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RecruitingNCT07186543

Co-Designing a Virtual Reality Intervention to Enhance Skill Development

Co-Designing a Virtual Reality Intervention to Enhance Skill Development With Adolescents Hospitalized for Suicide-Related Crises

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
26 (estimated)
Sponsor
University of North Carolina, Chapel Hill · Academic / Other
Sex
All
Age
13 Years – 18 Years
Healthy volunteers
Not accepted

Summary

This study is refining and pilot testing a novel Virtual Reality (VR) supplement for inpatient treatment: the Practice Experiences for School Reintegration (PrESR) program. The PrESR provides immersive school and social experiences for inpatient adolescents (with suicidal-related admissions) to practice skills in real-world settings with the guidance of a trained clinician within the confines of a hospital. The initial intervention was based on feedback from adolescent hospitalized for suicide-related crises, and school and hospital professionals, but did not provide tailored experiences to address the individual needs of ethnic-racial, gender, and sexual minoritized adolescents. Therefore, the VR environment of PrESR was adapted based on input from adolescents with previous suicide-related crises identifying as ethnic, racial, sex, or gender minoritized. This pilot randomized controlled trial (RCT) aims to explore the feasibility, acceptability, and facilitators/barriers to implementation of the adapted version of PrESR for improving outcomes in hospitalized adolescents. This study is not powered to test hypotheses; however, in addition to assessing feasibility, acceptability, and barriers/facilitators, this pilot trial will assess candidate intermediary and outcome measures.

Detailed description

This study recruits a prospective sample of youth hospitalized for suicide-related crises. Target sample size is approximately N = 26 enrolled adolescents, with the intention of recruiting at least 16 participants who identify as ethnic, racial, sex, or gender minoritized. The pilot RCT includes two conditions: an enhanced treatment as usual condition and an experimental condition. All participants will receive standard treatment, as well as researcher provided worksheets addressing introduction to cognitive behavioral therapy, cognitive restructuring, problem-solving, and affect regulation. Participants randomized to the experimental condition will also receive one or more sessions with PrESR. Outcomes will be assessed during hospitalization and again 3-weeks following hospital discharge.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCognitive Behavioral Therapy (CBT) WorksheetsThe researchers will provide instructions for participants to complete a packet of worksheets teaching introduction to cognitive behavioral therapy (CBT), affect regulation, cognitive restructuring, and problem solving.
BEHAVIORALPractice Experiences for School Reintegration (PrESR)Participants will receive an overview of cognitive behavioral therapy skills in virtual reality (VR) and then have the opportunity to practice using skills in a brief immersive experience designed to mimic difficult school and social experiences. Session begin with goal setting and conclude with a debrief summary following the VR experience. Prior to discharge and following the conclusion of the VR sessions, participants will be invited to collaborate on a safety planning intervention informed by their experiences in VR that addresses school and social experiences.

Timeline

Start date
2025-10-13
Primary completion
2026-10-30
Completion
2026-10-30
First posted
2025-09-22
Last updated
2025-10-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07186543. Inclusion in this directory is not an endorsement.