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Clinical Trials/NCT05696769
NCT05696769
Completed
Not Applicable

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

Wake Forest University Health Sciences1 site in 1 country43 target enrollmentMarch 4, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tourette Syndrome
Sponsor
Wake Forest University Health Sciences
Enrollment
43
Locations
1
Primary Endpoint
Change in Tourette Discrimination-Stigmatization (TD-STIGMA) scores
Status
Completed
Last Updated
7 months ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
March 4, 2023
End Date
June 27, 2024
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Exclusion criteria:
  • 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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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