Importance of Multidimensional Assessments in Accompanying Schooling of Children With Mild to Moderate Intellectual Disability. (EVAL'ID)

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.

Study Overview

• Status: Completed
• Conditions: Disability, Intellectual
• Intervention / Treatment: Other: Cognitive, adaptive, behavioral and academic assessment

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No insurance coverage
• No parents agreement

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of the ID assessment kit results in the records	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 a year before the inclusion in the study.	within one year before the inclusion
List of tests available in the children' records, other than the ones from the ID kit.	All the available tests will be listed.	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.	All the available tests will be listed	within a year before the inclusion
WISC-IV (Wechsler Intelligence Scale for Children 4th edition)	The Intellectual Quotient of the patient will be assessed using a Wechsler scale, adapted to the age of the patient (WISC-IV).	within one year before the latest child orientation decision
Vineland Adaptive Behavioral Scale II	The Vineland adaptive behavioral scale performed during a semi-structured interview of each child's parents, will allow to assess the adaptive behavior of the child (including communication, daily living skills, socialization, motricity and the global adaptive score).	within one year before the latest child orientation decision
GECEN rating form (Grille d'Evaluation Comportementale pour Enfants Nisonger	The GECEN rating form (Grille d'Evaluation Comportementale pour Enfants Nisonger) is the French translation of the Nisonger Child Behavior Rating Form and will allow the assessment of behavior disorders including: conduct disorders, anxiety, hyperactivity, automutilation/stereotyped behavior, self-isolation/rituals, sensitivity/susceptibility.	within one year before the latest child orientation decision
an academic skills rating form	The academic skills rating form will assess 4 domains: the spoken and the written language, the "discovery of the world", and "being a student".	within one year before the latest child orientation decision
Rehabilitation programs	We will record from the MDPH files the type of rehabilitations that the children had at the latest child orientation decision.	one year after Day 0

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Vincent Des PORTES, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 16, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): March 23, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Intellectual Deficiency; cognitive, adaptive; behavioral and academic profile; regular and special schools
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Intellectual Disability
• Other Study ID Numbers: 69HCL15_0257

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No