REHABILITUS: a New Cognitive Remediation Tool for Adults With Intellectual Deficiency With Behavioral Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Change in sub-score hyperactivity / non compliance on Aberrant Behavior Checklist scale
研究概览
简要总结
Adults 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 adults with intellectual disabilities manner in their daily functioning
详细描述
Réhabilitus is a remediation program focused on attentional functions and visuospatial, to limit the presence of behavioral disorders among adults with intellectual disabilities. The main objective is to validate the effectiveness of Réhabilitus program on behavioral disorders in adults with intellectual disabilities 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)
盲法说明
Blindness of the psychologist for the secondary judgment criteria.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 45 inclusive;
- •Behavioral disorders corresponding to a total score on the ABC scale > 15
- •Presence of a family caregiver (parent, friend) or professional (reeducator, professional of the medico-social sector) stakeholder of the project;
- •Diagnosis of mild to moderate intellectual disability (assessed by WAIS-IV battery and VABS-II less than 3 years ago;
- •French or secondary mother tongue;
- •Psychoactive treatment unchanged during the month prior to inclusion;
- •Adult or legal representative who has given written and informed consent to participate in the study. By default, the adult's oral agreement will be collected (as well as the written consent of the legal representative);
- •Affiliation to the social security scheme or beneficiary of such a scheme.
排除标准
- •Neurological disorders of vascular, infectious or neurodegenerative origin;
- •Taking medications for general medical purposes with a neurological or psychiatric impact (eg corticosteroids);
- •Simultaneous participation in any other cognitive remediation program targeting attentional, visuospatial and social cognition;
- •Refusal of participation of the person and/or his/her legal representative;
- •Not family or professional caregiver;
- •Presence of Autistic Spectrum Disorders (evaluated by ADOS and ADI if necessary according to the assessment of the investigator)
结局指标
主要结局
Change in sub-score hyperactivity / non compliance on Aberrant Behavior Checklist scale
时间窗: 6 months
Aberrant Behavior Checklist scale (ABC) The ABC scale \[20\] is a 58-item scale for people close to the autistic person. Scores are distributed in five subscale: irritability, agitation, crying; of lethargy and social withdrawal; stereotyped behaviors; hyperactivity; inappropriate language.
次要结局
- 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(6 months)
- Change from baseline in attentional functions(6 months)
- Change from baseline in facial emotion recognition task(6 months)