Trial Outcomes & Findings for Practice Experiences for School Reintegration (NCT NCT05934396)
NCT ID: NCT05934396
Last Updated: 2025-09-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
Baseline
Results posted on
2025-09-25
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
Hospital Professionals
Clinicians who delivered the intervention to inform acceptability and feasibility of the intervention within their clinical workflow.
|
Adolescent Patients Selected by Hospital Professionals
Adolescent patients receiving the intervention delivered by hospital professional participants
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Optimization Trial
STARTED
|
6
|
5
|
6
|
5
|
5
|
5
|
5
|
5
|
0
|
0
|
|
Optimization Trial
Completed Baseline
|
6
|
5
|
6
|
4
|
5
|
5
|
4
|
5
|
0
|
0
|
|
Optimization Trial
Completed 2-Week Journal
|
0
|
4
|
1
|
1
|
3
|
0
|
2
|
2
|
0
|
0
|
|
Optimization Trial
Completed 2-Week Return to School Follow-Up
|
2
|
5
|
4
|
3
|
2
|
2
|
2
|
3
|
0
|
0
|
|
Optimization Trial
Completed 3-Month Return to School Follow-Up
|
1
|
5
|
3
|
1
|
3
|
2
|
2
|
1
|
0
|
0
|
|
Optimization Trial
COMPLETED
|
0
|
4
|
1
|
0
|
2
|
0
|
2
|
1
|
0
|
0
|
|
Optimization Trial
NOT COMPLETED
|
6
|
1
|
5
|
5
|
3
|
5
|
3
|
4
|
0
|
0
|
|
Open Trial Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
5
|
|
Open Trial Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
5
|
|
Open Trial Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Practice Experiences for School Reintegration
Baseline characteristics by cohort
| Measure |
Enhanced Control
n=6 Participants
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.
|
Affect Regulation
n=5 Participants
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.
|
Problem Solving
n=6 Participants
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.
|
Affect Regulation + Problem Solving
n=5 Participants
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.
|
Cognitive Restructuring
n=5 Participants
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.
|
Affect Regulation + Cognitive Restructuring
n=5 Participants
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.
|
Cognitive Restructuring + Problem Solving
n=5 Participants
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.
|
Affect Regulation + Cognitive Restructuring + Problem Solving
n=5 Participants
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.
|
Hospital Professionals
n=7 Participants
Clinicians who delivered the intervention to inform acceptability and feasibility of the intervention within their clinical workflow.
|
Adolescent Patients Selected by Hospital Professionals
n=5 Participants
Adolescent patients receiving the intervention delivered by hospital professional participants
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
5 Participants
|
47 Participants
n=19 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
7 Participants
n=114 Participants
|
0 Participants
|
7 Participants
n=19 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Sex/Gender, Customized
Female/Girl/Woman
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
3 Participants
|
29 Participants
n=19 Participants
|
|
Sex/Gender, Customized
Male/Boy/Man
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
2 Participants
|
18 Participants
n=19 Participants
|
|
Sex/Gender, Customized
Female/Identifies in Some Other Way
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
3 Participants
n=19 Participants
|
|
Sex/Gender, Customized
Female/Boy/Man
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
2 Participants
n=19 Participants
|
|
Sex/Gender, Customized
Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
|
Sex/Gender, Customized
Female/Transgender
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
2 Participants
|
14 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
7 Participants
n=114 Participants
|
3 Participants
|
38 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
2 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
1 Participants
|
15 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
4 Participants
|
24 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
8 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
6 Participants
n=19 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
7 Participants
n=114 Participants
|
5 Participants
|
54 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
All Potential Adolescent Participants Who Were Approached
n=125 Participants
Adolescents hospitalized for suicide-related crises, identified through electronic health records and deemed appropriate for the intervention by clinicians.
|
Affect Regulation
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation
|
Problem Solving
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving
|
Affect Regulation + Problem Solving
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving
|
Cognitive Restructuring
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring
|
Affect Regulation + Cognitive Restructuring
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring
|
Cognitive Restructuring + Problem Solving
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
|
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
|
Hospital Professionals
Clinicians who delivered the intervention to inform acceptability and feasibility of the intervention within their clinical workflow.
|
Adolescent Patients Selected by Hospital Professionals
Adolescent patients receiving the intervention delivered by hospital professional participants
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Patients in the Target Population Who Agree to Participate
|
0.384 proportion of potential participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
All Potential Adolescent Participants Who Were Approached
n=48 Participants
Adolescents hospitalized for suicide-related crises, identified through electronic health records and deemed appropriate for the intervention by clinicians.
|
Affect Regulation
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation
|
Problem Solving
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving
|
Affect Regulation + Problem Solving
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving
|
Cognitive Restructuring
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring
|
Affect Regulation + Cognitive Restructuring
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring
|
Cognitive Restructuring + Problem Solving
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
|
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
|
Hospital Professionals
Clinicians who delivered the intervention to inform acceptability and feasibility of the intervention within their clinical workflow.
|
Adolescent Patients Selected by Hospital Professionals
Adolescent patients receiving the intervention delivered by hospital professional participants
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Patients in the Target Population Excluded Due to Motion Sickness Screening
|
0.021 proportion of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: up to 3-months following school re-entryPopulation: 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.
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.
Outcome measures
| Measure |
All Potential Adolescent Participants Who Were Approached
n=6 Participants
Adolescents hospitalized for suicide-related crises, identified through electronic health records and deemed appropriate for the intervention by clinicians.
|
Affect Regulation
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation
|
Problem Solving
n=6 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving
|
Affect Regulation + Problem Solving
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving
|
Cognitive Restructuring
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring
|
Affect Regulation + Cognitive Restructuring
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring
|
Cognitive Restructuring + Problem Solving
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
|
Affect Regulation + Cognitive Restructuring + Problem Solving
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
|
Hospital Professionals
Clinicians who delivered the intervention to inform acceptability and feasibility of the intervention within their clinical workflow.
|
Adolescent Patients Selected by Hospital Professionals
Adolescent patients receiving the intervention delivered by hospital professional participants
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants Who Complete All Study Procedures
|
0 proportion of participants
|
0.800 proportion of participants
|
0.167 proportion of participants
|
0 proportion of participants
|
0.400 proportion of participants
|
0 proportion of participants
|
0.400 proportion of participants
|
0.200 proportion of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: up to 3-months following school re-entryPopulation: 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).
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.
Outcome measures
| Measure |
All Potential Adolescent Participants Who Were Approached
n=5 Participants
Adolescents hospitalized for suicide-related crises, identified through electronic health records and deemed appropriate for the intervention by clinicians.
|
Affect Regulation
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation
|
Problem Solving
n=6 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving
|
Affect Regulation + Problem Solving
n=4 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving
|
Cognitive Restructuring
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring
|
Affect Regulation + Cognitive Restructuring
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring
|
Cognitive Restructuring + Problem Solving
n=4 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
|
Affect Regulation + Cognitive Restructuring + Problem Solving
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
|
Hospital Professionals
Clinicians who delivered the intervention to inform acceptability and feasibility of the intervention within their clinical workflow.
