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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23MH122775 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Control | Active Comparator | Cognitive Behavioral Therapy (CBT) Worksheets |
|
| Affect Regulation | Active Comparator | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation |
|
| Problem Solving | Active Comparator | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving |
|
| Affect Regulation + Problem Solving | Active Comparator | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving |
|
| Cognitive Restructuring |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safety Planning | Behavioral | 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). |
| 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. |
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Inclusion Criteria:
Adolescent Participants:
Hospital professionals:
Exclusion Criteria:
Adolescent Participants
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| Name | Affiliation | Role |
|---|---|---|
| Marisa Marraccini, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Adolescent Psychiatry Inpatient Unit | Chapel Hill | North Carolina | 27599 | United States |
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125 parents/guardians were called based on chart review and 94 were successfully contacted; out of those, 54 provided permission for their adolescent to participate. Of 54 adolescents contacted, 48 provided assent, of whom 1 was screened out due to risk for cybersickness. Of the remaining 47 adolescents, 5 were in the open trial and 42 were in the optimization trial. 7 hospital professionals consented to participate in the open trial, of whom 4 delivered the intervention to at least one patient.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Control | Cognitive Behavioral Therapy (CBT) Worksheets 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. |
| FG001 | Affect Regulation | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation 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). 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. 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. |
| FG002 | Problem Solving | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving 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). 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. 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. |
| FG003 | Affect Regulation + Problem Solving | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving 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). 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. 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. 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. |
| FG004 | Cognitive Restructuring | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring 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). 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. 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. |
| FG005 | Affect Regulation + Cognitive Restructuring | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring 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). 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. 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. 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. |
| FG006 | Cognitive Restructuring + Problem Solving | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving 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). 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. 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. 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. |
| FG007 | 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 Safety Planning: Prior to discharge and after Virtual Reality (VR) sessions, the participant develops a safety plan for schools. VR Enhanced Affect Regulation: Participants receive an overview of affect regulation in VR and then can 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. VR Enhanced Cognitive Restructuring: Participants receive an overview of cognitive restructuring in VR and then can 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. VR Enhanced Problem Solving: Participants receive an overview of problem solving in VR and then can 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. CBT Worksheets: The researchers will provide instructions for participants to complete a packet of worksheets teaching introduction to CBT, affect regulation, cognitive restructuring, and problem solving. |
| FG008 | Hospital Professionals | Clinicians who delivered the intervention to inform acceptability and feasibility of the intervention within their clinical workflow. |
| FG009 | Adolescent Patients Selected by Hospital Professionals | Adolescent patients receiving the intervention delivered by hospital professional participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Optimization Trial |
| |||||||||||||||||||||||||
| Open Trial Period |
|
Data pertaining to Adolescent Patients Selected by Hospital Professionals are only analyzed for the outcomes related to overall patient recruitment and screening: "Proportion of Patients in the Target Population Who Agree to Participate [Time Frame: Baseline]" and "Proportion of Patients in the Target Population Excluded Due to Motion Sickness Screening [Time Frame: Baseline]".
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Control | Cognitive Behavioral Therapy (CBT) Worksheets 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis population includes adolescents hospitalized for suicide-related crises, identified through electronic health records and deemed appropriate for the intervention by clinicians, including those considered for the Optimization Trial and the Open Trial. | Posted | Number | proportion of potential participants | Baseline |
|
For the Optimization Trial, from signing the informed consent until the 3-Month Return to School Follow-Up or early withdrawal. This time was dependent on the duration of hospital stay and timing of return to school and therefore varied greatly (ranging from 1 day to 405 days). For the Open Trial Period, adverse events for the Adolescent Patients Selected by Hospital Professionals were only monitored during intervention delivery.
The Open Trial Period Hospital Professionals were not considered to be at risk for adverse events and data were not collected for this arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enhanced Control | Cognitive Behavioral Therapy (CBT) Worksheets 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Department Visit for Suicide-Related Risk or Associated Symptoms | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Distress | Social circumstances | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marisa Marraccini, PhD | University of North Carolina at Chapel Hill | 919-843-5099 | mmarracc@unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 16, 2025 | Aug 15, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 23, 2024 | Jan 22, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring |
|
| Affect Regulation + Cognitive Restructuring | Active Comparator | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring |
|
| Cognitive Restructuring + Problem Solving | Active Comparator | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving |
|
| Affect Regulation + Cognitive Restructuring + Problem Solving | Active Comparator | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving |
|
|
| VR Enhanced Affect Regulation | Behavioral | 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. |
|
| VR Enhanced Cognitive Restructuring | Behavioral | 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. |
|
| VR Enhanced Problem Solving | Behavioral | 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. |
|
| Cognitive Behavioral Therapy (CBT) Worksheets | Behavioral | 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. |
|
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
| Affect Regulation |
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation 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). 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. 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. |
| BG002 | Problem Solving | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving 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). 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. 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. |
| BG003 | Affect Regulation + Problem Solving | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving 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). 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. 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. 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. |
| BG004 | Cognitive Restructuring | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring 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). 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. 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. |
| BG005 | Affect Regulation + Cognitive Restructuring | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring 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). 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. 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. 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. |
| BG006 | Cognitive Restructuring + Problem Solving | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving 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). 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. 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. 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. |
| BG007 | 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 Safety Planning: Prior to discharge and after Virtual Reality (VR) sessions, the participant develops a safety plan for schools. VR Enhanced Affect Regulation: Participants receive an overview of affect regulation in VR and then can 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. VR Enhanced Cognitive Restructuring: Participants receive an overview of cognitive restructuring in VR and then can 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. VR Enhanced Problem Solving: Participants receive an overview of problem solving in VR and then can 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. CBT Worksheets: The researchers will provide instructions for participants to complete a packet of worksheets teaching introduction to CBT, affect regulation, cognitive restructuring, and problem solving. |
| BG008 | Hospital Professionals | Clinicians who delivered the intervention to inform acceptability and feasibility of the intervention within their clinical workflow. |
| BG009 | Adolescent Patients Selected by Hospital Professionals | Adolescent patients receiving the intervention delivered by hospital professional participants |
| BG010 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | For adolescents, sex/gender is categorized by sex (male, female, intersex) / gender (man/boy, woman/girl, in some other way, "I do not know what this question is asking", "I do not know if I am transgender"). For hospital professionals, sex/gender is categorized by sex (male, female) / gender (female, male, transgender, or "I do not identify as female, male, or transgender"). Unknown refers to missing data or not reported data. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | 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. | Analysis population includes adolescents hospitalized for suicide-related crises, identified through electronic health records and deemed appropriate for the intervention by clinicians, including those considered for the Optimization Trial and the Open Trial. | Posted | Number | proportion of participants | Baseline |
|
|
|
| Primary | 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. | This outcome applies to participants in the Optimization Trial only. Data were not collected for Hospital Professionals or Adolescent Patients Selected by Hospital Professionals for the Open Trial Period. | Posted | Number | proportion of participants | up to 3-months following school re-entry |
|
|
|
| Primary | 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. | This outcome applies to participants in the Optimization Trial only. Data were not collected for Hospital Professionals or Adolescent Patients Selected by Hospital Professionals for the Open Trial Period. Numbers of Participants Analyzed per Row differs from the Overall Numbers of Participants due to number of individuals completing meetings across timepoints (i.e., not all participants completed every meeting). | Posted | Mean | Standard Deviation | hours | up to 3-months following school re-entry |
|
|
|
| Primary | 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. | This outcome applies to participants randomized to receive one or more components of the intervention in the Optimization Trial only. Data were not collected for adolescents randomized to the Enhanced Control condition in the Optimization Trial or Hospital Professionals or Adolescent Patients Selected by Hospital Professionals for the Open Trial Period. | Posted | Mean | Standard Deviation | minutes | Baseline |
|
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| Primary | 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. | This outcome applies to participants randomized to receive one or more components of the intervention in the Optimization Trial only. Data were not collected for adolescents randomized to the Enhanced Control condition in the Optimization Trial or Hospital Professionals or Adolescent Patients Selected by Hospital Professionals for the Open Trial Period. | Posted | Number | percentage of participants | Baseline |
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| Primary | 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). | This outcome applies to participants randomized to receive one or more components of the intervention in the Optimization Trial only. Data were not collected for adolescents randomized to the Enhanced Control condition in the Optimization Trial or Hospital Professionals or Adolescent Patients Selected by Hospital Professionals for the Open Trial Period. | Posted | Number | percentage of participants | Baseline |
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| Primary | 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. | This outcome applies to Hospital Professionals for the Open Trial Period. Data were not collected for adolescents in the Optimization Trial or Adolescent Patients Selected by Hospital Professionals for the Open Trial Period. | Posted | Number | percentage of participants | Baseline |
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| Primary | 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). | This outcome applies to participants randomized to receive one or more components of the intervention in the Optimization Trial only. Data were not collected for adolescents randomized to the Enhanced Control condition in the Optimization Trial or Hospital Professionals or Adolescent Patients Selected by Hospital Professionals for the Open Trial Period. | Posted | Count of Participants | Participants | Baseline |
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| Primary | 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. | This outcome applies to Hospital Professionals for the Open Trial Period. Data were not collected for adolescents in the Optimization Trial or Adolescent Patients Selected by Hospital Professionals for the Open Trial Period. | Posted | Count of Participants | Participants | Baseline |
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| 0 |
| 6 |
| 3 |
| 6 |
| 1 |
| 6 |
| EG001 | Affect Regulation | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation 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). 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. 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. | 0 | 5 | 1 | 5 | 1 | 5 |
| EG002 | Problem Solving | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving 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). 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. 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. | 0 | 6 | 1 | 6 | 0 | 6 |
| EG003 | Affect Regulation + Problem Solving | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving 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). 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. 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. 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. | 0 | 5 | 1 | 5 | 0 | 5 |
| EG004 | Cognitive Restructuring | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring 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). 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. 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. | 0 | 5 | 1 | 5 | 0 | 5 |
| EG005 | Affect Regulation + Cognitive Restructuring | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring 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). 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. 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. 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. | 0 | 5 | 1 | 5 | 0 | 5 |
| EG006 | Cognitive Restructuring + Problem Solving | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving 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). 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. 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. 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. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG007 | 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 Safety Planning: Prior to discharge and after Virtual Reality (VR) sessions, the participant develops a safety plan for schools. VR Enhanced Affect Regulation: Participants receive an overview of affect regulation in VR and then can 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. VR Enhanced Cognitive Restructuring: Participants receive an overview of cognitive restructuring in VR and then can 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. VR Enhanced Problem Solving: Participants receive an overview of problem solving in VR and then can 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. CBT Worksheets: The researchers will provide instructions for participants to complete a packet of worksheets teaching introduction to CBT, affect regulation, cognitive restructuring, and problem solving. | 0 | 5 | 3 | 5 | 1 | 5 |
| EG008 | Hospital Professionals | Clinicians who delivered the intervention to inform acceptability and feasibility of the intervention within their clinical workflow. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG009 | Adolescent Patients Selected by Hospital Professionals | Adolescent patients receiving the intervention delivered by hospital professional participants | 0 | 5 | 0 | 5 | 0 | 5 |
| Hospitalization for Suicide-Related Risk or Associated Symptoms | Psychiatric disorders | Non-systematic Assessment |
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| Hospitalization for Medical Procedure: GI | Gastrointestinal disorders | Non-systematic Assessment |
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| Hospitalization for Medical Procedure: Skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Parent Distress Related to Adolescent Risk Behaviors | Psychiatric disorders | Non-systematic Assessment | Parent concern related to adolescent psychiatric concerns (i.e., suicide-related risk and running away) |
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| Medical Procedure or Action | Surgical and medical procedures | Non-systematic Assessment | Evaluated for ingesting a coin |
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| Medical Action | Vascular disorders | Non-systematic Assessment | Assessment of syncope symptoms |
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Not provided
Not provided
Not provided
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| Baseline Post-assessments |
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| 2-Week Return to School Follow-Up |
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| 3-Month Return to School Follow-Up |
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| Identified Aspects that Could Be Improved |
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| Preferred Learning in Traditional Ways or Described Learning in Virtual Reality as Difficult |
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| Identified Preference or Benefit to Learning in Virtual Realty (as Opposed to Traditional Ways) |
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