Practice Experiences for School Reintegration

Not Applicable

• Conditions: Suicide
• Interventions: Behavioral: Safety Planning; Behavioral: VR Enhanced Affect Regulation; Behavioral: VR Enhanced Problem Solving; Behavioral: VR Enhanced Cognitive Restructuring; Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets

• Registration Number: NCT05934396
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-06-28
• Study First Posted: 2023-07-07
• Study Start: 2023-08-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 48

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).

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Affect Regulation	VR Enhanced Affect Regulation	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation
Affect Regulation	Cognitive Behavioral Therapy (CBT) Worksheets	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation
Cognitive Restructuring	Cognitive Behavioral Therapy (CBT) Worksheets	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring
Affect Regulation	Safety Planning	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation
Problem Solving	VR Enhanced Problem Solving	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving
Affect Regulation + Problem Solving	Safety Planning	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving
Affect Regulation + Problem Solving	VR Enhanced Affect Regulation	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving
Affect Regulation + Problem Solving	VR Enhanced Problem Solving	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving
Cognitive Restructuring	Safety Planning	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring
Affect Regulation + Cognitive Restructuring	Safety Planning	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring
Enhanced Control	Cognitive Behavioral Therapy (CBT) Worksheets	Cognitive Behavioral Therapy (CBT) Worksheets
Problem Solving	Cognitive Behavioral Therapy (CBT) Worksheets	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving
Cognitive Restructuring	VR Enhanced Cognitive Restructuring	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring
Affect Regulation + Cognitive Restructuring	VR Enhanced Cognitive Restructuring	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring
Cognitive Restructuring + Problem Solving	VR Enhanced Problem Solving	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
Affect Regulation + Cognitive Restructuring + Problem Solving	Safety Planning	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
Problem Solving	Safety Planning	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving
Affect Regulation + Cognitive Restructuring	VR Enhanced Affect Regulation	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring
Affect Regulation + Cognitive Restructuring + Problem Solving	VR Enhanced Cognitive Restructuring	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
Affect Regulation + Problem Solving	Cognitive Behavioral Therapy (CBT) Worksheets	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving
Cognitive Restructuring + Problem Solving	VR Enhanced Cognitive Restructuring	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
Cognitive Restructuring + Problem Solving	Cognitive Behavioral Therapy (CBT) Worksheets	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
Affect Regulation + Cognitive Restructuring + Problem Solving	Cognitive Behavioral Therapy (CBT) Worksheets	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
Affect Regulation + Cognitive Restructuring	Cognitive Behavioral Therapy (CBT) Worksheets	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring
Cognitive Restructuring + Problem Solving	Safety Planning	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
Affect Regulation + Cognitive Restructuring + Problem Solving	VR Enhanced Affect Regulation	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
Affect Regulation + Cognitive Restructuring + Problem Solving	VR Enhanced Problem Solving	Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving

Primary Outcome Measures

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

Trial Locations

Locations (1)

UNC Adolescent Psychiatry Inpatient Unit; 🇺🇸 Chapel Hill, North Carolina, United States