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

Sponsor
Medical University of South Carolina (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05816083
Collaborator
(none)
50
1
17

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virtual Reality Tool
N/A

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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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

Primary Outcome Measures

  1. 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 Criteria

Criteria

Ages Eligible for Study:
13 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

No locations specified.

Sponsors and Collaborators

  • Medical University of South Carolina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Apr 18, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 18, 2023