Trial record 1 of 9 for:    Open Studies | "Adolescent Behavior"
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Games & Well-Being Study (GWB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
Richard Davidson, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01886911
First received: June 19, 2013
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Attentional Processing
Adolescent Behavior
Other: Attention Training Intervention Game
Other: Prosocial Training Intervention Game
Other: Control for Attention Intervention
Other: Control for Prosocial Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Neural Correlates of Video Game Based Training to Foster Mindfulness and Prosocial Skills in Adolescents

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Change from baseline in behavioral measures [ Time Frame: baseline and up to 3 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 460
Study Start Date: June 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Other: Control for Attention Intervention
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: Prosocial Training Intervention Game
Other Name: Crystals of Kaydor
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: Attention Training Intervention Game
Other Name: Tenacity
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).
Other: Control for Prosocial Intervention

  Eligibility

Ages Eligible for Study:   12 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Fluent English speaker
  • Enrolled in 7th or 8th grade

Exclusion Criteria:

  • Currently on psychotropic medications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886911

Locations
United States, Wisconsin
University of Wisconsin - Madison Recruiting
Madison, Wisconsin, United States, 53705
Contact: Rick Solis, B.A.    608-890-1386    SOLIS2@WISC.EDU   
Principal Investigator: Richard J Davidson, PhD         
Sub-Investigator: Constance Squire, PhD         
Sub-Investigator: Reza Farajian, PhD         
Sub-Investigator: Kurt Squire, PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Richard Davidson, PhD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Richard Davidson, Vilas Professor of Psychology and Psychiatry, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01886911     History of Changes
Other Study ID Numbers: Davidson-GWB, Bill & Melinda Gates, Grant Number
Study First Received: June 19, 2013
Last Updated: June 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
prosocial behavior
prosocial
attention training
attention
empathy
emotion recognition

ClinicalTrials.gov processed this record on August 21, 2014