Clinical trial NCT02144870: Efficacy of Psychotherapy Treatment of Children With Tics
Official title: Randomized Control Trial on the Efficacy of Habit Reversal Treatment Programme in Children and Adolescents - a Comparison With Resource Activation Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tic-Disorder
Keywords: Tic-Disorder, Tourette-Disorder, Habit Reversal Training, Resources activation
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2014-05-22
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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 -

Primary outcomes:
measure: Change from baseline in Symptom Checklist for Tic-Symptoms (FBB-TIC, parent rating) at week 8, 16 and 24
timeFrame: eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)
measure: Change in Quality of Life (Tic-HRQoL-FBB)(parent rating)
timeFrame: eight weeks (T1) and twenty-four weeks (T3)
Secondary outcomes:
measure: Change in Symptom Checklist for Tic-Symptoms (FBB-/SBB-TIC), Teacher-/self-rating
timeFrame: eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)
measure: Change in Symptom Checklist for Tic-Symptoms, clinical rating
timeFrame: eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)
measure: Change of comorbid ADHD Symptoms (FBB/SBB-ADHD), parent, teacher and self-rating
timeFrame: eight weeks (T1), and 24 weeks (T3)
measure: Change of comorbid OCD Symptoms (ZWIK-E), parent-rating
timeFrame: eight weeks (T1), and 24 weeks (T3)
measure: Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating
timeFrame: eight weeks (T1), and 24 weeks (T3)
measure: Change in self-esteem (Harter-Scale-SBB)(self rating)
timeFrame: eight weeks (T1), and 24 weeks (T3)
measure: Change in Tic-Symptoms (YGTSS-TIC), overall score
timeFrame: eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)
measure: Change in Tic-Symptoms (observation)
timeFrame: 24 weeks (weekly assessment)
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne, Department of Childhood and Adolescent Psychiatry and Psychotherapy
Study officials:
affiliation: Department of Childhood and Adolescent Psychiatry and Psychotherapy
name: Manfred Döpfner, Prof. Dr.
role: STUDY_DIRECTOR
References: