Cognitus & Moi: a New Cognitive Remediation Tool

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Cognitus & Moi: a New Cognitive Remediation Tool for Children With Intellectual Deficiency With Behavioral Disorders

Conditions
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Mental Retardation

Intervention / Treatment
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* Behavioral: Cognitive remediation program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with intellectual deficiency (5-13 years) (40 < total IQ < 75) with or without autism spectrum disorders Native French speaker Clinically stable Parental consent Exclusion Criteria: visual or auditory disorder history of neurological illness or trauma Absence of language

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitus and Me<br>Cognitus & Me is a cognitiv remediation program focused on the functions of attention and visuospatial that is to say that can move in space, to perceive objects of our environment and organize them, to mentally imagine a physically absent operation object very involved in social behavior, in order to limit the presence of behavioral disorders among children with intellectual disabilities. | Behavioral: Cognitive remediation program<br>* Comparison between a cognitive remediation program (Cognitus and Me) (groupe 1) and a training group of fine motor skills (group 2)<br>|
| Active Comparator: control group<br>the control management that involves fine motor skills and research computer information,management control is usually done | Behavioral: Cognitive remediation program<br>* Comparison between a cognitive remediation program (Cognitus and Me) (groupe 1) and a training group of fine motor skills (group 2)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aberrant Behavior Checklist scale | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MDI-C scale ( Multiscore Depression Inventory for Children scale) | The Aberrant Behavior Checklist-Community (ABC-C; Aman & Singh, 1994) is a rating scale that measures the severity of a range of problem behaviors commonly observed in individuals with intellectual and developmental disabilities | 6 months | 
| KIDSCREEN-27 scale | The KIDSCREEN-27 with five dimensions resulted. All five dimensions are Rasch scales: Physical Well-Being (5 items), Psychological Well-Being (7 items), Autonomy & Parents (7 items), Peers & Social Support (4 items), and School Environment (4 items). | 6 months | 
| Vineland 2 scale (Vineland Adaptive Behavior Scale) | A measure of adaptive behavior from birth to adulthood | 6 months | 
| ABC scale (Irritability and social withdrawal) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attentional disorders, intellectual deficiency