"Cognitus & Moi": a New Cognitive Remediation Tool for Children With Intellectual Deficiency With Behavioral Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Aberrant Behavior Checklist scale
研究概览
简要总结
Holders children with intellectual disabilities have great difficulty in adapting to social situations and relationships.Cognitive impairment associated with intellectual disability are important factors to understand their difficulties in processing social information. In the field of recognition of facial emotions in particular, basic cognitive processes such as visuospatial and attentional functions, are heavily involved.Cognitive remediation is a management tool widely used by practitioners to help patients who experience cognitive difficulties. Currently, no program can meet specific and validated the problems are children with intellectual disabilities manner in their daily functioning.
详细描述
Cognitus & ME is a remediation program focused on attentional functions and visuospatial, to limit the presence of behavioral disorders among children with intellectual disabilities.The main objective is to validate the effectiveness of Cognitus & ME program on behavioral disorders in children with intellectual disabilities (with or without autism spectrum disorder associated).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with intellectual deficiency (5-13 years) (40 < total IQ < 75) with or without autism spectrum disorders
- •Native French speaker
- •Clinically stable
- •Parental consent
排除标准
- •visual or auditory disorder
- •history of neurological illness or trauma
- •Absence of language
结局指标
主要结局
Aberrant Behavior Checklist scale
时间窗: 6 months
Change in sub-score " hyperactivity / non compliance " (scale " Aberrant Behavior Checklist ") (completed by parents or the educational team). This measure is repeated at the end of the intervention to highlight the impact of the " Cognitus and Me " program, and 6 months later to investigate the possible long-lasting effects of the benefits.
次要结局
- KIDSCREEN-27 scale(6 months)
- Vineland 2 scale (Vineland Adaptive Behavior Scale)(6 months)
- ABC scale (Irritability and social withdrawal)(6 months)
- MDI-C scale ( Multiscore Depression Inventory for Children scale)(6 months)