Efficacy of Psychotherapy Treatment of Children With Tics

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 compared to an alternative treatment which aims at the activation of resources 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 (THICS, Woitecki & Döpfner, 2014) compared to an intervention aimed at the activation of resources (STARK, Perri et al., 2014) 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). The activation of resources treatment programme was also developed at this Department and is currently evaluated in different studies. Effects are expected in both interventions, but a larger effect is expected in the THICS treatment

Official Title
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Randomized Control Trial on the Efficacy of Habit Reversal Treatment Programme in Children and Adolescents - a Comparison With Resource Activation Treatment

Conditions
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Tic-Disorder

Intervention / Treatment
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* Behavioral: Habit Reversal Training
* Behavioral: Resources activation


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 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 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 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>|
| Active Comparator: Resources activation<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | eight weeks (T1), sixteen weeks (T2) and 24 weeks (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 | eight weeks (T1), sixteen 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. | eight weeks (T1), and 24 weeks (T3) | 
| Change of comorbid OCD Symptoms (ZWIK-E), parent-rating | The ZWIK assess OCD criteria. | eight weeks (T1), and 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. | eight weeks (T1), and 24 weeks (T3) | 
| Change in self-esteem (Harter-Scale-SBB)(self rating) | The Harter-Scale is used to assess self-esteem | eight weeks (T1), and 24 weeks (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 | eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3) | 
| Change in Tic-Symptoms (observation) | Tic symptoms are observed through video tapes and are rated through clinicians. | 24 weeks (weekly assessment) | 

 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, Resources activation