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Clinical Trials/NCT04449003
NCT04449003
Completed
Not Applicable

Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome

Vanderbilt University Medical Center1 site in 1 country66 target enrollmentMarch 29, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tourette Syndrome in Adolescence
Sponsor
Vanderbilt University Medical Center
Enrollment
66
Locations
1
Primary Endpoint
Youth Quality of Life Research Version (YQOL-R)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 29, 2021
End Date
February 10, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Isaacs

Assistant Professor of Neurology

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Youth Quality of Life Research Version (YQOL-R)

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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