Practice Experiences for School Reintegration

Suicide Clinical Trial

— PrESR  

Official title:

Practice Experiences for School Reintegration: An Immersive Virtual Reality Program to Enhance Skill Development of Hospitalized Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05934396
• Other study ID #: 20-3464
• Secondary ID: 5K23MH122775
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: July 2024

Study information

• Verified date: March 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Marisa E Marraccini, PhD
• Phone: 919-843-5099
• Email: mmarracc[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 13 Years

Eligibility

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)

Related Conditions & MeSH terms

• Suicide

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	UNC Adolescent Psychiatry Inpatient Unit	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients in the target population who agree to participate	Rate of Recruitment	Baseline
Primary	Proportion of patients in the target population excluded due to motion sickness screening	Rate of recruitment related to motion sickness, with participant scores greater or equal than 50th percentile on motion sickness questionnaire excluded	Baseline
Primary	Proportion of participants who complete all study procedures	Rate of Retention	up to 3-months following school re-entry
Primary	Average number of hours to complete assessments at each time point	Time to complete assessments, assessments are expected to last less than 4 hours	up to 3-months following school re-entry
Primary	Average number of minutes to complete each intervention session	Time to complete intervention sessions, each session is expected to last less than 60 minutes	Baseline
Primary	Average proportion of components of intervention completed based on fidelity checklist	Adherence to delivery of key components of intervention, proportion is expected to be 80%	Baseline
Primary	Adolescents' Mean Acceptability Scores	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).	Baseline
Primary	Professionals' Mean Acceptability Scores	Percent of 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).	Baseline
Primary	Adolescents' Perceptions of Acceptability	Qualitative feedback based on transcribed interviews.	Baseline
Primary	Professional' Perceptions of Acceptability	Qualitative feedback based on transcribed interviews.	Baseline