Importance of Multidimensional Assessments in Accompanying Schooling of Children With Mild to Moderate Intellectual Disability.

NCT03088007 — Completed, 150 participants, Hospices Civils de Lyon

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Registry	NCT03088007, acronym EVAL'ID
Status	Completed
Study type	Observational
Enrollment	150 (Actual)
Sponsor	Hospices Civils de Lyon (Other)
Conditions	Disability, Intellectual
Interventions	Cognitive, adaptive, behavioral and academic assessment (Other)
Dates	start 2014-08-01, primary completion 2016-10-01, completion 2017-03-01, first posted 2017-03-23, last updated 2017-03-23
Locations	1 site in France

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
IME attending ID children		Other: Cognitive, adaptive, behavioral and academic assessment	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).
ULIS attending ID children		Other: Cognitive, adaptive, behavioral and academic assessment	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)

Cognitive, adaptive, behavioral and academic assessment (Other): 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.

+Outcome measures

Primary outcomes

Presence of the ID assessment kit results in the records [within one year before the latest child orientation decision]: 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.

Secondary outcomes

Presence of the ID assessment kit results in the records [within one year before the inclusion]: 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.
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]: All the available tests will be listed.
List of tests available in the children's records, other than the ones from the ID kit. [within a year before the inclusion]: All the available tests will be listed
WISC-IV (Wechsler Intelligence Scale for Children 4th edition) [within one year before the latest child orientation decision]: The Intellectual Quotient of the patient will be assessed using a Wechsler scale, adapted to the age of the patient (WISC-IV).
Vineland Adaptive Behavioral Scale II [within one year before the latest child orientation decision]: 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).
GECEN rating form (Grille d'Evaluation Comportementale pour Enfants Nisonger [within one year before the latest child orientation decision]: 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.
an academic skills rating form [within one year before the latest child orientation decision]: The academic skills rating form will assess 4 domains: the spoken and the written language, the "discovery of the world", and "being a student".
Rehabilitation programs [one year after Day 0]: We will record from the MDPH files the type of rehabilitations that the children had at the latest child orientation decision.

+Eligibility

Sex: All, ages: 6 Years to 14 Years

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

+Locations (1)

Facility	City	Country	Status
Hospices Civils de Lyon	Bron	France

+Investigators

Vincent Des PORTES, MD, Principal investigator, Hospices Civils de Lyon