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

NCT ID: NCT05816083

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-06
• Study Completion Date: 2026-02-28

Brief Summary

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.

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.

Conditions

Substance Use Disorders; HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual Reality

All participants will receive the same intervention

Group Type: EXPERIMENTAL

Virtual Reality Tool

Intervention Type: BEHAVIORAL

Virtual Reality Tool for At-Risk Trauma-Exposed Young People

Interventions

Virtual Reality Tool

Virtual Reality Tool for At-Risk Trauma-Exposed Young People

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielson

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

National Crime Victims Research and Treatment Center

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Charli Kirby, BA

Role: CONTACT

kirbych@musc.edu

(843) 408-6140

Carla Danielson, PhD

Role: CONTACT

danielso@musc.edu

Facility Contacts

Carla K Danielson, Ph.D.

Role: primary

danielso@musc.edu

L

Role: backup

Other Identifiers

Pro00105369

Identifier Type: -

Identifier Source: org_study_id