Tourette SyndromeTDNCT05696769
Tourette Discrimination (TD) Stigma Scale
An observational study of Tourette Syndrome and Tourette Syndrome in Children, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The goal of this qualitative study is to understand the challenges of stigmatization and discrimination in children and young adults with Chronic Tic Disorders (CTD), including Tourette Syndrome. Measuring and understanding how stigma affects those with CTD will help inform future work. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Tourette Syndrome, Tourette Syndrome in Children, Tourette Syndrome in Adolescence
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2023to 27 Jun 2024
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Youth and Young adults with CTD (Chronic Tic Disorder, Tourette) Supporters of individuals with CTD - parents or caregivers, partners Providers/advocates of individuals with CTD - clinicians, therapists, patient advocacy group representatives
Who may be able to join
- CTD Cohort
- Physician-confirmed diagnosis of CTD based on the Diagnostic and Statistical Manual for Mental Disorders-Fifth Edition (DSM-V) criteria
- 8-30 years old.
- Parent/caregivers, supporters, medical providers, advocate cohort (s)
- Involved in the care of a child, youth or young adult with CTD
- The known person with CTD has had tics for more than a year at the time of screening
Who cannot join
- CTD Cohort
- Non-English speaking
- Diagnosis of intellectual disability
- Diagnosis of psychosis
- Any other condition that, in the Principle Investigator's opinion, would limit the participant's (or parent's) ability to understand study measures.
- Parent/caregivers, supporters, medical providers, advocate cohort (s)
- 1) The known person with CTD has an intellectual disability or diagnosis of psychosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Measuring Stigmatization in Chronic Tic Disorders: Development and Validation of the Tourette Discrimination-Stigmatization (TD-STIGMA) Scale
The goal of this qualitative study is to understand the challenges of stigmatization and discrimination in children and young adults with Chronic Tic Disorders (CTD), including Tourette Syndrome. Measuring and understanding how stigma affects those with CTD will help inform future work.
Read the detailed description
This study will utilize a phased approach, where (1) Narrative and thematic content data will be obtained through in-depth qualitative interviews of CTD stakeholders. (2) Based on these results, a novel scale will be developed through the Delphi Method with CTD stakeholders. (3) Preliminary analyses of the scale's psychometric properties.
- Conditions
- Tourette Syndrome, Tourette Syndrome in Children, Tourette Syndrome in Adolescence, Tic Disorder, Childhood, Tics
- Keywords
- Stigma
- Medical subject headings
- Tourette Syndrome, Tic Disorders, Tics, Social Stigma
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 |
|---|---|---|
| Youth with CTD Ages 8-12 | Youth (8-12 years) will be recruited for a qualitative interview using the exploratory questionnaire developed for the study. Parent/caregivers will also be asked questions related to their child's CTD. Participants will be asked for feedback on the ease of completion, content, readability and completion time. After development of the TD Stigma scale, prior and new participants with CTD will be asked to complete the TD-Stigma scale with companion measures. Feedback on the scale will be elicited as well. | |
| Supporters: Parents/Caregivers | Qualitative interviews will be administered and adapted to the caregiver's perspective. Parents/caregivers will also be asked to complete questionnaires child's CTD history, family history and impact of CTD on different aspects of the child's life. Participants will be asked for feedback on the ease of completion, content, readability and completion time. | |
| Provider/ advocate cohort | For providers and advocates, qualitative interview administered will begin with the participant's experience and qualifications in caring for individuals with CTD and adapted to the provider's perspective. Participants will be asked for feedback on the ease of completion, content, readability and completion time. | |
| Youth with CTD Ages 13-17 | Youth (13-17 years) will be recruited for a qualitative interview using the exploratory questionnaire developed for the study. Parent/caregivers will also be asked questions related to their child's CTD. Participants will be asked for feedback on the ease of completion, content, readability and completion time. After development of the TD Stigma scale, prior and new participants with CTD will be asked to complete the TD-Stigma scale with companion measures. Feedback on the scale will be elicited as well. | |
| Adults with CTD Ages (18-30) | Adults with CTD (Ages 18-30) will be recruited for a qualitative interview using the exploratory questionnaire developed for the study. Participants will be asked for feedback on the ease of completion, content, readability and completion time. After development of the TD Stigma scale, prior and new participants with CTD will be asked to complete the TD-Stigma scale with companion measures. Feedback on the scale will be elicited as well. | |
| Supporters: Partners/Spouses/Significant others | For Partners/Spouses/Significant others, qualitative interview administered will begin with the participant's experience and qualifications in caring for individuals with CTD and adapted to the supporter's perspective. Participants will be asked for feedback on the ease of completion, content, readability and completion time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tourette Discrimination-Stigmatization (TD-STIGMA) scores
Confirmatory factor analysis will be used to assess the factor structure of the hypothesized domains. Mean TD-STIGMA scores will be calculated. Internal consistency (both overall and within each domain) will be evaluated using Cronbach's alpha. Intraclass correlation will be used to evaluate test-retest reliability by retesting a subset of participants (n=20) two weeks after test administration. Some items may be removed from the list based on the results of the factor analysis, internal consistency, and test-retest evaluation. Both convergent validity and known-group validity will be evaluated. Analyses will use SAS 9.3.
Measured: Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start4 Mar 2023
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Tourette Association of America, University of Rochester
- Responsible party
- Sponsor
- Investigators
- Jaclyn M Martindale, DO, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696769
- Sponsor's protocol ID
- IRB00080472
- Acronym
- TD
- Status last verified
- Sep 2025
- First submitted
- 12 Jan 2023
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentified
Publications
Martindale JM, Chapman L, Carson AJ, Reilly K, Malli M, Storch EA, Salsman J, Daniel S. Beyond the Tics: Experiences of Stigma and Psychosocial Impact in Tourette Syndrome. Child Psychiatry Hum Dev. 2026 Jan 24. doi: 10.1007/s10578-026-01965-0. Online ahead of print.
