SuicidePrESRNCT05934396
Practice Experiences for School Reintegration
A study testing Safety Planning, VR Enhanced Affect Regulation and VR Enhanced Cognitive Restructuring in people with Suicide, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This study is developing and refining a novel Virtual Reality (VR) supplement for inpatient treatment: the Practice Experiences for School Reintegration (PrESR) program. The PrESR will provide immersive school experiences for inpatient adolescents (with suicidal-related admissions) to practice skills in real-world… Read more about this study
- Who is it for?
- Ages 13 to 99 years
- Conditions the study is for
- Suicide
- What is being tested?
- Safety Planning, VR Enhanced Affect Regulation and VR Enhanced Cognitive Restructuring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adolescent Participants:
- current hospitalization for suicidal thoughts and behaviors
- ages 13-18
- expected return to school following discharge
- ability to speak, read, and understand English sufficiently to complete study procedures,
- consent of a parent/legal guardian (in English or Spanish; for minor participants)
Show all 13Show fewer
- adolescent assent or consent (in English)
- clinician approval.
- Hospital professionals:
- Works as a clinician at the hospital site who delivers treatment including CBT to hospitalized adolescents,
- Hospital professional consent (in English)
- consent of patient's parent/legal guardian (in English or Spanish; for minor participants)
- adolescent patient assent or consent (in English).
Who cannot join
- Adolescent Participants
- evidence of active psychosis,
- evidence of intellectual disability
- Risk for Cyber-sickness (greater than or equal to 50th percentile as measured on the Motion Sickness Susceptibility Questionnaire)
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Adolescent Psychiatry Inpatient Unit
Chapel Hill, North Carolina, 27599
About this study
Official title: Practice Experiences for School Reintegration: An Immersive Virtual Reality Program to Enhance Skill Development of Hospitalized Adolescents
This study is developing and refining a novel Virtual Reality (VR) supplement for inpatient treatment: the Practice Experiences for School Reintegration (PrESR) program. The PrESR will provide immersive school experiences for inpatient adolescents (with suicidal-related admissions) to practice skills in real-world settings with the guidance of a trained clinician within the confines of a hospital. This pilot study follows a Multiphase Optimization Strategy (MOST) to conduct a pilot optimization trial of the PrESR to inform the feasibility of training clinicians, the ability to recruit adolescent inpatient participants, and management of experimental conditions. This study is not powered to test hypotheses; however, in addition to assessing feasibility and acceptability, this pilot trial will assess candidate intermediary and outcome measures.
Read the detailed description
This study follows a multiphased optimization (MOST) research design; this clinical trial is considered to be a pilot optimization component of the MOST framework. For the present study, a prospective sample of adolescents hospitalized for suicidal thoughts and behaviors will be randomly selected into one of 8 experimental conditions (N=5-6 per group). Although the intervention for the pilot optimization trial will be implemented by a member of research staff, this study will also aim to recruit 2-5 clinicians to deliver the full intervention to a separate sample of adolescent patients to inform acceptability and feasibility of the intervention within their clinical workflow.
- Conditions
- Suicide
- Being tested
- Safety Planning, VR Enhanced Affect Regulation, VR Enhanced Cognitive Restructuring, VR Enhanced Problem Solving, Cognitive Behavioral Therapy (CBT) Worksheets
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety PlanningBehavioural
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 RegulationBehavioural
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 RestructuringBehavioural
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 SolvingBehavioural
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) WorksheetsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Control | Active comparator | Cognitive Behavioral Therapy (CBT) Worksheets Receives: Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets |
| Affect Regulation | Active comparator | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation Receives: Behavioral: Safety Planning; Behavioral: VR Enhanced Affect Regulation; Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets |
| Problem Solving | Active comparator | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving Receives: Behavioral: Safety Planning; Behavioral: VR Enhanced Problem Solving; Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets |
| Affect Regulation + Problem Solving | Active comparator | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving Receives: Behavioral: Safety Planning; Behavioral: VR Enhanced Affect Regulation; Behavioral: VR Enhanced Problem Solving; Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets |
| Cognitive Restructuring | Active comparator | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring Receives: Behavioral: Safety Planning; Behavioral: VR Enhanced Cognitive Restructuring; Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets |
| Affect Regulation + Cognitive Restructuring | Active comparator | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring Receives: Behavioral: Safety Planning; Behavioral: VR Enhanced Affect Regulation; Behavioral: VR Enhanced Cognitive Restructuring; Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets |
| Cognitive Restructuring + Problem Solving | Active comparator | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving Receives: Behavioral: Safety Planning; Behavioral: VR Enhanced Cognitive Restructuring; Behavioral: VR Enhanced Problem Solving; Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets |
| Affect Regulation + Cognitive Restructuring + Problem Solving | Active comparator | Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving Receives: Behavioral: Safety Planning; Behavioral: VR Enhanced Affect Regulation; Behavioral: VR Enhanced Cognitive Restructuring; Behavioral: VR Enhanced Problem Solving; Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients in the Target Population Who Agree to Participate
Recruitment rate was determined based on the proportion of adolescents providing assent and parents or legal guardians providing permission relative to the number of parents or legal guardians approached.
