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

Study Overview
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Brief Summary
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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) and adolescents with substance use disorder (SUD) between the ages of 13 - 25 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
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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.

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

Conditions
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Substance Use Disorders, HIV Infections

Intervention / Treatment
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* Behavioral: Virtual Reality Tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for YMSM are as follows: Someone who identifies as a YMSM Is aged 13-25 Have experienced at least one interpersonal traumatic event (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 6 months Inclusion Criteria for adolescents with SUD are as follows: Someone who reports using substances Is aged 13-18 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 6 months 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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity and Frequency of Substance Use | 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) |