Clinical trial NCT02190383: Efficacy of a Habit Reversal Treatment on Tic-symptoms
Official title: Within Subject Design on the Efficacy of Habit Reversal Treatment Programme in Children and Adolescents With Tics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tic-Disorder
Keywords: Tic-Disorder, Tourette-Disorder, Habit Reversal Training
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Symptom Checklist for Tic-Symptoms (FBB-TIC), parent rating
timeFrame: Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24weeks (T3)
Secondary outcomes:
measure: Change in Symptom Checklist for Tic-Symptoms (FBB-/SBB-TIC), Teacher-/self-rating
timeFrame: Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24weeks (T3)
measure: Change in Symptom Checklist for Tic-Symptoms, clinical rating
timeFrame: Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24 weeks (T3)
measure: Change of comorbid ADHD Symptoms (FBB/SBB-ADHD), parent, teacher and self-rating
timeFrame: T0, after 8 weeks (T1), 24weeks (T3)
measure: Change of comorbid OCD Symptoms (ZWIK-E), parent-rating
timeFrame: T0, after 8 weeks (T1), 24 weeks (T3)
measure: Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating
timeFrame: T0, after 8weeks (T1), 24weeks (T3)
measure: Change in Tic-Symptoms (YGTSS-TIC), overall score
timeFrame: Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24weeks (T3)
measure: Change in Tic-Symptoms (observation)
timeFrame: Between T1 and T3 up to 16 weeks, during each session/week
measure: Change in self-esteem (Harter-Scale-SBB)(self rating)
timeFrame: T0, after 8 weeks (T1), 24weeks (T3)
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne, Department of Childhood and Adolescent Psychiatry and Psychotherapy
Study officials:
affiliation: Department of Childhood and Adolescent Psychiatry and Psychotherapy
name: Manfred Döpfner, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Woitecki K, Dopfner M. [Changes in comorbid symptoms and subjective interference in a habit reversal therapy in children with chronic tic disorder - a pilot study]. Z Kinder Jugendpsychiatr Psychother. 2012 May;40(3):181-90. doi: 10.1024/1422-4917/a000168. German.
citation: Woitecki K, Dopfner M. [Effects of habit reversal training in children with chronic tic disorder - a pilot study]. Z Kinder Jugendpsychiatr Psychother. 2011 Nov;39(6):387-97. doi: 10.1024/1422-4917/a000137. German.
citation: Woitecki, K. & Döpfner, M. (2014). Therapieprogramm für Kinder und Jugendliche mit Tic-Störungen (THICS). Göttingen: Hogrefe.