Characterization of Executive Functions and Patterns of Eye Movements in Children With Developmental Disabilities

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bar-Ilan University, Israel
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00716235
First received: July 15, 2008
Last updated: January 15, 2009
Last verified: January 2009
  Purpose

The purpose of this study is to characterize the profile of executive functions and eye movements in several populations of children with developmental disabilities.


Condition
Attention Deficit Hyperactivity Disorder
Autistic Disorder
Developmental Coordination Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Characterization of Executive Functions and Patterns of Eye Movements in Children With Developmental Disabilities

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 160
Study Start Date: January 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
DCD
Children with a diagnosis of DCD
Autism
Children with a diagnosis of Autism disorder
ADHD
Children with a diagnosis of ADHD
Control
Control group - children with no neurological or psychiatric problems

Detailed Description:

Abnormal Executive function (EF) profile was considered a major characteristic of Attention deficit / hyperactivity disorder (ADHD) and autism, and is frequently implicated in Developmental coordination disorder (DCD) children as well. The scientific literature implies that the EF profile among these three groups share some common abnormalities, but differ significantly in specific features. Abnormal EF profile may be a core feature of the developmental trajectory of each syndrome.

The fine measurement of eye movements may shed light on the underlying mechanisms of specific disorders, and point to abnormal attention, information processing, or motor organization. Gaze is an important component of social interaction. Eye contact and recognition of other's gaze direction are crucial to empathy assessment.

The current study will embark in the assessment of a wide range of EF in these populations and in a matched control group, as well as their relation to other important parameters such as daily function skills and comorbid neurobehavioral characteristics. It will also assess the pattern of eye movements in response to various visual stimuli in these populations. The main purpose is to characterize the similarities and differences of each of these populations, in terms of EF and eye movements.

Assessment methods:

Clinical parameters:

  • Intelligence tests (according to the child's age)
  • Communication: DSM-IV, ADOS, Stony Brook questionnaire
  • Motor / Coordination: Movement Advanced Battery for Children (M-ABC)
  • Attention: Conners Rating Scales - Revised (CRS-R 3rd ed.)
  • Sleep: Sleep habits questionnaire

Executive functions will be assessed using the following methods:

  • NEPSI-II
  • BRIEF questionnaire
  • Wisconsin Card Sorting Test
  • Tower of Hanoi

Eye movements will be measured using an infra-red video camera produced by ISCAN inc. the following visual stimuli will be presented:

  • Human faces presenting various emotions
  • Various objects
  • Saccade and anti-saccade tasks
  Eligibility

Ages Eligible for Study:   4 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • Age of 4-10 years
  • A medical diagnosis according to the relevant study group
  • Normal vision without glasses or contact lens.

Exclusion Criteria - clinical groups:

  • Intelligence Quotient below 70
  • A known brain damage
  • A known hearing impairment
  • Regular use of medications (except for psychostimulants)
  • Evidence for a known genetic syndrome
  • History of fetal CMV infection, birth asphyxia, major head injury or epilepsy

Exclusion Criteria - control group:

  • Intelligence Quotient below 70
  • Regular use of medications
  • Evidence for a neurological / psychiatric disorder, birth injury, developmental delay, head injury, or other medical disorders that affect the central nervous system
  • Family History - first degree) of autism, DCD, ADHD or other neurological/psychiatric disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716235

Contacts
Contact: Lidia Gabis, MD +972-3-5302236 lidia.gabis@sheba.health.gov.il
Contact: Raanan Raz, Ph.D +972-3-5302236 Raanan.Raz@sheba.health.gov.il

Locations
Israel
Weinberg Child Development Center, Sheba Medical Center, Tel-Hashomer Recruiting
Ramat-Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Bar-Ilan University, Israel
Investigators
Principal Investigator: Lidia Gabis, MD Sheba Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Lidia Gabis, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00716235     History of Changes
Other Study ID Numbers: SHEBA-08-5185-LG-CTIL
Study First Received: July 15, 2008
Last Updated: January 15, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
ADHD
ASD
PDD
DCD
Executive Functions

Additional relevant MeSH terms:
Developmental Disabilities
Child Development Disorders, Pervasive
Attention Deficit Disorder with Hyperactivity
Autistic Disorder
Disease
Hyperkinesis
Motor Skills Disorders
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014