Patient-centric Model for Remote Management, Treatment and Rehabilitation of Children With Autism - Michelangelo / GOLIAH (Gaming Open Library for Intervention in Autism at Home) Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- change from baseline in Autism Diagnostic Observation Schedule (ADOS) at 6 months
研究概览
简要总结
To meet the required intensive intervention hour for treating children with autism spectrum disorder (ASD), the investigators developed an automated serious gaming platform (11 games) to deliver intensive intervention at home (GOLIAH). The major objective of the study is to test GOLIAH during a 6-month matched controlled exploratory study were to assess (1) the usefulness and acceptability of the gaming platform; (2) how experimental children performed using the different Imitation and JA games; and (3) whether children from the experimental group improved significantly more than children treated as usual (control group).
详细描述
Background: To meet the required intensive intervention hour for treating children with autism spectrum disorder (ASD), the investigators developed an automated serious gaming platform (11 games) to deliver intensive intervention at home (GOLIAH) by mapping the Imitation and Joint Attention (JA) subset of age-adapted stimuli from the Early Start Denver Model (ESDM) intervention. For the purpose of this study, 24 ASD children will be recruited (one half in Pisa and the other half in Paris). They will be divided into two groups: an Experimental group (N=14) and a Control group (N=10). The Control group will not go through the training sessions, they will participate only in the assessment sessions. All patients will be referred to treatment as usual, according to local facilities.
The protocol is organized into 3 periods (with two assessments at T0 and T6).
- During the initial stage of the protocol (T0), all the ASD children (experimental participants and controls) will be evaluated during a clinical session.
- During the rehabilitation period, only half of the children will participate in the training sessions designed to improve their imitation and joint attention capacities.
- During the final stage of the protocol (T6), all children will be evaluated again during a second clinical session.
The clinical assessments will occur at stage 0 and at stage 6. The same tools will be used for these two assessments. The improvement of children's capabilities will be measured by the progress made between stage 0 and stage 6. The investigators will be able to affirm that the training was beneficial by comparing the clinical session performance between the trained and control children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a current diagnosis of ASD confirmed by clinical assessment and the Autism Diagnostic Interview-Revised;
- •an intellectual quotient ≥ 60;
- •aged between 5 to 8 years.
- •Inclusion in the experimental group was based on parents' motivation to follow such a heavy protocol both at home and for the one session per week at the hospital.
- •Controls were matched for sex, age, IQ, study sites and treatment.
排除标准
- •known organic syndrome and/or non-stabilized neuropediatric (e.g. seizures) or medical (e.g. diabetes mellitus) comorbidities.
结局指标
主要结局
change from baseline in Autism Diagnostic Observation Schedule (ADOS) at 6 months
时间窗: at baseline and 6 months
次要结局
- change from baseline in Vineland II at 6 months(at baseline and 6 months)
- change from baseline in Social Communication Questionnaire at 6 months(at baseline and 6 months)
- change from baseline in Wechsler Intelligence scale at 6 months(at baseline and 6 months)
- change from baseline in Child Behavior Check List at 6 months(at baseline and 6 months)
- change from baseline in Parental Stress Index at 6 months(at baseline and 6 months)