Practice Experiences for School Reintegration (PrESR)

September 22, 2025 updated by: University of North Carolina, Chapel Hill

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Marisa E Marraccini, PhD
  • Phone Number: 919-843-5099
  • Email: mmarracc@unc.edu

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Patients in the Target Population Who Agree to Participate
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: up to 3-months following school re-entry
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 Frame: up to 3-months following school re-entry
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 Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: Baseline
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marisa Marraccini, PhD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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