ClinicalTrials.gg
Status unknownNCT02144870Updated Mar 16, 2017

Efficacy of Psychotherapy Treatment of Children With Tics

An interventional study of Habit Reversal Training and Resources activation in Tic-Disorder, sponsored by University of Cologne. Status unknown at 1 site in Germany. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-03-16.

Sponsored by University of Cologne · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
8 Years to 18 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Tic-Disorder

Keywords

  • Tic-Disorder, Tourette-Disorder, Habit Reversal Training, Resources activation
03

In context

Tics

65 studies on the registry are indexed under Tics; 11 are open to participants now.

This study's planned enrollment of 100 is above the median of 34 across 51 interventional studies indexed under Tics.

Browse Tics studies →

Lead sponsor

University of Cologne is the lead sponsor of 203 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Diagnosis of Autism Spectrum Disorder or Psychosis Parallel continuous psychotherapy of tics or comorbid -

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralHabit Reversal Training

    awareness training, competing response training

  • BehavioralResources activation
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)

  2. 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

    Time frame: eight weeks (T1) and twenty-four weeks (T3)

Secondary outcomes

  1. 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

    Time frame: eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)

  2. 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

    Time frame: eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)

  3. 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.

    Time frame: eight weeks (T1), and 24 weeks (T3)

  4. Change of comorbid OCD Symptoms (ZWIK-E), parent-rating

    The ZWIK assess OCD criteria.

    Time frame: eight weeks (T1), and 24 weeks (T3)

  5. Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating

    The CBCL, TRF and YSR assess a variation of different criteria.

    Time frame: eight weeks (T1), and 24 weeks (T3)

  6. Change in self-esteem (Harter-Scale-SBB)(self rating)

    The Harter-Scale is used to assess self-esteem

    Time frame: eight weeks (T1), and 24 weeks (T3)

  7. 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

    Time frame: eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)

  8. Change in Tic-Symptoms (observation)

    Tic symptoms are observed through video tapes and are rated through clinicians.

    Time frame: 24 weeks (weekly assessment)

07

Study locations

1 of 1 sites recruiting
  • University Hospital of Cologne, Department of Childhood and Adolescent Psychiatry and Psychotherapy
    Cologne, 50931, Germany
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2013, a primary completion of Jul 2017 and a completion of Sep 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 14, 2014
First posted
May 22, 2014
Start
Nov 2013
Primary completionEst.
Jul 2017
CompletionEst.
Sep 2017
Last update
Mar 16, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02144870
Responsible party
Manfred Doepfner (Leading psychologist at the Department of Childhood and Adolescence Psychiatry, University of Cologne) — Principal investigator
First posted
May 22, 2014
Start date
Nov 2013
Primary completion
Jul 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
Mar 16, 2017

Study contacts

Manfred Döpfner, Prof. Dr.
study director · Department of Childhood and Adolescent Psychiatry and Psychotherapy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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