- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01886911
Games & Well-Being Study (GWB)
September 30, 2015 updated by: University of Wisconsin, Madison
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
192
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
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Madison, Wisconsin, United States, 53705
- University of Wisconsin - Madison
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 15 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Fluent English speaker
- Enrolled in 7th or 8th grade
Exclusion Criteria:
- Currently on psychotropic medications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control for Attention Intervention
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).
|
|
|
Experimental: Prosocial Training Intervention Game
The prosocial intervention group, which we expect will be play the experimental prosocial training game for 2 weeks (plus or minus 7 days).
|
Other Names:
|
|
Experimental: Attention Training Intervention Game
The attention intervention group, which we expect will be play the experimental attention training game for 2 weeks (plus or minus 7 days).
|
Other Names:
|
|
Active Comparator: Control for Prosocial Intervention
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline and up to 3 weeks
|
|
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.
|
baseline and up to 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard Davidson, PhD, University of Wisconsin, Madison
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
June 19, 2013
First Submitted That Met QC Criteria
June 21, 2013
First Posted (Estimate)
June 26, 2013
Study Record Updates
Last Update Posted (Estimate)
October 2, 2015
Last Update Submitted That Met QC Criteria
September 30, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- Davidson-GWB
- Bill & Melinda Gates (Other Grant/Funding Number: Bill & Melinda Gates Foundation)
- Grant Number (Other Grant/Funding Number: opp1033728)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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