Tourette Discrimination (TD) Stigma Scale

Tourette Syndrome Clinical Trial

— TD  

Official title:

Measuring Stigmatization in Chronic Tic Disorders: Development and Validation of the Tourette Discrimination-Stigmatization (TD-STIGMA) Scale

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05696769
• Other study ID #: IRB00080472
• Status: Recruiting
• Start date: March 4, 2023
• Est. completion date: March 2025

Study information

• Verified date: September 2023
• Source: Wake Forest University Health Sciences
• Contact: Jaclyn M Martindale, DO
• Phone: 336-716-4104
• Email: jmartind[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: March 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

CTD Cohort

1. Physician-confirmed diagnosis of CTD based on the Diagnostic and Statistical Manual for Mental Disorders-Fifth Edition (DSM-V) criteria

2. 8-30 years old.

Parent/caregivers, supporters, medical providers, advocate cohort (s)

1. Involved in the care of a child, youth or young adult with CTD

2. The known person with CTD has had tics for more than a year at the time of screening

Exclusion Criteria:

CTD Cohort

Exclusion criteria:

1. Non-English speaking

2. Diagnosis of intellectual disability

3. Diagnosis of psychosis

4. 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

Related Conditions & MeSH terms

• Syndrome
• Tic Disorder, Childhood
• Tic Disorders
• Tics
• Tourette Syndrome
• Tourette Syndrome in Adolescence
• Tourette Syndrome in Children

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Tourette Association of America, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative Interviews	Stakeholder interviews will be audio-recorded, transcribed, and input into NVivo software for qualitative analysis. Transcripts will be compared with original recordings to ensure accuracy. Interviews will be analyzed using deductive thematic content analysis practices to identify emerging themes and subthemes.	3 hours
Other	Tourette Discrimination-Stigmatization (TD-STIGMA) Scale psychometric properties	A de-identified summary document of thematic content and narrative content analysis from Aim 1 will be securely emailed to stakeholders. Content will be alphabetized to avoid introducing bias. Stakeholders will be blind-copied to maintain anonymity. Using the Delphi Method, they will be asked to prioritize responses, provide feedback and propose solutions. The feedback process will continue until there is an 80% consensus among stakeholders. The outcome will be a close-ended TD-STIGMA scale. The Flesch Reading Ease score and Flesch-Kincaid Grade level will be used to assess questionnaire readability.	Month 4
Primary	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.	Month 7