"Cognitus & Moi": a New Cognitive Remediation Tool

NCT ID: NCT02797418

Last Updated: 2021-08-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-14
• Study Completion Date: 2021-04-30

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).

Conditions

Mental Retardation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitus and Me

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.

Group Type: EXPERIMENTAL

Cognitive remediation program

Intervention Type: BEHAVIORAL

Comparison between a cognitive remediation program (Cognitus and Me") (groupe 1) and a training group of fine motor skills (group 2)

control group

the control management that involves fine motor skills and research computer information,management control is usually done

Group Type: ACTIVE_COMPARATOR

Cognitive remediation program

Intervention Type: BEHAVIORAL

Comparison between a cognitive remediation program (Cognitus and Me") (groupe 1) and a training group of fine motor skills (group 2)

Interventions

Cognitive remediation program

Comparison between a cognitive remediation program (Cognitus and Me") (groupe 1) and a training group of fine motor skills (group 2)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital le Vinatier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

DEMILY DR CAROLINE, MD PH

Role: PRINCIPAL_INVESTIGATOR

Le Vinatier Hospital

Locations

Demily Caroline

Bron, LYON, France

Countries

France

References

Favre E, Peyroux E, Babinet MN, Poisson A, Demily C. Computer-based cognitive remediation program for the treatment of behavioral problems in children with intellectual disability: the <<COGNITUS & MOI>> study protocol for a randomized controlled trial. BMC Psychiatry. 2018 Jul 20;18(1):235. doi: 10.1186/s12888-018-1810-z.

Reference Type: DERIVED

PMID: 30029627 (View on PubMed)

Other Identifiers

2015-A00858-41

Identifier Type: -

Identifier Source: org_study_id