (PCDI), and Difficult Child (DC). Items are scored using the following 5-point scale: 1) SA (Strongly Agree); 2) A (Agree); 3) NS (Not Sure); 4) D (Disagree); 5) SD (Strongly Disagree).The normal range of scores is between the 15th and 80th percentile. Scores at or above the 85th percentile are considered high and Defensive Reponding scores at 10 or below are considered extremely low.

  T0 (baseline) and T1 (after 3 months)

Secondary Outcomes (4)

• Efficacy of SUPER Digital Platform to support rehabilitation about adaptive behaviour in children with ASD by VABS-2

  T0 (baseline), T2 (after 6 months)

• Efficacy of SUPER Digital Platform to support rehabilitation about behaviour of ASD children by CBCL

  T0 (baseline), T1 (after 3 months); T2 (after 6 months)

• Efficacy of SUPER Digital Platform to support the improvement of autistic symptoms in ASD children by CARS-2

  T0 (baseline), T2 (after 6 months)

• Efficacy of SUPER Digital Platform to support the improvement of social communication ASD children by SCQ

  T0 (baseline), T1 (after 3 months), T2 (after 6 months)

Study Arms (2)

Experimental Group

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

Behavioral: SUPER digital platform

Control Group

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

Interventions

SUPER digital platform 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).

Experimental Group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with Autism Spectrum Disorders that perform rehabilitative programs

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (2)

ASST Monza, University of Milano Bicocca

Monza, 20128, Italy

RECRUITING

Centro Riabilitativo Pompei

Pompei, 80045, Italy

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Renata Nacinovich, MD

  University of Milano Bicocca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giulia Purpura, PhD

CONTACT

+39 3381321252; giulia.purpura@unimib.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Researcher

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: July 26, 2022
• Study Start: May 9, 2022
• Primary Completion: September 9, 2023
• Study Completion: April 30, 2024
• Last Updated: November 25, 2022

Record last verified: 2022-11

Locations

IT (2)