Co-Designing a Virtual Reality Intervention to Enhance Skill Development

NCT07186543 | Recruiting DMC

• 1 other identifier: 23-0388
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Suicide

Outcome Measures

Primary Outcomes (8)

• Proportion of Patients in the Target Population Who Agree to Participate

  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.

  Baseline

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

  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.

  Baseline

• Proportion of Participants Who Complete All Study Procedures

  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.

  up to 3-weeks following hospital discharge

• Average Number of Hours to Complete Assessments at Each Time Point

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

  up to 3-weeks following hospital discharge

• Average Number of Minutes to Complete Each Intervention Session

  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.

  Baseline

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

  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.

  Baseline

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

  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.

  Baseline

• Adolescents' Perceptions of Acceptability

  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.

  Baseline

Study Arms (2)

Enhanced Control

ACTIVE COMPARATOR

Cognitive Behavioral Therapy (CBT) Worksheets

Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets

PrESR Intervention

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets; Behavioral: Practice Experiences for School Reintegration (PrESR)

Interventions

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.

Enhanced Control; PrESR Intervention

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.

PrESR Intervention

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• MQ Mental Health Research: collaborator

Study Sites (1)

UNC Adolescent Psychiatry Inpatient Unit

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Suicide

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Marisa Marraccini, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 22, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC

Locations

US (1)