NCT03128125

Brief Summary

The main objective of this study is to determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

April 6, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2018

Completed
Last Updated

October 5, 2020

Status Verified

October 1, 2020

Enrollment Period

1.4 years

First QC Date

March 22, 2017

Last Update Submit

October 1, 2020

Conditions

High Intellectual PotentialChildren

Outcome Measures

Primary Outcomes (10)

  • Neuropsychological assessment

    Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children with WISC-V scale (Wechsler).

    1 day

  • Neurological assessments

    Dysfunction (yes/no) for children with high intellectual potential compared to control children.

    1 day

  • Neuropsychological assessment

    Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With Purdue Pegboard test.

    1 day

  • Neuropsychological assessment

    Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With subtest Fluence Verbale (NEPSY-II)

    1 day

  • Neuropsychological assessment

    Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With subtest of motricity (NEPSY-II)

    1 day

  • Neuropsychological assessment

    Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With Rey test

    1 day

  • Neuropsychological assessment

    Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With writing test (BHK)

    1 day

  • Neuropsychological assessment

    Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With New card sorting test

    1 day

  • Neuropsychological assessment

    Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With comportemental scale (BRIEF)

    1 day

  • Neuropsychological assessment

    Determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children. With M-ABC-II questionary

    1 day

Study Arms (2)

High intellectual potential

EXPERIMENTAL

Participation in the study involves the conduct of a clinical examination in neurology, the collection of anamnestic elements and a neuropsychological examination in children with high intellectual potential.

Other: clinical examination in neurologyOther: neuropsychological examinationOther: anamnestic elements

Control

OTHER

Participation in the study involves the conduct of a clinical examination in neurology, the collection of anamnestic elements and a neuropsychological examination in control children with no particularities.

Other: clinical examination in neurologyOther: neuropsychological examinationOther: anamnestic elements

Interventions

clinical examination in neurologyOTHER

This examination is based on the movement of the child in a standing position (forward and backward on a straight line, jumping on a foot ...), seated (visual continuation ...) and elongated (tone, patellar and achillian reflexes, superficial sensitivity ...) . This makes it possible to evaluate all the neurological systems.

ControlHigh intellectual potential
neuropsychological examinationOTHER

This examination is based on the use of standardized psychometric tools and validated with children, usually used in clinical practice.

ControlHigh intellectual potential
anamnestic elementsOTHER

Several elements will be collected during the clinical interview to inform the history of the child's development, such as neonatal data (term of pregnancy, APGAR score ...), age of appearance of the first words , seating, walking, possible care, level of education ans level of education of the parents.

ControlHigh intellectual potential

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All participants :
  • Informed consent of the child and both parents obtained
  • Affiliated to Social Security
  • Participants must be between 6 and 16 years of age.
  • Child with high intellectual potential :
  • Score ≥ 130 on an intellectual efficiency scale administered by a psychologist
  • Control child :
  • They will have to be intellectually efficient in the standard. To ensure this, the two sub-tests of the Intellectual Efficiency Scale (WISC-V) most closely correlated with intelligence (Vocabulary and Matrices) will be administered to them. Thus, the child must meet one of the following criteria in order to be included:
  • Have two standard notes between -1 and +1 DS (between 7 and 13);
  • Have one of its two notes between -1 and + 1DS (between 7 and 13) and the other between -2DS and \<+ 2DS (between 5 and 15).

You may not qualify if:

  • All participants :
  • Neurological history (epilepsy, cranial trauma, prematurity ...)
  • Psychiatric history (Autistic Spectrum Disorder ...),
  • Known genetic disease,
  • Motor deficiency (eg hemiplegia),
  • Elementary sensory disorder (auditory and visual) or insufficient command of French, limiting the understanding and participation in the study likely to impact the results to the protocol.
  • Gnosic visual or linguistic deficiency.
  • Sensory disorder
  • Psychotropic Intake
  • Control child :
  • High intellectual potential
  • Known or suspected learning disability (no dyslexia-dysorthography, dysphasia, dyspraxia, dyscalculia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Brest, 29200, France

Location

MeSH Terms

Interventions

Restraint, PhysicalNeuropsychological Tests

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative TechniquesPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Sylviane PEUDENIER

    CHRU Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Case-control study, monocentric.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2017

First Posted

April 25, 2017

Study Start

April 6, 2017

Primary Completion

August 22, 2018

Study Completion

August 22, 2018

Last Updated

October 5, 2020

Record last verified: 2020-10

Locations

FR(1)