Group Intervention for Children With Chronic Tics Syndrome or Tourette Syndrome: CBIT vs Psycho-Educational Intervention
Primary Purpose
Tourette Syndrome, Motor or Vocal Tic Disorder, Chronic
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CBIT group
Psycho-Educational group
Sponsored by
About this trial
This is an interventional treatment trial for Tourette Syndrome
Eligibility Criteria
Inclusion Criteria:
- diagnosis of Tourettes syndrome or chronic tic disorder
- age 9-15 years
- native Hebrew speakers
Exclusion Criteria:
- intellectual disability (FSIQ < 80)
- current diagnosis of substance abuse/dependence
- life time diagnosis of pervasive developmental disorder, mania or psychosis.
- previous treatment with 4 or more individual sessions of CBIT
Children receiving medications for tics: eligible if the dose is stable for 6 weeks prior to study with no planned changes during study participation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CBIT group
Psycho-Educational group
Arm Description
Outcomes
Primary Outcome Measures
Yale Global Tic Severity Scale
semi-structured clinical interview carried out with parent and child. Questions relate to tic severity over the previous week. Separate ratings are recorded for motor and phonic tics in terms of their number, frequency, intensity, complexity, and interference on a 6-point Likert scale. Three composite scores are generated which are total motor tic severity (rated from 0 to 25), total phonic tic severity (rated from 0 to 25) and total tic severity overall (rated from 0 to 50).
Secondary Outcome Measures
Full Information
NCT ID
NCT02407951
First Posted
March 31, 2015
Last Updated
March 31, 2015
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02407951
Brief Title
Group Intervention for Children With Chronic Tics Syndrome or Tourette Syndrome: CBIT vs Psycho-Educational Intervention
Official Title
Tel Aviv Sourasky Medical Center
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Tourette Syndrome (TS) is a disorder characterized by motor and vocal tics. The most studied and promising intervention is Habit Reversal Training (HRT) and its variations: Behavioral Comprehensive Intervention for Tics (CBIT). Group intervention for children with TS has not been evaluated. The aim of this study is to assess the efficacy of CBIT group intervention compared with Psycho-Educational-Supportive group in terms of tic severity.
Detailed Description
Tourette Syndrome (TS) is a neuro-developmental disorder characterized by motor and vocal tics, frequently associated with behavioral and functional problems, impacting significantly on children's quality of life . Current evidence supports the contribution of individual behavioral treatment for TS both for reducing tics and improving children's quality of life. The most studied and promising intervention is Habit Reversal Training (HRT) and its variations: Behavioral Comprehensive Intervention for Tics (CBIT). One of the developments of behavioral treatments is group interventions, supported in various types of psychological difficulties, adding benefit of providing peer support. However, group intervention for children with TS has not been empirically evaluated.
The aim of this study is to assess the efficacy of CBIT group intervention. We hypothesize that CBIT group intervention will be more effective than Psycho-Educational-Supportive (PES) group in terms of tic severity, and that both groups will be effective in quality of life measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome, Motor or Vocal Tic Disorder, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBIT group
Arm Type
Experimental
Arm Title
Psycho-Educational group
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
CBIT group
Intervention Description
Child group: 8 weekly group sessions lasting 90 mins, additional three monthly booster sessions.
During sessions, children create a tic hierarchy from most to least distressing, with more distressing tics addressed earlier in the treatment. Awareness training and competing response training is implemented and practiced. Competing response training is added, involving engagement in a voluntary behavior physically incompatible with the tic, contingent on the premonitory urge or other signs of impeding tic occurrence. Relaxation training addresses situations that sustained or worsened tics, training focuses on developing individual behavioral strategies to reduce the influence of these factor.
Parallel parent-group sessions simultaneously run during first 4 sessions of child-group. parents-group includes psycho-education and use of reward strategies.
Meetings executed by two trained clinicians.
Intervention Type
Behavioral
Intervention Name(s)
Psycho-Educational group
Intervention Description
Child group: 8 weekly group sessions lasting 90 mins each, as well as additional three monthly booster sessions afterwards.
During the educational group sessions, each session will focus on educating the participants in regard to a specific subject: Tourette syndrome, Self-esteem, Anger, OCD (obssesive compulsive disorder), School and bullying, Anxiety, Attention, and a final session Quiz.
Parent group: Parent-group sessions will simultaneously run during the first 4 sessions of the child-group. The parents-group will include psycho-education and the use of reward strategies.
All group meetings will be executed and managed by two trained clinicians.
Primary Outcome Measure Information:
Title
Yale Global Tic Severity Scale
Description
semi-structured clinical interview carried out with parent and child. Questions relate to tic severity over the previous week. Separate ratings are recorded for motor and phonic tics in terms of their number, frequency, intensity, complexity, and interference on a 6-point Likert scale. Three composite scores are generated which are total motor tic severity (rated from 0 to 25), total phonic tic severity (rated from 0 to 25) and total tic severity overall (rated from 0 to 50).
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of Tourettes syndrome or chronic tic disorder
age 9-15 years
native Hebrew speakers
Exclusion Criteria:
intellectual disability (FSIQ < 80)
current diagnosis of substance abuse/dependence
life time diagnosis of pervasive developmental disorder, mania or psychosis.
previous treatment with 4 or more individual sessions of CBIT
Children receiving medications for tics: eligible if the dose is stable for 6 weeks prior to study with no planned changes during study participation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Rotstein, MD
Phone
972-36974517
Email
michaelr@tlvmc.gov.il
12. IPD Sharing Statement
Citations:
PubMed Identifier
21555779
Citation
Woods DW, Piacentini JC, Scahill L, Peterson AL, Wilhelm S, Chang S, Deckersbach T, McGuire J, Specht M, Conelea CA, Rozenman M, Dzuria J, Liu H, Levi-Pearl S, Walkup JT. Behavior therapy for tics in children: acute and long-term effects on psychiatric and psychosocial functioning. J Child Neurol. 2011 Jul;26(7):858-65. doi: 10.1177/0883073810397046. Epub 2011 May 9.
Results Reference
background
PubMed Identifier
33415472
Citation
Zimmerman-Brenner S, Pilowsky-Peleg T, Rachamim L, Ben-Zvi A, Gur N, Murphy T, Fattal-Valevski A, Rotstein M. Group behavioral interventions for tics and comorbid symptoms in children with chronic tic disorders. Eur Child Adolesc Psychiatry. 2022 Apr;31(4):637-648. doi: 10.1007/s00787-020-01702-5. Epub 2021 Jan 7.
Results Reference
derived
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Group Intervention for Children With Chronic Tics Syndrome or Tourette Syndrome: CBIT vs Psycho-Educational Intervention
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