Efficacy of Psychotherapy Treatment of Children With Tics

Not Applicable

• Conditions: Tic-Disorder
• Interventions: Behavioral: Resources activation; Behavioral: Habit Reversal Training

• Registration Number: NCT02144870
• Lead Sponsor: University of Cologne

Brief Summary

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.

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-04-14
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-22
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-03-16
• Primary Completion: 2017-07
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resources activation	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.
Habit Reversal Training	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Symptom Checklist for Tic-Symptoms (FBB-TIC, parent rating) at week 8, 16 and 24	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)	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

Secondary Outcome Measures

Name	Time	Method
Change in Symptom Checklist for Tic-Symptoms (FBB-/SBB-TIC), Teacher-/self-rating	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 of comorbid ADHD Symptoms (FBB/SBB-ADHD), parent, teacher and self-rating	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	eight weeks (T1), and 24 weeks (T3)	The ZWIK assess OCD criteria.
Change in self-esteem (Harter-Scale-SBB)(self rating)	eight weeks (T1), and 24 weeks (T3)	The Harter-Scale is used to assess self-esteem
Change in Tic-Symptoms (observation)	24 weeks (weekly assessment)	Tic symptoms are observed through video tapes and are rated through clinicians.
Change in Tic-Symptoms (YGTSS-TIC), overall score	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 Symptom Checklist for Tic-Symptoms, clinical rating	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 Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating	eight weeks (T1), and 24 weeks (T3)	The CBCL, TRF and YSR assess a variation of different criteria.

Trial Locations

Locations (1)

University Hospital of Cologne, Department of Childhood and Adolescent Psychiatry and Psychotherapy; 🇩🇪 Cologne, Germany