Clinical Trials Directory

Trials / Completed

CompletedNCT05934396

Practice Experiences for School Reintegration

Practice Experiences for School Reintegration: An Immersive Virtual Reality Program to Enhance Skill Development of Hospitalized Adolescents

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
54 (actual)
Sponsor
University of North Carolina, Chapel Hill · Academic / Other
Sex
All
Age
13 Years – 99 Years
Healthy volunteers
Not accepted

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.

Detailed description

This study follows a multiphased optimization (MOST) research design; this clinical trial is considered to be a pilot optimization component of the MOST framework. For the present study, a prospective sample of adolescents hospitalized for suicidal thoughts and behaviors will be randomly selected into one of 8 experimental conditions (N=5-6 per group). Although the intervention for the pilot optimization trial will be implemented by a member of research staff, this study will also aim to recruit 2-5 clinicians to deliver the full intervention to a separate sample of adolescent patients to inform acceptability and feasibility of the intervention within their clinical workflow.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSafety PlanningPrior to discharge and following the conclusion of all Virtual Reality (VR) sessions, the participant will develop a safety planning intervention for school settings in collaboration with relevant individuals (e.g., the researcher, a school professional).
BEHAVIORALVR Enhanced Affect RegulationParticipants will receive an overview of affect regulation in VR and then have the opportunity to practice using affect regulation in a brief immersive experience designed to mimic difficult school experiences. Each session begins with goal setting prior to the VR experience and concludes with a debrief summary following the VR experience.
BEHAVIORALVR Enhanced Cognitive RestructuringParticipants will receive an overview of cognitive restructuring in VR and then have the opportunity to practice using cognitive restructuring in a brief immersive experience designed to mimic difficult school experiences. Each session begins with goal setting prior to the VR experience and concludes with a debrief summary following the VR experience.
BEHAVIORALVR Enhanced Problem SolvingParticipants will receive an overview of problem solving in VR and then have the opportunity to practice using problem solving in a brief immersive experience designed to mimic difficult school experiences. Each session begins with goal setting prior to the VR experience and concludes with a debrief summary following the VR experience.
BEHAVIORALCognitive Behavioral Therapy (CBT) WorksheetsThe 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.

Timeline

Start date
2023-08-01
Primary completion
2024-12-20
Completion
2024-12-20
First posted
2023-07-07
Last updated
2025-09-25
Results posted
2025-09-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05934396. Inclusion in this directory is not an endorsement.