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NCT Number: NCT05816083

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

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.

Recruiting

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Key information

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Crime Victims Research and Treatment Center

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Carla K Danielson, Ph.D.

CONTACT

[email protected]

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CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Tool

Behavioral

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carla Danielson, PhD

CONTACT

[email protected]

Charli Kirby, BA

CONTACT

[email protected]

(843) 408-6140

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2023
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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