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

March 16, 2017 updated by: Hospices Civils de Lyon

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
within one year before the latest child orientation decision

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
within one year before the inclusion
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.
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.
Time Frame: within a year before the inclusion
All the available tests will be listed
within a year before the inclusion
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).
within one year before the latest child orientation decision
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).
within one year before the latest child orientation decision
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.
within one year before the latest child orientation decision
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".
within one year before the latest child orientation decision
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.
one year after Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vincent Des PORTES, MD, Hospices Civils De Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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