Eliciting Affect in Teens in a Virtual World (Project AVATAR)

HIV Infections Clinical Trial

Official title:

Eliciting Affect in Teens in a Virtual World (Project AVATAR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338063
• Other study ID #: 0079-10
• Secondary ID: 5R42MH087322-03
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 9, 2015
• Last updated: April 5, 2016
• Start date: May 2010

Study information

• Verified date: April 2016
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether immersive virtual reality technology is an effective intervention tool for HIV Prevention with adolescents.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Virtual Reality
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.
• Health Promotion
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.

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adolescent-reported self-efficacy for HIV prevention behaviors		3 months	No
Secondary	Adolescent-reported condom use self-efficacy		3 months	No