Mental Retardation Clinical Trial
— COGNITUSOfficial title:
"Cognitus & Moi": a New Cognitive Remediation Tool for Children With Intellectual Deficiency With Behavioral Disorders
| Verified date | August 2021 |
| Source | Hôpital le Vinatier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 18 |
| Est. completion date | April 30, 2021 |
| Est. primary completion date | April 30, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 5 Years to 13 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Demily Caroline | Bron | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hôpital le Vinatier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | Vineland 2 scale (Vineland Adaptive Behavior Scale) | A measure of adaptive behavior from birth to adulthood | 6 months | |
| Secondary | 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 |
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