Tic-DisorderNCT02144870
Efficacy of Psychotherapy Treatment of Children With Tics
A study testing Habit Reversal Training and Resources activation in people with Tic-Disorder, run by University of Cologne at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Tic-Disorder
- What is being tested?
- Habit Reversal Training and Resources activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- No change in medication treatment is planned
- Ability to participate in weekly outpatient treatment
- Acceptance of randomization
Who cannot join
- Diagnosis of Autism Spectrum Disorder or Psychosis Parallel continuous psychotherapy of tics or comorbid -
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Cologne, Department of Childhood and Adolescent Psychiatry and Psychotherapy
Cologne, 50931
Katrin Woitecki, Dr, (+49)221-478-97991, Katrin.woitecki@uk-koeln.de
About this study
Official title: 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.
Read the 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
- Conditions
- Tic-Disorder
- Being tested
- Habit Reversal Training, Resources activation
- Keywords
- Tic-Disorder, Tourette-Disorder, Habit Reversal Training, Resources activation
- Medical subject headings
- Tics, Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habit Reversal TrainingBehavioural
awareness training, competing response training
Resources activationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Habit Reversal Training | Active comparator | 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. Receives: Behavioral: Habit Reversal Training |
| Resources activation | Active comparator | 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. Receives: Behavioral: Resources activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: eight weeks (T1) and twenty-four weeks (T3)
Secondary outcomes (8)
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
Measured: 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
Measured: 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.
Measured: eight weeks (T1), and 24 weeks (T3)
Change of comorbid OCD Symptoms (ZWIK-E), parent-rating
The ZWIK assess OCD criteria.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 24 weeks (weekly assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startNov 2013
- Primary completionJul 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tic-DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manfred Doepfner, University of Cologne
- Investigators
- Manfred Döpfner, Prof. Dr., Study director, Department of Childhood and Adolescent Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144870
- Sponsor's protocol ID
- THICS-Study
- Status last verified
- Mar 2017
- First submitted
- 14 Apr 2014
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial on the Efficacy of Habit Reversal Treatment Programme in Children and Adolescents - a Comparison With Resource Activation Treatment
- ClinicalTrials.gov ID
- NCT02144870
- Acronym / sponsor ID
- THICS-Study
- Conditions
- Tic-Disorder
- Keywords
- Tic-Disorder, Tourette-Disorder, Habit Reversal Training, Resources activation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 22 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Habit Reversal Training | Active comparator | Behavioral: Habit Reversal TrainingAt 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. |
| Resources activation | Active comparator | Behavioral: Resources activationAt 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- Diagnosis of Autism Spectrum Disorder or Psychosis Parallel continuous psychotherapy of tics or comorbid -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Habit Reversal Trainingawareness training, competing response training | Behavioural | Habit Reversal Training |
| Resources activation | Behavioural | Resources activation |
Primary outcome
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
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
8 secondary outcomes
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)
Change in Symptom Checklist for Tic-Symptoms, clinical rating
Time frame: 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)
Change of comorbid OCD Symptoms (ZWIK-E), parent-rating
Time frame: 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)
Change in self-esteem (Harter-Scale-SBB)(self rating)
Time frame: 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)
Change in Tic-Symptoms (observation)
Time frame: 24 weeks (weekly assessment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University Hospital of Cologne, Department of Childhood and Adolescent Psychiatry and Psychotherapy
Cologne, Germany
Manfred Döpfner, Prof. Dr. study director
Department of Childhood and Adolescent Psychiatry and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Habit Reversal Training and Resources activation in people with Tic-Disorder, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.