NCT02797418

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

September 14, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

4.6 years

First QC Date

June 8, 2016

Last Update Submit

August 6, 2021

Conditions

Mental Retardation

Keywords

Attentional disorders, intellectual deficiency

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (4)

  • MDI-C scale ( Multiscore Depression Inventory for Children scale)

    6 months

  • KIDSCREEN-27 scale

    6 months

  • Vineland 2 scale (Vineland Adaptive Behavior Scale)

    6 months

  • ABC scale (Irritability and social withdrawal)

    6 months

Study Arms (2)

Cognitus and Me

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Behavioral: Cognitive remediation program

Interventions

Cognitive remediation programBEHAVIORAL

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

Cognitus and Mecontrol group

Eligibility Criteria

Age5 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with intellectual deficiency (5-13 years) (40 \< total IQ \< 75) with or without autism spectrum disorders
  • Native French speaker
  • Clinically stable
  • Parental consent

You may not qualify if:

  • visual or auditory disorder
  • history of neurological illness or trauma
  • Absence of language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Demily Caroline

Bron, LYON, 69678, France

Location

Related Publications (1)

  • 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.

    PMID: 30029627DERIVED

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • DEMILY DR CAROLINE, MD PH

    Le Vinatier Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2016

First Posted

June 13, 2016

Study Start

September 14, 2016

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

August 13, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)