Clinical trial NCT05696769: Tourette Discrimination (TD) Stigma Scale
Official title: Measuring Stigmatization in Chronic Tic Disorders: Development and Validation of the Tourette Discrimination-Stigmatization (TD-STIGMA) Scale
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tourette Syndrome
Tourette Syndrome in Children
Tourette Syndrome in Adolescence
Tic Disorder, Childhood
Tics
Keywords: Stigma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Tourette Association of America
name: University of Rochester
First posted: 2023-01-25
Enrollment: 135
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Tourette Discrimination-Stigmatization (TD-STIGMA) scores
timeFrame: Month 7
Secondary outcomes:
Other outcomes:
measure: Qualitative Interviews
timeFrame: 3 hours
measure: Tourette Discrimination-Stigmatization (TD-STIGMA) Scale psychometric properties
timeFrame: Month 4
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jaclyn M Martindale, DO
role: PRINCIPAL_INVESTIGATOR
References: