Correlating Real and Virtual World Behavioral Fluctuation... | NCT02281825

Studies
Correlating Real and Virtual World Behavioral Fluctuations in Adolescence

NCT02281825

Sponsor

Shalvata Mental Health Center

Status

Completed

Last Update Posted

Apr 14, 2016Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Attention-Deficit and Hyperactivity Disorder
Anxiety
Disruptive Mood Dysregulation Disorder
Depression
Oppositional Defiant Disorder
Conduct

Interventions

Not provided

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

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Dec 2015Actual

Completion Date

Feb 2016Actual

First Submitted Date

Oct 29, 2014

First Submission Date that Met QC Criteria

Nov 3, 2014

First Posted Date

Nov 4, 2014Estimated

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

Apr 13, 2016

Last Update Posted Date

Apr 14, 2016Estimated

Name	Class
University of Haifa	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

The present study will explore a new approach to ongoing evaluation and monitoring of fluctuations in personality traits via commercial video games. The aim of this longitudinal study is to examine the influence of everyday life event on video games performance as a function of individual differences in gaming behavioral patterns. focusing on the ongoing performance vacillations of the patient on commercial video games will offer insights in to possibly new generation of real time assessment medium of ongoing behavior.

Detailed Description

Not provided

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control		Adolescents without any psychiatric disorder
Study		Adolescents with psychiatric disorder of the following: Attention-Deficit and Hyperactivity Disorder, Conduct, Oppositional defiant Disorder, Anxiety, Depression, Disruptive Mood Dysregulation Disorder

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Impulsivity manifested within game-play	In-Game kill/Stealth ratio	3 weeks
Activity manifested within game-play	In-Game number of missions and sub-mission attained	3 weeks
Aggresion manifested within game-play	In-Game aimed killing	3 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All subjects will have normal or corrected to normal vision with no sensory/motor disturbance
An accessible computer at the house hold
Previous experience in playing computer games.

Exclusion Criteria:

drug abuse
head injury
living in a boarding school and a major psychiatric or neurological disorder.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Male adolescents, 13-18, with and without psychopathology, evaluated and diagnosed by psychiatrists. Adolescents will be recruited from Shalvata MHC children and adolescents outpatient clinic and from convinience sample in the community.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aviv Segev, MD	Shalvata MHC, Sackler Faculty of Medicine, TA Uni.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shalvata MHC		Hod HaSharon			Israel

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity
D001008	Anxiety Disorders
D003863	Depression
D000096865	Oppositional Defiant Disorder
D001519	Behavior
D007175	Impulsive Behavior

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided