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CompletedNCT02338063Updated Apr 6, 2016

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

A Phase 1/2 interventional study of Virtual Reality and Health Promotion in HIV Infections, sponsored by Rhode Island Hospital. Completed at 1 site in United States. Open to participants aged 12 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-06.

Sponsored by Rhode Island Hospital · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
196
Allocation
Randomized
Ages
12 Years to 16 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • HIV Infections

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Keywords

  • Adolescent Risk Behavior
  • Emotion Regulation
  • Health Promotion
  • Intervention
  • Mental Health
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 196 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Rhode Island Hospital is the lead sponsor of 187 studies on the registry; 37 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 7th \& 8th graders at participating public schools.

Exclusion criteria

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
196 participants (actual)

Study arms

  • Experimental
    1

    Virtual Reality

    Behavioral: Virtual Reality

  • Experimental
    2

    Health Promotion

    Behavioral: Health Promotion

Interventions

  • BehavioralVirtual 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.

    Also known as: IVRE intervention

  • BehavioralHealth 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.

06

What researchers measure

Primary outcomes

  1. Adolescent-reported self-efficacy for HIV prevention behaviors

    Time frame: 3 months

Secondary outcomes

  1. Adolescent-reported condom use self-efficacy

    Time frame: 3 months

07

Study locations

1 site
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02338063
Lead sponsor
Rhode Island Hospital
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Jan 14, 2015
Start date
May 2010
Primary completion
Jan 2016
Last update
Apr 6, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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