|
Adolescent Patients Selected by Hospital Professionals
Adolescent patients receiving the intervention delivered by hospital professional participants
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Average Number of Hours to Complete Assessments at Each Time Point
Baseline Pre-assessments
|
0.603 hours
Standard Deviation 0.182
|
0.847 hours
Standard Deviation 0.197
|
0.842 hours
Standard Deviation 0.333
|
0.762 hours
Standard Deviation 0.219
|
0.900 hours
Standard Deviation 0.365
|
0.747 hours
Standard Deviation 0.220
|
1.079 hours
Standard Deviation 0.414
|
0.780 hours
Standard Deviation 0.177
|
—
|
—
|
|
Average Number of Hours to Complete Assessments at Each Time Point
Baseline Post-assessments
|
0.357 hours
Standard Deviation 0.056
|
0.550 hours
Standard Deviation 0.272
|
0.608 hours
Standard Deviation 0.431
|
0.242 hours
Standard Deviation 0.073
|
0.613 hours
Standard Deviation 0.364
|
0.667 hours
Standard Deviation 0.426
|
0.562 hours
Standard Deviation 0.299
|
0.563 hours
Standard Deviation 0.289
|
—
|
—
|
|
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
|
0.621 hours
Standard Deviation 0.138
|
1.208 hours
Standard Deviation 0.620
|
0.761 hours
Standard Deviation 0.281
|
0.933 hours
Standard Deviation 0.094
|
1.133 hours
Standard Deviation 0.306
|
1.342 hours
Standard Deviation 0.884
|
0.644 hours
Standard Deviation 0.287
|
—
|
—
|
|
Average Number of Hours to Complete Assessments at Each Time Point
3-Month Return to School Follow-Up
|
.500 hours
Standard Deviation NA
n=1 so standard deviation is not relevant
|
.653 hours
Standard Deviation 0.245
|
1.044 hours
Standard Deviation 0.474
|
0.250 hours
Standard Deviation NA
n=1 so standard deviation is not relevant
|
0.592 hours
Standard Deviation 0.295
|
0.958 hours
Standard Deviation 0.295
|
1.017 hours
Standard Deviation 0.731
|
0.983 hours
Standard Deviation NA
n=1 so standard deviation is not relevant
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
All Potential Adolescent Participants Who Were Approached
Adolescents hospitalized for suicide-related crises, identified through electronic health records and deemed appropriate for the intervention by clinicians.
|
Affect Regulation
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation
|
Problem Solving
n=6 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving
|
Affect Regulation + Problem Solving
n=4 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving
|
Cognitive Restructuring
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring
|
Affect Regulation + Cognitive Restructuring
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring
|
Cognitive Restructuring + Problem Solving
n=4 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
|
Affect Regulation + Cognitive Restructuring + Problem Solving
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
|
Hospital Professionals
Clinicians who delivered the intervention to inform acceptability and feasibility of the intervention within their clinical workflow.
|
Adolescent Patients Selected by Hospital Professionals
Adolescent patients receiving the intervention delivered by hospital professional participants
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Average Number of Minutes to Complete Each Intervention Session
|
—
|
26.864 minutes
Standard Deviation 12.241
|
26.333 minutes
Standard Deviation 12.473
|
27.500 minutes
Standard Deviation 12.103
|
25.938 minutes
Standard Deviation 13.188
|
37.083 minutes
Standard Deviation 15.197
|
29.714 minutes
Standard Deviation 16.838
|
30.522 minutes
Standard Deviation 14.145
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
All Potential Adolescent Participants Who Were Approached
Adolescents hospitalized for suicide-related crises, identified through electronic health records and deemed appropriate for the intervention by clinicians.
|
Affect Regulation
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation
|
Problem Solving
n=6 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving
|
Affect Regulation + Problem Solving
n=4 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving
|
Cognitive Restructuring
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring
|
Affect Regulation + Cognitive Restructuring
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring
|
Cognitive Restructuring + Problem Solving
n=4 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
|
Affect Regulation + Cognitive Restructuring + Problem Solving
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
|
Hospital Professionals
Clinicians who delivered the intervention to inform acceptability and feasibility of the intervention within their clinical workflow.
|
Adolescent Patients Selected by Hospital Professionals
Adolescent patients receiving the intervention delivered by hospital professional participants
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Adolescent Participants in Which Intervention Delivered With Greater Than or Equal to 80% Fidelity
|
—
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
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).
Outcome measures
| Measure |
All Potential Adolescent Participants Who Were Approached
Adolescents hospitalized for suicide-related crises, identified through electronic health records and deemed appropriate for the intervention by clinicians.
|
Affect Regulation
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation
|
Problem Solving
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving
|
Affect Regulation + Problem Solving
n=4 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving
|
Cognitive Restructuring
n=4 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring
|
Affect Regulation + Cognitive Restructuring
n=4 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring
|
Cognitive Restructuring + Problem Solving
n=3 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
|
Affect Regulation + Cognitive Restructuring + Problem Solving
n=4 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
|
Hospital Professionals
Clinicians who delivered the intervention to inform acceptability and feasibility of the intervention within their clinical workflow.
|
Adolescent Patients Selected by Hospital Professionals
Adolescent patients receiving the intervention delivered by hospital professional participants
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Adolescent Participants With Average Acceptability Scores Less Than or Equal to 2
|
—
|
60 percentage of participants
|
60 percentage of participants
|
100 percentage of participants
|
75 percentage of participants
|
50 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
All Potential Adolescent Participants Who Were Approached
Adolescents hospitalized for suicide-related crises, identified through electronic health records and deemed appropriate for the intervention by clinicians.
|
Affect Regulation
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation
|
Problem Solving
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving
|
Affect Regulation + Problem Solving
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving
|
Cognitive Restructuring
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring
|
Affect Regulation + Cognitive Restructuring
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring
|
Cognitive Restructuring + Problem Solving
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
|
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
|
Hospital Professionals
n=4 Participants
Clinicians who delivered the intervention to inform acceptability and feasibility of the intervention within their clinical workflow.
|
Adolescent Patients Selected by Hospital Professionals
Adolescent patients receiving the intervention delivered by hospital professional participants
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Hospital Professional Participants With Average Acceptability Scores Less Than or Equal to 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
25 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
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).
Outcome measures
| Measure |
All Potential Adolescent Participants Who Were Approached
Adolescents hospitalized for suicide-related crises, identified through electronic health records and deemed appropriate for the intervention by clinicians.
|
Affect Regulation
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation
|
Problem Solving
n=6 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving
|
Affect Regulation + Problem Solving
n=4 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving
|
Cognitive Restructuring
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring
|
Affect Regulation + Cognitive Restructuring
n=4 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring
|
Cognitive Restructuring + Problem Solving
n=4 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
|
Affect Regulation + Cognitive Restructuring + Problem Solving
n=5 Participants
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
|
Hospital Professionals
Clinicians who delivered the intervention to inform acceptability and feasibility of the intervention within their clinical workflow.
|
Adolescent Patients Selected by Hospital Professionals
Adolescent patients receiving the intervention delivered by hospital professional participants
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Adolescents' Perceptions of Acceptability
Endorsed Part or All of the Intervention
|
—
|
5 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
|
Adolescents' Perceptions of Acceptability
Identified Aspects that Could Be Improved
|
—
|
5 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
|
Adolescents' Perceptions of Acceptability
Preferred Learning in Traditional Ways or Described Learning in Virtual Reality as Difficult
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Adolescents' Perceptions of Acceptability
Identified Preference or Benefit to Learning in Virtual Realty (as Opposed to Traditional Ways)
|
—
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
All Potential Adolescent Participants Who Were Approached
Adolescents hospitalized for suicide-related crises, identified through electronic health records and deemed appropriate for the intervention by clinicians.
|
Affect Regulation
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation
|
Problem Solving
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving
|
Affect Regulation + Problem Solving
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving
|
Cognitive Restructuring
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring
|
Affect Regulation + Cognitive Restructuring
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring
|
Cognitive Restructuring + Problem Solving
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
|
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
|
Hospital Professionals
n=4 Participants
Clinicians who delivered the intervention to inform acceptability and feasibility of the intervention within their clinical workflow.
|
Adolescent Patients Selected by Hospital Professionals
Adolescent patients receiving the intervention delivered by hospital professional participants
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Hospital Professionals' Perceptions of Acceptability
Endorsed Part or All of the Intervention
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
—
|
|
Hospital Professionals' Perceptions of Acceptability
Identified Aspects That Could be Improved
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
—
|
Adverse Events
Enhanced Control
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Affect Regulation
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Problem Solving
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Affect Regulation + Problem Solving
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Restructuring
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Affect Regulation + Cognitive Restructuring
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Restructuring + Problem Solving
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Affect Regulation + Cognitive Restructuring + Problem Solving
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Hospital Professionals
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adolescent Patients Selected by Hospital Professionals
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enhanced Control
n=6 participants at risk
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.
|
Affect Regulation
n=5 participants at risk
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.
|
Problem Solving
n=6 participants at risk
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.
|
Affect Regulation + Problem Solving
n=5 participants at risk
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.
|
Cognitive Restructuring
n=5 participants at risk
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.
|
Affect Regulation + Cognitive Restructuring
n=5 participants at risk
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.
|
Cognitive Restructuring + Problem Solving
n=5 participants at risk
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.
|
Affect Regulation + Cognitive Restructuring + Problem Solving
n=5 participants at risk
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.
|
Hospital Professionals
Clinicians who delivered the intervention to inform acceptability and feasibility of the intervention within their clinical workflow.
|
Adolescent Patients Selected by Hospital Professionals
n=5 participants at risk
Adolescent patients receiving the intervention delivered by hospital professional participants
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Emergency Department Visit for Suicide-Related Risk or Associated Symptoms
|
33.3%
2/6 • Number of events 2 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
20.0%
1/5 • Number of events 1 • 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.
|
0.00%
0/5 • 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.
|
20.0%
1/5 • Number of events 5 • 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.
|
—
0/0 • 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.
|
0.00%
0/5 • 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.
|
|
Psychiatric disorders
Hospitalization for Suicide-Related Risk or Associated Symptoms
|
16.7%
1/6 • Number of events 1 • 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.
|
20.0%
1/5 • Number of events 1 • 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.
|
0.00%
0/6 • 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.
|
20.0%
1/5 • Number of events 1 • 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.
|
20.0%
1/5 • Number of events 1 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
40.0%
2/5 • Number of events 2 • 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.
|
—
0/0 • 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.
|
0.00%
0/5 • 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.
|
|
Gastrointestinal disorders
Hospitalization for Medical Procedure: GI
|
16.7%
1/6 • Number of events 1 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
—
0/0 • 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.
|
0.00%
0/5 • 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.
|
|
Skin and subcutaneous tissue disorders
Hospitalization for Medical Procedure: Skin
|
16.7%
1/6 • Number of events 1 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
—
0/0 • 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.
|
0.00%
0/5 • 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.
|
|
Psychiatric disorders
Parent Distress Related to Adolescent Risk Behaviors
|
0.00%
0/6 • 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.
|
0.00%
0/5 • 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.
|
16.7%
1/6 • Number of events 2 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
—
0/0 • 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.
|
0.00%
0/5 • 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.
|
Other adverse events
| Measure |
Enhanced Control
n=6 participants at risk
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.
|
Affect Regulation
n=5 participants at risk
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.
|
Problem Solving
n=6 participants at risk
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.
|
Affect Regulation + Problem Solving
n=5 participants at risk
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.
|
Cognitive Restructuring
n=5 participants at risk
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.
|
Affect Regulation + Cognitive Restructuring
n=5 participants at risk
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.
|
Cognitive Restructuring + Problem Solving
n=5 participants at risk
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.
|
Affect Regulation + Cognitive Restructuring + Problem Solving
n=5 participants at risk
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.
|
Hospital Professionals
Clinicians who delivered the intervention to inform acceptability and feasibility of the intervention within their clinical workflow.
|
Adolescent Patients Selected by Hospital Professionals
n=5 participants at risk
Adolescent patients receiving the intervention delivered by hospital professional participants
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Social circumstances
Distress
|
0.00%
0/6 • 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.
|
20.0%
1/5 • Number of events 1 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
—
0/0 • 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.
|
0.00%
0/5 • 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.
|
|
Surgical and medical procedures
Medical Procedure or Action
|
16.7%
1/6 • Number of events 1 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
—
0/0 • 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.
|
0.00%
0/5 • 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.
|
|
Vascular disorders
Medical Action
|
0.00%
0/6 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
0.00%
0/5 • 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.
|
20.0%
1/5 • Number of events 1 • 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.
|
—
0/0 • 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.
|
0.00%
0/5 • 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.
|
Additional Information
Marisa Marraccini, PhD
University of North Carolina at Chapel Hill
Phone: 919-843-5099
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place