Practice Experiences for School Reintegration (PrESR)

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

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.

Study Overview

• Status: Completed
• Conditions: Suicide
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets; Behavioral: Safety Planning; Behavioral: VR Enhanced Affect Regulation; Behavioral: VR Enhanced Problem Solving; Behavioral: VR Enhanced Cognitive Restructuring

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Adolescent Psychiatry Inpatient Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enhanced Control; Cognitive Behavioral Therapy (CBT) Worksheets	Behavioral: 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.
Active Comparator: Affect Regulation; Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation	Behavioral: 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.; Behavioral: Safety Planning; Prior 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).; Behavioral: VR Enhanced Affect Regulation; Participants 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.
Active Comparator: Problem Solving; Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving	Behavioral: 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.; Behavioral: Safety Planning; Prior 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).; Behavioral: VR Enhanced Problem Solving; Participants 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.
Active Comparator: Affect Regulation + Problem Solving; Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving	Behavioral: 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.; Behavioral: Safety Planning; Prior 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).; Behavioral: VR Enhanced Affect Regulation; Participants 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.; Behavioral: VR Enhanced Problem Solving; Participants 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.
Active Comparator: Cognitive Restructuring; Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring	Behavioral: 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.; Behavioral: Safety Planning; Prior 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).; Behavioral: VR Enhanced Cognitive Restructuring; Participants 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.
Active Comparator: Affect Regulation + Cognitive Restructuring; Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring	Behavioral: 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.; Behavioral: Safety Planning; Prior 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).; Behavioral: VR Enhanced Affect Regulation; Participants 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.; Behavioral: VR Enhanced Cognitive Restructuring; Participants 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.
Active Comparator: Cognitive Restructuring + Problem Solving; Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving	Behavioral: 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.; Behavioral: Safety Planning; Prior 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).; Behavioral: VR Enhanced Problem Solving; Participants 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.; Behavioral: VR Enhanced Cognitive Restructuring; Participants 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.
Active Comparator: Affect Regulation + Cognitive Restructuring + Problem Solving; Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving	Behavioral: 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.; Behavioral: Safety Planning; Prior 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).; Behavioral: VR Enhanced Affect Regulation; Participants 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.; Behavioral: VR Enhanced Problem Solving; Participants 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.; Behavioral: VR Enhanced Cognitive Restructuring; Participants 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients in the Target Population Who Agree to Participate	Recruitment rate was 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 was 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 was determined based on the proportion of adolescents completing study procedures at Baseline, 2-week follow-up, 3-month follow-up, and journals over the two weeks of their return to school relative to the total number of adolescents participating in that condition.	up to 3-months following school re-entry
Average Number of Hours to Complete Assessments at Each Time Point	Time to complete assessments, assessments are expected to last less than 4 hours. Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition was withdrawn or withdrew.	up to 3-months following school re-entry
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. Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition was withdrawn or withdrew.	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 was calculated based on the number of key components completed relative to the total number of key components expected to be completed for each participant. Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition was withdrawn or withdrew.	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 five-point scale from 1 (strongly agree) to 5 (strongly disagree). Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition was withdrawn or withdrew, and due to missing post-baseline data for "Problem Solving" (1 participant), "Cognitive Restructuring" (1 participant), "Affect Regulation + Cognitive Restructuring" (1 participant), "Cognitive Restructuring + Problem Solving" (1 participant), and "Affect Regulation + Cognitive Restructuring + Problem Solving" (1 participant).	Baseline
Percentage of Hospital Professional Participants With Average Acceptability Scores Less Than or Equal to 2	Percent of hospital professionals with average acceptability score less than or equal to 2 (or "agree") on a five-point scale from 1 (strongly agree) to 5 (strongly disagree). Note that the number of participants to start a Period is not equal to the number who completed previous Period for Hospital Professionals because 7 professionals consented into the study, but only 4 delivered the intervention to a patient following consent.	Baseline
Adolescents' Perceptions of Acceptability	Qualitative feedback provided by adolescents receiving the intervention in the Optimization Trial about acceptability of the intervention. Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition was withdrawn or withdrew, and due to missing post-baseline data for "Cognitive Restructuring + Problem Solving" (1 participant).	Baseline
Hospital Professionals' Perceptions of Acceptability	Qualitative feedback provided by Hospital Professionals delivering the intervention to one or more hospitalized adolescents about acceptability of the intervention. Note that the number of participants to start a Period is not equal to the number who completed previous Period for Hospital Professionals because 7 professionals consented into the study, but only 4 delivered the intervention to a patient following consent.	Baseline

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Marisa Marraccini, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Behavior; Suicide; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: 20-3464; 5K23MH122775 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No