Efficacy of a Habit Reversal Treatment on Tic-symptoms

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

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.

Study Overview

• Status: Unknown
• Conditions: Tic-Disorder
• Intervention / Treatment: Behavioral: Habit Reversal Training

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).

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50931
    • Recruiting
    • University Hospital of Cologne, Department of Childhood and Adolescent Psychiatry and Psychotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Habit Reversal Training; 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; awareness training, competing response training

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Cologne

Publications and helpful links

General Publications

• 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.
• 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.
• Woitecki, K. & Döpfner, M. (2014). Therapieprogramm für Kinder und Jugendliche mit Tic-Störungen (THICS). Göttingen: Hogrefe.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: April 14, 2014
• First Submitted That Met QC Criteria: July 12, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Actual): March 15, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Tic-Disorder, Tourette-Disorder, Habit Reversal Training
• Additional Relevant MeSH Terms: Mental Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Neurodevelopmental Disorders; Tic Disorders; Tics
• Other Study ID Numbers: THICS-Study 2