Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

"Cognitus & Moi": a New Cognitive Remediation Tool (COGNITUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02797418
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Hôpital le Vinatier

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.

Condition or disease Intervention/treatment Phase
Mental Retardation Behavioral: Cognitive remediation program Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "Cognitus & Moi": a New Cognitive Remediation Tool for Children With Intellectual Deficiency With Behavioral Disorders
Study Start Date : September 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Cognitive remediation program
Comparison between a cognitive remediation program (Cognitus and Me") (groupe 1) and a training group of fine motor skills (group 2)

Active Comparator: control group
the control management that involves fine motor skills and research computer information,management control is usually done
Behavioral: Cognitive remediation program
Comparison between a cognitive remediation program (Cognitus and Me") (groupe 1) and a training group of fine motor skills (group 2)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. MDI-C scale ( Multiscore Depression Inventory for Children scale) [ Time Frame: 6 months ]
    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

  2. KIDSCREEN-27 scale [ Time Frame: 6 months ]
    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).

  3. Vineland 2 scale (Vineland Adaptive Behavior Scale) [ Time Frame: 6 months ]
    A measure of adaptive behavior from birth to adulthood

  4. ABC scale (Irritability and social withdrawal) [ Time Frame: 6 months ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797418


Contacts
Layout table for location contacts
Contact: DEMILY DR CAROLINE, MD PH +33437915163 caroline.demily@ch-le-vinatier.fr

Locations
Layout table for location information
France
Demily Caroline Recruiting
Bron, Lyon, France, 69678
Contact: BABINET MARIE NOELLE    0033437915163    marie-noelle.babinet@ch-le-vinatier.fr   
Contact: VIAL VERONIQUE    0033437915531    veronique.vial@ch-le-vinatier.fr   
Sponsors and Collaborators
Hôpital le Vinatier
Investigators
Layout table for investigator information
Principal Investigator: DEMILY DR CAROLINE, MD PH Le Vinatier Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT02797418     History of Changes
Other Study ID Numbers: 2015-A00858-41
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hôpital le Vinatier:
Attentional disorders, intellectual deficiency

Additional relevant MeSH terms:
Layout table for MeSH terms
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders