CompletedNot Applicable

Practice Experiences for School Reintegration

United States54 participantsStarted 2023-08-01

Plain-language summary

This study is developing and refining a novel Virtual Reality (VR) supplement for inpatient treatment: the Practice Experiences for School Reintegration (PrESR) program. The PrESR will provide immersive school experiences for inpatient adolescents (with suicidal-related admissions) to practice skills in real-world settings with the guidance of a trained clinician within the confines of a hospital. This pilot study follows a Multiphase Optimization Strategy (MOST) to conduct a pilot optimization trial of the PrESR to inform the feasibility of training clinicians, the ability to recruit adolescent inpatient participants, and management of experimental conditions. This study is not powered to test hypotheses; however, in addition to assessing feasibility and acceptability, this pilot trial will assess candidate intermediary and outcome measures.

Who can participate

Age range

13 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Adolescent Participants: * current hospitalization for suicidal thoughts and behaviors * ages 13-18 * expected return to school following discharge * ability to speak, read, and understand English sufficiently to complete study procedures, * consent of a parent/legal guardian (in English or Spanish; for minor participants) * adolescent assent or consent (in English) * clinician approval. Hospital professionals: * Works as a clinician at the hospital site who delivers treatment including CBT to hospitalized adolescents, * Hospital professional consent (in English) * consent of patient's parent/legal guardian (in English or Spanish; for minor participants) * adolescent patient assent or consent (in English). Exclusion Criteria: Adolescent Participants * evidence of active psychosis, * evidence of intellectual disability * Risk for Cyber-sickness (greater than or equal to 50th percentile as measured on the Motion Sickness Susceptibility Questionnaire)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Patients in the Target Population Who Agree to Participate

Timeframe: Baseline

Proportion of Patients in the Target Population Excluded Due to Motion Sickness Screening

Timeframe: Baseline

Proportion of Participants Who Complete All Study Procedures

Timeframe: up to 3-months following school re-entry

Average Number of Hours to Complete Assessments at Each Time Point

Timeframe: up to 3-months following school re-entry

Average Number of Minutes to Complete Each Intervention Session

Timeframe: Baseline

Percentage of Adolescent Participants in Which Intervention Delivered With Greater Than or Equal to 80% Fidelity

Timeframe: Baseline

Percentage of Adolescent Participants With Average Acceptability Scores Less Than or Equal to 2

Timeframe: Baseline

Trial details

NCT IDNCT05934396

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-20

Results submitted2025-08-26

View on ClinicalTrials.gov More Suicide trials

Plain-language summary

Who can participate

Age range

13 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Proportion of Patients in the Target Population Who Agree to Participate

Timeframe: Baseline

Proportion of Patients in the Target Population Excluded Due to Motion Sickness Screening

Timeframe: Baseline

Proportion of Participants Who Complete All Study Procedures

Timeframe: up to 3-months following school re-entry

Average Number of Hours to Complete Assessments at Each Time Point

Timeframe: up to 3-months following school re-entry

Average Number of Minutes to Complete Each Intervention Session

Timeframe: Baseline

Percentage of Adolescent Participants in Which Intervention Delivered With Greater Than or Equal to 80% Fidelity

Timeframe: Baseline

Percentage of Adolescent Participants With Average Acceptability Scores Less Than or Equal to 2

Timeframe: Baseline