Efficacy of Psychotherapy Treatment of Children With Tics

Tic-Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02144870
• Other study ID #: THICS-Study
• Status: Recruiting
• Phase: N/A
• First received: April 14, 2014
• Last updated: March 14, 2017
• Start date: November 2013
• Est. completion date: September 2017

Study information

• Verified date: March 2017
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Tic Disorders
• Tic-Disorder
• Tics

Intervention

Behavioral:
• Habit Reversal Training
awareness training, competing response training
• Resources activation

Locations

Country	Name	City	State
Germany	University Hospital of Cologne, Department of Childhood and Adolescent Psychiatry and Psychotherapy	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Change of comorbid OCD Symptoms (ZWIK-E), parent-rating	The ZWIK assess OCD criteria.	eight weeks (T1), and 24 weeks (T3)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Change in Tic-Symptoms (observation)	Tic symptoms are observed through video tapes and are rated through clinicians.	24 weeks (weekly assessment)