NCT02190370

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 15, 2017

Status Verified

March 1, 2017

Enrollment Period

3.6 years

First QC Date

April 14, 2014

Last Update Submit

March 14, 2017

Conditions

Tic-Disorder

Keywords

Tic-Disorder, Tourette-Disorder, Resources activation

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (7)

  • 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 of comorbid ADHD Symptoms (FBB/SBB-ADHD), parent, teacher and self-rating

    T0, after 8 weeks (T1), 24 weeks (T3)

  • 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)

  • +2 more secondary outcomes

Study Arms (1)

Resources activation

EXPERIMENTAL

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

Resources activationBEHAVIORAL
Resources activation

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Cologne, Department of Childhood and Adolescent Psychiatry and Psychotherapy

Cologne, 50931, Germany

RECRUITING

Related Publications (1)

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

    BACKGROUND

MeSH Terms

Conditions

TicsTourette Syndrome

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental Disorders

Study Officials

  • Manfred Döpfner, Prof. Dr.

    Department of Childhood and Adolescent Psychiatry and Psychotherapy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Leading psychologist at the Department of Childhood and Adolescence Psychiatry

Study Record Dates

First Submitted

April 14, 2014

First Posted

July 15, 2014

Study Start

November 1, 2013

Primary Completion

June 1, 2017

Study Completion

August 1, 2017

Last Updated

March 15, 2017

Record last verified: 2017-03

Locations

DE(1)