Tic DisorderNCT00675675
Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders
A study testing Comprehensive Behavioral Intervention for Tics (CBIT) and Minimal Contact Waitlist in people with Tic Disorder, run by John Piacentini at 1 site in United States.
Trial summary
The study aims to clarify the functional anatomy of key brain circuits associated with cognitive control in children and adolescents with chronic tic disorders (CTD) and to compare and contrast hypothesized mechanisms related to increased tic control associated with Habit Reversal Training, a behavioral treatment that… Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Tic Disorder
- What is being tested?
- Comprehensive Behavioral Intervention for Tics (CBIT) and Minimal Contact Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2011
- 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 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- DSM-IV diagnostic criteria for CTD (CMVT or TS)
- Clinical Global Impressions - Severity Score > 3 (moderately ill or worse)
- YGTSS Total Score > 14 (or Total Score > 10 if CTD with motor tics only)
- Unmedicated or on stable psychotropic medication for at least 6 weeks prior to study entry, with no planned changes for duration of study participation
- Child is fluent English speaker
- Parental Informed Consent and Child Informed Assent.
Who cannot join
- Total YGTSS Score>35 (Cases above this threshold otherwise eligible will be reviewed by Clinical Caseness Panel for potential study participation)
- IQ < 80 on the Wechsler Abbreviated Scale of Intelligence (WASI)
- Problematic Substance Use or DSM-IV Conduct Disorder in past 3 months
- Lifetime DSM-IV diagnosis of PDD, Mania, or Psychotic Disorder
- Any serious psychiatric, psychosocial, or neurological condition requiring immediate treatment other than that provided in the current study
- Previous treatment with four or more sessions of HRT for tics
- Contraindication to fMRI scan
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90024
About this study
Official title: TRECC: Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders
The study aims to clarify the functional anatomy of key brain circuits associated with cognitive control in children and adolescents with chronic tic disorders (CTD) and to compare and contrast hypothesized mechanisms related to increased tic control associated with Habit Reversal Training, a behavioral treatment that been previously shown to be effective in treating CTD. We also seek to better understand the relationship between fMRI and quantitative EEG in relevant brain circuits with the hope of establishing EEG as a valid and cost-effective marker of treatment responsiveness. A total of 25 subjects will be randomized to 10 weeks of Habit Reversal Training (HRT), a behavioral treatment, and 25 to 10 weeks of minimal-contact waitlist. Treatment responders will be re-assessed at three months. Waitlist nonresponders will be provided with 10 weeks of HRT. Study assessments, including a neurocognitive battery and quantitative EEG will be administered at baseline, Wk 5, Wk 10, and 3-month follow-up. Neuroimaging (fMRI) will be conducted at baseline and Wk 10.
- Conditions
- Tic Disorder
- Being tested
- Comprehensive Behavioral Intervention for Tics (CBIT), Minimal Contact Waitlist
- Keywords
- Tourette Syndrome, Chronic Tic Disorder, Tics, Behavior Therapy, Habit Reversal Training, Child, Adolescent, Neuroimaging
- Medical subject headings
- Tic Disorders, Tourette Syndrome, Tics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Behavioral Intervention for Tics (CBIT)Behavioural
Habit Reversal Training plus functional assessment/intervention designed to identify and ameliorate tic triggers (antecedents) and maintaining consequences.
Minimal Contact WaitlistBehavioural
Bimonthly phone check-in to assess clinical status and enhance subject retention
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Behavioral Intervention for Tics (CBIT) | Active comparator | Habit Reversal Training (HRT) plus functional assessment/intervention designed to identify and ameliorate environmental triggers for and consequences to tics that might serve to maintain and/or generalize these symptoms Receives: Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT) |
| Minimal Contact Waitlist | Other | Bimonthly phone check-in to assess illness severity and maximize subject retention Receives: Behavioral: Minimal Contact Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impressions - Improvement
Measured: Wks 0, 5, 10
Secondary outcomes (1)
Yale Global Tic Severity Scale
Measured: Wks 0, 5, 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startJul 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tic DisorderStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Piacentini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Piacentini, University of California, Los Angeles
- Investigators
- John Piacentini, Ph.D., Study director, University of California, Los AngelesJames McCracken, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675675
- Sponsor's protocol ID
- UCLAP500772484
- Other IDs
- P50MH077248
- Status last verified
- Aug 2015
- First submitted
- 7 May 2008
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRECC: Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders
- ClinicalTrials.gov ID
- NCT00675675
- Acronym / sponsor ID
- UCLAP500772484
- Conditions
- Tic Disorder
- Keywords
- Tourette Syndrome, Chronic Tic Disorder, Tics, Behavior Therapy, Habit Reversal Training, Child, Adolescent, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- John PiacentiniUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 May 2008 (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.
