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

August 6, 2021 updated by: Hôpital le Vinatier

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Lyon
      • Bron, Lyon, France, 69678
        • Demily Caroline

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 13 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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).
6 months
Vineland 2 scale (Vineland Adaptive Behavior Scale)
Time Frame: 6 months
A measure of adaptive behavior from birth to adulthood
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital le Vinatier

Investigators

  • Principal Investigator: DEMILY DR CAROLINE, MD PH, Le Vinatier Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 14, 2016

Primary Completion (ACTUAL)

April 30, 2021

Study Completion (ACTUAL)

April 30, 2021

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

June 8, 2016

First Posted (ESTIMATE)

June 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 6, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A00858-41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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