Trials / Recruiting
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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Cognitive Behavioral Therapy (CBT) Worksheets | The 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. |
| BEHAVIORAL | Practice 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.