NCT04449003|Completed
Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome
InSPSCTS
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InSPSCTS
Sponsor study identifier
observational
66
1 country
1
Study Start
March 29, 2021
Actual (reported)Primary Completion
December 28, 2022
Actual (reported)Study Completion
February 10, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 10, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 20, 2020
Actual (reported)June 26, 2020
Actual (reported)March 29, 2021
Actual (reported)December 28, 2022
Actual (reported)February 10, 2023
Actual (reported)Youth Quality of Life Research Version (YQOL-R)
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.
Baseline
Cohen's Perceived Stress Scale
Baseline
PedsQL - Family Impact Module
Baseline
Conners-3 Parent Short QuikScore Forms
Baseline
Revised Children's Anxiety and Depression Scale (RCADS) - Parent Report
Baseline
Revised Children's Anxiety and Depression Scale (RCADS) - Self-Report
Baseline
Adolescents (aged 13-17 years) with Tourette Syndrome
Adolescents (aged 13-17 years) without any history of tics
The patient study population consists of adolescents aged 13-17 years of age with Tourette syndrome presenting for routine clinical care, as well as the adolescents' caregivers. The control study population consists of adolescents aged 13-17 years of age without tics, as well as the adolescents' caregivers.
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-5400, United States
David A Isaacs, MD, MPH
Vanderbilt University Medical Center
Heather Riordan, MD
Vanderbilt Children's Hospital
66 participants (actual enrollment reported by the registry).
First Submitted
June 20, 2020
First Posted
June 26, 2020
Study Start
March 29, 2021
Actual (reported)A Study to Explore the Effect of Sepranolone in Tourette Syndrome
Contact the study team to confirm eligibility.
Primary Completion
December 28, 2022
Actual (reported)Study Completion
February 10, 2023
Actual (reported)Last Updated
February 24, 2023
Record last verified: 2023-02
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Source: ClinicalTrials.gov.
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