Attentional ProcessingGWBNCT01886911
Games & Well-Being Study
A study testing Attention Training Intervention Game and Prosocial Training Intervention Game in people with Attentional Processing and Adolescent Behavior, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This project is focused on the neural and behavioral correlates of two different videos games that will be used as training tools. The two video games, developed by the Games Learning Society research group at the University of Wisconsin-Madison (UW) and the Wisconsin Institute for Discovery, are tailored to train… Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Attentional Processing, Adolescent Behavior
- What is being tested?
- Attention Training Intervention Game and Prosocial Training Intervention Game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to May 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 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Fluent English speaker
- Enrolled in 7th or 8th grade
Who cannot join
- Currently on psychotropic medications
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53705
About this study
Official title: Neural Correlates of Video Game Based Training to Foster Mindfulness and Prosocial Skills in Adolescents
This project is focused on the neural and behavioral correlates of two different videos games that will be used as training tools. The two video games, developed by the Games Learning Society research group at the University of Wisconsin-Madison (UW) and the Wisconsin Institute for Discovery, are tailored to train mindfulness, particularly the regulation of attention; and prosocial behavior, especially sensitivity to others, in adolescents. This study will evaluate the hypothesis that systematic playing of mindfulness and prosocial games will change brain function in specific attentional, social and emotional circuits in potentially beneficial ways, and will impact performance on cognitive tasks of attention, and on measures of social cue perception and the propensity to share and behave altruistically. The investigators will employ behavioral and functional MRI-based neuroimaging measures to evaluate the investigators hypothesis.
- Conditions
- Attentional Processing, Adolescent Behavior
- Being tested
- Attention Training Intervention Game, Prosocial Training Intervention Game, Control for Attention Intervention, Control for Prosocial Intervention
- Keywords
- prosocial behavior, prosocial, attention training, attention, empathy, emotion recognition
- Medical subject headings
- Adolescent Behavior, Altruism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Training Intervention GameOther
Also called Tenacity
Prosocial Training Intervention GameOther
Also called Crystals of Kaydor
Control for Attention InterventionOther
Control for Prosocial InterventionOther
| Study group | Role | What they receive |
|---|---|---|
| Control for Attention Intervention | Active comparator | Attentional Control Game is an active control group. We expect subjects in this group to play a control game for 2 weeks (plus or minus 7 days). Receives: Other: Control for Attention Intervention |
| Prosocial Training Intervention Game | Experimental | The prosocial intervention group, which we expect will be play the experimental prosocial training game for 2 weeks (plus or minus 7 days). Receives: Other: Prosocial Training Intervention Game |
| Attention Training Intervention Game | Experimental | The attention intervention group, which we expect will be play the experimental attention training game for 2 weeks (plus or minus 7 days). Receives: Other: Attention Training Intervention Game |
| Control for Prosocial Intervention | Active comparator | This is an active control group. We expect subjects in this group to play a control game for 2 weeks (plus or minus 7 days). Receives: Other: Control for Prosocial Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in behavioral measures
Change in behavioral measures before and after attentional video game training. Timeframe is up to 7 days following the end of the 2 week game playing period.
Measured: baseline and up to 3 weeks
Change from baseline in fMRI
Change in fMRI neural markers of empathic accuracy before and after attentional video game training. Timeframe is up to 7 days following the 2 week game playing period.
Measured: baseline and up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attentional ProcessingStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Davidson, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886911
- Sponsor's protocol ID
- Davidson-GWB
- Other IDs
- Bill & Melinda Gates, Grant Number
- Acronym
- GWB
- Status last verified
- Jun 2015
- First submitted
- 19 Jun 2013
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Patsenko EG, Adluru N, Birn RM, Stodola DE, Kral TRA, Farajian R, Flook L, Burghy CA, Steinkuehler C, Davidson RJ. Mindfulness video game improves connectivity of the fronto-parietal attentional network in adolescents: A multi-modal imaging study. Sci Rep. 2019 Dec 10;9(1):18667. doi: 10.1038/s41598-019-53393-x.
