Attention-Deficit and Hyperactivity DisorderNCT02281825
Correlating Real and Virtual World Behavioral Fluctuations in Adolescence
An observational study of Attention-Deficit and Hyperactivity Disorder and Anxiety, run by Shalvata Mental Health Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Attention-Deficit and Hyperactivity Disorder, Anxiety, Disruptive Mood Dysregulation Disorder
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2014to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- drug abuse
- head injury
- living in a boarding school and a major psychiatric or neurological disorder.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Attention-Deficit and Hyperactivity Disorder, Anxiety, Disruptive Mood Dysregulation Disorder, Depression, Oppositional Defiant Disorder, Conduct
- Keywords
- Attention-Deficit and Hyperactivity Disorder, Anxiety, Impulsivity, Computer Games, Depression
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Anxiety Disorders, Depression, Oppositional Defiant Disorder, Behavior, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impulsivity manifested within game-play
In-Game kill/Stealth ratio
Measured: 3 weeks
Activity manifested within game-play
In-Game number of missions and sub-mission attained
Measured: 3 weeks
Aggresion manifested within game-play
In-Game aimed killing
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit and Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Haifa
- Responsible party
- Sponsor
- Investigators
- Aviv Segev, MD, Principal investigator, Shalvata MHC, Sackler Faculty of Medicine, TA Uni.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281825
- Sponsor's protocol ID
- sha-0001-14
- Status last verified
- Apr 2016
- First submitted
- 29 Oct 2014
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlating Real and Virtual World Behavioral Fluctuations in Adolescence
- ClinicalTrials.gov ID
- NCT02281825
- Acronym / sponsor ID
- sha-0001-14
- Conditions
- Attention-Deficit and Hyperactivity Disorder, Anxiety, Disruptive Mood Dysregulation Disorder, Depression, Oppositional Defiant Disorder, Conduct
- Keywords
- Attention-Deficit and Hyperactivity Disorder, Anxiety, Impulsivity, Computer Games, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Collaborators
- University of Haifa
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 4 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- drug abuse
- head injury
- living in a boarding school and a major psychiatric or neurological disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impulsivity manifested within game-play
Time frame: 3 weeks
In-Game kill/Stealth ratio
Activity manifested within game-play
Time frame: 3 weeks
In-Game number of missions and sub-mission attained
Aggresion manifested within game-play
Time frame: 3 weeks
In-Game aimed killing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aviv Segev, MD principal investigator
Shalvata MHC, Sackler Faculty of Medicine, TA Uni.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention-Deficit and Hyperactivity Disorder and Anxiety, run by Shalvata Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impulsivity manifested within game-play (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.