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

• ClinicalTrials.gov Identifier: NCT04449003
• Recruitment Status: Recruiting
• First Posted: June 26, 2020
• Last Update Posted: April 29, 2022
• Sponsor: Vanderbilt University Medical Center
• Information provided by (Responsible Party): David Isaacs, Vanderbilt University Medical Center

Study Description

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.

Condition or disease
Tourette Syndrome in Adolescence; Tourette Syndrome; Tourette Syndrome in Children

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 Design

• Study Type: Observational
• Estimated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome
• Actual Study Start Date: March 29, 2021
• Estimated Primary Completion Date: December 28, 2022
• Estimated Study Completion Date: February 2023

Groups and Cohorts

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 neurologic or psychiatric diagnoses

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Cohen's Perceived Stress Scale [ Time Frame: Baseline ]
   Self-report stress scale comprised of 10 items (total score range 0-40). Higher scores indicate greater perceived stress.
2. PedsQL - Family Impact Module [ Time Frame: Baseline ]
   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).
3. Conners-3 Parent Short QuikScore Forms [ Time Frame: Baseline ]
   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.
4. Revised Children's Anxiety and Depression Scale (RCADS) - Parent Report [ Time Frame: Baseline ]
   Caregiver-report scale comprised of 47 items assessing mood symptoms. T-scores are generated, with higher scores indicating greater deviation from norms.
5. Revised Children's Anxiety and Depression Scale (RCADS) - Self-Report [ Time Frame: Baseline ]
   Self-report scale comprised of 47 items assessing mood symptoms. T-scores are generated, with higher scores indicating greater deviation from norms.
6. Yale Global Tic Severity Scale (YGTSS) [ Time Frame: Baseline ]
   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.
7. School and Mental Health Services Inventory [ Time Frame: Baseline ]
   Questionnaire assessing educational and functional status of child. No total score generated.
8. Rosenberg Self Esteem Scale [ Time Frame: Baseline ]
   Self-report self-esteem scale comprised of 10 items (total score range 10-40). Higher scores indicate higher self-esteem.
9. Kearney's Daily Life Stressors Scale [ Time Frame: Baseline ]
   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.
10. McMaster Family Assessment Device [ Time Frame: Baseline ]
    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.
11. PROMIS Peer Relationships Short Form 8a - Self Report [ Time Frame: Baseline ]
    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.
12. PROMIS Peer Relationships Short Form 8a - Proxy-Report [ Time Frame: Baseline ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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 any neurologic or psychiatric diagnoses, as well as the adolescents' caregivers.

Criteria

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 prior neurologic or psychiatric diagnoses
• 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

Contacts and Locations

Contacts

Contact: Michelle Eckland, BS; +1 (615)875-7394; michelle.r.eckland.1@vumc.org

Locations

United States, Tennessee

Vanderbilt University Medical Center; Recruiting

Nashville, Tennessee, United States, 37232-5400

Contact: Michelle Eckland, BS 615-875-7394 michelle.r.eckland.1@vumc.org

Principal Investigator: David Isaacs, MD, MPH

Principal Investigator: Heather Riordan, MD

Sub-Investigator: Andrew Molnar, PhD

Sub-Investigator: Jessica Schwartzman, MS

Sponsors and Collaborators

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

More Information

• Responsible Party: David Isaacs, Assistant Professor of Neurology, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT04449003
• Other Study ID Numbers: U11234
• First Posted: June 26, 2020
• Last Update Posted: April 29, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Isaacs, Vanderbilt University Medical Center:

Stress; Self-esteem; Quality of life

Additional relevant MeSH terms:

Tourette Syndrome; Syndrome; Disease; Pathologic Processes; 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; Neurodevelopmental Disorders; Mental Disorders