Tourette SyndromeM_CBITNCT02900144
Modified Comprehensive Behavioral Intervention for Tics (M_CBIT)
A study testing Modified Comprehensive Behavioral Intervention for Tics and Comprehensive Behavioral Intervention for Tics in people with Tourette Syndrome and ADHD, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The main purpose of this trial is to develop and investigate the effects of a modified comprehensive behavioral intervention for tics (CBIT) protocol for children and adolescents with chronic tic disorders and ADHD. CBIT is a first-line behavioral treatment for individuals with tic disorders. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Tourette Syndrome, ADHD
- What is being tested?
- Modified Comprehensive Behavioral Intervention for Tics and Comprehensive Behavioral Intervention for Tics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 10 Apr 2019
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have a DSM-5-based diagnosis of Tourette Syndrome or Persistent Motor or Vocal Tic Disorder
- Have a diagnosis of ADHD by DSM-5 standards, or a previous diagnosis of ADHD where there are some residual symptoms (at least 7/18) but does not currently meet diagnostic criteria due to current medications.
- Tic disorder is the most problematic psychiatric disorder and the primary reason for seeking treatment
- Have a current total tic severity score of >13 (or >9 if CTD) on the Yale Global Tic Severity Score (YGTSS), and a current total impairment score of >19 on the YGTSS
- Be male or female and between 10-17 years of age at the start of the treatment, inclusive
- Be able to communicate meaningfully with the investigators and be competent to provide written assent; both parental informed consent and adolescent assent must be obtained
- Be English speaking
Who cannot join
- Comorbid psychiatric diagnoses including: alcohol or substance abuse or dependence within the past 3 months, psychosis, organic mental disorder, current mania, developmental delay, estimated IQ <80 on the Wechsler Abbreviated Scale of Intelligence (WASI), other cognitive impairment that would interfere with ability to engage in CBT, or other developmental/cognitive impairment that precludes the participant from being able to communicate meaningfully with the treater
- Those deemed to pose a serious suicidal or homicidal threat (e.g., suicide attempt within past 6 months and/or endorsement of "I want to kill myself" on the Children's Depression Inventory (CDI)).
- Current illness (tics or otherwise) so severe that an immediate psychopharmacological evaluation is warranted
- Any clinical features requiring a higher level of care than outpatient (as determined by evaluator).
- Intent to travel for a period longer than two weeks (such that three sessions would be missed) during the proposed time-frame of the study. However, this criterion may be waived as per the discretion of the Principal investigator.
- In general, the participant cannot be engaged in concurrent psychotherapy - if they are, they would need to stop (no lag time required between stopping current therapy and beginning this intervention). Decisions can be made on a case by case basis if the therapy is for a concern/disorder separate from mood, anxiety or OCD-spectrum disorders (e.g. gender dysphoria).
- Four or more sessions of previous CBT treatment similar to the current treatment (CBIT and/or CBT for ADHD) within the last five years
- Participants can be receiving psychotropic medication, but they must be on a stable dose for four weeks prior to the study baseline assessment and maintain this dosage throughout the course of the study. If a potential participant is taking psychotropic medication at the time of the phone evaluation or the first in-person study assessment and wishes to discontinue this medication to enter the trial, the participant will be asked to discuss this option with their prescribing physician to determine whether medication discontinuation would be safe and in the participant's best interest. We will not influence the decision or procedures participants choose with their prescribing physician. If the participant decides to discontinue treatment with the psychotropic medication, he/she must wait for four weeks before receiving a baseline assessment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Modified Comprehensive Behavioral Intervention for Tics: Treating Children With Tic Disorders, Co-occurring ADHD and Psychosocial Impairment
The main purpose of this trial is to develop and investigate the effects of a modified comprehensive behavioral intervention for tics (CBIT) protocol for children and adolescents with chronic tic disorders and ADHD.
