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

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...).

Study Overview

• Status: Recruiting
• Conditions: Tourette Syndrome
• Intervention / Treatment: Diagnostic test: Rathus Assertiveness scale

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: 334.73.754.963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • France
    • Clermont-Ferrand, France, France
      • Recruiting
      • CHU Clermont-Ferrand
      • Contact: Lise Laclautre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Tourette syndrome
• Participants aged 18 years or over

Exclusion Criteria:

• Participants under legal protection
• Inability to complete questionnaires alone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rathus Assertiveness scale; All participants	Diagnostic test: Rathus Assertiveness scale; Questionnaire completion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
HADS	The HADS is a self-questionnaire to assess depression (7 items) and anxiety (7 items).	3 minutes at inclusion
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Isabelle JALENQUES, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Estimated): May 5, 2026
• Study Completion (Estimated): November 5, 2026

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Genetic Diseases, Inborn; Neurodegenerative Diseases; Neurodevelopmental Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Basal Ganglia Diseases; Tic Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tourette Syndrome
• Other Study ID Numbers: RNI 2023 JALENQUES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No