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Completed

NCT Number: NCT07186543

Co-Designing a Virtual Reality Intervention to Enhance Skill Development

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.

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Key information

Conditions

Suicide Behavior Behavioral Symptoms Self-Injurious Behavior

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Adolescent Psychiatry Inpatient Unit

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current hospitalization for suicidal thoughts and behaviors
  • Ages 13-18
  • Clinician approval
  • Ability to speak, read, and understand English sufficiently to complete study procedures
  • Consent of a parent/legal guardian (in English or Spanish; for minor participants)
  • Adolescent assent or consent (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).

Treatment and study plan

Cognitive Behavioral Therapy (CBT) Worksheets

Behavioral

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.

Practice Experiences for School Reintegration (PrESR)

Behavioral

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.

Primary outcomes

  1. Proportion of Patients in the Target Population Who Agree to Participate

    Time frame: Baseline

    Recruitment rate determined based on the proportion of adolescents providing assent and parents or legal guardians providing permission relative to the number of parents or legal guardians approached.

  2. Proportion of Patients in the Target Population Excluded Due to Motion Sickness Screening

    Time frame: Baseline

    Rate of recruitment related to motion sickness determined based on the proportion of assented adolescents whose scores were >/= than 50th percentile on motion sickness questionnaire relative to the number of assented adolescents.

  3. Proportion of Participants Who Complete All Study Procedures

    Time frame: up to 3-weeks following hospital discharge

    Proportion of participants who complete all study procedures determined based on the proportion of adolescents completing study procedures at Baseline and 3-week follow-up relative to the total number of adolescents participating in that condition.

  4. Average Number of Hours to Complete Assessments at Each Time Point

    Time frame: up to 3-weeks following hospital discharge

    Time to complete assessments, assessments are expected to last less than 4 hours.

  5. Average Number of Minutes to Complete Each Intervention Session

    Time frame: Baseline

    Time to complete intervention sessions, each session is expected to last less than 60 minutes. Average calculated by summing all sessions in each condition and dividing by total number of sessions.

  6. Percentage of Adolescent Participants in Which Intervention Delivered With Greater Than or Equal to 80% Fidelity

    Time frame: Baseline

    Percentage of participants in which adherence to delivery of key components of intervention (i.e., skill lessons or practice sessions) across sessions in each condition was 80% or greater. Adherence calculated based on the number of key components completed relative to the total number of key components expected to be completed for each participant.

  7. Percentage of Adolescent Participants With Average Acceptability Scores Less Than or Equal to 2

    Time frame: Baseline

    Percent of adolescents with average acceptability score less than or equal to 2 (or "agree") on a structured feedback form developed by the researchers. The structured feedback form includes an average of four items related to acceptability on a five-point scale from 1 (strongly agree) to 5 (strongly disagree), with lower scores reflecting higher acceptability.

  8. Adolescents' Perceptions of Acceptability

    Time frame: Baseline

    Qualitative feedback provided by adolescents receiving the intervention about acceptability of the intervention, with the two most common points of feedback collected from a structured interview reported.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • MQ Mental Health Research

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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