Eliciting Affect in Teens in a Virtual World (Project AVATAR)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality
Health Promotion
Sponsored by

About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Adolescent Risk Behavior, Emotion Regulation, Health Promotion, Intervention, Mental Health
Eligibility Criteria
Inclusion Criteria:
- 7th & 8th graders at participating public schools.
Exclusion Criteria:
- Adolescent is illiterate.
- Adolescent has parent/guardian who does not speak English.
- Adolescents has high risk of motion sickness.
- For Phase II only, previous participation in Project Trac or Phase I.
Sites / Locations
- Rhode Island Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Virtual Reality
Health Promotion
Outcomes
Primary Outcome Measures
Adolescent-reported self-efficacy for HIV prevention behaviors
Secondary Outcome Measures
Adolescent-reported condom use self-efficacy
Full Information
NCT ID
NCT02338063
First Posted
January 9, 2015
Last Updated
April 5, 2016
Sponsor
Rhode Island Hospital
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT02338063
Brief Title
Eliciting Affect in Teens in a Virtual World (Project AVATAR)
Official Title
Eliciting Affect in Teens in a Virtual World (Project AVATAR)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhode Island Hospital
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether immersive virtual reality technology is an effective intervention tool for HIV Prevention with adolescents.
Detailed Description
The project will examine the use of immersive virtual reality technology as an intervention tool for HIV Prevention with adolescents. Adolescents are at risk for contracting HIV while affect dysregulation is common among adolescents. Research has demonstrated connections between poor affect management abilities and risky sexual behavior among adolescents. This research suggests that the ability to regulate one's emotions is key to avoiding risk behaviors and that adolescents are at greater risk for poor affect management skills. Fortunately, these skills can be taught via teaching and modeling, making them an excellent target for intervention, which has previously been approached through role-playing. Immersive virtual reality offers many advantages over group based role-plays, used in HIV prevention interventions for adolescents, in its ability to simulate real-world environments and enhance the impact of HIV prevention interventions. Immersive virtual reality is a promising technology for giving teens the opportunity to experientially practice using effective affect regulation skills in a highly realistic, context specific virtual environment. Additional benefits of this technology will likely be increased engagement and retention in HIV prevention interventions among young adolescents. The overall aims of Phase I and Phase II of this project are to develop, refine, and evaluate virtual reality environments for adolescents targeting affect management. In Phase I, the research team developed and refined an immersive virtual environment that elicited affect in a high-risk situation. The final immersive virtual reality environments (completed in Phase II) can be used by health promotion interventionists in conjunction with an HIV prevention intervention manual as a means to elicit affect and provide adolescents with a "real world" environment in which to practice emotion regulation skills related to substance use and HIV prevention. These aims will be achieved through the collaboration of researchers at Rhode Island Hospital/Brown and Virtually Better, Inc. a small business that specializes in creating immersive virtual reality environments for treatment, education, and training purposes. This tool will represent a significant advance in the way in which affect regulation skills are practiced and honed, currently achieved via role plays or imaginal exposure, by increasing the salience of cues used to elicit affect, thus making it highly marketable to interventionists, schools, and mental health clinicians.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Adolescent Risk Behavior, Emotion Regulation, Health Promotion, Intervention, Mental Health
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Virtual Reality
Arm Title
2
Arm Type
Experimental
Arm Description
Health Promotion
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality
Other Intervention Name(s)
IVRE intervention
Intervention Description
4-session group intervention including affect management training as well as sexual health skills training to prevent the transmission of HIV. Group will practice skills using 3-D goggles for some activities.
Intervention Type
Behavioral
Intervention Name(s)
Health Promotion
Intervention Description
4-session group intervention including affect management training as well as sexual health skills training to prevent the transmission of HIV. Group will practice skills using traditional role-plays for some activities.
Primary Outcome Measure Information:
Title
Adolescent-reported self-efficacy for HIV prevention behaviors
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Adolescent-reported condom use self-efficacy
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- 7th & 8th graders at participating public schools.
Exclusion Criteria:
Adolescent is illiterate.
Adolescent has parent/guardian who does not speak English.
Adolescents has high risk of motion sickness.
For Phase II only, previous participation in Project Trac or Phase I.
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Eliciting Affect in Teens in a Virtual World (Project AVATAR)
We'll reach out to this number within 24 hrs