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临床试验/NCT04449003
NCT04449003已完成不适用

Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2021年3月29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
66
试验地点
1
主要终点
Youth Quality of Life Research Version (YQOL-R)

研究概览

简要总结

Investigators propose a cross-sectional, observational pilot study to examine the contribution of stress, family dynamics, and peer relationships to quality of life (QOL) in adolescents with Tourette syndrome (TS). Investigators will recruit two groups of participants: 1) adolescents aged 13-17 years of age with TS and 2) adolescents aged 13-17 without any neurologic or psychiatric diagnoses. Participants and one of their parents/caregivers will complete a series of questionnaires screening for and quantifying the extent of stress and mental health symptoms, including anxiety, depression, obsessive compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD). Participants will also complete instruments characterizing family interactions and peer relationships. Adolescents with TS will also undergo a semi-structured interview assessing the severity of their tics.

详细描述

Tourette syndrome (TS) is a multi-faceted neurodevelopmental disorder with wide-ranging impact on adolescent quality of life (QOL). Comorbid psychiatric and psychological factors exert greater influence on QOL than tics in TS, but the specific role of stress, family dynamics, and peer relationships has been largely overlooked, despite the fact that these factors are known to impact QOL in those with chronic disease. Investigators propose a cross-sectional, observational pilot study to examine the contribution of stress, family dynamics, and peer relationships to QOL in adolescents with TS. The primary goal of this study is to collect sufficient data for hypothesis-generation and power analysis refinement in planning of a larger scale study.

Investigators will recruit adolescents aged 13-17 years of age with TS presenting for regular care at the Vanderbilt Pediatric Neurology Clinic. Adolescents without any neurologic or psychiatric diagnoses will be recruited as a control population. Participants and one of their parents/caregivers will complete a series of questionnaires screening for and quantifying the extent of stress and mental health symptoms, including anxiety, depression, obsessive compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD). Participants will also complete instruments characterizing family interactions and peer relationships. The scale battery can be completed by the adolescent and caregiver in parallel and is anticipated to take 60-75 minutes total to complete. Adolescents with TS will also undergo a semi-structured interview assessing the severity of their tics. The study plans to enroll subjects over a 12-month time frame.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Youth Quality of Life Research Version (YQOL-R)

时间窗: Baseline

Self-report quality of life scale comprised of 42 items with 10-point Likert scale (raw total score 0-420) and 15 additional items with open-ended and demographic questions. Higher scores indicate better overall quality of life.

次要结局

  • PedsQL - Family Impact Module(Baseline)
  • Revised Children's Anxiety and Depression Scale (RCADS) - Parent Report(Baseline)
  • Kearney's Daily Life Stressors Scale(Baseline)
  • Cohen's Perceived Stress Scale(Baseline)
  • Conners-3 Parent Short QuikScore Forms(Baseline)
  • Yale Global Tic Severity Scale (YGTSS)(Baseline)
  • School and Mental Health Services Inventory(Baseline)
  • Rosenberg Self Esteem Scale(Baseline)
  • McMaster Family Assessment Device(Baseline)
  • PROMIS Peer Relationships Short Form 8a - Self Report(Baseline)
  • PROMIS Peer Relationships Short Form 8a - Proxy-Report(Baseline)
  • Revised Children's Anxiety and Depression Scale (RCADS) - Self-Report(Baseline)

研究者

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

David Isaacs

Assistant Professor of Neurology

Vanderbilt University Medical Center

研究点 (1)

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