Menu
Recruiting NCT05816083

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

No phase Interventional Substance Use Disorders HIV Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality Tool.
Who it may be relevant to
Registry conditions: Substance Use Disorders, HIV Infections. Basic parameters: 15 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Quantity and Frequency of Substance Use [Time frame: Day 0 (Session 1) up to Day 14 (Session 3)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • National Crime Victims Research and Treatment Center — Charleston

Identifiers

NCT: NCT05816083 · Pro00105369

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