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Efficacy of a Habit Reversal Treatment on Tic-symptoms

Primary Purpose

Tic-Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Habit Reversal Training
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tic-Disorder focused on measuring Tic-Disorder, Tourette-Disorder, Habit Reversal Training

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Cologne, Department of Childhood and Adolescent Psychiatry and PsychotherapyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Habit Reversal Training

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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.
Change of comorbid OCD Symptoms (ZWIK-E), parent-rating
The ZWIK assess OCD criteria.
Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating
The CBCL, TRF and YSR assess a variation of different criteria.
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
Change in Tic-Symptoms (observation)
Tic symptoms are observed through video tapes and are rated through clinicians.
Change in self-esteem (Harter-Scale-SBB)(self rating)
The Harter-Scale is used to assess self-esteem

Full Information

First Posted
April 14, 2014
Last Updated
March 14, 2017
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT02190383
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tic-Disorder
Keywords
Tic-Disorder, Tourette-Disorder, Habit Reversal Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manfred Döpfner, Prof. Dr.
Organizational Affiliation
Department of Childhood and Adolescent Psychiatry and Psychotherapy
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Cologne, Department of Childhood and Adolescent Psychiatry and Psychotherapy
City
Cologne
ZIP/Postal Code
50931
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrin Woitecki, Dr
Phone
(+49)221-478-97991
Email
Tic-Ambulanz@uk-koeln.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
22532110
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.
Results Reference
background
PubMed Identifier
22031011
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.
Results Reference
background
Citation
Woitecki, K. & Döpfner, M. (2014). Therapieprogramm für Kinder und Jugendliche mit Tic-Störungen (THICS). Göttingen: Hogrefe.
Results Reference
background

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Efficacy of a Habit Reversal Treatment on Tic-symptoms

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