Efficacy of Psychotherapy Treatment of Children With Tics

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

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.

Study Overview

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

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• 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
    • Contact: Katrin Woitecki, Dr; Phone Number: (+49)221-478-97991; Email: Katrin.woitecki@uk-koeln.de

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
• 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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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
Active Comparator: Resources activation; 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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Cologne

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: April 14, 2014
• First Submitted That Met QC Criteria: May 19, 2014
• First Posted (Estimate): May 22, 2014

Study Record Updates

• Last Update Posted (Actual): March 16, 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, Resources activation
• 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