Co-Designing a Virtual Reality Intervention to Enhance Skill Development

University of North Carolina (UNC)

Status: Enrolling

Conditions: Suicide

Treatments: Behavioral: Practice Experiences for School Reintegration (PrESR); Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets

Study type: Interventional

Funder types: Other

Identifiers

NCT07186543

23-0388

Details and patient eligibility

About

This study is refining and pilot testing a novel Virtual Reality (VR) supplement for inpatient treatment: the Practice Experiences for School Reintegration (PrESR) program. The PrESR provides immersive school and social 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. The initial intervention was based on feedback from adolescent hospitalized for suicide-related crises, and school and hospital professionals, but did not provide tailored experiences to address the individual needs of ethnic-racial, gender, and sexual minoritized adolescents. Therefore, the VR environment of PrESR was adapted based on input from adolescents with previous suicide-related crises identifying as ethnic, racial, sex, or gender minoritized. This pilot randomized controlled trial (RCT) aims to explore the feasibility, acceptability, and facilitators/barriers to implementation of the adapted version of PrESR for improving outcomes in hospitalized adolescents. This study is not powered to test hypotheses; however, in addition to assessing feasibility, acceptability, and barriers/facilitators, this pilot trial will assess candidate intermediary and outcome measures.

Full description

This study recruits a prospective sample of youth hospitalized for suicide-related crises. Target sample size is approximately N = 26 enrolled adolescents, with the intention of recruiting at least 16 participants who identify as ethnic, racial, sex, or gender minoritized. The pilot RCT includes two conditions: an enhanced treatment as usual condition and an experimental condition. All participants will receive standard treatment, as well as researcher provided worksheets addressing introduction to cognitive behavioral therapy, cognitive restructuring, problem-solving, and affect regulation. Participants randomized to the experimental condition will also receive one or more sessions with PrESR. Outcomes will be assessed during hospitalization and again 3-weeks following hospital discharge.

Enrollment: 26 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current hospitalization for suicidal thoughts and behaviors
• Ages 13-18
• Clinician approval
• 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)

Exclusion criteria

• Evidence of active psychosis
• Evidence of intellectual disability
• Risk for cybersickness (greater or equal to 50th percentile as measured on the Motion Sickness Susceptibility Questionnaire).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Enhanced Control

Active Comparator group

Description:

Cognitive Behavioral Therapy (CBT) Worksheets

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets

PrESR Intervention

Experimental group

Description:

Cognitive Behavioral Therapy (CBT) Worksheets; Virtual Reality (VR) Enhanced CBT Skill/Practice; Safety Planning

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT) Worksheets

Behavioral: Practice Experiences for School Reintegration (PrESR)