Efficacy of a Habit Reversal Treatment on Tic-symptoms

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the efficacy of a habit reversal based treatment programme in children and adolescents aged 8 to 18 years with tic disorders.

Detailed Description
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The main purpose of this study is to evaluate the efficacy of a habit reversal based treatment programme for children and adolescents with tic disorders. This habit reversal treatment programme was developed at the Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne and has already been evaluated in a pilot-study (Woitecki & Döpfner, 2011, 2012).

Official Title
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Within Subject Design on the Efficacy of Habit Reversal Treatment Programme in Children and Adolescents With Tics

Conditions
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Tic-Disorder

Intervention / Treatment
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* Behavioral: Habit Reversal Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 8-18 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 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 Exclusion Criteria: Diagnosis of Autism Spectrum Disorder or Psychosis Parallel continuous psychotherapy of tics or comorbid

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Habit Reversal Training<br>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<br>* awareness training, competing response training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Symptom Checklist for Tic-Symptoms (FBB-TIC), parent rating | The FBB-TIC is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by parents | Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24weeks (T3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Symptom Checklist for Tic-Symptoms (FBB-/SBB-TIC), Teacher-/self-rating | The SBB-TIC is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by parents | Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24weeks (T3) | 
| Change in Symptom Checklist for Tic-Symptoms, clinical rating | The Checklist is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by clinicians | Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24 weeks (T3) | 
| Change of comorbid ADHD Symptoms (FBB/SBB-ADHD), parent, teacher and self-rating | The Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-/SBB-ADHS) assess all symptom criteria according to DSM IV and ICD-10. | T0, after 8 weeks (T1), 24weeks (T3) | 
| Change of comorbid OCD Symptoms (ZWIK-E), parent-rating | The ZWIK assess OCD criteria. | T0, after 8 weeks (T1), 24 weeks (T3) | 
| Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating | The CBCL, TRF and YSR assess a variation of different criteria. | T0, after 8weeks (T1), 24weeks (T3) | 
| Change in Tic-Symptoms (YGTSS-TIC), overall score | The YGTSS is used to assess Tic-Symptoms in a semi structured interview with parents and patients | Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24weeks (T3) | 
| Change in Tic-Symptoms (observation) | Tic symptoms are observed through video tapes and are rated through clinicians. | Between T1 and T3 up to 16 weeks, during each session/week | 
| Change in self-esteem (Harter-Scale-SBB)(self rating) | The Harter-Scale is used to assess self-esteem | T0, after 8 weeks (T1), 24weeks (T3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tic-Disorder, Tourette-Disorder, Habit Reversal Training