Within Subject Design on the Efficacy of a Resources Activation Treatment Programme in Children and Adolescents With Tics
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Cologne
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Change in self-esteem (Harter-Scale-SBB)(self rating)
Study Overview
Brief Summary
The main purpose of this study is to evaluate the efficacy of a resources activation based treatment programme 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 an intervention aimed at the activation of resources for children and adolescents with tic disorders. The activation of resources treatment programme was developed at Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne and is currently evaluated in different studies.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
Change in self-esteem (Harter-Scale-SBB)(self rating)
Time Frame: T0, after 8 weeks (T1), 24weeks (T3)
The Harter-Scale is used to assess self-esteem
Change in Symptom Checklist for Tic-Symptoms (FBB-TIC), parent rating
Time Frame: Baseline (T0), after 8 weeks (T1), 16weeks (T2), 24weeks (T3)
The FBB-TIC is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by parents
Secondary Outcomes
- Change of comorbid ADHD Symptoms (FBB/SBB-ADHD), parent, teacher and self-rating(T0, after 8 weeks (T1), 24 weeks (T3))
- Change in Symptom Checklist for Tic-Symptoms (FBB-/SBB-TIC), Teacher-/self-rating(Baseline (T0), after 8 weeks (T1), 16 weeks (T2), 24weeks (T3))
- Change in Symptom Checklist for Tic-Symptoms, clinical rating(Baseline (T0), after 8 weeks (T1), 16weeks (T2), 24weeks (T3))
- Change in Tic-Symptoms (observation)(Between T1 and T3 up to 16 weeks, during each session/week)
- Change of comorbid OCD Symptoms (ZWIK-E), parent-rating(T0, after 8 weeks (T1), 24weeks (T3))
- Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating(T0, after 8 weeks (T1), 24weeks (T3))
- Change in Tic-Symptoms (YGTSS-TIC), overall score(Baseline (T0), after 8 weeks (T1),16weeks (T2), 24weeks (T3))
Investigators
Manfred Doepfner
Leading psychologist at the Department of Childhood and Adolescence Psychiatry
University of Cologne