Differences in Attentional Profile of Children Diagnosed... | NCT02942030

Studies
Differences in Attentional Profile of Children Diagnosed With ADHD Versus Children Diagnosed With Other Mental Conditions

NCT02942030

Sponsor

Clalit Health Services

Status

Unknown status

Last Update Posted

Nov 29, 2016Estimated

Enrollment

70Estimated

Phase

Not provided

Conditions

ADHD

Interventions

Computerized assesment battery

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Nov 2017Estimated

Completion Date

Nov 2017Estimated

First Submitted Date

Oct 20, 2016

First Submission Date that Met QC Criteria

Oct 20, 2016

First Posted Date

Oct 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2016

Last Update Posted Date

Nov 29, 2016Estimated

Name	Class
Tel Aviv University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Attentional symptoms characterize both ADHD and other mental conditions in children.

The diagnosis is based on clinical psychiatric evaluation.

With the expanding knowledge regarding the neurobiological basis in ADHD the investigators have learned that attention is not a general property of the whole brain, but involves several coordinated networks. This knowledge promoted the scientific community to the stage in which scientists can recognize different types of attention domains.

in the current study, the investigators use computerized battery to separate between the different attention abilities and provide specific attentional profile. in this study the investigators aim to characterize different attentional profiles in children who are diagnosed with ADHD versus children who diagnosed with other mental condition (which are common differential diagnoses of ADHD)

Detailed Description

Attentional symptoms characterize both ADHD and other mental conditions in children.

The diagnosis of ADHD is based on clinical psychiatric evaluation in different clinical situations the differential diagnosis is not straight forward and the clinician considers a common co-morbid conditions and common differential diagnoses.

With the expanding knowledge regarding the neurobiological basis in ADHD the scientific community have learned that attention is not a general property of the whole brain, but involves several coordinated networks. This knowledge promoted us to the stage in which scientists can recognize different types of attention domains. this knowledge raises the question - can the clinician use this knowledge to make the correct diagnosis based on specific attentional profile?

In the current study, the investigators use computerized battery in order to separate between the different attention abilities and provide specific attentional profile. in this study the investigators aim to characterize different attentional profiles in children who are diagnosed with ADHD versus children who diagnosed with other mental condition (which are common differential diagnoses of ADHD)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ADHD		Children diagnosed with ADHD after a complete psychiatric evaluation.	Other: Computerized assesment battery
Non-ADHD		Children diagnosed with other mental conditions after a complete psychiatric evaluation.	Other: Computerized assesment battery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Computerized assesment battery	Other	All participants will do a computerized assessment battery to identify specific attentional profile	ADHD Non-ADHD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diagnosis - after psychiatric evaluation		november 2017
attentional computerized profile		november 2017

Secondary Outcomes

Measure	Description	Time Frame
correlations - clinical diagnosis and attentional profile		november 2017

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 8-12
normal intelligence quotient (IQ)
suspected ADHD

Exclusion Criteria:

Autism Spectrum Disorder
blindness
deafness
abnormal intelligence quotient (IQ) (below 70)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

8-12 y/o children reffered to a psychiatric clinic for evaluation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
shlomit tsafrir, MD	Contact	972-2-5663638		stsafrir@clalit.org.il

Overall Officials

Name	Affiliation	Role
shlomit tsafrir, MD	Clalit Health Services	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mishmar Ha'Am Clinic		Jerusalem			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided