Tourette SyndromeNCT00486551
Anger Control Training for Youth With Tourette Syndrome
A study of Tourette Syndrome and Chronic Tic Disorder, run by Yale University at 1 site in United States.
Trial summary
This is a clinical study of a cognitive-behavioral therapy known as anger control training in adolescents with Tourette Syndrome and explosive, disruptive behavior. ACT is compared to treatment as usual (TAU) in a randomized clinical trial. Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Tourette Syndrome, Chronic Tic Disorder, Oppositional Defiant Disorder
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Jan 2006
- 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 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Boys and girls, 11 to 16 years of age.
- Diagnosis of Tourette syndrome (TS) or chronic tic disorder (CTD).
- Significant level of disruptive behavior
Who cannot join
- Current diagnosis of Severe Major Depression, Bipolar Disorder, Pervasive Developmental Disorder, or Psychotic Disorder.
- Significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, seizure disorder that may require more pressing treatment.
- Initiation or discontinuation of a psychotropic medication treatment within six weeks of enrollment in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine, Child Study Center
New Haven, Connecticut, 06520
About this study
This is a clinical study of a cognitive-behavioral therapy known as anger control training in adolescents with Tourette Syndrome and explosive, disruptive behavior. ACT is compared to treatment as usual (TAU) in a randomized clinical trial.
Read the detailed description
This is a randomized controlled study of a cognitive-behavioral, anger control training (ACT) in adolescents with Tourette Syndrome (TS) complicated by disruptive behavior. Disruptive behaviors in TS may take numerous forms including noncompliance, anger outbursts, and physical aggression. Anger outbursts in TS have been described as rage attacks or rage storms due to their high intensity and unpredictability in response to minimal provocation. Whether these behaviors are part of TS, related to comorbid conditions, or due to the burden of chronic illness is not clear. Nevertheless, these disruptive behaviors can result in significant functional impairment and often require clinical attention. The purpose of the ACT intervention is to improve the explosive and noncompliant behavior in adolescents with TS by enhancing affect regulation and social problem-solving skills. The treatment is based on anger control training which has been empirically supported for reducing aggressive behaviors and improving social functioning in aggressive youths. The primary outcome measures include the parent-rated Oppositional Defiant Scale and the Clinicians Global Improvement Score assessed by a clinician blind to treatment assignment.
- Being tested
- Anger control training
- Keywords
- Anger control training, Cognitive behavioral therapy, Behavior therapy, Tourette Syndrome, Randomized trial, Anger, Aggression
- Medical subject headings
- Tourette Syndrome, Tic Disorders, Oppositional Defiant Disorder, Attention Deficit Disorder with Hyperactivity, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anger control trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
CGI-I assigned by clinician unaware of treatment assignment
Measured: three months
Parent rated disruptive behavior
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2007 (estimated)
- Study startAug 2001
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Yale 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
- Masking
- Single blind
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Tourette Association of America
- Investigators
- Denis G Sukhodolsky, Ph.D., Principal investigator, Yale UniversityLawrence D Scahill, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486551
- Sponsor's protocol ID
- 0102012121
- Other IDs
- 1R03MH067845
- Status last verified
- Jan 2022
- First submitted
- 12 Jun 2007
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sukhodolsky DG, Scahill L, Zhang H, Peterson BS, King RA, Lombroso PJ, Katsovich L, Findley D, Leckman JF. Disruptive behavior in children with Tourette's syndrome: association with ADHD comorbidity, tic severity, and functional impairment. J Am Acad Child Adolesc Psychiatry. 2003 Jan;42(1):98-105. doi: 10.1097/00004583-200301000-00016.
PubMed 12500082Sukhodolsky DG, do Rosario-Campos MC, Scahill L, Katsovich L, Pauls DL, Peterson BS, King RA, Lombroso PJ, Findley DB, Leckman JF. Adaptive, emotional, and family functioning of children with obsessive-compulsive disorder and comorbid attention deficit hyperactivity disorder. Am J Psychiatry. 2005 Jun;162(6):1125-32. doi: 10.1176/appi.ajp.162.6.1125.
PubMed 15930061Scahill 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 16554257Sukhodolsky DG, Vitulano LA, Carroll DH, McGuire J, Leckman JF, Scahill L. Randomized trial of anger control training for adolescents with Tourette's syndrome and disruptive behavior. J Am Acad Child Adolesc Psychiatry. 2009 Apr;48(4):413-421. doi: 10.1097/CHI.0b013e3181985050.
