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Clinical Trials/NCT02797418
NCT02797418
Terminated
N/A

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

Hôpital le Vinatier1 site in 1 country18 target enrollmentSeptember 14, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mental Retardation
Sponsor
Hôpital le Vinatier
Enrollment
18
Locations
1
Primary Endpoint
Aberrant Behavior Checklist scale
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

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

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).

Registry
clinicaltrials.gov
Start Date
September 14, 2016
End Date
April 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hôpital le Vinatier
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Aberrant Behavior Checklist scale

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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