<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04449003</url>
  </required_header>
  <id_info>
    <org_study_id>U11234</org_study_id>
    <nct_id>NCT04449003</nct_id>
  </id_info>
  <brief_title>Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome</brief_title>
  <acronym>InSPSCTS</acronym>
  <official_title>Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators propose a cross-sectional, observational pilot study to examine the&#xD;
      contribution of stress, family dynamics, and peer relationships to quality of life (QOL) in&#xD;
      adolescents with Tourette syndrome (TS). Investigators will recruit two groups of&#xD;
      participants: 1) adolescents aged 13-17 years of age with TS and 2) adolescents aged 13-17&#xD;
      without any neurologic or psychiatric diagnoses. Participants and one of their&#xD;
      parents/caregivers will complete a series of questionnaires screening for and quantifying the&#xD;
      extent of stress and mental health symptoms, including anxiety, depression, obsessive&#xD;
      compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD). Participants will&#xD;
      also complete instruments characterizing family interactions and peer relationships.&#xD;
      Adolescents with TS will also undergo a semi-structured interview assessing the severity of&#xD;
      their tics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tourette syndrome (TS) is a multi-faceted neurodevelopmental disorder with wide-ranging&#xD;
      impact on adolescent quality of life (QOL). Comorbid psychiatric and psychological factors&#xD;
      exert greater influence on QOL than tics in TS, but the specific role of stress, family&#xD;
      dynamics, and peer relationships has been largely overlooked, despite the fact that these&#xD;
      factors are known to impact QOL in those with chronic disease. Investigators propose a&#xD;
      cross-sectional, observational pilot study to examine the contribution of stress, family&#xD;
      dynamics, and peer relationships to QOL in adolescents with TS. The primary goal of this&#xD;
      study is to collect sufficient data for hypothesis-generation and power analysis refinement&#xD;
      in planning of a larger scale study.&#xD;
&#xD;
      Investigators will recruit adolescents aged 13-17 years of age with TS presenting for regular&#xD;
      care at the Vanderbilt Pediatric Neurology Clinic. Adolescents without any neurologic or&#xD;
      psychiatric diagnoses will be recruited as a control population. Participants and one of&#xD;
      their parents/caregivers will complete a series of questionnaires screening for and&#xD;
      quantifying the extent of stress and mental health symptoms, including anxiety, depression,&#xD;
      obsessive compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD).&#xD;
      Participants will also complete instruments characterizing family interactions and peer&#xD;
      relationships. The scale battery can be completed by the adolescent and caregiver in parallel&#xD;
      and is anticipated to take 60-75 minutes total to complete. Adolescents with TS will also&#xD;
      undergo a semi-structured interview assessing the severity of their tics. The study plans to&#xD;
      enroll subjects over a 12-month time frame.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 29, 2021</start_date>
  <completion_date type="Actual">February 10, 2023</completion_date>
  <primary_completion_date type="Actual">December 28, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Youth Quality of Life Research Version (YQOL-R)</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cohen's Perceived Stress Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-report stress scale comprised of 10 items (total score range 0-40). Higher scores indicate greater perceived stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PedsQL - Family Impact Module</measure>
    <time_frame>Baseline</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conners-3 Parent Short QuikScore Forms</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revised Children's Anxiety and Depression Scale (RCADS) - Parent Report</measure>
    <time_frame>Baseline</time_frame>
    <description>Caregiver-report scale comprised of 47 items assessing mood symptoms. T-scores are generated, with higher scores indicating greater deviation from norms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revised Children's Anxiety and Depression Scale (RCADS) - Self-Report</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-report scale comprised of 47 items assessing mood symptoms. T-scores are generated, with higher scores indicating greater deviation from norms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Yale Global Tic Severity Scale (YGTSS)</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>School and Mental Health Services Inventory</measure>
    <time_frame>Baseline</time_frame>
    <description>Questionnaire assessing educational and functional status of child. No total score generated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rosenberg Self Esteem Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-report self-esteem scale comprised of 10 items (total score range 10-40). Higher scores indicate higher self-esteem.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kearney's Daily Life Stressors Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>McMaster Family Assessment Device</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Peer Relationships Short Form 8a - Self Report</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Peer Relationships Short Form 8a - Proxy-Report</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">66</enrollment>
  <condition>Tourette Syndrome in Adolescence</condition>
  <condition>Tourette Syndrome</condition>
  <condition>Tourette Syndrome in Children</condition>
  <arm_group>
    <arm_group_label>Adolescents with Tourette Syndrome</arm_group_label>
