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

Disability, Intellectual Clinical Trial

— EVAL'ID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03088007
• Other study ID #: 69HCL15_0257
• Status: Completed
• Phase: N/A
• First received: March 10, 2017
• Last updated: March 16, 2017
• Start date: August 1, 2014
• Est. completion date: March 1, 2017

Study information

• Verified date: March 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 1, 2017
• Est. primary completion date: October 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Disability, Intellectual
• Intellectual Disability

Intervention

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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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