Efficacy of a Resources Activation Treatment on Tic-symptoms

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

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.

Study Overview

• Status: Unknown
• Conditions: Tic-Disorder
• Intervention / Treatment: Behavioral: Resources activation

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50931
    • Recruiting
    • University Hospital of Cologne, Department of Childhood and Adolescent Psychiatry and Psychotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
Change of comorbid OCD Symptoms (ZWIK-E), parent-rating	The ZWIK assess OCD criteria.	T0, after 8 weeks (T1), 24weeks (T3)
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)
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)
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

Collaborators and Investigators

• Sponsor: University of Cologne

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ANTICIPATED): June 1, 2017
• Study Completion (ANTICIPATED): August 1, 2017

Study Registration Dates

• First Submitted: April 14, 2014
• First Submitted That Met QC Criteria: July 12, 2014
• First Posted (ESTIMATE): July 15, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Tic-Disorder, Tourette-Disorder, Resources activation
• Additional Relevant MeSH Terms: Mental Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Neurodevelopmental Disorders; Tic Disorders; Tics
• Other Study ID Numbers: THICS-Study 3