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

T

Tel Aviv Sourasky Medical Center

Status

Unknown

Conditions

Tourette Syndrome
Motor or Vocal Tic Disorder, Chronic

Treatments

Behavioral: CBIT group
Behavioral: Psycho-Educational group

Study type

Interventional

Funder types

Other

Identifiers

NCT02407951
0437-17-TLV

Details and patient eligibility

About

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.

Full 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.

Enrollment

96 estimated patients

Sex

All

Ages

9 to 15 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

96 participants in 2 patient groups, including a placebo group

CBIT group
Experimental group
Treatment:
Behavioral: CBIT group
Psycho-Educational group
Placebo Comparator group
Treatment:
Behavioral: Psycho-Educational group

Trial contacts and locations

0

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Central trial contact

Michael Rotstein, MD

Data sourced from clinicaltrials.gov

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