Efficacy of Psychotherapy Treatment of Children With Tics

March 14, 2017 updated by: Manfred Doepfner, University of Cologne

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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
eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)
Change in Quality of Life (Tic-HRQoL-FBB)(parent rating)
Time Frame: 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
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
Time Frame: 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
eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)
Change in Symptom Checklist for Tic-Symptoms, clinical rating
Time Frame: 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
eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)
Change of comorbid ADHD Symptoms (FBB/SBB-ADHD), parent, teacher and self-rating
Time Frame: 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.
eight weeks (T1), and 24 weeks (T3)
Change of comorbid OCD Symptoms (ZWIK-E), parent-rating
Time Frame: eight weeks (T1), and 24 weeks (T3)
The ZWIK assess OCD criteria.
eight weeks (T1), and 24 weeks (T3)
Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating
Time Frame: eight weeks (T1), and 24 weeks (T3)
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)
Time Frame: eight weeks (T1), and 24 weeks (T3)
The Harter-Scale is used to assess self-esteem
eight weeks (T1), and 24 weeks (T3)
Change in Tic-Symptoms (YGTSS-TIC), overall score
Time Frame: 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
eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)
Change in Tic-Symptoms (observation)
Time Frame: 24 weeks (weekly assessment)
Tic symptoms are observed through video tapes and are rated through clinicians.
24 weeks (weekly assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THICS-Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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