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

Primary Purpose

Substance Use Disorders, HIV Infections

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Reality Tool
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders

Eligibility Criteria

13 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Virtual Reality

    Arm Description

    All participants will receive the same intervention

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 23, 2023
    Last Updated
    September 15, 2023
    Sponsor
    Medical University of South Carolina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05816083
    Brief Title
    Development and Evaluation of a Virtual Reality Tool for At-Risk Trauma-Exposed Young People
    Official Title
    Development and Evaluation of a Virtual Reality Tool for At-Risk Trauma-Exposed Young People
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2024 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of South Carolina

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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) 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Substance Use Disorders, HIV Infections

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Virtual Reality
    Arm Type
    Experimental
    Arm Description
    All participants will receive the same intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Virtual Reality Tool
    Intervention Description
    Virtual Reality Tool for At-Risk Trauma-Exposed Young People
    Primary Outcome Measure Information:
    Title
    Quantity and Frequency of Substance Use
    Description
    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.
    Time Frame
    Day 0 (Session 1) up to Day 14 (Session 3)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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