Efficacy of Psychotherapy Treatment of Children With Tics

NCT02144870 | Unknown

• 1 other identifier: THICS-Study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate the efficacy of a habit reversal based treatment programme compared to an alternative treatment which aims at the activation of resources in children and adolescents aged 8 to 18 years with tic disorders.

Conditions

Tic-Disorder

Keywords

Tic-Disorder, Tourette-Disorder, Habit Reversal Training, Resources activation

Outcome Measures

Primary Outcomes (2)

• Change from baseline in Symptom Checklist for Tic-Symptoms (FBB-TIC, parent rating) at week 8, 16 and 24

  The FBB-TIC is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by parents

  eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)

• Change in Quality of Life (Tic-HRQoL-FBB)(parent rating)

  The Tic-HRQoL-FBB is used to assess impairment and quality of life through tic symptoms and other comorbid symptoms rated by parents

  eight weeks (T1) and twenty-four weeks (T3)

Secondary Outcomes (8)

• Change in Symptom Checklist for Tic-Symptoms (FBB-/SBB-TIC), Teacher-/self-rating

  eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)

• Change in Symptom Checklist for Tic-Symptoms, clinical rating

  eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)

• Change of comorbid ADHD Symptoms (FBB/SBB-ADHD), parent, teacher and self-rating

  eight weeks (T1), and 24 weeks (T3)

• Change of comorbid OCD Symptoms (ZWIK-E), parent-rating

  eight weeks (T1), and 24 weeks (T3)

• Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating

  eight weeks (T1), and 24 weeks (T3)

Study Arms (2)

Habit Reversal Training

ACTIVE COMPARATOR

At first patients get informed about Tics in general. Then the individual Tics are specified and the tic-reaction is looked at further. The Tic-Symptoms are observed and the premonitory urge is specified. For all individual tics a specific reversal movement is developed. Relaxation methods are introduced.

Behavioral: Habit Reversal Training

Resources activation

ACTIVE COMPARATOR

At first patients get informed about Tics in general. Through different exercises existing resources and skills are activated and strengthened. Feeling of self-esteem and self-respect are strengthened. Also the emotional awareness is strengthened. Relaxation methods are also introduced.

Behavioral: Resources activation

Interventions

Habit Reversal Training BEHAVIORAL

awareness training, competing response training

Habit Reversal Training

Resources activation BEHAVIORAL

Resources activation

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years
• Diagnosis of chronic motor or vocal Tic (F95.1) or Tourette-Syndrome (F95.2)
• YGTSS total score F95.2\>13, F95.1\>9
• Tics are the main problems
• Intelligence IQ\>80
• If medication, then has been stable for at least one months in medicated patients
• No change in medication treatment is planned
• Ability to participate in weekly outpatient treatment
• Acceptance of randomization

You may not qualify if:

• Diagnosis of Autism Spectrum Disorder or Psychosis Parallel continuous psychotherapy of tics or comorbid -

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University Hospital of Cologne, Department of Childhood and Adolescent Psychiatry and Psychotherapy

Cologne, 50931, Germany

RECRUITING

MeSH Terms

Conditions

Tics; Tourette Syndrome

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Manfred Döpfner, Prof. Dr.

  Department of Childhood and Adolescent Psychiatry and Psychotherapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leading psychologist at the Department of Childhood and Adolescence Psychiatry

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: May 22, 2014
• Study Start: November 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 16, 2017

Record last verified: 2017-03

Locations

DE (1)