ADHDNCT01621815
Variance of Video Games Playing Patterns Among Adolescents With Psychiatric Disorders
A study testing Video Game in people with ADHD and Conduct, run by Shalvata Mental Health Center at 1 site in Israel.
Trial summary
As the use of video games (VG) is rapidly increasing, many studies have tries to understand the effects of VG on the children and adolescents playing them. Most of the research was directed towards negative effects (especially violence, attention and school performance), producing mixed results. 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
- ADHD, Conduct, Depression
- What is being tested?
- Video Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2012to Jan 2015
- Phase
- Interventional
- 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
Who may be able to join
- Age 13-18
- Diagnosis matching one of the defined research arms, made by a childhood and adolescents psychiatry specialist
- Playing various computer games regularly, for at least 2 years
- Informed consent has been given by the minor and his parents
Who cannot join
- Organic sensory depravation (blindness, deafness)
- Motor dysfunction, relevant of using keyboard, mouse or remote
- Additional psychiatric diagnosis, apart the one matching the arm to which he was allocated
- Using illicit drugs during the previous 48 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Variance of Video Games Playing Patterns Among Adolescents With Psychiatric Disorders: Diagnostical and Dynamic Meanings
As the use of video games (VG) is rapidly increasing, many studies have tries to understand the effects of VG on the children and adolescents playing them.
Most of the research was directed towards negative effects (especially violence, attention and school performance), producing mixed results.
Read more
Recently, more studies had focused their attention on the opposite angle: The influence of the player's mental and behavioral parameters, influencing his VG playing patterns. The focus of most of these researches was time of playing, addictive patterns and exposure to violence.
The current study will try to characterize the variance of VG playing pattern among adolescents diagnosed with psychiatric disorders, in order to better under the rich interaction between a player and his VG, and to understand whether VG playing patterns holds diagnostical clues for the child's diagnosis and his inner world.
Read the detailed description
The participants will be asked to attend 2 session, 2 hours each, at 3-14 days interval.
At the first session, after signing consent form, will asked to fill out questionaires regarding demographic data, personality, empathy trait, aggression state and trait and computer games usage.
also, they will be asked to complete HTP and TAT psycho-diagnostic tests. Then, using heart rate variability (HRV) and Galvanic skin response (GSR), monitor of sympathetic tonus will be measured while playing a shooting and race game.
At the end of the first session, they will be asked to fill additional aggression state questionaire.
On the second session, monitored by HRV and GSR, they will be asked to play a role playing game (RPG) and real-time strategy game (RTS). At the end of session, they will be asked to fill additional aggression state questionaire.
Parameters of playing patterns collected from the VG will be recorded and analyzed.
- Conditions
- ADHD, Conduct, Depression, Anxiety, PDD
- Being tested
- Video Game
- Keywords
- ADHD, Attention Deficit/Hyperactivity Disorder, Conduct, Depression, Anxiety, PDD, Pervasive Developmental Disorders
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Behavior, Depression, Anxiety Disorders, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video GameBehavioural
Also called Video Games, Computer Games, RPG, Role Playing Games
Playing various video games: RPG, Race, FPS, Strategy
| Study group | Role | What they receive |
|---|---|---|
| Anxiety and Depression | Active comparator | Adolescents diagnosed with anxiety and/or depression Receives: Behavioral: Video Game |
| ADD | Active comparator | Adolescents diagnosed with ADD (without hyperactive element) Receives: Behavioral: Video Game |
| ADHD, Behavioral | Active comparator | Adolescents diagnosed with ADHD (with hyperactivity), with or without behavioral problems Receives: Behavioral: Video Game |
| PDD | Active comparator | Adolescents diagnosed with PDD Spectrum Disorders Receives: Behavioral: Video Game |
| Control | Active comparator | Adolescents without a psychiatric diagnosis Receives: Behavioral: Video Game |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aviv Segev, Shalvata Mental Health Center
- Investigators
- Aviv Segev, MD, Principal investigator, Shalvata MHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621815
- Sponsor's protocol ID
- SH-12-13
- Status last verified
- May 2015
- First submitted
- 14 Jun 2012
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variance of Video Games Playing Patterns Among Adolescents With Psychiatric Disorders: Diagnostical and Dynamic Meanings
- ClinicalTrials.gov ID
- NCT01621815
- Acronym / sponsor ID
- SH-12-13
- Conditions
- ADHD, Conduct, Depression, Anxiety, PDD
- Keywords
- ADHD, Attention Deficit/Hyperactivity Disorder, Conduct, Depression, Anxiety, PDD, Pervasive Developmental Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Jun 2012 (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.
As the use of video games (VG) is rapidly increasing, many studies have tries to understand the effects of VG on the children and adolescents playing them.
Most of the research was directed towards negative effects (especially violence, attention and school performance), producing mixed results.
Recently, more studies had focused their attention on the opposite angle: The influence of the player's mental and behavioral parameters, influencing his VG playing patterns. The focus of most of these researches was time of playing, addictive patterns and exposure to violence.
The current study will try to characterize the variance of VG playing pattern among adolescents diagnosed with psychiatric disorders, in order to better under the rich interaction between a player and his VG, and to understand whether VG playing patterns holds diagnostical clues for the child's diagnosis and his inner world.
Detailed description
The participants will be asked to attend 2 session, 2 hours each, at 3-14 days interval.
At the first session, after signing consent form, will asked to fill out questionaires regarding demographic data, personality, empathy trait, aggression state and trait and computer games usage.
also, they will be asked to complete HTP and TAT psycho-diagnostic tests. Then, using heart rate variability (HRV) and Galvanic skin response (GSR), monitor of sympathetic tonus will be measured while playing a shooting and race game.
At the end of the first session, they will be asked to fill additional aggression state questionaire.
On the second session, monitored by HRV and GSR, they will be asked to play a role playing game (RPG) and real-time strategy game (RTS). At the end of session, they will be asked to fill additional aggression state questionaire.
Parameters of playing patterns collected from the VG will be recorded and analyzed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Anxiety and Depression | Active comparator | Behavioral: Video GameAdolescents diagnosed with anxiety and/or depression |
| ADD | Active comparator | Behavioral: Video GameAdolescents diagnosed with ADD (without hyperactive element) |
| ADHD, Behavioral | Active comparator | Behavioral: Video GameAdolescents diagnosed with ADHD (with hyperactivity), with or without behavioral problems |
| PDD | Active comparator | Behavioral: Video GameAdolescents diagnosed with PDD Spectrum Disorders |
| Control | Active comparator | Behavioral: Video GameAdolescents without a psychiatric diagnosis |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 13-18
- Diagnosis matching one of the defined research arms, made by a childhood and adolescents psychiatry specialist
- Playing various computer games regularly, for at least 2 years
- Informed consent has been given by the minor and his parents
Key exclusion criteria (4 listed)
- Organic sensory depravation (blindness, deafness)
- Motor dysfunction, relevant of using keyboard, mouse or remote
- Additional psychiatric diagnosis, apart the one matching the arm to which he was allocated
- Using illicit drugs during the previous 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video GameAlso: Video Games, Computer Games, RPG, Role Playing GamesPlaying various video games: RPG, Race, FPS, Strategy | Behavioural | ADD, ADHD, Behavioral, Anxiety and Depression, Control, PDD |
Primary outcome
Not reported in the source record.
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 20 May 2015.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Game in people with ADHD and Conduct, 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 4 inclusion and 4 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 20 May 2015. 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.
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 20 May 2015.