Co-Designing a Virtual Reality Intervention to Enhance Skill Development With Adolescents Hospitalized for Suicide-Related Crises
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Adolescents' Perceptions of Acceptability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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).
研究组 & 干预措施
Enhanced Control
Cognitive Behavioral Therapy (CBT) Worksheets
干预措施: Cognitive Behavioral Therapy (CBT) Worksheets (Behavioral)
PrESR Intervention
Cognitive Behavioral Therapy (CBT) Worksheets; Virtual Reality (VR) Enhanced CBT Skill/Practice; Safety Planning
干预措施: Cognitive Behavioral Therapy (CBT) Worksheets (Behavioral)
PrESR Intervention
Cognitive Behavioral Therapy (CBT) Worksheets; Virtual Reality (VR) Enhanced CBT Skill/Practice; Safety Planning
干预措施: Practice Experiences for School Reintegration (PrESR) (Behavioral)
结局指标
主要结局
Adolescents' Perceptions of Acceptability
时间窗: Baseline
Qualitative feedback provided by adolescents receiving the intervention about acceptability of the intervention, with the two most common points of feedback collected from a structured interview reported.
Proportion of Patients in the Target Population Who Agree to Participate
时间窗: Baseline
Recruitment rate determined based on the proportion of adolescents providing assent and parents or legal guardians providing permission relative to the number of parents or legal guardians approached.
Proportion of Patients in the Target Population Excluded Due to Motion Sickness Screening
时间窗: Baseline
Rate of recruitment related to motion sickness determined based on the proportion of assented adolescents whose scores were \>/= than 50th percentile on motion sickness questionnaire relative to the number of assented adolescents.
Proportion of Participants Who Complete All Study Procedures
时间窗: up to 3-weeks following hospital discharge
Proportion of participants who complete all study procedures determined based on the proportion of adolescents completing study procedures at Baseline and 3-week follow-up relative to the total number of adolescents participating in that condition.
Average Number of Hours to Complete Assessments at Each Time Point
时间窗: up to 3-weeks following hospital discharge
Time to complete assessments, assessments are expected to last less than 4 hours.
Average Number of Minutes to Complete Each Intervention Session
时间窗: Baseline
Time to complete intervention sessions, each session is expected to last less than 60 minutes. Average calculated by summing all sessions in each condition and dividing by total number of sessions.
Percentage of Adolescent Participants in Which Intervention Delivered With Greater Than or Equal to 80% Fidelity
时间窗: Baseline
Percentage of participants in which adherence to delivery of key components of intervention (i.e., skill lessons or practice sessions) across sessions in each condition was 80% or greater. Adherence calculated based on the number of key components completed relative to the total number of key components expected to be completed for each participant.
Percentage of Adolescent Participants With Average Acceptability Scores Less Than or Equal to 2
时间窗: Baseline
Percent of adolescents with average acceptability score less than or equal to 2 (or "agree") on a structured feedback form developed by the researchers. The structured feedback form includes an average of four items related to acceptability on a five-point scale from 1 (strongly agree) to 5 (strongly disagree), with lower scores reflecting higher acceptability.
Adolescents' Perceptions of Acceptability
时间窗: Baseline
Qualitative feedback provided by adolescents receiving the intervention about acceptability of the intervention, with the two most common points of feedback collected from a structured interview reported.
次要结局
未报告次要终点