The study aims to clarify the functional anatomy of key brain circuits associated with cognitive control in children and adolescents with chronic tic disorders (CTD) and to compare and contrast hypothesized mechanisms related to increased tic control associated with Habit Reversal Training, a behavioral treatment that been previously shown to be effective in treating CTD. We also seek to better understand the relationship between fMRI and quantitative EEG in relevant brain circuits with the hope of establishing EEG as a valid and cost-effective marker of treatment responsiveness. A total of 25 subjects will be randomized to 10 weeks of Habit Reversal Training (HRT), a behavioral treatment, and 25 to 10 weeks of minimal-contact waitlist. Treatment responders will be re-assessed at three months. Waitlist nonresponders will be provided with 10 weeks of HRT. Study assessments, including a neurocognitive battery and quantitative EEG will be administered at baseline, Wk 5, Wk 10, and 3-month follow-up. Neuroimaging (fMRI) will be conducted at baseline and Wk 10.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Behavioral Intervention for Tics (CBIT) | Active comparator | Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)Habit Reversal Training (HRT) plus functional assessment/intervention designed to identify and ameliorate environmental triggers for and consequences to tics that might serve to maintain and/or generalize these symptoms |
| Minimal Contact Waitlist | Other | Behavioral: Minimal Contact WaitlistBimonthly phone check-in to assess illness severity and maximize subject retention |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- DSM-IV diagnostic criteria for CTD (CMVT or TS)
- Clinical Global Impressions - Severity Score > 3 (moderately ill or worse)
- YGTSS Total Score > 14 (or Total Score > 10 if CTD with motor tics only)
- Unmedicated or on stable psychotropic medication for at least 6 weeks prior to study entry, with no planned changes for duration of study participation
- Child is fluent English speaker
Key exclusion criteria (7 listed)
- Total YGTSS Score>35 (Cases above this threshold otherwise eligible will be reviewed by Clinical Caseness Panel for potential study participation)
- IQ < 80 on the Wechsler Abbreviated Scale of Intelligence (WASI)
- Problematic Substance Use or DSM-IV Conduct Disorder in past 3 months
- Lifetime DSM-IV diagnosis of PDD, Mania, or Psychotic Disorder
- Any serious psychiatric, psychosocial, or neurological condition requiring immediate treatment other than that provided in the current 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 |
|---|---|---|
| Comprehensive Behavioral Intervention for Tics (CBIT)Habit Reversal Training plus functional assessment/intervention designed to identify and ameliorate tic triggers (antecedents) and maintaining consequences. | Behavioural | Comprehensive Behavioral Intervention for Tics (CBIT) |
| Minimal Contact WaitlistBimonthly phone check-in to assess clinical status and enhance subject retention | Behavioural | Minimal Contact Waitlist |
Primary outcome
Clinical Global Impressions - Improvement
Time frame: Wks 0, 5, 10
1 secondary outcome
Yale Global Tic Severity Scale
Time frame: Wks 0, 5, 10
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 21 Aug 2015.
Related trials for Tic Disorder
RecruitingObservational study
Distinguishing Tics and Functional Tics Using Clinical Neurophysiological Techniques
Tics, Functional Tics
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
Tourette Syndrome, Chronic Tic Disorder
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
Recruiting
Deep Brain Stimulation Therapy in Movement Disorders
Parkinson's Disease
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.
John Piacentini, Ph.D. study director
University of California, Los Angeles
James McCracken, M.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Behavioral Intervention for Tics (CBIT) and Minimal Contact Waitlist in people with Tic Disorder, run by John Piacentini 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 6 inclusion and 7 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 21 Aug 2015. 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?
Clinical Global Impressions - Improvement (time frame: Wks 0, 5, 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2015.