Back to resultsPractice Experiences for School Reintegration (PrESR)
Primary Purpose
Suicide
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety Planning
VR Enhanced Affect Regulation
VR Enhanced Cognitive Restructuring
VR Enhanced Problem Solving
Cognitive Behavioral Therapy (CBT) Worksheets
Sponsored by
About this trial
This is an interventional treatment trial for Suicide
Eligibility Criteria
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)
Sites / Locations
- UNC Adolescent Psychiatry Inpatient UnitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Enhanced Control
Affect Regulation
Problem Solving
Affect Regulation + Problem Solving
Cognitive Restructuring
Affect Regulation + Cognitive Restructuring
Cognitive Restructuring + Problem Solving
Affect Regulation + Cognitive Restructuring + Problem Solving
Arm Description
Cognitive Behavioral Therapy (CBT) Worksheets
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; 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
Outcomes
Primary Outcome Measures
Proportion of patients in the target population who agree to participate
Rate of Recruitment
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
Proportion of participants who complete all study procedures
Rate of Retention
Average number of hours to complete assessments at each time point
Time to complete assessments, assessments are expected to last less than 4 hours
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 proportion of components of intervention completed based on fidelity checklist
Adherence to delivery of key components of intervention, proportion is expected to be 80%
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).
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).
Adolescents' Perceptions of Acceptability
Qualitative feedback based on transcribed interviews.
Professional' Perceptions of Acceptability
Qualitative feedback based on transcribed interviews.
Secondary Outcome Measures
Full Information
NCT ID
NCT05934396
First Posted
June 28, 2023
Last Updated
October 2, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05934396
Brief Title
Practice Experiences for School Reintegration
Acronym
PrESR
Official Title
Practice Experiences for School Reintegration: An Immersive Virtual Reality Program to Enhance Skill Development of Hospitalized Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Enhanced Control
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy (CBT) Worksheets
Arm Title
Affect Regulation
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation
Arm Title
Problem Solving
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Problem Solving
Arm Title
Affect Regulation + Problem Solving
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Problem Solving
Arm Title
Cognitive Restructuring
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring
Arm Title
Affect Regulation + Cognitive Restructuring
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring
Arm Title
Cognitive Restructuring + Problem Solving
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
Arm Title
Affect Regulation + Cognitive Restructuring + Problem Solving
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy (CBT) Worksheets; Safety Planning; Virtual Reality (VR) Enhanced Affect Regulation; VR Enhanced Cognitive Restructuring; VR Enhanced Problem Solving
Intervention Type
Behavioral
Intervention Name(s)
Safety Planning
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
VR Enhanced Affect Regulation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
VR Enhanced Cognitive Restructuring
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
VR Enhanced Problem Solving
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT) Worksheets
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients in the target population who agree to participate
Description
Rate of Recruitment
Time Frame
Baseline
Title
Proportion of patients in the target population excluded due to motion sickness screening
Description
Rate of recruitment related to motion sickness, with participant scores greater or equal than 50th percentile on motion sickness questionnaire excluded
Time Frame
Baseline
Title
Proportion of participants who complete all study procedures
Description
Rate of Retention
Time Frame
up to 3-months following school re-entry
Title
Average number of hours to complete assessments at each time point
Description
Time to complete assessments, assessments are expected to last less than 4 hours
Time Frame
up to 3-months following school re-entry
Title
Average number of minutes to complete each intervention session
Description
Time to complete intervention sessions, each session is expected to last less than 60 minutes
Time Frame
Baseline
Title
Average proportion of components of intervention completed based on fidelity checklist
Description
Adherence to delivery of key components of intervention, proportion is expected to be 80%
Time Frame
Baseline
Title
Adolescents' Mean Acceptability Scores
Description
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).
Time Frame
Baseline
Title
Professionals' Mean Acceptability Scores
Description
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).
Time Frame
Baseline
Title
Adolescents' Perceptions of Acceptability
Description
Qualitative feedback based on transcribed interviews.
Time Frame
Baseline
Title
Professional' Perceptions of Acceptability
Description
Qualitative feedback based on transcribed interviews.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marisa E Marraccini, PhD
Phone
919-843-5099
Email
mmarracc@unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marisa Marraccini, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Adolescent Psychiatry Inpatient Unit
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marisa Marraccini, PhD
Email
mmarracc@unc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Practice Experiences for School Reintegration
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