Behavioral Therapy for Children and Adolescents With Tourette Syndrome

Tourette Syndrome Clinical Trial

Official title:

Behavioral Therapy for Children and Adolescents With Tourette Syndrome: A Randomized Controlled Trial in Taiwan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03621059
• Other study ID #: ju07310520
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: September 30, 2016

Study information

• Verified date: August 2018
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tourette Syndrome (TS) is a common neuropsychiatric disorder in childhood and adolescence, and often comorbid with psychiatric comorbidity. Antipsychotic medications are usually the first choices, but may associate with adverse effects. Behavioral intervention for TS has been shown to be an effective treatment for children and adolescents, yet have not been performed and evaluated using control trails in Taiwan.

Description:

TS is a common neuropsychiatric disorder in childhood and adolescence, and often comorbid with psychiatric comorbidity. Antipsychotic medications are usually the first choices, but may associate with adverse effects. Behavioral intervention for TS has been shown to be an effective treatment for children and adolescents, yet have not been performed and evaluated using control trails in Taiwan. This study therefore was to evaluate the efficacy of a comprehensive behavioral intervention therapy on improving tics and tic-related impairment for children and adolescents with Tourette syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

Inclusion Criteria:

• DSM-5 Diagnostic Criteria For Tourette Syndrome

• Patients aged from 6-15 years who were diagnosed with TS or CTD,

• Never received any pharmacological treatment

• Ability to understand the study purpose and/or provide consent for participation independently and via a caregiver serving as a proxy

Exclusion Criteria:

• Have been diagnosed with another mental illness,

• Had no physical or medical condition,

• Had been received CBIT or cognitive behavior therapy before.

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

Intervention

Behavioral:
• habit reversal training (HRT)
The intervention group received 4 sessions during 3months of behavior intervention and then, were reassessed at 3 and 6 months following treatment. Pyridoxine(50mg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

References & Publications (37)

Abramovitch A, Reese H, Woods DW, Peterson A, Deckersbach T, Piacentini J, Scahill L, Wilhelm S. Psychometric Properties of a Self-Report Instrument for the Assessment of Tic Severity in Adults With Tic Disorders. Behav Ther. 2015 Nov;46(6):786-96. doi: 1 — View Citation

Azrin NH, Nunn RG. Habit-reversal: a method of eliminating nervous habits and tics. Behav Res Ther. 1973 Nov;11(4):619-28. — View Citation

Azrin NH, Peterson AL. Habit reversal for the treatment of Tourette syndrome. Behav Res Ther. 1988;26(4):347-51. — View Citation

Bitsko RH, Holbrook JR, Visser SN, Mink JW, Zinner SH, Ghandour RM, Blumberg SJ. A national profile of Tourette syndrome, 2011-2012. J Dev Behav Pediatr. 2014 Jun;35(5):317-22. doi: 10.1097/DBP.0000000000000065. — View Citation

Blount TH, Lockhart AL, Garcia RV, Raj JJ, Peterson AL. Intensive outpatient comprehensive behavioral intervention for tics: A case series. World J Clin Cases. 2014 Oct 16;2(10):569-77. doi: 10.12998/wjcc.v2.i10.569. — View Citation

Bressan RA, Jones HM, Pilowsky LS. Atypical antipsychotic drugs and tardive dyskinesia: relevance of D2 receptor affinity. J Psychopharmacol. 2004 Mar;18(1):124-7. — View Citation

Bruggeman R, van der Linden C, Buitelaar JK, Gericke GS, Hawkridge SM, Temlett JA. Risperidone versus pimozide in Tourette's disorder: a comparative double-blind parallel-group study. J Clin Psychiatry. 2001 Jan;62(1):50-6. — View Citation

Chou IC, Lin HC, Lin CC, Sung FC, Kao CH. Tourette syndrome and risk of depression: a population-based cohort study in Taiwan. J Dev Behav Pediatr. 2013 Apr;34(3):181-5. doi: 10.1097/DBP.0b013e3182829f2b. — View Citation

Deckersbach T, Rauch S, Buhlmann U, Wilhelm S. Habit reversal versus supportive psychotherapy in Tourette's disorder: a randomized controlled trial and predictors of treatment response. Behav Res Ther. 2006 Aug;44(8):1079-90. Epub 2005 Nov 2. — View Citation

