Use of a Smartphone© Application to Study Autism Spectrum Disorders (ASD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Filling rate of the application
研究概览
简要总结
This is a prospective, longitudinal, exploratory, open study with a 6-month follow-up period to explore via a specific Smartphone© application the evolution of a child's behavior over 6 months and the (psychological and social) effects of these changes on the family.
详细描述
This is a prospective, longitudinal, exploratory, open study with a 6-month follow-up period to assess the feasibility of using a Smartphone© application designed for parents of patients with ASD and to longitudinally collect data on the quality of life and anxiety of parents of children with ASD and the children's functional symptoms over multiple weeks under natural conditions.
Population:
The investigators propose to study individuals diagnosed with ASD based on National Health Authority (HAS) recommendations (on ADI-R diagnoses) from 3-16 years of age in the Pays de la Loire region. The investigators propose to include 100 families. The study is exploratory in nature; thus, randomizing patients is unnecessary. The investigators will include the first 100 families agreeing to participate in the study and meeting the inclusion criteria. All participants will be recruited from the Department of Child and Adolescent Psychiatry of University Hospital of Nantes and from the Regional Center for Autism (CRA des Pays de la Loire).
Method:
At the inclusion visit, parents will receive a code to download the app from the "application store" of their choice (depending on their Smartphone©) and sign an informed consent form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having a child with an ASD diagnosis based on the International Classification of Diseases (ICD) 10 criteria.
- •Having at least one Smartphone© (iOS Apple or Android).
- •Signing the consent form for participation.
排除标准
- •Having several children with an ASD diagnosis.
- •Having children living in more than two areas
研究组 & 干预措施
ASD children families
干预措施: Ecological Momentary Assessment with Smartphone© Application (Other)
结局指标
主要结局
Filling rate of the application
时间窗: 6 months
The primary outcome measure will be the filling rate (R) and the use of our application by the parents over six months. This number will be Automatically Generated by Application (AGA) Number of fillings = R 60
次要结局
- Visual Analogic scale quotation about parental personal life(every 3 days for 6 months)
- the duration of use(every 3 days for 6 months)
- child sleep disorders(every 3 days for 6 months)
- Visual Analogic scale quotation about parental anxiety(every 3 days for 6 months)
- Visual Analogic scale quotation about parental pain(every 3 days for 6 months)
- child behavior with pairs(every 3 days for 6 months)
- Visual Analogic scale quotation about parental stress(every 3 days for 6 months)
- Visual Analogic scale quotation about parental social life(every 3 days for 6 months)
- child eating disorders(every 3 days for 6 months)
- Visual Analogic scale quotation about parental professional life(every 3 days for 6 months)
- child general behavior(every 3 days for 6 months)
- Visual Analogic scale quotation about parental sleep(every 3 days for 6 months)
- Visual Analogic scale quotation about parental self esteem(every 3 days for 6 months)
- Visual Analogic scale quotation about parental mood(every 3 days for 6 months)
- Visual Analogic scale quotation about parental support and resources(every 3 days for 6 months)
- the time of use(every 3 days for 6 months)
- rate of complete filling(every 3 days for 6 months)