Clinical trial NCT00716235: Characterization of Executive Functions and Patterns of Eye Movements in Children With Developmental Disabilities
Official title: Characterization of Executive Functions and Patterns of Eye Movements in Children With Developmental Disabilities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attention Deficit Hyperactivity Disorder
Autistic Disorder
Developmental Coordination Disorder
Keywords: ADHD
ASD
PDD
DCD
Executive Functions
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Bar-Ilan University, Israel
First posted: 2008-07-16
Enrollment: 160
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Weinberg Child Development Center, Sheba Medical Center, Tel-Hashomer
Study officials:
affiliation: Sheba Medical Center
name: Lidia Gabis, MD
role: PRINCIPAL_INVESTIGATOR
References: