Suicide
Conditions
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.
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.
Interventions
BEHAVIORALSafety 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).
BEHAVIORALVR 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.
BEHAVIORALVR 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.
BEHAVIORALVR 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.
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.
Sponsors
National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients in the Target Population Who Agree to Participate | 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. |
| Proportion of Patients in the Target Population Excluded Due to Motion Sickness Screening | 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. |
| Proportion of Participants Who Complete All Study Procedures | 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. |
| Average Number of Hours to Complete Assessments at Each Time Point | 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. |
| Average Number of Minutes to Complete Each Intervention Session | 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. |
| Percentage of Adolescent Participants in Which Intervention Delivered With Greater Than or Equal to 80% Fidelity | 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. |
| Percentage of Adolescent Participants With Average Acceptability Scores Less Than or Equal to 2 | 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). |
| Percentage of Hospital Professional Participants With Average Acceptability Scores Less Than or Equal to 2 | 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. |
| Adolescents' Perceptions of Acceptability | 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). |
| Hospital Professionals' Perceptions of Acceptability | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| 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. | 5 |
| 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. | 6 |
| 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. | 5 |
| 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. | 5 |
| 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. | 5 |
| 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. | 5 |
| 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. | 5 |
| Hospital Professionals Clinicians who delivered the intervention to inform acceptability and feasibility of the intervention within their clinical workflow. | 7 |
| Adolescent Patients Selected by Hospital Professionals Adolescent patients receiving the intervention delivered by hospital professional participants | 5 |
| Total | 54 |
Baseline characteristics
| Characteristic | Total | Affect Regulation | Problem Solving | Affect Regulation + Problem Solving | Cognitive Restructuring | Affect Regulation + Cognitive Restructuring | Enhanced Control | Cognitive Restructuring + Problem Solving | Affect Regulation + Cognitive Restructuring + Problem Solving | Hospital Professionals | Adolescent Patients Selected by Hospital Professionals |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 47 Participants | 5 Participants | 6 Participants | 5 Participants | 5 Participants | 5 Participants | 6 Participants | 5 Participants | 5 Participants | 0 Participants | 5 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 0 Participants | 3 Participants | 2 Participants | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 5 Participants | 3 Participants | 1 Participants | 4 Participants | 2 Participants | 6 Participants | 4 Participants | 3 Participants | 7 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants | 2 Participants | 4 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 3 Participants | 2 Participants | 1 Participants | 2 Participants | 4 Participants | 2 Participants | 0 Participants | 0 Participants | 6 Participants | 4 Participants |
| Region of Enrollment United States | 54 Participants | 5 Participants | 6 Participants | 5 Participants | 5 Participants | 5 Participants | 6 Participants | 5 Participants | 5 Participants | 7 Participants | 5 Participants |
| Sex/Gender, Customized Female/Boy/Man | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Female/Girl/Woman | 29 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 6 Participants | 3 Participants |
| Sex/Gender, Customized Female/Identifies in Some Other Way | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Female/Transgender | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Sex/Gender, Customized Male/Boy/Man | 18 Participants | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 1 Participants | 0 Participants | 2 Participants |
| Sex/Gender, Customized Unknown | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 | 0 / 6 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 0 | 0 / 5 |
| other Total, other adverse events | 1 / 6 | 1 / 5 | 0 / 6 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 1 / 5 | 0 / 0 | 0 / 5 |
| serious Total, serious adverse events | 3 / 6 | 1 / 5 | 1 / 6 | 1 / 5 | 1 / 5 | 1 / 5 | 0 / 5 | 3 / 5 | 0 / 0 | 0 / 5 |
Outcome results
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).
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Affect Regulation | Adolescents' Perceptions of Acceptability | Identified Preference or Benefit to Learning in Virtual Realty (as Opposed to Traditional Ways) | 0 Participants |
| Affect Regulation | Adolescents' Perceptions of Acceptability | Preferred Learning in Traditional Ways or Described Learning in Virtual Reality as Difficult | 1 Participants |
| Affect Regulation | Adolescents' Perceptions of Acceptability | Endorsed Part or All of the Intervention | 5 Participants |
| Affect Regulation | Adolescents' Perceptions of Acceptability | Identified Aspects that Could Be Improved | 5 Participants |
| Problem Solving | Adolescents' Perceptions of Acceptability | Identified Preference or Benefit to Learning in Virtual Realty (as Opposed to Traditional Ways) | 3 Participants |
| Problem Solving | Adolescents' Perceptions of Acceptability | Endorsed Part or All of the Intervention | 6 Participants |
| Problem Solving | Adolescents' Perceptions of Acceptability | Preferred Learning in Traditional Ways or Described Learning in Virtual Reality as Difficult | 0 Participants |
| Problem Solving | Adolescents' Perceptions of Acceptability | Identified Aspects that Could Be Improved | 6 Participants |
| Affect Regulation + Problem Solving | Adolescents' Perceptions of Acceptability | Endorsed Part or All of the Intervention | 4 Participants |
| Affect Regulation + Problem Solving | Adolescents' Perceptions of Acceptability | Identified Preference or Benefit to Learning in Virtual Realty (as Opposed to Traditional Ways) | 0 Participants |
| Affect Regulation + Problem Solving | Adolescents' Perceptions of Acceptability | Identified Aspects that Could Be Improved | 4 Participants |
| Affect Regulation + Problem Solving | Adolescents' Perceptions of Acceptability | Preferred Learning in Traditional Ways or Described Learning in Virtual Reality as Difficult | 0 Participants |
| Cognitive Restructuring | Adolescents' Perceptions of Acceptability | Identified Preference or Benefit to Learning in Virtual Realty (as Opposed to Traditional Ways) | 1 Participants |
| Cognitive Restructuring | Adolescents' Perceptions of Acceptability | Endorsed Part or All of the Intervention | 5 Participants |
| Cognitive Restructuring | Adolescents' Perceptions of Acceptability | Identified Aspects that Could Be Improved | 5 Participants |
| Cognitive Restructuring | Adolescents' Perceptions of Acceptability | Preferred Learning in Traditional Ways or Described Learning in Virtual Reality as Difficult | 0 Participants |
| Affect Regulation + Cognitive Restructuring | Adolescents' Perceptions of Acceptability | Preferred Learning in Traditional Ways or Described Learning in Virtual Reality as Difficult | 0 Participants |
| Affect Regulation + Cognitive Restructuring | Adolescents' Perceptions of Acceptability | Identified Preference or Benefit to Learning in Virtual Realty (as Opposed to Traditional Ways) | 3 Participants |
| Affect Regulation + Cognitive Restructuring | Adolescents' Perceptions of Acceptability | Identified Aspects that Could Be Improved | 4 Participants |
| Affect Regulation + Cognitive Restructuring | Adolescents' Perceptions of Acceptability | Endorsed Part or All of the Intervention | 4 Participants |
| Cognitive Restructuring + Problem Solving | Adolescents' Perceptions of Acceptability | Endorsed Part or All of the Intervention | 4 Participants |
| Cognitive Restructuring + Problem Solving | Adolescents' Perceptions of Acceptability | Preferred Learning in Traditional Ways or Described Learning in Virtual Reality as Difficult | 0 Participants |
| Cognitive Restructuring + Problem Solving | Adolescents' Perceptions of Acceptability | Identified Preference or Benefit to Learning in Virtual Realty (as Opposed to Traditional Ways) | 1 Participants |
| Cognitive Restructuring + Problem Solving | Adolescents' Perceptions of Acceptability | Identified Aspects that Could Be Improved | 4 Participants |
| Affect Regulation + Cognitive Restructuring + Problem Solving | Adolescents' Perceptions of Acceptability | Identified Aspects that Could Be Improved | 5 Participants |
| Affect Regulation + Cognitive Restructuring + Problem Solving | Adolescents' Perceptions of Acceptability | Preferred Learning in Traditional Ways or Described Learning in Virtual Reality as Difficult | 1 Participants |
| Affect Regulation + Cognitive Restructuring + Problem Solving | Adolescents' Perceptions of Acceptability | Identified Preference or Benefit to Learning in Virtual Realty (as Opposed to Traditional Ways) | 1 Participants |
| Affect Regulation + Cognitive Restructuring + Problem Solving | Adolescents' Perceptions of Acceptability | Endorsed Part or All of the Intervention | 5 Participants |
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.
Time frame: up to 3-months following school re-entry
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Potential Adolescent Participants Who Were Approached | Average Number of Hours to Complete Assessments at Each Time Point | Baseline Pre-assessments | 0.603 hours | Standard Deviation 0.182 |
| All Potential Adolescent Participants Who Were Approached | Average Number of Hours to Complete Assessments at Each Time Point | Baseline Post-assessments | 0.357 hours | Standard Deviation 0.056 |
| All Potential Adolescent Participants Who Were Approached | Average Number of Hours to Complete Assessments at Each Time Point | 3-Month Return to School Follow-Up | .500 hours | — |
| All Potential Adolescent Participants Who Were Approached | Average Number of Hours to Complete Assessments at Each Time Point | 2-Week Return to School Follow-Up | 1.242 hours | Standard Deviation 0.365 |
| Affect Regulation | Average Number of Hours to Complete Assessments at Each Time Point | Baseline Post-assessments | 0.550 hours | Standard Deviation 0.272 |
| Affect Regulation | Average Number of Hours to Complete Assessments at Each Time Point | 2-Week Return to School Follow-Up | 0.621 hours | Standard Deviation 0.138 |
| Affect Regulation | Average Number of Hours to Complete Assessments at Each Time Point | Baseline Pre-assessments | 0.847 hours | Standard Deviation 0.197 |
| Affect Regulation | Average Number of Hours to Complete Assessments at Each Time Point | 3-Month Return to School Follow-Up | .653 hours | Standard Deviation 0.245 |
| Problem Solving | Average Number of Hours to Complete Assessments at Each Time Point | 2-Week Return to School Follow-Up | 1.208 hours | Standard Deviation 0.62 |
| Problem Solving | Average Number of Hours to Complete Assessments at Each Time Point | Baseline Pre-assessments | 0.842 hours | Standard Deviation 0.333 |
| Problem Solving | Average Number of Hours to Complete Assessments at Each Time Point | Baseline Post-assessments | 0.608 hours | Standard Deviation 0.431 |
| Problem Solving | Average Number of Hours to Complete Assessments at Each Time Point | 3-Month Return to School Follow-Up | 1.044 hours | Standard Deviation 0.474 |
| Affect Regulation + Problem Solving | Average Number of Hours to Complete Assessments at Each Time Point | 3-Month Return to School Follow-Up | 0.250 hours | — |
| Affect Regulation + Problem Solving | Average Number of Hours to Complete Assessments at Each Time Point | Baseline Post-assessments | 0.242 hours | Standard Deviation 0.073 |
| Affect Regulation + Problem Solving | Average Number of Hours to Complete Assessments at Each Time Point | Baseline Pre-assessments | 0.762 hours | Standard Deviation 0.219 |
| Affect Regulation + Problem Solving | Average Number of Hours to Complete Assessments at Each Time Point | 2-Week Return to School Follow-Up | 0.761 hours | Standard Deviation 0.281 |
| Cognitive Restructuring | Average Number of Hours to Complete Assessments at Each Time Point | Baseline Pre-assessments | 0.900 hours | Standard Deviation 0.365 |
| Cognitive Restructuring | Average Number of Hours to Complete Assessments at Each Time Point | 3-Month Return to School Follow-Up | 0.592 hours | Standard Deviation 0.295 |
| Cognitive Restructuring | Average Number of Hours to Complete Assessments at Each Time Point | 2-Week Return to School Follow-Up | 0.933 hours | Standard Deviation 0.094 |
| Cognitive Restructuring | Average Number of Hours to Complete Assessments at Each Time Point | Baseline Post-assessments | 0.613 hours | Standard Deviation 0.364 |
| Affect Regulation + Cognitive Restructuring | Average Number of Hours to Complete Assessments at Each Time Point | Baseline Post-assessments | 0.667 hours | Standard Deviation 0.426 |
| Affect Regulation + Cognitive Restructuring | Average Number of Hours to Complete Assessments at Each Time Point | 2-Week Return to School Follow-Up | 1.133 hours | Standard Deviation 0.306 |
| Affect Regulation + Cognitive Restructuring | Average Number of Hours to Complete Assessments at Each Time Point | Baseline Pre-assessments | 0.747 hours | Standard Deviation 0.22 |
| Affect Regulation + Cognitive Restructuring | Average Number of Hours to Complete Assessments at Each Time Point | 3-Month Return to School Follow-Up | 0.958 hours | Standard Deviation 0.295 |
| Cognitive Restructuring + Problem Solving | Average Number of Hours to Complete Assessments at Each Time Point | Baseline Post-assessments | 0.562 hours | Standard Deviation 0.299 |
| Cognitive Restructuring + Problem Solving | Average Number of Hours to Complete Assessments at Each Time Point | Baseline Pre-assessments | 1.079 hours | Standard Deviation 0.414 |
| Cognitive Restructuring + Problem Solving | Average Number of Hours to Complete Assessments at Each Time Point | 3-Month Return to School Follow-Up | 1.017 hours | Standard Deviation 0.731 |
| Cognitive Restructuring + Problem Solving | Average Number of Hours to Complete Assessments at Each Time Point | 2-Week Return to School Follow-Up | 1.342 hours | Standard Deviation 0.884 |
| Affect Regulation + Cognitive Restructuring + Problem Solving | Average Number of Hours to Complete Assessments at Each Time Point | 3-Month Return to School Follow-Up | 0.983 hours | — |
| Affect Regulation + Cognitive Restructuring + Problem Solving | Average Number of Hours to Complete Assessments at Each Time Point | 2-Week Return to School Follow-Up | 0.644 hours | Standard Deviation 0.287 |
| Affect Regulation + Cognitive Restructuring + Problem Solving | Average Number of Hours to Complete Assessments at Each Time Point | Baseline Post-assessments | 0.563 hours | Standard Deviation 0.289 |
| Affect Regulation + Cognitive Restructuring + Problem Solving | Average Number of Hours to Complete Assessments at Each Time Point | Baseline Pre-assessments | 0.780 hours | Standard Deviation 0.177 |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Affect Regulation | Average Number of Minutes to Complete Each Intervention Session | 26.864 minutes | Standard Deviation 12.241 |
| Problem Solving | Average Number of Minutes to Complete Each Intervention Session | 26.333 minutes | Standard Deviation 12.473 |
| Affect Regulation + Problem Solving | Average Number of Minutes to Complete Each Intervention Session | 27.500 minutes | Standard Deviation 12.103 |
| Cognitive Restructuring | Average Number of Minutes to Complete Each Intervention Session | 25.938 minutes | Standard Deviation 13.188 |
| Affect Regulation + Cognitive Restructuring | Average Number of Minutes to Complete Each Intervention Session | 37.083 minutes | Standard Deviation 15.197 |
| Cognitive Restructuring + Problem Solving | Average Number of Minutes to Complete Each Intervention Session | 29.714 minutes | Standard Deviation 16.838 |
| Affect Regulation + Cognitive Restructuring + Problem Solving | Average Number of Minutes to Complete Each Intervention Session | 30.522 minutes | Standard Deviation 14.145 |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hospital Professionals | Hospital Professionals' Perceptions of Acceptability | Endorsed Part or All of the Intervention | 4 Participants |
| Hospital Professionals | Hospital Professionals' Perceptions of Acceptability | Identified Aspects That Could be Improved | 4 Participants |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Affect Regulation | Percentage of Adolescent Participants in Which Intervention Delivered With Greater Than or Equal to 80% Fidelity | 100 percentage of participants |
| Problem Solving | Percentage of Adolescent Participants in Which Intervention Delivered With Greater Than or Equal to 80% Fidelity | 100 percentage of participants |
| Affect Regulation + Problem Solving | Percentage of Adolescent Participants in Which Intervention Delivered With Greater Than or Equal to 80% Fidelity | 100 percentage of participants |
| Cognitive Restructuring | Percentage of Adolescent Participants in Which Intervention Delivered With Greater Than or Equal to 80% Fidelity | 100 percentage of participants |
| Affect Regulation + Cognitive Restructuring | Percentage of Adolescent Participants in Which Intervention Delivered With Greater Than or Equal to 80% Fidelity | 100 percentage of participants |
| Cognitive Restructuring + Problem Solving | Percentage of Adolescent Participants in Which Intervention Delivered With Greater Than or Equal to 80% Fidelity | 100 percentage of participants |
| Affect Regulation + Cognitive Restructuring + Problem Solving | Percentage of Adolescent Participants in Which Intervention Delivered With Greater Than or Equal to 80% Fidelity | 100 percentage of participants |
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).
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Affect Regulation | Percentage of Adolescent Participants With Average Acceptability Scores Less Than or Equal to 2 | 60 percentage of participants |
| Problem Solving | Percentage of Adolescent Participants With Average Acceptability Scores Less Than or Equal to 2 | 60 percentage of participants |
| Affect Regulation + Problem Solving | Percentage of Adolescent Participants With Average Acceptability Scores Less Than or Equal to 2 | 100 percentage of participants |
| Cognitive Restructuring | Percentage of Adolescent Participants With Average Acceptability Scores Less Than or Equal to 2 | 75 percentage of participants |
| Affect Regulation + Cognitive Restructuring | Percentage of Adolescent Participants With Average Acceptability Scores Less Than or Equal to 2 | 50 percentage of participants |
| Cognitive Restructuring + Problem Solving | Percentage of Adolescent Participants With Average Acceptability Scores Less Than or Equal to 2 | 100 percentage of participants |
| Affect Regulation + Cognitive Restructuring + Problem Solving | Percentage of Adolescent Participants With Average Acceptability Scores Less Than or Equal to 2 | 100 percentage of participants |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hospital Professionals | Percentage of Hospital Professional Participants With Average Acceptability Scores Less Than or Equal to 2 | 25 percentage of participants |
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.
Time frame: up to 3-months following school re-entry
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Potential Adolescent Participants Who Were Approached | Proportion of Participants Who Complete All Study Procedures | 0 proportion of participants |
| Affect Regulation | Proportion of Participants Who Complete All Study Procedures | 0.800 proportion of participants |
| Problem Solving | Proportion of Participants Who Complete All Study Procedures | 0.167 proportion of participants |
| Affect Regulation + Problem Solving | Proportion of Participants Who Complete All Study Procedures | 0 proportion of participants |
| Cognitive Restructuring | Proportion of Participants Who Complete All Study Procedures | 0.400 proportion of participants |
| Affect Regulation + Cognitive Restructuring | Proportion of Participants Who Complete All Study Procedures | 0 proportion of participants |
| Cognitive Restructuring + Problem Solving | Proportion of Participants Who Complete All Study Procedures | 0.400 proportion of participants |
| Affect Regulation + Cognitive Restructuring + Problem Solving | Proportion of Participants Who Complete All Study Procedures | 0.200 proportion of 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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Potential Adolescent Participants Who Were Approached | Proportion of Patients in the Target Population Excluded Due to Motion Sickness Screening | 0.021 proportion of participants |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Potential Adolescent Participants Who Were Approached | Proportion of Patients in the Target Population Who Agree to Participate | 0.384 proportion of potential participants |