N/A N=42 Randomized Treatment

Practice Experiences for School Reintegration

Suicide

Bottom Line

View on ClinicalTrials.gov: NCT05934396 ↗

Enrolled (actual)

Serious AEs

23.4%

Results posted

Sep 2025

Primary outcome: Primary: Proportion of Patients in the Target Population Who Agree to Participate — 0.384 proportion of potential participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Safety Planning (Behavioral); VR Enhanced Affect Regulation (Behavioral); VR Enhanced Cognitive Restructuring (Behavioral); VR Enhanced Problem Solving (Behavioral); Cognitive Behavioral Therapy (CBT) Worksheets (Behavioral)
Age: Pediatric, Adult, Older Adult · 13+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Dec 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Patients in the Target Population Who Agree to Participate	0.384	—
PRIMARY Proportion of Patients in the Target Population Excluded Due to Motion Sickness Screening	0.021	—
PRIMARY Proportion of Participants Who Complete All Study Procedures	0; 0.800; 0.167; 0; 0.400; 0	—
PRIMARY Average Number of Hours to Complete Assessments at Each Time Point	0.603; 0.847; 0.842; 0.762; 0.900; 0.747	—
PRIMARY Average Number of Minutes to Complete Each Intervention Session	26.864; 26.333; 27.500; 25.938; 37.083; 29.714	—
PRIMARY Percentage of Adolescent Participants in Which Intervention Delivered With Greater Than or Equal to 80% Fidelity	100; 100; 100; 100; 100; 100	—
PRIMARY Percentage of Adolescent Participants With Average Acceptability Scores Less Than or Equal to 2	60; 60; 100; 75; 50; 100	—
PRIMARY Percentage of Hospital Professional Participants With Average Acceptability Scores Less Than or Equal to 2	25	—
PRIMARY Adolescents' Perceptions of Acceptability	5; 6; 4; 5; 4; 4	—
PRIMARY Hospital Professionals' Perceptions of Acceptability	4; 4	—

Summary

This study is developing and refining a novel Virtual Reality (VR) supplement for inpatient treatment: the Practice Experiences for School Reintegration (PrESR) program. The PrESR will provide 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. This pilot study follows a Multiphase Optimization Strategy (MOST) to conduct a pilot optimization trial of the PrESR to inform the feasibility of training clinicians, the ability to recruit adolescent inpatient participants, and management of experimental conditions. This study is not powered to test hypotheses; however, in addition to assessing feasibility and acceptability, this pilot trial will assess candidate intermediary and outcome measures.

Eligibility Criteria

Inclusion Criteria

Adolescent Participants:

current hospitalization for suicidal thoughts and behaviors
ages 13-18
expected return to school following discharge
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)
clinician approval.

Hospital professionals:

Works as a clinician at the hospital site who delivers treatment including CBT to hospitalized adolescents,
Hospital professional consent (in English)
consent of patient's parent/legal guardian (in English or Spanish; for minor participants)
adolescent patient assent or consent (in English).

Exclusion Criteria

Adolescent Participants

evidence of active psychosis,
evidence of intellectual disability
Risk for Cyber-sickness (greater than or equal to 50th percentile as measured on the Motion Sickness Susceptibility Questionnaire)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05934396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.