Development and Evaluation of a Virtual Reality Tool for At-Risk Trauma-Exposed Young People

April 7, 2026 updated by: Medical University of South Carolina
This is a multi-phased study, funded through a National Institute on Drug Abuse (NIDA) K24 grant that aims to ultimately refine a virtual reality tool through qualitative and quantitative research targeting HIV and substance abuse risk behavior among at-risk young people who have experienced psychosocial trauma. Participants eligible for this study include young men who have sex with men (YMSM)/individuals who are romantically/physically attracted to men and adolescents with substance use disorder (SUD) between the ages of 15 - 30 and have experienced at least one traumatic event in their lifetime. Frontline healthcare workers who work within these populations are eligible for the study as well.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

YMSM and adolescents with SUD participants will complete 3 study sessions. During session 1, informed consent and baseline measures are administered. Approximately one week later, during session 2, participants use and assess the virtual reality tool. Approximately one week later, during session 3, baseline assessments are re-administered.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • National Crime Victims Research and Treatment Center
        • Contact:
          • L
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for YMSM are as follows:

  • Someone who identifies as a YMSM or identifies as someone with romantic or physical attraction to individuals who identify as men
  • Is aged 15-30 years
  • Have experienced at least one ITE in lifetime (i.e., sexual assault, physical assault, witnessed domestic or community violence)
  • Report being consensually sexually active or planning to become sexually active with a partner in the next 12 months
  • Live in the Charleston, SC/Tri-county area

Inclusion Criteria for adolescents with SUD are as follows:

  • Someone who reports using substances in the past year (for participants ages 15-17) or the past 6 months (for participants ages 18-30)
  • Is aged 15-30 years
  • Have experienced at least one ITE in lifetime (i.e., sexual assault, physical assault, witnessed domestic or community violence)
  • Report being consensually sexually active or planning to become sexually active with a partner in the next 12 months
  • Live in the Charleston, SC/Tri-county area

Inclusion Criteria for front line healthcare workers are as follows:

  • works directly with adolescents who have experienced ITE and/or
  • works directly with adolescents or young adults with SUD and/or
  • works directly with YMSM and/or
  • works directly with and/or adolescent or young adults who are HIV-positive

Exclusion Criteria for all participants are as follows:

  • exhibits psychotic symptoms;
  • exhibits significant cognitive disability;
  • reports a history of Pervasive Developmental Disorder;
  • has active suicidal or homicidal ideations
  • self-reports high levels of motion sickness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality
All participants will receive the same intervention
Behavioral: Virtual Reality Tool
Virtual Reality Tool for At-Risk Trauma-Exposed Young People

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantity and Frequency of Substance Use
Time Frame: Day 0 (Session 1) up to Day 14 (Session 3)
The Timeline Follow Back (TLFB) is a validated, subjective measure that uses a calendar for people to provide estimates of substance use (drugs/alcohol) on a daily basis, retrospectively. Key dates and calendars are used to aid in memory recall. The measure is beneficial in both clinical and research environments. Over time, the TLFB looks for a decrease in substance use. Higher numbers of substance use are indicative of greater substance use.
Day 0 (Session 1) up to Day 14 (Session 3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Danielson, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00105369

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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