Epidemiology of Assertiveness and Emotion Management Disorders in People With Tourette's Syndrome

Tourette Syndrome Clinical Trial

— AFFIRMATICS  

Official title:

Epidemiology of Assertiveness and Emotion Management Disorders in People With Tourette's Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06136572
• Other study ID #: RNI 2023 JALENQUES
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: November 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to evaluate the proportion of assertiveness difficulties in Tourette syndrome. Participants will complete several e-questionnaires (on assertiveness, Tourette severity, quality of life, self-esteem and comorbidities like depression, anxiety...).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Tourette syndrome

• Participants aged 18 years or over

Exclusion Criteria:

• Participants under legal protection

• Inability to complete questionnaires alone

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

Intervention

Diagnostic Test:
• Rathus Assertiveness scale
Questionnaire completion

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rathus assertiveness questionnaire	The Rathus assertiveness questionnaire includes 30 items, each scores from -3 to +30. A total score inferior or equal to -9 reveals assertiveness difficulties.	5 minutes at inclusion
Secondary	MOVES	The MOVES is a self-questionnaire including 20 items which measures the severity of the Tourette syndrome. Several scores are defined : motor tics, vocal tics, obsession, compulsion and other phenomena. The higher the score, the greater the severity.	less than 5 minutes at inclusion
Secondary	HADS	The HADS is a self-questionnaire to assess depression (7 items) and anxiety (7 items).	3 minutes at inclusion
Secondary	ASRS-5	The Adult AD-HD Self-Report Scale (ASRS-5) is a scale to assess the presence of Attention-Deficit / Hyperactivity Disorder. We used the first 6 items of the questionnaire for the screening of ADHD. The total score ranges from 0 to 24 and a cut off of 13 shows good screening performance.	2 minutes at inclusion
Secondary	Rosenberg Self-Esteem Scale	The Rosenberg Self-Esteem Scale is a self-questionnaire on self-esteem. It includes 10 items. The lower the score, the lower the self-esteem.	2-3 minutes at inclusion
Secondary	DERS	The Difficulties in Emotion Regulation Scale (DERS) is a self-questionnaire including 36 items. Lower scores indicate the presence of difficulties in emotion regulation.	5 minutes at inclusion
Secondary	GTS-QoL	The GTS-QoL is a specific Gilles de la Tourette Syndrome Quality of Life Scale. It consists of 27 items giving 6 dimensions: "Psychological", "Physical and activities of daily life", "Obsessive-compulsive", "Cognitive", "Social" and "Echo-coprophenomena", scored out of 100. The scores the highest represent a poorer quality of life.	5 minutes at inclusion