Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome

NCT04449003 | Completed

• 1 other identifier: U11234
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourette Syndrome in Adolescence; Tourette Syndrome; Tourette Syndrome in Children

Keywords

Stress; Self-esteem; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• 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

Study Arms (2)

Adolescents with Tourette Syndrome

Adolescents (aged 13-17 years) with Tourette Syndrome

Adolescents without any neurologic or psychiatric diagnoses

Adolescents (aged 13-17 years) without any history of tics

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• adolescent age 13-17 years of age
• adolescent diagnosis of Tourette syndrome (TS)
• English-speaking adolescent and caregiver (as validated questionnaires are in English)
• adolescent and caregiver willingness and ability to complete relevant questionnaires

You may not qualify if:

• cognitive or attentional impairment precluding ability of adolescent or caregiver to complete self-report questionnaires
• adolescent diagnosis of genetic conditions besides TS and its known comorbidities
• adolescent with severe medical conditions unrelated to TS (e.g. uncontrolled seizures, prominent heart conditions)
• adolescent age 13-17 years of age
• no history of tics
• English-speaking adolescent and caregiver
• adolescent and caregiver willingness and ability to complete relevant questionnaires
• cognitive or attentional impairment precluding ability of adolescent or caregiver to complete self-report questionnaires
• adolescent with severe medical conditions

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-5400, United States

Location

MeSH Terms

Conditions

Tourette Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• David A Isaacs, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Heather Riordan, MD

  Vanderbilt Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: June 20, 2020
• First Posted: June 26, 2020
• Study Start: March 29, 2021
• Primary Completion: December 28, 2022
• Study Completion: February 10, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

US (1)