Practice Experiences for School Reintegration

Study Overview
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Brief Summary
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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.

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

Conditions
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Suicide

Intervention / Treatment
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* Behavioral: Safety Planning
* Behavioral: VR Enhanced Affect Regulation
* Behavioral: VR Enhanced Cognitive Restructuring
* Behavioral: VR Enhanced Problem Solving
* Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enhanced Control<br>Cognitive Behavioral Therapy (CBT) Worksheets | Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets<br>* 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.<br>|
| Active Comparator: Affect Regulation<br>Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation | Behavioral: Safety Planning<br>* 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).<br>Behavioral: VR Enhanced Affect Regulation<br>* 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.<br>Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets<br>* 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.<br>|
| Active Comparator: Problem Solving<br>Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving | Behavioral: Safety Planning<br>* 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).<br>Behavioral: VR Enhanced Problem Solving<br>* 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.<br>Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets<br>* 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.<br>|
| Active Comparator: Affect Regulation + Problem Solving<br>Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving | Behavioral: Safety Planning<br>* 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).<br>Behavioral: VR Enhanced Affect Regulation<br>* 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.<br>Behavioral: VR Enhanced Problem Solving<br>* 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.<br>Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets<br>* 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.<br>|
| Active Comparator: Cognitive Restructuring<br>Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring | Behavioral: Safety Planning<br>* 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).<br>Behavioral: VR Enhanced Cognitive Restructuring<br>* 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.<br>Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets<br>* 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.<br>|
| Active Comparator: Affect Regulation + Cognitive Restructuring<br>Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring | Behavioral: Safety Planning<br>* 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).<br>Behavioral: VR Enhanced Affect Regulation<br>* 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.<br>Behavioral: VR Enhanced Cognitive Restructuring<br>* 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.<br>Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets<br>* 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.<br>|
| Active Comparator: Cognitive Restructuring + Problem Solving<br>Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving | Behavioral: Safety Planning<br>* 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).<br>Behavioral: VR Enhanced Cognitive Restructuring<br>* 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.<br>Behavioral: VR Enhanced Problem Solving<br>* 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.<br>Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets<br>* 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.<br>|
| Active Comparator: Affect Regulation + Cognitive Restructuring + Problem Solving<br>Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving | Behavioral: Safety Planning<br>* 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).<br>Behavioral: VR Enhanced Affect Regulation<br>* 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.<br>Behavioral: VR Enhanced Cognitive Restructuring<br>* 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.<br>Behavioral: VR Enhanced Problem Solving<br>* 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.<br>Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients in the target population who agree to participate | Rate of Recruitment | Baseline | 
| Proportion of patients in the target population excluded due to motion sickness screening | Rate of recruitment related to motion sickness, with participant scores greater or equal than 50th percentile on motion sickness questionnaire excluded | Baseline | 
| Proportion of participants who complete all study procedures | Rate of Retention | 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 | 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 | Baseline | 
| Average proportion of components of intervention completed based on fidelity checklist | Adherence to delivery of key components of intervention, proportion is expected to be 80% | Baseline | 
| Adolescents' Mean Acceptability Scores | 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). | Baseline | 
| Professionals' Mean Acceptability Scores | Percent of 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). | Baseline | 
| Adolescents' Perceptions of Acceptability | Qualitative feedback based on transcribed interviews. | Baseline | 
| Professional' Perceptions of Acceptability | Qualitative feedback based on transcribed interviews. | Baseline |