Tourette Syndrome in AdolescenceInSPSCTSNCT04449003
Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome
An observational study of Tourette Syndrome in Adolescence and Tourette Syndrome, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Tourette Syndrome in Adolescence, Tourette Syndrome, Tourette Syndrome in Children
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2021to 10 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-5400
About this study
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.
Read the 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.
- Keywords
- Stress, Self-esteem, Quality of life
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (12)
Cohen's Perceived Stress Scale
Self-report stress scale comprised of 10 items (total score range 0-40). Higher scores indicate greater perceived stress.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
School and Mental Health Services Inventory
Questionnaire assessing educational and functional status of child. No total score generated.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start29 Mar 2021
- Primary completion28 Dec 2022
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette Syndrome in AdolescenceStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Isaacs, Vanderbilt University Medical Center
- Investigators
- David A Isaacs, MD, MPH, Principal investigator, Vanderbilt University Medical CenterHeather Riordan, MD, Principal investigator, Vanderbilt Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449003
- Sponsor's protocol ID
- U11234
- Acronym
- InSPSCTS
- Status last verified
- Feb 2023
- First submitted
- 20 Jun 2020
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome
- ClinicalTrials.gov ID
- NCT04449003
- Acronym / sponsor ID
- InSPSCTS / U11234
- Keywords
- Stress, Self-esteem, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 26 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
12 secondary outcomes
Cohen's Perceived Stress Scale
Time frame: Baseline
PedsQL - Family Impact Module
Time frame: Baseline
Conners-3 Parent Short QuikScore Forms
Time frame: Baseline
Revised Children's Anxiety and Depression Scale (RCADS) - Parent Report
Time frame: Baseline
Revised Children's Anxiety and Depression Scale (RCADS) - Self-Report
Time frame: Baseline
Yale Global Tic Severity Scale (YGTSS)
Time frame: Baseline
School and Mental Health Services Inventory
Time frame: Baseline
Rosenberg Self Esteem Scale
Time frame: Baseline
Kearney's Daily Life Stressors Scale
Time frame: Baseline
McMaster Family Assessment Device
Time frame: Baseline
PROMIS Peer Relationships Short Form 8a - Self Report
Time frame: Baseline
PROMIS Peer Relationships Short Form 8a - Proxy-Report
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Isaacs, MD, MPH principal investigator
Vanderbilt University Medical Center
Heather Riordan, MD principal investigator
Vanderbilt Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tourette Syndrome in Adolescence and Tourette Syndrome, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Youth Quality of Life Research Version (YQOL-R) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.