Disability, IntellectualEVAL'IDNCT03088007
Importance of Multidimensional Assessments in Accompanying Schooling of Children With Mild to Moderate Intellectual Disability.
An observational study of Disability, Intellectual, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Disability, Intellectual
- What is being tested?
- Cognitive, adaptive, behavioral and academic assessment
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2014to 1 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Age : > 5 and <13 years
- With mild to moderate intellectual deficiency
- attending school either at ULIS or IME in the Rhône department.
Who cannot join
- No insurance coverage
- No parents agreement
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Disability, Intellectual
- Being tested
- Cognitive, adaptive, behavioral and academic assessment
- Keywords
- Intellectual Deficiency, cognitive, adaptive, behavioral and academic profile, regular and special schools
- Medical subject headings
- Intellectual Disability, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive, adaptive, behavioral and academic assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Cognitive, adaptive, behavioral and academic assessment | |
| 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) Receives: Other: Cognitive, adaptive, behavioral and academic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within one year before the latest child orientation decision
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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".
Measured: 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.
Measured: one year after Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start1 Aug 2014
- Primary completion1 Oct 2016
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disability, IntellectualStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Des PORTES, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088007
- Sponsor's protocol ID
- 69HCL15_0257
- Acronym
- EVAL'ID
- Status last verified
- Mar 2017
- First submitted
- 10 Mar 2017
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of Multidimensional Assessments in Accompanying Schooling of Children With Mild to Moderate Intellectual Disability.
- ClinicalTrials.gov ID
- NCT03088007
- Acronym / sponsor ID
- EVAL'ID / 69HCL15_0257
- Conditions
- Disability, Intellectual
- Keywords
- Intellectual Deficiency, cognitive, adaptive, behavioral and academic profile, regular and special schools
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 23 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IME attending ID children | – | Other: Cognitive, adaptive, behavioral and academic assessmentChildren 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 assessmentChildren with mild to moderate Intellectual Deficiency attending school at ULIS (Unités Localisées pour l'Inclusion Scolaire, which enables disabled children to attend regular schools) |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Age : > 5 and <13 years
- With mild to moderate intellectual deficiency
- attending school either at ULIS or IME in the Rhône department.
Key exclusion criteria (2 listed)
- No insurance coverage
- No parents agreement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive, adaptive, behavioral and academic assessmentCognitive, 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. | Other | IME attending ID children, ULIS attending ID children |
Primary outcome
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.
8 secondary outcomes
Presence of the ID assessment kit results in the records
Time frame: 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
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
WISC-IV (Wechsler Intelligence Scale for Children 4th edition)
Time frame: 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
GECEN rating form (Grille d'Evaluation Comportementale pour Enfants Nisonger
Time frame: 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
Rehabilitation programs
Time frame: one year after Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Des PORTES, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disability, Intellectual, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of the ID assessment kit results in the records (time frame: within one year before the latest child orientation decision). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.