Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome (InSPSCTS)

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.

Study Overview

• Status: Completed
• Conditions: Tourette Syndrome; Tourette Syndrome in Children; Tourette Syndrome in Adolescence

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.

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232-5400
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria for adolescents with TS:

• 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

Exclusion Criteria for adolescents with TS:

• 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)

Inclusion Criteria for adolescents without any neurologic or psychiatric diagnoses:

• 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

Exclusion Criteria for adolescents without any neurologic or psychiatric diagnoses:

• cognitive or attentional impairment precluding ability of adolescent or caregiver to complete self-report questionnaires
• adolescent with severe medical conditions

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohen's Perceived Stress Scale	Self-report stress scale comprised of 10 items (total score range 0-40). Higher scores indicate greater perceived stress.	Baseline
PedsQL - Family Impact Module	Caregiver-report scale comprised of 36 items (total score range 0-100) assessing impact of health condition(s) on family. Higher scores indicate better family functioning in context of health-related condition(s).	Baseline
Conners-3 Parent Short QuikScore Forms	Caregiver-report scale comprised of 45 items assessing inattention, hyperactivity, and executive functioning of child. T-scores are generated, with higher scores indicating greater deviation from norms.	Baseline
Revised Children's Anxiety and Depression Scale (RCADS) - Parent Report	Caregiver-report scale comprised of 47 items assessing mood symptoms. T-scores are generated, with higher scores indicating greater deviation from norms.	Baseline
Revised Children's Anxiety and Depression Scale (RCADS) - Self-Report	Self-report scale comprised of 47 items assessing mood symptoms. T-scores are generated, with higher scores indicating greater deviation from norms.	Baseline
Yale Global Tic Severity Scale (YGTSS)	Semi-structured clinician-administered interview assessing tic severity, with total tic score range of 0-50 and functional impairment scale range of 0-50. Higher scores indicate greater tic severity and functional impairment, respectively. This measure will only be administered to adolescents with TS.	Baseline
School and Mental Health Services Inventory	Questionnaire assessing educational and functional status of child. No total score generated.	Baseline
Rosenberg Self Esteem Scale	Self-report self-esteem scale comprised of 10 items (total score range 10-40). Higher scores indicate higher self-esteem.	Baseline
Kearney's Daily Life Stressors Scale	Self-report scale consisting of 30 items (total score range 0-120) assessing degree of stress caused by daily activities. Higher scores indicate greater burden from daily stressors.	Baseline
McMaster Family Assessment Device	Self-report scale consisting of 60 items (total score range 0-180) assessing structural, organizational, and interactional aspects of family environment. The scale contains subscales, the scores of which are added to create a composite overall score, with higher scores indicative of more supportive family environment.	Baseline
PROMIS Peer Relationships Short Form 8a - Self Report	Self-report scale consisting of 8 items (total score is composite of individual item scores, ranked on Likert scale from 1-5) assessing quality of peer relationships. Total raw scores are converted to a T-score. Higher scores indicate more positive perception of peer relationships.	Baseline
PROMIS Peer Relationships Short Form 8a - Proxy-Report	Proxy-report scale consisting of 8 items (total score is composite of individual item scores, ranked on Likert scale from 1-5) assessing quality of child's peer relationships. Total raw scores are converted to a T-score. Higher scores indicate more positive perception of child peer relationships.	Baseline

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: David A Isaacs, MD, MPH, Vanderbilt University Medical Center; Principal Investigator: Heather Riordan, MD, Vanderbilt Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Actual): December 28, 2022
• Study Completion (Actual): February 10, 2023

Study Registration Dates

• First Submitted: June 20, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (Actual): June 26, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Stress; Quality of life; Self-esteem
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Tic Disorders; Syndrome; Tourette Syndrome
• Other Study ID Numbers: U11234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No