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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
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome

Eligibility Criteria

9 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 31, 2015
    Last Updated
    March 31, 2015
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    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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