PubMed 31822684
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Video Game Based Training to Foster Mindfulness and Prosocial Skills in Adolescents
- ClinicalTrials.gov ID
- NCT01886911
- Acronym / sponsor ID
- GWB / Davidson-GWB
- Conditions
- Attentional Processing, Adolescent Behavior
- Keywords
- prosocial behavior, prosocial, attention training, attention, empathy, emotion recognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Jun 2013 (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.
This project is focused on the neural and behavioral correlates of two different videos games that will be used as training tools. The two video games, developed by the Games Learning Society research group at the University of Wisconsin-Madison (UW) and the Wisconsin Institute for Discovery, are tailored to train mindfulness, particularly the regulation of attention; and prosocial behavior, especially sensitivity to others, in adolescents. This study will evaluate the hypothesis that systematic playing of mindfulness and prosocial games will change brain function in specific attentional, social and emotional circuits in potentially beneficial ways, and will impact performance on cognitive tasks of attention, and on measures of social cue perception and the propensity to share and behave altruistically. The investigators will employ behavioral and functional MRI-based neuroimaging measures to evaluate the investigators hypothesis.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control for Attention Intervention | Active comparator | Other: Control for Attention InterventionAttentional Control Game is an active control group. We expect subjects in this group to play a control game for 2 weeks (plus or minus 7 days). |
| Prosocial Training Intervention Game | Experimental | Other: Prosocial Training Intervention GameThe prosocial intervention group, which we expect will be play the experimental prosocial training game for 2 weeks (plus or minus 7 days). |
| Attention Training Intervention Game | Experimental | Other: Attention Training Intervention GameThe attention intervention group, which we expect will be play the experimental attention training game for 2 weeks (plus or minus 7 days). |
| Control for Prosocial Intervention | Active comparator | Other: Control for Prosocial InterventionThis is an active control group. We expect subjects in this group to play a control game for 2 weeks (plus or minus 7 days). |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Fluent English speaker
- Enrolled in 7th or 8th grade
Key exclusion criteria (1 listed)
- Currently on psychotropic medications
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 |
|---|---|---|
| Attention Training Intervention GameAlso: Tenacity | Other | Attention Training Intervention Game |
| Prosocial Training Intervention GameAlso: Crystals of Kaydor | Other | Prosocial Training Intervention Game |
| Control for Attention Intervention | Other | Control for Attention Intervention |
| Control for Prosocial Intervention | Other | Control for Prosocial Intervention |
Primary outcome
Change from baseline in behavioral measures
Time frame: baseline and up to 3 weeks
Change in behavioral measures before and after attentional video game training. Timeframe is up to 7 days following the end of the 2 week game playing period.
Change from baseline in fMRI
Time frame: baseline and up to 3 weeks
Change in fMRI neural markers of empathic accuracy before and after attentional video game training. Timeframe is up to 7 days following the 2 week game playing period.
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 2 Oct 2015.
- Derived from this study: PubMed 31822684Patsenko EG, Adluru N, Birn RM, Stodola DE, Kral TRA, Farajian R, Flook L, Burghy CA, Steinkuehler C, Davidson RJ. Mindfulness video game improves connectivity of the fronto-parietal attentional network in adolescents: A multi-modal imaging study. Sci Rep. 2019 Dec 10;9(1):18667. doi: 10.1038/s41598-019-53393-x.
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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.
Richard Davidson, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention Training Intervention Game and Prosocial Training Intervention Game in people with Attentional Processing and Adolescent Behavior, run by University of Wisconsin, Madison at 1 site in United States.
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 2 inclusion and 1 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 2 Oct 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 United States. 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?
Change from baseline in behavioral measures (time frame: baseline and up to 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01886911, which also lists 1 linked publication.
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 2 Oct 2015.