NCT00218777

Brief Summary

This study will determine the effectiveness of cognitive behavior therapy (CBT) with habit reversal training (HRT) in treating chronic tic disorders (CTDs) in children and adolescents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2004

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

December 14, 2015

Status Verified

December 1, 2015

Enrollment Period

2.4 years

First QC Date

September 21, 2005

Last Update Submit

December 10, 2015

Conditions

Tourette SyndromeTic Disorders

Keywords

Chronic tic disorderMotor ticsVocal tics

Outcome Measures

Primary Outcomes (2)

  • Reduction in tic severity

    10-22 weeks

  • Reduction in tic-related impairment and distress (measured at Week 10)

    measured at week 10

Secondary Outcomes (2)

  • Tic severity and associated impairment and distress (measured at Week 36 follow-up)

    measured at week 36 follow-up

  • Changes in neurocognitive function (measured at Week 10)

    measured at week 10

Interventions

Comprehensive Behavioral Intervention for TicsBEHAVIORAL

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Meets DSM-IV diagnostic criteria for chronic tic disorder (chronic motor or vocal tic disorder or Tourette syndrome)
  • Score of at least 3 on the Clinical Global Impressions Severity Scale
  • Score of at least 14 on the Yale Global Tic Severity Scale (YGTSS) or at least 10 for individuals with motor tics only
  • Unmedicated or currently on a stable medication treatment for tics, obsessive compulsive disorder (OCD), ADHD, anxiety, and/or depressive disorder for at least 6 weeks, with no planned changes for the duration of study participation
  • Child speaks English

You may not qualify if:

  • Score greater than 30 on the YGTSS
  • IQ less than 80 on the Wechsler Abbreviated Scale of Intelligence (WASI)
  • Meets DSM-IV criteria for substance abuse or dependence within the 3 months prior to study entry
  • Meets DSM-IV criteria for conduct disorder within the 3 months prior to study entry
  • Lifetime DSM-IV diagnosis of pervasive developmental disorder, mania, or psychotic disorder
  • Any serious psychiatric, psychosocial, or neurological condition (i.e., OCD, ADHD, major depressive disorder, anxiety, severe aggression, or family discord) requiring immediate treatment other than what is provided in the current study (i.e., medication, school intervention, or family therapy)
  • Previous treatment with four or more sessions of HRT for tics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UCLA Child OCD, Anxiety, and Tic Disorders Program

Los Angeles, California, 90402, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

University of Wisconsin-Milwaukee

Milwaukee, Wisconsin, 53211, United States

Location

Related Publications (8)

  • Houghton DC, Capriotti MR, Scahill LD, Wilhelm S, Peterson AL, Walkup JT, Piacentini J, Woods DW. Investigating Habituation to Premonitory Urges in Behavior Therapy for Tic Disorders. Behav Ther. 2017 Nov;48(6):834-846. doi: 10.1016/j.beth.2017.08.004. Epub 2017 Aug 10.

    PMID: 29029679DERIVED

  • Sukhodolsky DG, Woods DW, Piacentini J, Wilhelm S, Peterson AL, Katsovich L, Dziura J, Walkup JT, Scahill L. Moderators and predictors of response to behavior therapy for tics in Tourette syndrome. Neurology. 2017 Mar 14;88(11):1029-1036. doi: 10.1212/WNL.0000000000003710. Epub 2017 Feb 15.

    PMID: 28202705DERIVED

  • Peterson AL, McGuire JF, Wilhelm S, Piacentini J, Woods DW, Walkup JT, Hatch JP, Villarreal R, Scahill L. An Empirical Examination of Symptom Substitution Associated With Behavior Therapy for Tourette's Disorder. Behav Ther. 2016 Jan;47(1):29-41. doi: 10.1016/j.beth.2015.09.001. Epub 2015 Sep 11.

    PMID: 26763495DERIVED

  • McGuire JF, Piacentini J, Scahill L, Woods DW, Villarreal R, Wilhelm S, Walkup JT, Peterson AL. Bothersome tics in patients with chronic tic disorders: Characteristics and individualized treatment response to behavior therapy. Behav Res Ther. 2015 Jul;70:56-63. doi: 10.1016/j.brat.2015.05.006. Epub 2015 May 12.

    PMID: 25988365DERIVED

  • McGuire JF, Nyirabahizi E, Kircanski K, Piacentini J, Peterson AL, Woods DW, Wilhelm S, Walkup JT, Scahill L. A cluster analysis of tic symptoms in children and adults with Tourette syndrome: clinical correlates and treatment outcome. Psychiatry Res. 2013 Dec 30;210(3):1198-204. doi: 10.1016/j.psychres.2013.09.021. Epub 2013 Sep 27.

    PMID: 24144615DERIVED

  • Jeon S, Walkup JT, Woods DW, Peterson A, Piacentini J, Wilhelm S, Katsovich L, McGuire JF, Dziura J, Scahill L. Detecting a clinically meaningful change in tic severity in Tourette syndrome: a comparison of three methods. Contemp Clin Trials. 2013 Nov;36(2):414-20. doi: 10.1016/j.cct.2013.08.012. Epub 2013 Aug 31.

    PMID: 24001701DERIVED

  • 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.

    PMID: 21555779DERIVED

  • Piacentini J, Woods DW, Scahill L, Wilhelm S, Peterson AL, Chang S, Ginsburg GS, Deckersbach T, Dziura J, Levi-Pearl S, Walkup JT. Behavior therapy for children with Tourette disorder: a randomized controlled trial. JAMA. 2010 May 19;303(19):1929-37. doi: 10.1001/jama.2010.607.

    PMID: 20483969DERIVED

Related Links

MeSH Terms

Conditions

Tourette SyndromeTic DisordersTics

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental DisordersDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John Piacentini, PhD

    University of California at Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, TSA Behavioral Sciences Consortium; Director, UCLA Child OCD, Anxiety and Tic Disorders Program

Study Record Dates

First Submitted

September 21, 2005

First Posted

September 22, 2005

Study Start

December 1, 2004

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

December 14, 2015

Record last verified: 2015-12

Locations

US(3)