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

NCT05816083 — Not applicable, Active not recruiting, 50 participants, Medical University of South Carolina

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RegistryNCT05816083
StatusActive not recruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment50 (Estimated)
SponsorMedical University of South Carolina (Other)
ConditionsSubstance Use Disorders, HIV Infections
InterventionsVirtual Reality Tool (Behavioral)
Datesstart 2025-02-06, primary completion 2026-08-28, completion 2027-02-28 (estimated), first posted 2023-04-18, last updated 2026-10-20
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Substance Use Disorders All trials for HIV Infections All trials of Virtual Reality Tool

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Virtual RealityExperimentalBehavioral: Virtual Reality ToolAll participants will receive the same intervention
  • Virtual Reality Tool (Behavioral): Virtual Reality Tool for At-Risk Trauma-Exposed Young People

+Outcome measures

Primary outcomes

  • Quantity and Frequency of Substance Use [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.

+Eligibility

Sex: All, ages: 15 Years to 30 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
National Crime Victims Research and Treatment CenterCharleston, South CarolinaUnited States

+Study documents

+Investigators

  • Danielson, Principal investigator, Medical University of South Carolina