NCT03088007

Brief Summary

The EVAL'ID study aims to demonstrate the value of a multidimensional assessment in accompanying schooling of children with Intellectual Disability. The study will be performed in the Rhône department (France) in children aged from 5 to 13 years with mild to moderate Intellectual Disability , and attending school either at ULIS (Unités Localisées pour l'Inclusion Scolaire, which enables disabled children to attend regular schools), or IME (Instituts Médico-Educatifs, which are special schools mandated to accommodate children and young people with Intellectual Disability at any level of disability). A multidimensional assessment encompasses the assessment of academic, cognitive, behavioral and adaptive skills of the children, with validated and reliable neuropsychological batteries, called ID Kit (Intellectual Deficiency assessment Kit), which includes the following scales : the Wechsler Intelligence Scale for Children 4th edition (WISC-IV), the Vineland Adaptive Behavioral Scale II, the GECEN rating form (Grille d'Evaluation Comportementale pour Enfants Nisonger, which is the French translation of the Nisonger Child Behavior Rating Form), and an academic skills rating form (GEVA-SCO). A comparison of the children neuropsychological profiles according to the type of school they attend, will be perform. The project consists of three phases:

  • Stage 1: Collection of information from each child records at MDPH (Departmental Administration for Disabled Persons), IME, ULIS schools, including the assessments that were performed, and from a survey of both caregivers and parents regarding their respective perception and knowledge of the child's disability
  • Stage 2: All the children who were not previously assessed with the ID kit will be further evaluated using these tests. The results of these assessments will be shared with parents and caregivers.
  • Stage 3: A survey regarding the perception and knowledge of the child's disability will be carried out again among caregivers and parents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

2.2 years

First QC Date

March 10, 2017

Last Update Submit

March 16, 2017

Conditions

Keywords

Intellectual Deficiencycognitive, adaptivebehavioral and academic profileregular and special schools

Outcome Measures

Primary Outcomes (1)

  • Presence of the ID assessment kit results in the records

    The primary outcome measure consists of the presence of the results of the neuropsychological tests included in the ID assessment kit: WISC-IV (IQ), Vineland Adaptive Behavioral Scale II, GECEN rating form, and an academic skills rating form (GEVA-SCO), in the records from the MDPH and the school records (ULIS or IME), and dated from within one year before the latest child orientation decision.

    within one year before the latest child orientation decision

Secondary Outcomes (8)

  • Presence of the ID assessment kit results in the records

    within one year before the inclusion

  • List of tests available in the children' records, other than the ones from the ID kit.

    within one year before the latest child orientation decision

  • List of tests available in the children's records, other than the ones from the ID kit.

    within a year before the inclusion

  • WISC-IV (Wechsler Intelligence Scale for Children 4th edition)

    within one year before the latest child orientation decision

  • Vineland Adaptive Behavioral Scale II

    within one year before the latest child orientation decision

  • +3 more secondary outcomes

Study Arms (2)

IME attending ID children

Children with mild to moderate Intellectual Deficiency attending school at IME (Instituts Médico-Educatifs, which are special schools mandated to accommodate children and young people with Intellectual Disability at any level of disability).

Other: Cognitive, adaptive, behavioral and academic assessment

ULIS attending ID children

Children with mild to moderate Intellectual Deficiency attending school at ULIS (Unités Localisées pour l'Inclusion Scolaire, which enables disabled children to attend regular schools)

Other: Cognitive, adaptive, behavioral and academic assessment

Interventions

Cognitive, adaptive, behavioral and academic assessment will be performed if not available in the records, using WISC-IV, VABS, GECEN and an academic skills rating form.

IME attending ID childrenULIS attending ID children

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged from 5 to 13 years with mild to moderate Intellectual Disability , and attending school either at ULIS (Unités Localisées pour l'Inclusion Scolaire, which enables disabled children to attend regular schools), or IME (Instituts Médico-Educatifs, which are special schools mandated to accommodate children and young people with Intellectual Disability at any level of disability), within the Rhône department, France.

You may qualify if:

  • Age : \> 5 and \<13 years
  • With mild to moderate intellectual deficiency
  • attending school either at ULIS or IME in the Rhône department.

You may not qualify if:

  • No insurance coverage
  • No parents agreement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

Location

MeSH Terms

Conditions

Intellectual DisabilityBehavior

Condition Hierarchy (Ancestors)

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

Study Officials

  • Vincent Des PORTES, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2017

First Posted

March 23, 2017

Study Start

August 1, 2014

Primary Completion

October 1, 2016

Study Completion

March 1, 2017

Last Updated

March 23, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations