Clinical trial NCT05934396: Practice Experiences for School Reintegration
Official title: Practice Experiences for School Reintegration: An Immersive Virtual Reality Program to Enhance Skill Development of Hospitalized Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-07-07
Enrollment: 51
Sex: ALL
Minimum age (years): 13
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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: This study follows a multiphased optimization (MOST) research design; this clinical trial is considered to be a pilot optimization component of the MOST framework. For the present study, a prospective sample of adolescents hospitalized for suicidal thoughts and behaviors will be randomly selected into one of 8 experimental conditions (N=5-6 per group). Although the intervention for the pilot optimization trial will be implemented by a member of research staff, this study will also aim to recruit 2-5 clinicians to deliver the full intervention to a separate sample of adolescent patients to inform acceptability and feasibility of the intervention within their clinical workflow.

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)

Primary outcomes:
measure: Proportion of patients in the target population who agree to participate
timeFrame: Baseline
measure: Proportion of patients in the target population excluded due to motion sickness screening
timeFrame: Baseline
measure: Proportion of participants who complete all study procedures
timeFrame: up to 3-months following school re-entry
measure: Average number of hours to complete assessments at each time point
timeFrame: up to 3-months following school re-entry
measure: Average number of minutes to complete each intervention session
timeFrame: Baseline
measure: Average proportion of components of intervention completed based on fidelity checklist
timeFrame: Baseline
measure: Adolescents' Mean Acceptability Scores
timeFrame: Baseline
measure: Professionals' Mean Acceptability Scores
timeFrame: Baseline
measure: Adolescents' Perceptions of Acceptability
timeFrame: Baseline
measure: Professional' Perceptions of Acceptability
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Adolescent Psychiatry Inpatient Unit
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Marisa Marraccini, PhD
role: PRINCIPAL_INVESTIGATOR
References: