Co-Designing a Virtual Reality Intervention to Enhance Skill Development

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-13

Study Completion Date

2026-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Research on the Intervention of VR-based Emotion Regulation Technology on Adolescent Non-suicide Self-injury Behavior

NCT05734872

Non-suicidal Self-injury

UNKNOWN NA

Virtual Reality (VR) for Stress Management

NCT06970652

Stress Resilience Quality of Life +4 more

COMPLETED NA

Virtual Reality and Speech Analysis for the Assessment of Impulsivity and Decision-making

NCT05109845

Suicidal Ideation

UNKNOWN

Using Virtual Reality to Improve Job Reentry in Adults With TBI

NCT04820634

Traumatic Brain Injury

RECRUITING NA

Virtual Reality Hypnosis and Nurses' Stress

NCT06786962

Hypnosis Virtual Reality Therapy Stress +4 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Suicide

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Enhanced Control

Cognitive Behavioral Therapy (CBT) Worksheets

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy (CBT) Worksheets

Intervention Type 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.

PrESR Intervention

Cognitive Behavioral Therapy (CBT) Worksheets; Virtual Reality (VR) Enhanced CBT Skill/Practice; Safety Planning

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy (CBT) Worksheets

Intervention Type 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)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No