PubMed 19242384
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anger Control Training for Youth With Tourette Syndrome
- ClinicalTrials.gov ID
- NCT00486551
- Acronym / sponsor ID
- 0102012121
- Keywords
- Anger control training, Cognitive behavioral therapy, Behavior therapy, Tourette Syndrome, Randomized trial, Anger, Aggression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Tourette Association of America
- Study start
- Aug 2001
- Study completion
- Jan 2006 (actual)
- First posted
- 14 Jun 2007 (estimated)
- 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.
This is a clinical study of a cognitive-behavioral therapy known as anger control training in adolescents with Tourette Syndrome and explosive, disruptive behavior. ACT is compared to treatment as usual (TAU) in a randomized clinical trial.
Detailed description
This is a randomized controlled study of a cognitive-behavioral, anger control training (ACT) in adolescents with Tourette Syndrome (TS) complicated by disruptive behavior. Disruptive behaviors in TS may take numerous forms including noncompliance, anger outbursts, and physical aggression. Anger outbursts in TS have been described as rage attacks or rage storms due to their high intensity and unpredictability in response to minimal provocation. Whether these behaviors are part of TS, related to comorbid conditions, or due to the burden of chronic illness is not clear. Nevertheless, these disruptive behaviors can result in significant functional impairment and often require clinical attention. The purpose of the ACT intervention is to improve the explosive and noncompliant behavior in adolescents with TS by enhancing affect regulation and social problem-solving skills. The treatment is based on anger control training which has been empirically supported for reducing aggressive behaviors and improving social functioning in aggressive youths. The primary outcome measures include the parent-rated Oppositional Defiant Scale and the Clinicians Global Improvement Score assessed by a clinician blind to treatment assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Boys and girls, 11 to 16 years of age.
- Diagnosis of Tourette syndrome (TS) or chronic tic disorder (CTD).
- Significant level of disruptive behavior
Key exclusion criteria (3 listed)
- Current diagnosis of Severe Major Depression, Bipolar Disorder, Pervasive Developmental Disorder, or Psychotic Disorder.
- Significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, seizure disorder that may require more pressing treatment.
- Initiation or discontinuation of a psychotropic medication treatment within six weeks of enrollment in the study
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 |
|---|---|---|
| Anger control training | Behavioural | – |
Primary outcome
CGI-I assigned by clinician unaware of treatment assignment
Time frame: three months
Parent rated disruptive behavior
Time frame: three months
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 11 Feb 2022.
- Background: PubMed 12500082Sukhodolsky DG, Scahill L, Zhang H, Peterson BS, King RA, Lombroso PJ, Katsovich L, Findley D, Leckman JF. Disruptive behavior in children with Tourette's syndrome: association with ADHD comorbidity, tic severity, and functional impairment. J Am Acad Child Adolesc Psychiatry. 2003 Jan;42(1):98-105. doi: 10.1097/00004583-200301000-00016.
- Background: PubMed 15930061Sukhodolsky DG, do Rosario-Campos MC, Scahill L, Katsovich L, Pauls DL, Peterson BS, King RA, Lombroso PJ, Findley DB, Leckman JF. Adaptive, emotional, and family functioning of children with obsessive-compulsive disorder and comorbid attention deficit hyperactivity disorder. Am J Psychiatry. 2005 Jun;162(6):1125-32. doi: 10.1176/appi.ajp.162.6.1125.
- Background: PubMed 16554257Scahill 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.
- Results publication: PubMed 19242384Sukhodolsky DG, Vitulano LA, Carroll DH, McGuire J, Leckman JF, Scahill L. Randomized trial of anger control training for adolescents with Tourette's syndrome and disruptive behavior. J Am Acad Child Adolesc Psychiatry. 2009 Apr;48(4):413-421. doi: 10.1097/CHI.0b013e3181985050.
- Related InfoLink provided by the sponsor.
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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.
Denis G Sukhodolsky, Ph.D. principal investigator
Yale University
Lawrence D Scahill, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Tourette Syndrome and Chronic Tic Disorder, run by Yale University at 1 site in United States.
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 3 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 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
CGI-I assigned by clinician unaware of treatment assignment (time frame: three months). The study lists 2 primary outcomes in all. 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 NCT00486551, which also lists 4 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 11 Feb 2022.