Co-Designing a Virtual Reality Intervention to Enhance Skill Development

Not Applicable

Not yet recruiting

• Conditions: Suicide

• Registration Number: NCT07186543
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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 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 PrESR for improving mediators and 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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-15
• Last Update Submitted: 2025-09-15
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Study Start: 2025-10-01
• Primary Completion: 2026-10-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Current hospitalization for suicidal thoughts and behaviors
• Ages 13-18 based
• Approval of treating clinician
• Ability to speak, read, and understand English sufficiently to complete study procedures
• Consent of a parent/legal guardian (in English or Spanish)
• Adolescent assent (in English)

Exclusion Criteria

• Evidence of active psychosis
• Evidence of intellectual disability
• Risk for cybersickness (greater or equal to 50th percentile as measured on the Motion Sickness Susceptibility Questionnaire).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients in the target population who agree to participate	Baseline	Rate of Recruitment
Proportion of patients in the target population excluded due to motion sickness screening	Baseline	Rate of recruitment related to motion sickness, with participant scores greater or equal than 50th percentile on motion sickness questionnaire excluded
Proportion of participants who complete all study procedures	up to 3-weeks following hospital discharge	Rate of Retention
Average number of hours to complete assessments at each time point	up to 3-weeks following hospital discharge	Time to complete assessments, assessments are expected to last less than 4 hours
Average number of minutes to complete each intervention session	Baseline	Time to complete intervention sessions, each session is expected to last less than 60 minutes
Average proportion of components of intervention completed based on fidelity checklist	Baseline	Adherence to delivery of key components of intervention, proportion is expected to be 80%
Adolescents' Mean Acceptability Scores	Baseline	Percent of adolescents with average acceptability score less than or equal to 2 (or "agree") on a five-point scale from 1 (strongly agree) to 5 (strongly disagree).
Adolescents' Perceptions of Acceptability	Baseline	Qualitative feedback based on transcribed interviews.

Trial Locations

Locations (1)

UNC Adolescent Psychiatry Inpatient Unit; 🇺🇸 Chapel Hill, North Carolina, United States