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

Primary Purpose

Mental Retardation

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive remediation program
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Retardation focused on measuring Attentional disorders, intellectual deficiency

Eligibility Criteria

5 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Demily Caroline

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitus and Me

control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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).
Vineland 2 scale (Vineland Adaptive Behavior Scale)
A measure of adaptive behavior from birth to adulthood
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

Full Information

First Posted
June 8, 2016
Last Updated
August 6, 2021
Sponsor
Hôpital le Vinatier
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1. Study Identification

Unique Protocol Identification Number
NCT02797418
Brief Title
"Cognitus & Moi": a New Cognitive Remediation Tool
Acronym
COGNITUS
Official Title
"Cognitus & Moi": a New Cognitive Remediation Tool for Children With Intellectual Deficiency With Behavioral Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties
Study Start Date
September 14, 2016 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Retardation
Keywords
Attentional disorders, intellectual deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitus and Me
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
the control management that involves fine motor skills and research computer information,management control is usually done
Intervention Type
Behavioral
Intervention Name(s)
Cognitive remediation program
Intervention Description
Comparison between a cognitive remediation program (Cognitus and Me") (groupe 1) and a training group of fine motor skills (group 2)
Primary Outcome Measure Information:
Title
Aberrant Behavior Checklist scale
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
MDI-C scale ( Multiscore Depression Inventory for Children scale)
Description
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
Time Frame
6 months
Title
KIDSCREEN-27 scale
Description
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).
Time Frame
6 months
Title
Vineland 2 scale (Vineland Adaptive Behavior Scale)
Description
A measure of adaptive behavior from birth to adulthood
Time Frame
6 months
Title
ABC scale (Irritability and social withdrawal)
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DEMILY DR CAROLINE, MD PH
Organizational Affiliation
Le Vinatier Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Demily Caroline
City
Bron
State/Province
Lyon
ZIP/Postal Code
69678
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30029627
Citation
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.
Results Reference
derived

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"Cognitus & Moi": a New Cognitive Remediation Tool

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