Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007302

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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

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Organizational Data

  •   DRKS00007302
  •   2015/08/14
  •   2014/04/14
  •   yes
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Secondary IDs

  •   NCT02144870  (ClinicalTrials.gov)
  •   THICS-Study  (University of Cologne)
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Health Condition or Problem studied

  •   Tic-Disorder
  •   F95 -  Tic disorders
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Interventions/Observational Groups

  •   Behavioral: Habit Reversal Training
  •   Behavioral: Resources activation
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, assessor
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

- Change from baseline in Symptom Checklist for Tic-Symptoms (FBB-TIC, parent rating) at week 8, 16 and 24; time frame: eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3); The FBB-TIC is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by parents
- Change in Quality of Life (Tic-HRQoL-FBB)(parent rating); time frame: eight weeks (T1) and twenty-four weeks (T3); The Tic-HRQoL-FBB is used to assess impairment and quality of life through tic symptoms and other comorbid symptoms rated by parents

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Secondary Outcome

- Change in Symptom Checklist for Tic-Symptoms (FBB-/SBB-TIC), Teacher-/self-rating; time frame: eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3); The SBB-TIC is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by parents
- Change in Symptom Checklist for Tic-Symptoms, clinical rating; time frame: eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3); The Checklist is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by clinicians
- Change of comorbid ADHD Symptoms (FBB/SBB-ADHD), parent, teacher and self-rating; time frame: eight weeks (T1), and 24 weeks (T3); The Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-/SBB-ADHS) assess all symptom criteria according to DSM IV and ICD-10.
- Change of comorbid OCD Symptoms (ZWIK-E), parent-rating; time frame: eight weeks (T1), and 24 weeks (T3); The ZWIK assess OCD criteria.
- Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating; time frame: eight weeks (T1), and 24 weeks (T3); The CBCL, TRF and YSR assess a variation of different criteria.
- Change in self-esteem (Harter-Scale-SBB)(self rating); time frame: eight weeks (T1), and 24 weeks (T3); The Harter-Scale is used to assess self-esteem
- Change in Tic-Symptoms (YGTSS-TIC), overall score; time frame: eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3); The YGTSS is used to assess Tic-Symptoms in a semi structured interview with parents and patients
- Change in Tic-Symptoms (observation); time frame: 24 weeks (weekly assessment); Tic symptoms are observed through video tapes and are rated through clinicians.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2013/11/30
  •   100
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Inclusion Criteria

  •   Both, male and female
  •   8   Years
  •   18   Years
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Additional 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

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Exclusion Criteria

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

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Addresses

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    • University of Cologne
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    • Department of Childhood and Adolescent Psychiatry and Psychotherapy
    • Manfred Döpfner, Prof. Dr. 
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    • Department of Childhood and Adolescent Psychiatry and Psychotherapy
    • Manfred Döpfner, Prof. Dr. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.