Practice Experiences for School Reintegration
PrESR
2 other identifiers
interventional
54
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2023
CompletedFirst Posted
Study publicly available on registry
July 7, 2023
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2024
CompletedResults Posted
Study results publicly available
September 25, 2025
CompletedSeptember 25, 2025
January 1, 2025
1.4 years
June 28, 2023
August 26, 2025
September 22, 2025
Conditions
Outcome Measures
Primary Outcomes (10)
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
Study Arms (8)
Enhanced Control
ACTIVE COMPARATORCognitive Behavioral Therapy (CBT) Worksheets
Affect Regulation
ACTIVE COMPARATORCognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation
Problem Solving
ACTIVE COMPARATORCognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving
Affect Regulation + Problem Solving
ACTIVE COMPARATORCognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving
Cognitive Restructuring
ACTIVE COMPARATORCognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring
Affect Regulation + Cognitive Restructuring
ACTIVE COMPARATORCognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring
Cognitive Restructuring + Problem Solving
ACTIVE COMPARATORCognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
Affect Regulation + Cognitive Restructuring + Problem Solving
ACTIVE COMPARATORCognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
Interventions
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).
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UNC Adolescent Psychiatry Inpatient Unit
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marisa Marraccini, PhD
- Organization
- University of North Carolina at Chapel Hill
Study Officials
- PRINCIPAL INVESTIGATOR
Marisa Marraccini, PhD
University of North Carolina, Chapel Hill
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2023
First Posted
July 7, 2023
Study Start
August 1, 2023
Primary Completion
December 20, 2024
Study Completion
December 20, 2024
Last Updated
September 25, 2025
Results First Posted
September 25, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share