Efficacy of a Resources Activation Treatment on Tic-symptoms

Tic-Disorder Clinical Trial

Official title:

Within Subject Design on the Efficacy of a Resources Activation Treatment Programme in Children and Adolescents With Tics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02190370
• Other study ID #: THICS-Study 3
• Status: Recruiting
• Phase: N/A
• First received: April 14, 2014
• Last updated: March 14, 2017
• Start date: November 2013
• Est. completion date: August 2017

Study information

• Verified date: March 2017
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

• 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

Related Conditions & MeSH terms

• Tic Disorders
• Tic-Disorder
• Tics

Intervention

Behavioral:
• Resources activation

Locations

Country	Name	City	State
Germany	University Hospital of Cologne, Department of Childhood and Adolescent Psychiatry and Psychotherapy	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Perri, D., Mandler, J. & Döpfner, M. (2015). STARK - Supportive Therapie zur Aktivierung von Ressourcen. Göttingen: Hogrefe.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Symptom Checklist for Tic-Symptoms (FBB-TIC), parent rating	The FBB-TIC is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by parents	Baseline (T0), after 8 weeks (T1), 16weeks (T2), 24weeks (T3)
Primary	Change in self-esteem (Harter-Scale-SBB)(self rating)	The Harter-Scale is used to assess self-esteem	T0, after 8 weeks (T1), 24weeks (T3)
Secondary	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	Baseline (T0), after 8 weeks (T1), 16 weeks (T2), 24weeks (T3)
Secondary	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	Baseline (T0), after 8 weeks (T1), 16weeks (T2), 24weeks (T3)
Secondary	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.	T0, after 8 weeks (T1), 24 weeks (T3)
Secondary	Change of comorbid OCD Symptoms (ZWIK-E), parent-rating	The ZWIK assess OCD criteria.	T0, after 8 weeks (T1), 24weeks (T3)
Secondary	Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating	The CBCL, TRF and YSR assess a variation of different criteria.	T0, after 8 weeks (T1), 24weeks (T3)
Secondary	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	Baseline (T0), after 8 weeks (T1),16weeks (T2), 24weeks (T3)
Secondary	Change in Tic-Symptoms (observation)	Tic symptoms are observed through video tapes and are rated through clinicians	Between T1 and T3 up to 16 weeks, during each session/week