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临床试验/NCT05566236
NCT05566236已完成不适用

Study on the Effectiveness of an Evidence-based Board Game Project to Help Improve Tics and Interpersonal Interactions of Adolescents with Tourette Syndrome

National Taipei University of Nursing and Health Sciences2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Positive Mental Health Scale

研究概览

简要总结

The study aims to investigate the effectiveness of using a board game to improve adolescents' tics, mental health, and interpersonal interactions.

详细描述

This study utilizes a randomized control study design. According to the situated learning theory and qualitative research findings, this study develops a board game. This study enrolled adolescents with Tourette syndrome aged 12 to 18 as the subjects. Participants played board games at home at least once (about 60 minutes) a week for four consecutive weeks. The control group received the usual standard of care (psychoeducation regarding Tourette Syndrome and one 50-mg tablet of pyridoxine daily). The effectiveness indicators include self-reported status of positive mental health, tics severity, social adjustment, and depression by adolescents with TS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescents between the ages of 12 and 18 years were diagnosed with Tourette Syndrome or chronic tics disorder by a pediatrician, according to the DSM V.
  • Ability to speak and understand Mandarin.
  • Adolescents and their parents were willing to participate and fill in consent forms.

排除标准

  • · Adolescents with Tourette Syndrome have mental illness and serious diseases.

结局指标

主要结局

Positive Mental Health Scale

时间窗: Pre-intervention (baseline), immediately after completion of the intervention (4 weeks after baseline) and at follow-up (12 weeks post-baseline).

This study will use the Positive Mental Health Scale(25 items) to evaluate adolescents' degree of positive mental health. The lowest and highest total scores were 25 and 125, respectively. A high score indicates favorable positive mental health.

Yale Global Tic Severity Scale

时间窗: Pre-intervention (baseline), immediately after completion of the intervention (4 weeks after baseline) and at follow-up (12 weeks post-baseline).

The Yale Global Tic Severity Scale (YGTSS) will assess participants' motor and vocal tics' frequency, intensity, number, complexity, and interference. YGTSS also includes an overall Impairment Rating to determine each participant's interpersonal, academic, and occupational skill domains. Finally, the Global Severity Score will be acquired by adding the Total Motor Tic Score(0-25), Total Vocal Tic Score (0-25), and Overall Impairment Rating (0-50). The YGTSS has a total score ranging from 0 to 100, with the high score indicating a higher tics severity.

次要结局

  • Social adjustment scale for adolescents with Tourette syndrome(Pre-intervention (baseline), immediately after completion of the intervention (4 weeks after baseline) and at follow-up (12 weeks post-baseline).)
  • Chinese Version Beck Youth Inventories II (depression inventory)(Pre-intervention (baseline), immediately after completion of the intervention (4 weeks after baseline) and at follow-up (12 weeks post-baseline).)

研究者

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

Mei-Yin Lee

Associate Professor

National Taipei University of Nursing and Health Sciences

研究点 (2)

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