Autism Spectrum DisorderSUPERNCT05473754
Super: a Joint System in a Rehabilitation Educational Digital Platform
An observational study of Autism Spectrum Disorder and Telerehabilitation, run by University of Milano Bicocca at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Autism Spectrum Disorder, Telerehabilitation
- What is being tested?
- SUPER digital platform
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 2 sitesItaly
- Study dates
- 9 May 2022to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with Autism Spectrum Disorders that perform rehabilitative programs
Who may be able to join
- 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
Who cannot join
- Patients with severe genetic degenerative diseases
- Patients with severe sensory disabilities
- Patients with severe medical complications
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
ASST Monza, University of Milano Bicocca
Monza, 20128
Giulia Purpura, giulia.purpura@unimib.it
Luca Tagliabue
- Recruiting
Centro Riabilitativo Pompei
Pompei, 80045
Giovanna Gison, giovannagison@gmail.com
Ersilia Vallefuoco
About this study
Official title: Feasibility Study About Super Digital Platform: a Joint System for Rehabilitation and Educational Projects for Children With Autism Spectrum Disorder
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
- Being tested
- SUPER digital platform
- 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.
SUPER digital platformBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Families, teachers, and clinicians use SUPER digital platform in addition to usual rehabilitative and educative interventions. Receives: Behavioral: SUPER digital platform | |
| Control Group | Families, teachers, and clinicians perform usual rehabilitative and educative interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Vineland Adaptive Behavior Scales- 2 (VABS-2) is designed to measure adaptive behavior in daily settings for children and adults from birth to 90 years of age. The Vineland-II items are arranged from 11 simple to more complex behavior subdomains across four main domains: Communication, Daily Living Skills, Socialization, and Motor Skills. It also provides an optional Maladaptive Behavior Index. Items are arranged in a developmental sequence within each subdomain, with each item rated on a 3-point scale (i.e., 0 = Behavior Never Performed, 1 = Behavior Sometimes or Partially Performed, or 2 = Behavior Usually or Habitually Performed).
The Adaptive Behavior Composite and domains yield age-based standard scores with a normative M=100 and SD=15, and subdomains yield standard scores with a M=15 and SD=3.
Measured: T0 (baseline), T2 (after 6 months)
Efficacy of SUPER Digital Platform to support rehabilitation about behaviour of ASD children by CBCL
Child Behavior Checklist (CBCL) is a standardized questionnaires that provides information on six scales: affective problems, attention-deficit/hyperactivity, anxiety, oppositional defiance, somatic problems, and conduct problems. It has two separate forms, one for children 1.5-5 years old and one for children 6-18 years old. On both versions, there is a Total Problems score, as well as composites for Internalizing and Externalizing Problems. DSM-Oriented Scales were formed based on experts' ratings of how well the items fit DSM criteria for relevant Major and Dysthymia for Affective Problems, Anxiety Problems, Oppositional Defiant Problems, and Conduct Problems. The preschool version the DSM-Oriented scales are for Affective Problems, Anxiety Problems, Pervasive Developmental Problems, Attention-Deficit/Hyperactivity Problems, and Oppositional Defiant Problems.
Measured: 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
Childhood Autism Rating Scale - Second Edition (CARS-2) is extremely useful in identifying symptoms of autism. The clinician rates the individual on each item (15 items), using a 4-point response scale. Ratings are based not only on the frequency of the behavior in question, but also on its intensity, peculiarity, and duration.Scores above the cutoff (28) can be broken down into "mild-to-moderate" level of autistic behaviors vs. "severe" level.
Measured: T0 (baseline), T2 (after 6 months)
Efficacy of SUPER Digital Platform to support the improvement of social communication ASD children by SCQ
SCQ is a parent-report tool to evaluate communication skills and social functioning in children who may have autism or autism spectrum disorders. The questionnaire is composed of just 40 yes-or-no questions. Both forms can be given directly to the parent, who can answer the questions without supervision. Higher scores mean a worse functioning. It produces results that can be helpful in treatment planning, educational intervention, and measurement of change over time.
Measured: T0 (baseline), T1 (after 3 months), T2 (after 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start9 May 2022
- Primary completion9 Sep 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulia Purpura, University of Milano Bicocca
- Investigators
- Renata Nacinovich, MD, Principal investigator, University of Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473754
- Sponsor's protocol ID
- SUPER
- Acronym
- SUPER
- Status last verified
- Nov 2022
- First submitted
- 9 May 2022
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study About Super Digital Platform: a Joint System for Rehabilitation and Educational Projects for Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05473754
- Acronym / sponsor ID
- SUPER / SUPER
- Conditions
- Autism Spectrum Disorder, Telerehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 9 Sep 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | Behavioral: SUPER digital platformFamilies, teachers, and clinicians use SUPER digital platform in addition to usual rehabilitative and educative interventions. |
| Control Group | – | –Families, teachers, and clinicians perform usual rehabilitative and educative interventions. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with Autism Spectrum Disorders that perform rehabilitative programs
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with severe genetic degenerative diseases
- Patients with severe sensory disabilities
- Patients with severe medical complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUPER digital platformSUPER 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). | Behavioural | Experimental Group |
Primary outcome
Change from baseline at 3 months in a specific questionnaire that evaluates perception of taking charge
Time frame: T0 (baseline) and T1 (after 3 months)
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.
Acceptability of SUPER Digital Platform
Time frame: T1 (after 3 months of use of SUPER by parents, clinicians and teachers)
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.
Usability of SUPER Digital Platform via System Usability Scale
Time frame: T1 (after 3 months of use of SUPER by parents, clinicians and teachers)
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.
Change from baseline at 3 months in the Parent Stress Index-Short Form (PSI-SF)
Time frame: T0 (baseline) and T1 (after 3 months)
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.
4 secondary outcomes
Efficacy of SUPER Digital Platform to support rehabilitation about adaptive behaviour in children with ASD by VABS-2
Time frame: T0 (baseline), T2 (after 6 months)
Efficacy of SUPER Digital Platform to support rehabilitation about behaviour of ASD children by CBCL
Time frame: 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
Time frame: T0 (baseline), T2 (after 6 months)
Efficacy of SUPER Digital Platform to support the improvement of social communication ASD children by SCQ
Time frame: T0 (baseline), T1 (after 3 months), T2 (after 6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renata Nacinovich, MD principal investigator
University of Milano Bicocca
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Telerehabilitation, run by University of Milano Bicocca at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giulia Purpura, PhD (+39 3381321252, giulia.purpura@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline at 3 months in a specific questionnaire that evaluates perception of taking charge (time frame: T0 (baseline) and T1 (after 3 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2022; AzTrials last refreshed its copy on 1 Nov 2026.