SuicideNCT07186543
Co-Designing a Virtual Reality Intervention to Enhance Skill Development
A study testing Cognitive Behavioral Therapy (CBT) Worksheets and Practice Experiences for School Reintegration (PrESR) in people with Suicide, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This study is refining and pilot testing a novel Virtual Reality (VR) supplement for inpatient treatment: the Practice Experiences for School Reintegration (PrESR) program. The PrESR provides immersive school and social experiences for inpatient adolescents (with suicidal-related admissions) to practice skills in… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Suicide
- What is being tested?
- Cognitive Behavioral Therapy (CBT) Worksheets and Practice Experiences for School Reintegration (PrESR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2025to 10 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Current hospitalization for suicidal thoughts and behaviors
- Ages 13-18
- Clinician approval
- Ability to speak, read, and understand English sufficiently to complete study procedures
- Consent of a parent/legal guardian (in English or Spanish; for minor participants)
- Adolescent assent or consent (in English)
Who cannot join
- Evidence of active psychosis
- Evidence of intellectual disability
- Risk for cybersickness (greater 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: Co-Designing a Virtual Reality Intervention to Enhance Skill Development With Adolescents Hospitalized for Suicide-Related Crises
This study is refining and pilot testing a novel Virtual Reality (VR) supplement for inpatient treatment: the Practice Experiences for School Reintegration (PrESR) program. The PrESR provides immersive school and social 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. The initial intervention was based on feedback from adolescent hospitalized for suicide-related crises, and school and hospital professionals, but did not provide tailored experiences to address the individual needs of ethnic-racial, gender, and sexual minoritized adolescents. Therefore, the VR environment of PrESR was adapted based on input from adolescents with previous suicide-related crises identifying as ethnic, racial, sex, or gender minoritized. This pilot randomized controlled trial (RCT) aims to explore the feasibility, acceptability, and facilitators/barriers to implementation of the adapted version of PrESR for improving outcomes in hospitalized adolescents. This study is not powered to test hypotheses; however, in addition to assessing feasibility, acceptability, and barriers/facilitators, this pilot trial will assess candidate intermediary and outcome measures.
Read the detailed description
This study recruits a prospective sample of youth hospitalized for suicide-related crises. Target sample size is approximately N = 26 enrolled adolescents, with the intention of recruiting at least 16 participants who identify as ethnic, racial, sex, or gender minoritized. The pilot RCT includes two conditions: an enhanced treatment as usual condition and an experimental condition. All participants will receive standard treatment, as well as researcher provided worksheets addressing introduction to cognitive behavioral therapy, cognitive restructuring, problem-solving, and affect regulation. Participants randomized to the experimental condition will also receive one or more sessions with PrESR. Outcomes will be assessed during hospitalization and again 3-weeks following hospital discharge.
- Conditions
- Suicide
- Being tested
- Cognitive Behavioral Therapy (CBT) Worksheets, Practice Experiences for School Reintegration (PrESR)
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Practice Experiences for School Reintegration (PrESR)Behavioural
Participants will receive an overview of cognitive behavioral therapy skills in virtual reality (VR) and then have the opportunity to practice using skills in a brief immersive experience designed to mimic difficult school and social experiences. Session begin with goal setting and conclude with a debrief summary following the VR experience. Prior to discharge and following the conclusion of the VR sessions, participants will be invited to collaborate on a safety planning intervention informed by their experiences in VR that addresses school and social experiences.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Control | Active comparator | Cognitive Behavioral Therapy (CBT) Worksheets Receives: Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets |
| PrESR Intervention | Experimental | Cognitive Behavioral Therapy (CBT) Worksheets; Virtual Reality (VR) Enhanced CBT Skill/Practice; Safety Planning Receives: Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets; Behavioral: Practice Experiences for School Reintegration (PrESR) |
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 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 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 determined based on the proportion of adolescents completing study procedures at Baseline and 3-week follow-up relative to the total number of adolescents participating in that condition.
Measured: up to 3-weeks following hospital discharge
Average Number of Hours to Complete Assessments at Each Time Point
Time to complete assessments, assessments are expected to last less than 4 hours.
Measured: up to 3-weeks following hospital discharge
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.
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 calculated based on the number of key components completed relative to the total number of key components expected to be completed for each participant.
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 structured feedback form developed by the researchers. The structured feedback form includes an average of four items related to acceptability on a five-point scale from 1 (strongly agree) to 5 (strongly disagree), with lower scores reflecting higher acceptability.
Measured: Baseline
Adolescents' Perceptions of Acceptability
Qualitative feedback provided by adolescents receiving the intervention about acceptability of the intervention, with the two most common points of feedback collected from a structured interview reported.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start13 Oct 2025
- Primary completion10 Jun 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- MQ Mental Health Research
- Responsible party
- Sponsor
- Investigators
- Marisa Marraccini, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186543
- Sponsor's protocol ID
- 23-0388
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-Designing a Virtual Reality Intervention to Enhance Skill Development With Adolescents Hospitalized for Suicide-Related Crises
- ClinicalTrials.gov ID
- NCT07186543
- Acronym / sponsor ID
- 23-0388
- Conditions
- Suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- MQ Mental Health Research
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
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 refining and pilot testing a novel Virtual Reality (VR) supplement for inpatient treatment: the Practice Experiences for School Reintegration (PrESR) program. The PrESR provides immersive school and social 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. The initial intervention was based on feedback from adolescent hospitalized for suicide-related crises, and school and hospital professionals, but did not provide tailored experiences to address the individual needs of ethnic-racial, gender, and sexual minoritized adolescents. Therefore, the VR environment of PrESR was adapted based on input from adolescents with previous suicide-related crises identifying as ethnic, racial, sex, or gender minoritized. This pilot randomized controlled trial (RCT) aims to explore the feasibility, acceptability, and facilitators/barriers to implementation of the adapted version of PrESR for improving outcomes in hospitalized adolescents. This study is not powered to test hypotheses; however, in addition to assessing feasibility, acceptability, and barriers/facilitators, this pilot trial will assess candidate intermediary and outcome measures.
Detailed description
This study recruits a prospective sample of youth hospitalized for suicide-related crises. Target sample size is approximately N = 26 enrolled adolescents, with the intention of recruiting at least 16 participants who identify as ethnic, racial, sex, or gender minoritized. The pilot RCT includes two conditions: an enhanced treatment as usual condition and an experimental condition. All participants will receive standard treatment, as well as researcher provided worksheets addressing introduction to cognitive behavioral therapy, cognitive restructuring, problem-solving, and affect regulation. Participants randomized to the experimental condition will also receive one or more sessions with PrESR. Outcomes will be assessed during hospitalization and again 3-weeks following hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Control | Active comparator | Behavioral: Cognitive Behavioral Therapy (CBT) WorksheetsCognitive Behavioral Therapy (CBT) Worksheets |
| PrESR Intervention | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets, Behavioral: Practice Experiences for School Reintegration (PrESR)Cognitive Behavioral Therapy (CBT) Worksheets; Virtual Reality (VR) Enhanced CBT Skill/Practice; Safety Planning |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Current hospitalization for suicidal thoughts and behaviors
- Ages 13-18
- Clinician approval
- 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 (3 listed)
- Evidence of active psychosis
- Evidence of intellectual disability
- Risk for cybersickness (greater 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 |
|---|---|---|
| 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 | Enhanced Control, PrESR Intervention |
| Practice Experiences for School Reintegration (PrESR)Participants will receive an overview of cognitive behavioral therapy skills in virtual reality (VR) and then have the opportunity to practice using skills in a brief immersive experience designed to mimic difficult school and social experiences. Session begin with goal setting and conclude with a debrief summary following the VR experience. Prior to discharge and following the conclusion of the VR sessions, participants will be invited to collaborate on a safety planning intervention informed by their experiences in VR that addresses school and social experiences. | Behavioural | PrESR Intervention |
Primary outcome
Proportion of Patients in the Target Population Who Agree to Participate
Time frame: Baseline
Recruitment rate 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 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-weeks following hospital discharge
Proportion of participants who complete all study procedures determined based on the proportion of adolescents completing study procedures at Baseline and 3-week follow-up 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-weeks following hospital discharge
Time to complete assessments, assessments are expected to last less than 4 hours.
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.
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 calculated based on the number of key components completed relative to the total number of key components expected to be completed for each participant.
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 structured feedback form developed by the researchers. The structured feedback form includes an average of four items related to acceptability on a five-point scale from 1 (strongly agree) to 5 (strongly disagree), with lower scores reflecting higher acceptability.
Adolescents' Perceptions of Acceptability
Time frame: Baseline
Qualitative feedback provided by adolescents receiving the intervention about acceptability of the intervention, with the two most common points of feedback collected from a structured interview reported.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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 Cognitive Behavioral Therapy (CBT) Worksheets and Practice Experiences for School Reintegration (PrESR) 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 6 inclusion and 3 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 23 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 8 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 23 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.