Measured: Baseline
Proportion of Patients in the Target Population Excluded Due to Motion Sickness Screening
Rate of recruitment related to motion sickness was determined based on the proportion of assented adolescents whose scores were >/= than 50th percentile on motion sickness questionnaire relative to the number of assented adolescents.
Measured: Baseline
Proportion of Participants Who Complete All Study Procedures
Proportion of participants who complete all study procedures was determined based on the proportion of adolescents completing study procedures at Baseline, 2-week follow-up, 3-month follow-up, and journals over the two weeks of their return to school relative to the total number of adolescents participating in that condition.
Measured: up to 3-months following school re-entry
Average Number of Hours to Complete Assessments at Each Time Point
Time to complete assessments, assessments are expected to last less than 4 hours. Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition was withdrawn or withdrew.
Measured: up to 3-months following school re-entry
Average Number of Minutes to Complete Each Intervention Session
Time to complete intervention sessions, each session is expected to last less than 60 minutes. Average calculated by summing all sessions in each condition and dividing by total number of sessions. Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition was withdrawn or withdrew.
Measured: Baseline
Percentage of Adolescent Participants in Which Intervention Delivered With Greater Than or Equal to 80% Fidelity
Percentage of participants in which adherence to delivery of key components of intervention (i.e., skill lessons or practice sessions) across sessions in each condition was 80% or greater. Adherence was calculated based on the number of key components completed relative to the total number of key components expected to be completed for each participant. Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition was withdrawn or withdrew.
Measured: Baseline
Percentage of Adolescent Participants With Average Acceptability Scores Less Than or Equal to 2
Percent of adolescents with average acceptability score less than or equal to 2 (or "agree") on a five-point scale from 1 (strongly agree) to 5 (strongly disagree). Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition was withdrawn or withdrew, and due to missing post-baseline data for "Problem Solving" (1 participant), "Cognitive Restructuring" (1 participant), "Affect Regulation + Cognitive Restructuring" (1 participant), "Cognitive Restructuring + Problem Solving" (1 participant), and "Affect Regulation + Cognitive Restructuring + Problem Solving" (1 participant).
Measured: Baseline
Percentage of Hospital Professional Participants With Average Acceptability Scores Less Than or Equal to 2
Percent of hospital professionals with average acceptability score less than or equal to 2 (or "agree") on a five-point scale from 1 (strongly agree) to 5 (strongly disagree). Note that the number of participants to start a Period is not equal to the number who completed previous Period for Hospital Professionals because 7 professionals consented into the study, but only 4 delivered the intervention to a patient following consent.
Measured: Baseline
Adolescents' Perceptions of Acceptability
Qualitative feedback provided by adolescents receiving the intervention in the Optimization Trial about acceptability of the intervention. Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition was withdrawn or withdrew, and due to missing post-baseline data for "Cognitive Restructuring + Problem Solving" (1 participant).
Measured: Baseline
Hospital Professionals' Perceptions of Acceptability
Qualitative feedback provided by Hospital Professionals delivering the intervention to one or more hospitalized adolescents about acceptability of the intervention. Note that the number of participants to start a Period is not equal to the number who completed previous Period for Hospital Professionals because 7 professionals consented into the study, but only 4 delivered the intervention to a patient following consent.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Aug 2023
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Marisa Marraccini, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934396
- Sponsor's protocol ID
- 20-3464
- Other IDs
- 5K23MH122775
- Acronym
- PrESR
- Status last verified
- Jan 2025
- First submitted
- 28 Jun 2023
- Last updated
- 25 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice Experiences for School Reintegration: An Immersive Virtual Reality Program to Enhance Skill Development of Hospitalized Adolescents
- ClinicalTrials.gov ID
- NCT05934396
- Acronym / sponsor ID
- PrESR / 20-3464
- Conditions
- Suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Posted 25 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is developing and refining a novel Virtual Reality (VR) supplement for inpatient treatment: the Practice Experiences for School Reintegration (PrESR) program. The PrESR will provide immersive school experiences for inpatient adolescents (with suicidal-related admissions) to practice skills in real-world settings with the guidance of a trained clinician within the confines of a hospital. This pilot study follows a Multiphase Optimization Strategy (MOST) to conduct a pilot optimization trial of the PrESR to inform the feasibility of training clinicians, the ability to recruit adolescent inpatient participants, and management of experimental conditions. This study is not powered to test hypotheses; however, in addition to assessing feasibility and acceptability, this pilot trial will assess candidate intermediary and outcome measures.
Detailed description
This study follows a multiphased optimization (MOST) research design; this clinical trial is considered to be a pilot optimization component of the MOST framework. For the present study, a prospective sample of adolescents hospitalized for suicidal thoughts and behaviors will be randomly selected into one of 8 experimental conditions (N=5-6 per group). Although the intervention for the pilot optimization trial will be implemented by a member of research staff, this study will also aim to recruit 2-5 clinicians to deliver the full intervention to a separate sample of adolescent patients to inform acceptability and feasibility of the intervention within their clinical workflow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Enhanced Control | Active comparator | Behavioral: Cognitive Behavioral Therapy (CBT) WorksheetsCognitive Behavioral Therapy (CBT) Worksheets |
| Affect Regulation | Active comparator | Behavioral: Safety Planning, Behavioral: VR Enhanced Affect Regulation, Behavioral: Cognitive Behavioral Therapy (CBT) WorksheetsCognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation |
| Problem Solving | Active comparator | Behavioral: Safety Planning, Behavioral: VR Enhanced Problem Solving, Behavioral: Cognitive Behavioral Therapy (CBT) WorksheetsCognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving |
| Affect Regulation + Problem Solving | Active comparator | Behavioral: Safety Planning, Behavioral: VR Enhanced Affect Regulation, Behavioral: VR Enhanced Problem Solving, Behavioral: Cognitive Behavioral Therapy (CBT) WorksheetsCognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving |
| Cognitive Restructuring | Active comparator | Behavioral: Safety Planning, Behavioral: VR Enhanced Cognitive Restructuring, Behavioral: Cognitive Behavioral Therapy (CBT) WorksheetsCognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring |
| Affect Regulation + Cognitive Restructuring | Active comparator | Behavioral: Safety Planning, Behavioral: VR Enhanced Affect Regulation, Behavioral: VR Enhanced Cognitive Restructuring, Behavioral: Cognitive Behavioral Therapy (CBT) WorksheetsCognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring |
| Cognitive Restructuring + Problem Solving | Active comparator | Behavioral: Safety Planning, Behavioral: VR Enhanced Cognitive Restructuring, Behavioral: VR Enhanced Problem Solving, Behavioral: Cognitive Behavioral Therapy (CBT) WorksheetsCognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving |
| Affect Regulation + Cognitive Restructuring + Problem Solving | Active comparator | Behavioral: Safety Planning, Behavioral: VR Enhanced Affect Regulation, Behavioral: VR Enhanced Cognitive Restructuring, Behavioral: VR Enhanced Problem Solving, Behavioral: Cognitive Behavioral Therapy (CBT) WorksheetsCognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving |
Who may qualify
- Ages
- 13 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- current hospitalization for suicidal thoughts and behaviors
- ages 13-18
- expected return to school following discharge
- ability to speak, read, and understand English sufficiently to complete study procedures,
- consent of a parent/legal guardian (in English or Spanish; for minor participants)
Key exclusion criteria (4 listed)
- Adolescent Participants
- evidence of active psychosis,
- evidence of intellectual disability
- Risk for Cyber-sickness (greater than or equal to 50th percentile as measured on the Motion Sickness Susceptibility Questionnaire)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safety PlanningPrior 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). | Behavioural | Affect Regulation, Affect Regulation + Cognitive Restructuring, Affect Regulation + Cognitive Restructuring + Problem Solving, Affect Regulation + Problem Solving, Cognitive Restructuring, Cognitive Restructuring + Problem Solving, Problem Solving |
| VR Enhanced Affect RegulationParticipants 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. | Behavioural | Affect Regulation, Affect Regulation + Cognitive Restructuring, Affect Regulation + Cognitive Restructuring + Problem Solving, Affect Regulation + Problem Solving |
| VR Enhanced Cognitive RestructuringParticipants 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. | Behavioural | Affect Regulation + Cognitive Restructuring, Affect Regulation + Cognitive Restructuring + Problem Solving, Cognitive Restructuring, Cognitive Restructuring + Problem Solving |
| VR Enhanced Problem SolvingParticipants 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. | Behavioural | Affect Regulation + Cognitive Restructuring + Problem Solving, Affect Regulation + Problem Solving, Cognitive Restructuring + Problem Solving, Problem Solving |
| Cognitive Behavioral Therapy (CBT) WorksheetsThe 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. | Behavioural | Affect Regulation, Affect Regulation + Cognitive Restructuring, Affect Regulation + Cognitive Restructuring + Problem Solving, Affect Regulation + Problem Solving, Cognitive Restructuring, Cognitive Restructuring + Problem Solving, Enhanced Control, Problem Solving |
Primary outcome
Proportion of Patients in the Target Population Who Agree to Participate
Time frame: Baseline
Recruitment rate was determined based on the proportion of adolescents providing assent and parents or legal guardians providing permission relative to the number of parents or legal guardians approached.
Proportion of Patients in the Target Population Excluded Due to Motion Sickness Screening
Time frame: Baseline
Rate of recruitment related to motion sickness was determined based on the proportion of assented adolescents whose scores were >/= than 50th percentile on motion sickness questionnaire relative to the number of assented adolescents.
Proportion of Participants Who Complete All Study Procedures
Time frame: up to 3-months following school re-entry
Proportion of participants who complete all study procedures was determined based on the proportion of adolescents completing study procedures at Baseline, 2-week follow-up, 3-month follow-up, and journals over the two weeks of their return to school relative to the total number of adolescents participating in that condition.
Average Number of Hours to Complete Assessments at Each Time Point
Time frame: up to 3-months following school re-entry
Time to complete assessments, assessments are expected to last less than 4 hours. Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition was withdrawn or withdrew.
Average Number of Minutes to Complete Each Intervention Session
Time frame: Baseline
Time to complete intervention sessions, each session is expected to last less than 60 minutes. Average calculated by summing all sessions in each condition and dividing by total number of sessions. Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition was withdrawn or withdrew.
Percentage of Adolescent Participants in Which Intervention Delivered With Greater Than or Equal to 80% Fidelity
Time frame: Baseline
Percentage of participants in which adherence to delivery of key components of intervention (i.e., skill lessons or practice sessions) across sessions in each condition was 80% or greater. Adherence was calculated based on the number of key components completed relative to the total number of key components expected to be completed for each participant. Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition was withdrawn or withdrew.
Percentage of Adolescent Participants With Average Acceptability Scores Less Than or Equal to 2
Time frame: Baseline
Percent of adolescents with average acceptability score less than or equal to 2 (or "agree") on a five-point scale from 1 (strongly agree) to 5 (strongly disagree). Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition was withdrawn or withdrew, and due to missing post-baseline data for "Problem Solving" (1 participant), "Cognitive Restructuring" (1 participant), "Affect Regulation + Cognitive Restructuring" (1 participant), "Cognitive Restructuring + Problem Solving" (1 participant), and "Affect Regulation + Cognitive Restructuring + Problem Solving" (1 participant).
Percentage of Hospital Professional Participants With Average Acceptability Scores Less Than or Equal to 2
Time frame: Baseline
Percent of hospital professionals with average acceptability score less than or equal to 2 (or "agree") on a five-point scale from 1 (strongly agree) to 5 (strongly disagree). Note that the number of participants to start a Period is not equal to the number who completed previous Period for Hospital Professionals because 7 professionals consented into the study, but only 4 delivered the intervention to a patient following consent.
Adolescents' Perceptions of Acceptability
Time frame: Baseline
Qualitative feedback provided by adolescents receiving the intervention in the Optimization Trial about acceptability of the intervention. Note that the number of participants to start a Period is not equal to the number who completed previous Period for "Affect Regulation + Problem Solving" and "Cognitive Restructuring + Problem Solving" because 1 participant in each condition was withdrawn or withdrew, and due to missing post-baseline data for "Cognitive Restructuring + Problem Solving" (1 participant).
Hospital Professionals' Perceptions of Acceptability
Time frame: Baseline
Qualitative feedback provided by Hospital Professionals delivering the intervention to one or more hospitalized adolescents about acceptability of the intervention. Note that the number of participants to start a Period is not equal to the number who completed previous Period for Hospital Professionals because 7 professionals consented into the study, but only 4 delivered the intervention to a patient following consent.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marisa Marraccini, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Planning, VR Enhanced Affect Regulation and VR Enhanced Cognitive Restructuring in people with Suicide, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients in the Target Population Who Agree to Participate (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.