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临床试验/NCT05259462
NCT05259462已完成1 期

Improving Social Isolation and Loneliness Among Children With Physical Disabilities Through Group-Based Online Virtual Reality Gaming

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年6月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
12
试验地点
1
主要终点
Changes in Social Isolation / Loneliness

研究概览

简要总结

COVID-19 has had a negative impact on the mental health of many children with physical disabilities. This project aims to test the potential effects of an online multiplayer virtual reality group-based, active video game program on social isolation and depression and will include a total of 12 children with physical disabilities.

详细描述

This pilot feasibility study will investigate the potential effects of a revised multiplayer virtual reality exergaming program on depression, socialization, and loneliness among children with physical disabilities. This proposed study will use both quantitative and qualitative research methods, to gain a deep understanding of program benefits and implementation procedures that can be refined for a large clinical trial. The active video game program will last 1-month and include 2 supervised 1-hour sessions per week of group-based gaming. Game sessions will be supervised by 2 research staff who will act as gaming and mindfulness coaches. Outcomes will be measured by self-report questionnaires before and after the program. The program will be completed in two waves (6 people per wave). After the program, participants will undergo a one-on-one semi-structured interview, where they can describe their perceptions of the program.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •self-reported mobility disability (e.g., use of a mobility device or presence of a mobility impairment)
  • •access to a Wi-Fi internet connection in the home
  • •a caregiver to support the child if <18 years of age
  • •a Facebook account to link to the virtual reality head-mounted display

排除标准

  • •physically active (defined as >150 minutes/week of moderate-to-vigorous intensity exercise)
  • •cannot use the arms for exercise or operate the controller buttons using their fingers
  • •prone to seizures
  • •complete blindness or deafness
  • •unable to communicate verbally in English

研究组 & 干预措施

Group-active virtual reality gaming

Experimental

Participants will undergo the intervention.

干预措施: Intervention (Behavioral)

结局指标

主要结局

Changes in Social Isolation / Loneliness

时间窗: Changes from baseline (week 0) to post-intervention (week 5)

Measured by the version 3 of the UCLA Loneliness Scale 20 items (UCLA-20).

Changes in Depression

时间窗: Changes from baseline (week 0) to post-intervention (week 5)

Changes in self-reported feelings of depression measured by the Children's Depression Inventory 2 Short Form (CDI-S 2).

次要结局

  • Multiplayer feedback survey(Week 5)
  • Participants Perceptions of Completing the Program(Week 5)
  • Class attendance(Weeks 1 - 4)
  • Exercise volume(Week 0 and Week 5)
  • Quality of social interactions(Week 5)
  • Perceived enjoyment of the group classes(Week 5)
  • Satisfaction with program delivery(Week 5)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Byron Lai

Assistant Professor

University of Alabama at Birmingham

研究点 (1)

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