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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05816083
Recruitment Status : Not yet recruiting
First Posted : April 18, 2023
Last Update Posted : February 15, 2024
Sponsor:
Information provided by (Responsible Party):
Carla Kmett Danielson, Medical University of South Carolina

Study Description
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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.

Condition or disease Intervention/treatment Phase
Substance Use Disorders HIV Infections Behavioral: Virtual Reality Tool Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development and Evaluation of a Virtual Reality Tool for At-Risk Trauma-Exposed Young People
Estimated Study Start Date : April 1, 2024
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Virtual Reality
All participants will receive the same intervention
 Behavioral: Virtual Reality Tool
Virtual Reality Tool for At-Risk Trauma-Exposed Young People


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Carla Kmett Danielson, Dr. Carla Kmett Danielson, Principal Investigator, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT05816083    
Other Study ID Numbers: Pro00105369
First Posted: April 18, 2023    Key Record Dates
Last Update Posted: February 15, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders