Feasibility Study About Super Digital Platform: a Joint System for Rehabilitation and Educational Projects for Children With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change from baseline at 3 months in a specific questionnaire that evaluates perception of taking charge
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients with severe genetic degenerative diseases
- •Patients with severe sensory disabilities
- •Patients with severe medical complications
结局指标
主要结局
Change from baseline at 3 months in a specific questionnaire that evaluates perception of taking charge
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- 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 rehabilitation about adaptive behaviour in children with ASD by VABS-2(T0 (baseline), 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))
研究者
Giulia Purpura
PhD, Researcher
University of Milano Bicocca