An interventional study of Cognitive Behavioral Therapy (CBT) Worksheets and Practice Experiences for School Reintegration (PrESR) in Suicide, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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.
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.
701 studies on the registry are indexed under Suicide; 183 are open to participants now.
This study's enrollment of 26 is below the median of 104 across 560 interventional studies indexed under Suicide.
Browse Suicide studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
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Exclusion Criteria:
Cognitive Behavioral Therapy (CBT) Worksheets
Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets
Cognitive Behavioral Therapy (CBT) Worksheets; Virtual Reality (VR) Enhanced CBT Skill/Practice; Safety Planning
Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets · Behavioral: Practice Experiences for School Reintegration (PrESR)
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Plan to share: 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.
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill