Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04449003
Recruitment Status : Recruiting
First Posted : June 26, 2020
Last Update Posted : April 29, 2022
Sponsor:
Information provided by (Responsible Party):
David Isaacs, Vanderbilt University Medical Center

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


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



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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04449003


Contacts
Layout table for location contacts
Contact: Michelle Eckland, BS +1 (615)875-7394 michelle.r.eckland.1@vumc.org

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: David A Isaacs, MD, MPH Vanderbilt University Medical Center
Principal Investigator: Heather Riordan, MD Vanderbilt Children's Hospital
Layout table for additonal 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    Key Record Dates
Last Update Posted: April 29, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Layout table for 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