Group Intervention for Children With Chronic Tics Syndrome or Tourette Syndrome: CBIT vs Psycho-Educational Intervention

NCT ID: NCT02407951

Last Updated: 2015-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-04-30

Brief Summary

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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

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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.

Conditions

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Tourette Syndrome Motor or Vocal Tic Disorder, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBIT group

Group Type EXPERIMENTAL

CBIT group

Intervention Type BEHAVIORAL

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.

Psycho-Educational group

Group Type PLACEBO_COMPARATOR

Psycho-Educational group

Intervention Type BEHAVIORAL

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.

Interventions

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CBIT group

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

Psycho-Educational group

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Michael Rotstein, MD

Role: CONTACT

972-36974517

References

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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.

Reference Type BACKGROUND
PMID: 21555779 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33415472 (View on PubMed)

Other Identifiers

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0437-17-TLV

Identifier Type: -

Identifier Source: org_study_id

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