Du YS, Li HF, Vance A, Zhong YQ, Jiao FY, Wang HM, Wang MJ, Su LY, Yu DL, Ma SW, Wu JB. Randomized double-blind multicentre placebo-controlled clinical trial of the clonidine adhesive patch for the treatment of tic disorders. Aust N Z J Psychiatry. 2008 S — View Citation

Dutta N, Cavanna AE. The effectiveness of habit reversal therapy in the treatment of Tourette syndrome and other chronic tic disorders: a systematic review. Funct Neurol. 2013 Jan-Mar;28(1):7-12. Review. — View Citation

Elstner K, Selai CE, Trimble MR, Robertson MM. Quality of Life (QOL) of patients with Gilles de la Tourette's syndrome. Acta Psychiatr Scand. 2001 Jan;103(1):52-9. — View Citation

Gaffney GR, Perry PJ, Lund BC, Bever-Stille KA, Arndt S, Kuperman S. Risperidone versus clonidine in the treatment of children and adolescents with Tourette's syndrome. J Am Acad Child Adolesc Psychiatry. 2002 Mar;41(3):330-6. — View Citation

Garcia-Lopez R, Perea-Milla E, Garcia CR, Rivas-Ruiz F, Romero-Gonzalez J, Moreno JL, Faus V, Aguas Gdel C, Diaz JC. New therapeutic approach to Tourette Syndrome in children based on a randomized placebo-controlled double-blind phase IV study of the effe — View Citation

Himle MB, Woods DW, Piacentini JC, Walkup JT. Brief review of habit reversal training for Tourette syndrome. J Child Neurol. 2006 Aug;21(8):719-25. Review. — View Citation

Ho CS, Chen HJ, Chiu NC, Shen EY, Lue HC. Short-term sulpiride treatment of children and adolescents with Tourette syndrome or chronic tic disorder. J Formos Med Assoc. 2009 Oct;108(10):788-93. doi: 10.1016/S0929-6646(09)60406-X. — View Citation

Kim DD, Warburton DER, Wu N, Barr AM, Honer WG, Procyshyn RM. Effects of physical activity on the symptoms of Tourette syndrome: A systematic review. Eur Psychiatry. 2018 Feb;48:13-19. doi: 10.1016/j.eurpsy.2017.11.002. Epub 2018 Jan 10. — View Citation

King RA, Scahill L. Emotional and behavioral difficulties associated with Tourette syndrome. Adv Neurol. 2001;85:79-88. Review. — View Citation

Leckman JF, Riddle MA, Hardin MT, Ort SI, Swartz KL, Stevenson J, Cohen DJ. The Yale Global Tic Severity Scale: initial testing of a clinician-rated scale of tic severity. J Am Acad Child Adolesc Psychiatry. 1989 Jul;28(4):566-73. — View Citation

Leckman JF, Zhang H, Vitale A, Lahnin F, Lynch K, Bondi C, Kim YS, Peterson BS. Course of tic severity in Tourette syndrome: the first two decades. Pediatrics. 1998 Jul;102(1 Pt 1):14-9. — View Citation

Müller-Vahl KR, Buddensiek N, Geomelas M, Emrich HM. The influence of different food and drink on tics in Tourette syndrome. Acta Paediatr. 2008 Apr;97(4):442-6. doi: 10.1111/j.1651-2227.2008.00675.x. Epub 2008 Feb 27. — View Citation

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: — View Citation

Rizzo R, Gulisano M, Pellico A, Calì PV, Curatolo P. Tourette syndrome and comorbid conditions: a spectrum of different severities and complexities. J Child Neurol. 2014 Oct;29(10):1383-9. doi: 10.1177/0883073814534317. Epub 2014 May 14. — View Citation

Rizzo R, Pellico A, Silvestri PR, Chiarotti F, Cardona F. A Randomized Controlled Trial Comparing Behavioral, Educational, and Pharmacological Treatments in Youths With Chronic Tic Disorder or Tourette Syndrome. Front Psychiatry. 2018 Mar 27;9:100. doi: 1 — View Citation

