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Efficacy of Psychotherapy Treatment of Children With Tics

Primary Purpose

Tic-Disorder

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Habit Reversal Training

Resources activation

About this trial

This is an interventional treatment trial for Tic-Disorder focused on measuring Tic-Disorder, Tourette-Disorder, Habit Reversal Training, Resources activation

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Habit Reversal Training

Resources activation

Arm Description

At first patients get informed about Tics in general. Then the individual Tics are specified and the tic-reaction is looked at further. The Tic-Symptoms are observed and the premonitory urge is specified. For all individual tics a specific reversal movement is developed. Relaxation methods are introduced.

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.

Outcomes

Primary Outcome Measures

Change from baseline in Symptom Checklist for Tic-Symptoms (FBB-TIC, parent rating) at week 8, 16 and 24

The FBB-TIC is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by parents

Change in Quality of Life (Tic-HRQoL-FBB)(parent rating)

The Tic-HRQoL-FBB is used to assess impairment and quality of life through tic symptoms and other comorbid symptoms rated by parents

Secondary Outcome Measures

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

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

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.

Change of comorbid OCD Symptoms (ZWIK-E), parent-rating

The ZWIK assess OCD criteria.

Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating

The CBCL, TRF and YSR assess a variation of different criteria.

Change in self-esteem (Harter-Scale-SBB)(self rating)

The Harter-Scale is used to assess self-esteem

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

Change in Tic-Symptoms (observation)

Tic symptoms are observed through video tapes and are rated through clinicians.

Full Information

NCT ID

NCT02144870

First Posted

April 14, 2014

Last Updated

March 14, 2017

Sponsor

University of Cologne

1. Study Identification

Unique Protocol Identification Number

NCT02144870

Brief Title

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

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 2013 (undefined)

Primary Completion Date

July 2017 (Anticipated)

Study Completion Date

September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cologne

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tic-Disorder

Keywords

Tic-Disorder, Tourette-Disorder, Habit Reversal Training, Resources activation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Habit Reversal Training

Arm Type

Active Comparator

Arm Description

Arm Title

Resources activation

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Habit Reversal Training

Intervention Description

awareness training, competing response training

Intervention Type

Behavioral

Intervention Name(s)

Resources activation

Primary Outcome Measure Information:

Title

Change from baseline in Symptom Checklist for Tic-Symptoms (FBB-TIC, parent rating) at week 8, 16 and 24

Description

The FBB-TIC is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by parents

Time Frame

eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)

Title

Change in Quality of Life (Tic-HRQoL-FBB)(parent rating)

Description

The Tic-HRQoL-FBB is used to assess impairment and quality of life through tic symptoms and other comorbid symptoms rated by parents

Time Frame

eight weeks (T1) and twenty-four weeks (T3)

Secondary Outcome Measure Information:

Title

Change in Symptom Checklist for Tic-Symptoms (FBB-/SBB-TIC), Teacher-/self-rating

Description

The SBB-TIC is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by parents

Time Frame

eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)

Title

Change in Symptom Checklist for Tic-Symptoms, clinical rating

Description

The Checklist is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by clinicians

Time Frame

eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)

Title

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

Description

The Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-/SBB-ADHS) assess all symptom criteria according to DSM IV and ICD-10.

Time Frame

eight weeks (T1), and 24 weeks (T3)

Title

Change of comorbid OCD Symptoms (ZWIK-E), parent-rating

Description

The ZWIK assess OCD criteria.

Time Frame

eight weeks (T1), and 24 weeks (T3)

Title

Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating

Description

The CBCL, TRF and YSR assess a variation of different criteria.

Time Frame

eight weeks (T1), and 24 weeks (T3)

Title

Change in self-esteem (Harter-Scale-SBB)(self rating)

Description

The Harter-Scale is used to assess self-esteem

Time Frame

eight weeks (T1), and 24 weeks (T3)

Title

Change in Tic-Symptoms (YGTSS-TIC), overall score

Description

The YGTSS is used to assess Tic-Symptoms in a semi structured interview with parents and patients

Time Frame

eight weeks (T1), sixteen weeks (T2) and 24 weeks (T3)

Title

Change in Tic-Symptoms (observation)

Description

Tic symptoms are observed through video tapes and are rated through clinicians.

Time Frame

24 weeks (weekly assessment)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manfred Döpfner, Prof. Dr.

Organizational Affiliation

Department of Childhood and Adolescent Psychiatry and Psychotherapy

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Cologne

ZIP/Postal Code

50931

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katrin Woitecki, Dr

Phone

(+49)221-478-97991

Katrin.woitecki@uk-koeln.de

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Psychotherapy Treatment of Children With Tics

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