    <description>Adolescents (aged 13-17 years) with Tourette Syndrome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adolescents without any neurologic or psychiatric diagnoses</arm_group_label>
    <description>Adolescents (aged 13-17 years) without any history of tics</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The patient study population consists of adolescents aged 13-17 years of age with Tourette&#xD;
        syndrome presenting for routine clinical care, as well as the adolescents' caregivers. The&#xD;
        control study population consists of adolescents aged 13-17 years of age without tics, as&#xD;
        well as the adolescents' caregivers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for adolescents with TS:&#xD;
&#xD;
          -  adolescent age 13-17 years of age&#xD;
&#xD;
          -  adolescent diagnosis of Tourette syndrome (TS)&#xD;
&#xD;
          -  English-speaking adolescent and caregiver (as validated questionnaires are in English)&#xD;
&#xD;
          -  adolescent and caregiver willingness and ability to complete relevant questionnaires&#xD;
&#xD;
        Exclusion Criteria for adolescents with TS:&#xD;
&#xD;
          -  cognitive or attentional impairment precluding ability of adolescent or caregiver to&#xD;
             complete self-report questionnaires&#xD;
&#xD;
          -  adolescent diagnosis of genetic conditions besides TS and its known comorbidities&#xD;
&#xD;
          -  adolescent with severe medical conditions unrelated to TS (e.g. uncontrolled seizures,&#xD;
             prominent heart conditions)&#xD;
&#xD;
        Inclusion Criteria for adolescents without any neurologic or psychiatric diagnoses:&#xD;
&#xD;
          -  adolescent age 13-17 years of age&#xD;
&#xD;
          -  no history of tics&#xD;
&#xD;
          -  English-speaking adolescent and caregiver&#xD;
&#xD;
          -  adolescent and caregiver willingness and ability to complete relevant questionnaires&#xD;
&#xD;
        Exclusion Criteria for adolescents without any neurologic or psychiatric diagnoses:&#xD;
&#xD;
          -  cognitive or attentional impairment precluding ability of adolescent or caregiver to&#xD;
             complete self-report questionnaires&#xD;
&#xD;
          -  adolescent with severe medical conditions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David A Isaacs, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Heather Riordan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232-5400</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>February 21, 2023</last_update_submitted>
  <last_update_submitted_qc>February 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>David Isaacs</investigator_full_name>
    <investigator_title>Assistant Professor of Neurology</investigator_title>
  </responsible_party>
  <keyword>Stress</keyword>
  <keyword>Self-esteem</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tourette Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04449003
org study id: U11234
nct id: NCT04449003
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: Youth Quality of Life Research Version (YQOL-R)
time frame: Baseline
description: 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.
measure: Cohen's Perceived Stress Scale
time frame: Baseline
description: Self-report stress scale comprised of 10 items (total score range 0-40). Higher scores indicate greater perceived stress.
measure: PedsQL - Family Impact Module
time frame: Baseline
description: 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).
measure: Conners-3 Parent Short QuikScore Forms
time frame: Baseline
description: 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.
measure: Revised Children's Anxiety and Depression Scale (RCADS) - Parent Report
time frame: Baseline
description: Caregiver-report scale comprised of 47 items assessing mood symptoms. T-scores are generated, with higher scores indicating greater deviation from norms.
measure: Revised Children's Anxiety and Depression Scale (RCADS) - Self-Report
time frame: Baseline
description: Self-report scale comprised of 47 items assessing mood symptoms. T-scores are generated, with higher scores indicating greater deviation from norms.
measure: Yale Global Tic Severity Scale (YGTSS)
time frame: Baseline
description: 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.
measure: School and Mental Health Services Inventory
time frame: Baseline
description: Questionnaire assessing educational and functional status of child. No total score generated.
measure: Rosenberg Self Esteem Scale
time frame: Baseline
description: Self-report self-esteem scale comprised of 10 items (total score range 10-40). Higher scores indicate higher self-esteem.
measure: Kearney's Daily Life Stressors Scale
time frame: Baseline
description: 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.
measure: McMaster Family Assessment Device
time frame: Baseline
description: 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.
measure: PROMIS Peer Relationships Short Form 8a - Self Report
time frame: Baseline
description: 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.
measure: PROMIS Peer Relationships Short Form 8a - Proxy-Report
time frame: Baseline
description: 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.
arm group label: Adolescents with Tourette Syndrome
description: Adolescents (aged 13-17 years) with Tourette Syndrome
arm group label: Adolescents without any neurologic or psychiatric diagnoses
description: Adolescents (aged 13-17 years) without any history of tics
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: No
last name: David A Isaacs, MD, MPH
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
last name: Heather Riordan, MD
role: Principal Investigator
affiliation: Vanderbilt Children's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: David Isaacs
investigator title: Assistant Professor of Neurology
mesh term: Tourette Syndrome
mesh term: Syndrome
sharing ipd: Undecided