Robertson MM, Banerjee S, Eapen V, Fox-Hiley P. Obsessive compulsive behaviour and depressive symptoms in young people with Tourette syndrome. A controlled study. Eur Child Adolesc Psychiatry. 2002 Dec;11(6):261-5. — View Citation

Robertson MM, Eapen V, Cavanna AE. The international prevalence, epidemiology, and clinical phenomenology of Tourette syndrome: a cross-cultural perspective. J Psychosom Res. 2009 Dec;67(6):475-83. doi: 10.1016/j.jpsychores.2009.07.010. Review. — View Citation

Roessner V, Plessen KJ, Rothenberger A, Ludolph AG, Rizzo R, Skov L, Strand G, Stern JS, Termine C, Hoekstra PJ; ESSTS Guidelines Group. European clinical guidelines for Tourette syndrome and other tic disorders. Part II: pharmacological treatment. Eur Ch — View Citation

Sallee FR, Gilbert DL, Vinks AA, Miceli JJ, Robarge L, Wilner K. Pharmacodynamics of ziprasidone in children and adolescents: impact on dopamine transmission. J Am Acad Child Adolesc Psychiatry. 2003 Aug;42(8):902-7. — View Citation

Scahill L, Erenberg G, Berlin CM Jr, Budman C, Coffey BJ, Jankovic J, Kiessling L, King RA, Kurlan R, Lang A, Mink J, Murphy T, Zinner S, Walkup J; Tourette Syndrome Association Medical Advisory Board: Practice Committee. Contemporary assessment and pharm — View Citation

Shprecher D, Kurlan R. The management of tics. Mov Disord. 2009 Jan 15;24(1):15-24. doi: 10.1002/mds.22378. Review. — View Citation

Storch EA, Murphy TK, Geffken GR, Sajid M, Allen P, Roberti JW, Goodman WK. Reliability and validity of the Yale Global Tic Severity Scale. Psychol Assess. 2005 Dec;17(4):486-91. — View Citation

Wang HS, Kuo MF. Tourette's syndrome in Taiwan: an epidemiological study of tic disorders in an elementary school at Taipei County. Brain Dev. 2003 Dec;25 Suppl 1:S29-31. — View Citation

Watson TS, Sterling HE. Brief functional analysis and treatment of a vocal tic. J Appl Behav Anal. 1998 Fall;31(3):471-4. — View Citation

Wilhelm S, Peterson AL, Piacentini J, Woods DW, Deckersbach T, Sukhodolsky DG, Chang S, Liu H, Dziura J, Walkup JT, Scahill L. Randomized trial of behavior therapy for adults with Tourette syndrome. Arch Gen Psychiatry. 2012 Aug;69(8):795-803. doi: 10.100 — View Citation

Woods DW, Miltenberger RG. Habit reversal: a review of applications and variations. J Behav Ther Exp Psychiatry. 1995 Jun;26(2):123-31. Review. — View Citation

Woods DW, Twohig MP, Flessner CA, Roloff TJ. Treatment of vocal tics in children with Tourette syndrome: investigating the efficacy of habit reversal. J Appl Behav Anal. 2003 Spring;36(1):109-12. — View Citation

Yates R, Edwards K, King J, Luzon O, Evangeli M, Stark D, McFarlane F, Heyman I, Ince B, Kodric J, Murphy T. Habit reversal training and educational group treatments for children with tourette syndrome: A preliminary randomised controlled trial. Behav Res — View Citation

* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eefficacy of a behavioral therapy on improving tics with Tourette syndrome	Behavioral intervention group led to a significantly greater decrease in total motor score on the Yale Global Tic Severity Scale .The gold-standard measure of tic severity in TS, the YGTSS is a clinician-completed measure consisting of a tic symptom checklist, motor and vocal tic severity ratings, and a global tic impairment rating. To ascertain tic severity ratings, the examiner rates five different dimensions of tic severity each on a 0-5 scale: tic number, frequency, duration, intensity, and complexity. Each of the dimensions is scored separately for motor and vocal tics to produce motor and vocal tic subscale scores (range 0-25). These subscales are then combined to produce a total tic severity score (range 0-50), with higher numbers indicating more severe tics. The YGTSS has demonstrated acceptable internal consistency and acceptable convergent and divergent validity).	at 3rd month and 6rd months following treatment.