NCT00700453

Brief Summary

  1. 1.Young adults who are exposed to 7-10 days of play of violent video games will show reduced activation in certain regions of the dorsolateral prefrontal cortex and anterior cingulate cortex.
  2. 2.Young adults who are exposed to 7-10 days of violent video games will show increased activation in regions of the amygdala.
  3. 3.Young adults who abstain from violent video games for a week, after 7-10 days of play of violent video games, will show increased activation of regions in the dorsolateral prefrontal cortex and anterior cingulate cortex and decreased activation of the amygdala, on pre-post fMRI and compared to young adults who continue to play violent video games.
  4. 4.Young adults who complete a computerized attention-training program after 7-10 days of violent video games will show increased activation of regions in the dorsolateral prefrontal cortex and anterior cingulate cortex and decreased activation of the amygdala, on pre-post fMRI and compared to young adults who continue to play violent video games.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
7.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 3, 2012

Status Verified

April 1, 2012

Enrollment Period

2.7 years

First QC Date

June 11, 2008

Last Update Submit

May 2, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Functional Magnetic Resonance Imaging

    Completed at visit 2, 3, and 4 (each visit 7-10 days apart)

Study Arms (4)

Control 1 Group

ACTIVE COMPARATOR

Subjects randomized to the Control 1 group will abstain from playing any video games for the entire study participation.

Behavioral: Control group with no video game play

VG1- Control 2 Group

ACTIVE COMPARATOR

Subjects randomized to the Control 2 group will play a selected violent video game for 60-120 minutes/day during week 2 of the study and will abstain from any video game play during week 3 of the study.

Behavioral: control 2

VG1- VG2 group

ACTIVE COMPARATOR

Subjects randomized for VG1-VG2 group will play 60-120 minutes/day of a violent video game during weeks 2 \& 3 of study participation.

Behavioral: VG1 group (2 weeks of violent video game play)

VG1-CT group

ACTIVE COMPARATOR

Subjects randomized to the VG1-CT group will play 60-120 minutes of a selected violent video game during week 2 of the study and play a selected computerized cognitive training program for 60-120 minutes/day during week 3 of the study.

Behavioral: Cognitive Training

Interventions

Subjects will abstain from all video game play during study participation.

Also known as: Control 1 group
Control 1 Group
control 2BEHAVIORAL

Subjects will play 1 week of violent video game play followed by 1 week of no video game play.

Also known as: Control 2 group
VG1- Control 2 Group

Subjects will play a violent video game for 2 weeks of study participation.

Also known as: VG1-VG2
VG1- VG2 group

Subjects will play a violent video game for 1 week followed by 1 week of Cognitive Training program.

Also known as: VG1-CT group
VG1-CT group

Eligibility Criteria

Age18 Years - 29 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Have K-BIT-2 Matrices IQ\>70.
  • Must be 18-29 years old for the entire study.
  • Only males will participate in the study.
  • Must be judged by the investigator to be reliable and cooperative for clinic visits and procedures.
  • Must speak English, be proficient in spoken and written English, and have an educational level and understanding of English required to complete all tests and questionnaires. This is important because some of the tests require automatic and rapid processing of written English.
  • Must have a baseline level of violent video game play averaging less than or equal to 2 hours per week in the year prior to the study, and must have a baseline level of total video game play averaging less than or equal to 5 hours per week in the year prior to the study. These values are based on research by Kronenberger et al. (2005a) showing that nonviolent control adolescent subjects averaged about 2-3 hours of video game play in a week (of which 1-2 hours are spent with violent video games), compared to aggressive adolescent subjects, who averaged about 4-7 hours of video game play per week (of which 3-4 hours are spent with violent video games). Green and Bavalier (2003) based their selection criteria for "action video game players" (VGP) on an average of 1 hour per day for 4 days a week of violent/action video game play and found differences between the VGP group and a non-VGP group on visual processing. It is important to select subjects who are not frequent game players in order for the experimental manipulation (8-16 hours of violent video game play) to be different from their baseline behavioral habits.
  • Must be willing to make lifestyle changes about media habits during the 3-5 week duration of the study.
  • Must have basic level of proficiency with computer to load and play video games.

You may not qualify if:

  • Organic brain conditions or seizure disorder (history of febrile seizures with no neurological sequelae is acceptable).
  • Any physical condition or risk that would preclude or invalidate an MRI.
  • Any current mental health diagnosis (other than Adjustment Disorder), based on the Adult Inventory - 4 and follow-up questions from the interviewer, which would be defined as moderate or more severe using the Clinical Global Index - Severity.
  • Treatment of a behavioral or emotional problem (excluding normal adjustment issues, such as adjustment to divorce) by a mental health professional in the past year.
  • Any historical diagnoses of Attention-Deficit/Hyperactivity Disorder, Conduct Disorder, Oppositional-Defiant Disorder, Bipolar Disorder, Schizophrenia (or other disorder involving psychosis), Personality Disorders, or Pervasive Developmental Disorders.
  • Any history of Attention-Deficit/Hyperactivity Disorder, Conduct Disorder, Oppositional-Defiant Disorder, Bipolar Disorder, Schizophrenia (or other disorder involving psychosis), Personality Disorders, or Pervasive Developmental Disorders in first degree relatives (mother, father, siblings, children).
  • Current diagnosis of Substance Abuse or Dependence
  • Use of psychotropic medication for treatment of a mental or behavioral disorder at any time in the study or in the year prior to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radiology-- Research 2 building

Indianapolis, Indiana, 46202, United States

Location

Riley Outpatient Center Rm 4300

Indianapolis, Indiana, 46202, United States

Location

Related Links

MeSH Terms

Interventions

Control GroupsCognitive Training

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsNeurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Vincent P Mathews, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2008

First Posted

June 18, 2008

Study Start

July 1, 2008

Primary Completion

March 1, 2011

Study Completion

December 1, 2018

Last Updated

May 3, 2012

Record last verified: 2012-04

Locations