Tourette SyndromeNCT03621059
Behavioral Therapy for Children and Adolescents With Tourette Syndrome
A study testing habit reversal training (HRT) in people with Tourette Syndrome, run by Taipei Medical University.
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. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- habit reversal training (HRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Have been diagnosed with another mental illness,
- Had no physical or medical condition,
- Had been received CBIT or cognitive behavior therapy before.
About this study
Official title: Behavioral Therapy for Children and Adolescents With Tourette Syndrome: A Randomized Controlled Trial in Taiwan
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.
Read the detailed 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.
- Conditions
- Tourette Syndrome
- Being tested
- habit reversal training (HRT)
- Keywords
- Tourette syndrome, behavior therapy, children and adolescents
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
habit reversal training (HRT)Behavioural
The intervention group received 4 sessions during 3months of behavior intervention and then, were reassessed at 3 and 6 months following treatment.
Pyridoxine(50mg)
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Therapy with TS | Experimental | habit reversal training (HRT) Receives: Behavioral: habit reversal training (HRT) |
| observational | No intervention | observational and usual care Pyridoxine(50mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at 3rd month and 6rd months following treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Jan 2015
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A collection of behavioral skills named as Comprehensive Behavioral Intervention (CBIT) for Tics had been found to be effective (Piacentini et al., 2010).The major components of CBIT includes psychoeducation of tics, habit reversal training (HRT), function-based interventions, and relaxation training (Piacentini et al., 2010).The HRT consists of several therapeutic activities, including awareness training (i.e., observing the premonitory urge or other signs preceding the occurrence of a tic), competing response training (i.e., engaging in a voluntary behavior that is physically incompatible with the tic to manage the premonitory urge), self-monitoring of tics and relaxation training (Himle et al., 2006).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang, Hsiu-Ju, Taipei Medical University
- Investigators
- hsiu-ju Chang, PHD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621059
- Sponsor's protocol ID
- ju07310520
- Status last verified
- Aug 2018
- First submitted
- 2 Aug 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24906033Robertson 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.
PubMed 19913651Wang 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. doi: 10.1016/s0387-7604(03)90005-2.
PubMed 14980369Chou 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.
PubMed 23572168King RA, Scahill L. Emotional and behavioral difficulties associated with Tourette syndrome. Adv Neurol. 2001;85:79-88. No abstract available.
PubMed 11530448Robertson 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. doi: 10.1007/s00787-002-0301-3.
PubMed 12541004Rizzo R, Gulisano M, Pellico A, Cali 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.
PubMed 24832397Leckman 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. doi: 10.1542/peds.102.1.14.
PubMed 9651407Elstner 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. doi: 10.1034/j.1600-0447.2001.00147.x.
PubMed 11202129Shprecher D, Kurlan R. The management of tics. Mov Disord. 2009 Jan 15;24(1):15-24. doi: 10.1002/mds.22378.
PubMed 19170198Muller-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.
PubMed 18307557Garcia-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 effectiveness and safety of magnesium and vitamin B6. Trials. 2009 Mar 10;10:16. doi: 10.1186/1745-6215-10-16.
PubMed 19284553Scahill 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 pharmacotherapy of Tourette syndrome. NeuroRx. 2006 Apr;3(2):192-206. doi: 10.1016/j.nurx.2006.01.009.
PubMed 16554257Roessner 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 Child Adolesc Psychiatry. 2011 Apr;20(4):173-96. doi: 10.1007/s00787-011-0163-7.
PubMed 21445724Bruggeman 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. doi: 10.4088/jcp.v62n0111.
PubMed 11235929
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Therapy for Children and Adolescents With Tourette Syndrome: A Randomized Controlled Trial in Taiwan
- ClinicalTrials.gov ID
- NCT03621059
- Acronym / sponsor ID
- ju07310520
- Conditions
- Tourette Syndrome
- Keywords
- Tourette syndrome, behavior therapy, children and adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A collection of behavioral skills named as Comprehensive Behavioral Intervention (CBIT) for Tics had been found to be effective (Piacentini et al., 2010).The major components of CBIT includes psychoeducation of tics, habit reversal training (HRT), function-based interventions, and relaxation training (Piacentini et al., 2010).The HRT consists of several therapeutic activities, including awareness training (i.e., observing the premonitory urge or other signs preceding the occurrence of a tic), competing response training (i.e., engaging in a voluntary behavior that is physically incompatible with the tic to manage the premonitory urge), self-monitoring of tics and relaxation training (Himle et al., 2006).
| Arm | Type | Receives |
|---|---|---|
| Behavioral Therapy with TS | Experimental | Behavioral: habit reversal training (HRT)habit reversal training (HRT) |
| observational | No intervention | –observational and usual care Pyridoxine(50mg) |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Have been diagnosed with another mental illness,
- Had no physical or medical condition,
- Had been received CBIT or cognitive behavior therapy before.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Behavioural | Behavioral Therapy with TS |
Primary outcome
Eefficacy of a behavioral therapy on improving tics with Tourette syndrome
Time frame: at 3rd month and 6rd months following treatment.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Results publication: PubMed 24906033Bitsko 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.
- Results publication: PubMed 19913651Robertson 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.
- Results publication: PubMed 14980369Wang 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. doi: 10.1016/s0387-7604(03)90005-2.
- Results publication: PubMed 23572168Chou 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.
- Results publication: PubMed 11530448King RA, Scahill L. Emotional and behavioral difficulties associated with Tourette syndrome. Adv Neurol. 2001;85:79-88. No abstract available.
- Results publication: PubMed 12541004Robertson 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. doi: 10.1007/s00787-002-0301-3.
- Results publication: PubMed 24832397Rizzo R, Gulisano M, Pellico A, Cali 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.
- Results publication: PubMed 9651407Leckman 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. doi: 10.1542/peds.102.1.14.
- Results publication: PubMed 11202129Elstner 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. doi: 10.1034/j.1600-0447.2001.00147.x.
- Results publication: PubMed 19170198Shprecher D, Kurlan R. The management of tics. Mov Disord. 2009 Jan 15;24(1):15-24. doi: 10.1002/mds.22378.
- Results publication: PubMed 18307557Muller-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.
- Results publication: PubMed 19284553Garcia-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 effectiveness and safety of magnesium and vitamin B6. Trials. 2009 Mar 10;10:16. doi: 10.1186/1745-6215-10-16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hsiu-ju Chang, PHD principal investigator
Taipei Medical University
Questions about this trial
What is this clinical trial studying?
A study testing habit reversal training (HRT) in people with Tourette Syndrome, run by Taipei Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eefficacy of a behavioral therapy on improving tics with Tourette syndrome (time frame: at 3rd month and 6rd months following treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03621059, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.