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Completed

NCT Number: NCT03088007

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

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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Key information

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Presence of the ID assessment kit results in the records

    Time frame: 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

  1. Presence of the ID assessment kit results in the records

    Time frame: 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.

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

    Time frame: within one year before the latest child orientation decision

    All the available tests will be listed.

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

    Time frame: within a year before the inclusion

    All the available tests will be listed

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

    Time frame: 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).

  5. Vineland Adaptive Behavioral Scale II

    Time frame: 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).

  6. GECEN rating form (Grille d'Evaluation Comportementale pour Enfants Nisonger

    Time frame: 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.

  7. an academic skills rating form

    Time frame: 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".

  8. Rehabilitation programs

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: EVAL'ID

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Mar 23, 2017
Registry last updated
Mar 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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