PubMed 41579326
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Stigmatization in Chronic Tic Disorders: Development and Validation of the Tourette Discrimination-Stigmatization (TD-STIGMA) Scale
- ClinicalTrials.gov ID
- NCT05696769
- Acronym / sponsor ID
- TD / IRB00080472
- Conditions
- Tourette Syndrome, Tourette Syndrome in Children, Tourette Syndrome in Adolescence, Tic Disorder, Childhood, Tics
- Keywords
- Stigma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Tourette Association of America, University of Rochester
- Study start
- 4 Mar 2023 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 25 Jan 2023 (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.
The goal of this qualitative study is to understand the challenges of stigmatization and discrimination in children and young adults with Chronic Tic Disorders (CTD), including Tourette Syndrome. Measuring and understanding how stigma affects those with CTD will help inform future work.
Detailed description
This study will utilize a phased approach, where (1) Narrative and thematic content data will be obtained through in-depth qualitative interviews of CTD stakeholders. (2) Based on these results, a novel scale will be developed through the Delphi Method with CTD stakeholders. (3) Preliminary analyses of the scale's psychometric properties.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Youth with CTD Ages 8-12 | – | –Youth (8-12 years) will be recruited for a qualitative interview using the exploratory questionnaire developed for the study. Parent/caregivers will also be asked questions related to their child's CTD. Participants will be asked for feedback on the ease of completion, content, readability and completion time. After development of the TD Stigma scale, prior and new participants with CTD will be asked to complete the TD-Stigma scale with companion measures. Feedback on the scale will be elicited as well. |
| Supporters: Parents/Caregivers | – | –Qualitative interviews will be administered and adapted to the caregiver's perspective. Parents/caregivers will also be asked to complete questionnaires child's CTD history, family history and impact of CTD on different aspects of the child's life. Participants will be asked for feedback on the ease of completion, content, readability and completion time. |
| Provider/ advocate cohort | – | –For providers and advocates, qualitative interview administered will begin with the participant's experience and qualifications in caring for individuals with CTD and adapted to the provider's perspective. Participants will be asked for feedback on the ease of completion, content, readability and completion time. |
| Youth with CTD Ages 13-17 | – | –Youth (13-17 years) will be recruited for a qualitative interview using the exploratory questionnaire developed for the study. Parent/caregivers will also be asked questions related to their child's CTD. Participants will be asked for feedback on the ease of completion, content, readability and completion time. After development of the TD Stigma scale, prior and new participants with CTD will be asked to complete the TD-Stigma scale with companion measures. Feedback on the scale will be elicited as well. |
| Adults with CTD Ages (18-30) | – | –Adults with CTD (Ages 18-30) will be recruited for a qualitative interview using the exploratory questionnaire developed for the study. Participants will be asked for feedback on the ease of completion, content, readability and completion time. After development of the TD Stigma scale, prior and new participants with CTD will be asked to complete the TD-Stigma scale with companion measures. Feedback on the scale will be elicited as well. |
| Supporters: Partners/Spouses/Significant others | – | –For Partners/Spouses/Significant others, qualitative interview administered will begin with the participant's experience and qualifications in caring for individuals with CTD and adapted to the supporter's perspective. Participants will be asked for feedback on the ease of completion, content, readability and completion time. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Youth and Young adults with CTD (Chronic Tic Disorder, Tourette) Supporters of individuals with CTD - parents or caregivers, partners Providers/advocates of individuals with CTD - clinicians, therapists, patient advocacy group representatives
Key inclusion criteria (6 listed)
- CTD Cohort
- Physician-confirmed diagnosis of CTD based on the Diagnostic and Statistical Manual for Mental Disorders-Fifth Edition (DSM-V) criteria
- 8-30 years old.
- Parent/caregivers, supporters, medical providers, advocate cohort (s)
- Involved in the care of a child, youth or young adult with CTD
Key exclusion criteria (7 listed)
- CTD Cohort
- Non-English speaking
- Diagnosis of intellectual disability
- Diagnosis of psychosis
- Any other condition that, in the Principle Investigator's opinion, would limit the participant's (or parent's) ability to understand study measures.
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
Change in Tourette Discrimination-Stigmatization (TD-STIGMA) scores
Time frame: Month 7
Confirmatory factor analysis will be used to assess the factor structure of the hypothesized domains. Mean TD-STIGMA scores will be calculated. Internal consistency (both overall and within each domain) will be evaluated using Cronbach's alpha. Intraclass correlation will be used to evaluate test-retest reliability by retesting a subset of participants (n=20) two weeks after test administration. Some items may be removed from the list based on the results of the factor analysis, internal consistency, and test-retest evaluation. Both convergent validity and known-group validity will be evaluated. Analyses will use SAS 9.3.
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 10 Sep 2025.
- Derived from this study: PubMed 41579326Martindale JM, Chapman L, Carson AJ, Reilly K, Malli M, Storch EA, Salsman J, Daniel S. Beyond the Tics: Experiences of Stigma and Psychosocial Impact in Tourette Syndrome. Child Psychiatry Hum Dev. 2026 Jan 24. doi: 10.1007/s10578-026-01965-0. Online ahead of print.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentified
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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.
Jaclyn M Martindale, DO principal investigator
Wake Forest University Health Sciences
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 and Tourette Syndrome in Children, run by Wake Forest University Health Sciences 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 6 inclusion and 7 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 10 Sep 2025. 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?
Change in Tourette Discrimination-Stigmatization (TD-STIGMA) scores (time frame: Month 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05696769, which also lists 1 linked publication.
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 10 Sep 2025.