CBIT is a first-line behavioral treatment for individuals with tic disorders. However, the benefit of CBIT is mitigated in those with co-occurring ADHD, as ADHD is negatively associated with effect size in behavioral treatments for tics. Additionally, while tic disorders are associated with reduced quality of life measures, CBIT is 'tic-specific.' Despite improving tics, measures do not show associated improved quality of life. Currently, there are no standardized behavioral treatments for tics that account for ADHD symptoms and/or addresses the impact that tics and ADHD symptoms have on quality of life.
Read more
The first aim is to develop a treatment protocol that combines elements from CBIT, Cognitive Behavioral Therapy (CBT) for ADHD and factors targeting psychosocial impairment.
The second aim is to determine the treatment feasibility and acceptability (e.g. retention, reasons for treatment refusal and dropout, and motivation) of this modified CBIT treatment. The investigators will evaluate and assess the randomization process, the treatment modules, and the expectations and satisfaction of the participants and their parents.
The final aim is to use a pilot randomized control trial (RCT) design to evaluate improvement using measures including tic, ADHD and quality of life scales as rated by a blinded clinician. Though the investigators will evaluate efficacy of the modified protocol, the primary purpose will remain feasibility. The hope is to use this study to develop larger trials in the future.
Read the detailed description
Comprehensive behavior intervention for tics (CBIT) is a first-line behavioral treatment for individuals with tic disorders. However, the benefit of CBIT is mitigated in those with co-occurring ADHD, as ADHD is negatively associated with effect size in behavioral treatments for tics. Additionally, while tic disorders are associated with reduced quality of life measures, CBIT is 'tic-specific.' Despite improving tics, measures do not show associated improved quality of life. Currently, there are no standardized behavioral treatments for tics that account for ADHD symptoms and/or address the impact that tics and ADHD symptoms have on quality of life. The main purpose of this trial is to develop and then investigate the effects of a modified comprehensive behavioral intervention for tics (CBIT) protocol for children and adolescents with chronic tic disorders and ADHD.
Aim 1: Development a treatment protocol. The first aim is to develop a treatment protocol that combines elements from CBIT, Cognitive Behavioral Therapy (CBT) for ADHD, and factors targeting psychosocial impairment. A new treatment protocol, called "Living With Tics" was recently developed by Dr. Eric Storch et al to help improve quality of life in those with tic disorders. In addition to incorporating components of modules of the above listed treatments, the modules themselves will be adapted to be more accessible to those with ADHD. As tic disorders often have a significant impact on the family, the investigators will incorporate parent involvement into the treatment as well.
Aim 2: Treatment Feasibility and Acceptability. The investigators' second aim is to determine the treatment feasibility and acceptability of the developed protocol. They will examine the retention rates, reasons for treatment refusal and dropout, and subject/parents motivation for this modified CBIT treatment. They plan to evaluate and assess the randomization process, the treatment modules, and the expectations and satisfaction of the participants and their parents. They will use measures including expectancy and satisfaction scales, and Likert scales will be provided at the end of each session to help determine which components of the modules were most and/or least helpful. From those results, the investigators can continue to adapt the treatment protocol for future, larger studies.
Aim 3: Pilot test the treatment's effectiveness. The final aim is to conduct a pilot randomized control trial (RCT) to test the developed protocol in youth with tic disorders and co-morbid ADHD. Half the subjects will undergo treatment with the modified protocol, and half of the subjects will receive standard CBIT treatment. A broad range of outcome measures will be used to evaluate tic symptoms, ADHD symptoms, and quality of life, and predictors of treatment response will be explored. The following scales will be used: Yale Global Tic Severity Scale (YGTSS), NICHQ Vanderbilt Assessment Scales, and Pediatric Quality of Life Inventory-Child Version (PedsQL) scale, as rated by a blinded clinician. Additionally, the investigators will compare which components were most/least helpful to subjects. Though the investigators will evaluate efficacy of the modified protocol, the primary purpose will remain feasibility. The investigators hope to use this study to develop larger randomized controlled trials in the future.
The modified CBIT treatment will be based on the original CBIT protocol developed by Dr. John Piacentini et al in 2010, a CBT for ADHD in adolescents protocol recently developed by Dr. Susan Sprich et al, and Dr. Eric Storch's "Living with Tics" protocol. Techniques from other studies, which combined and adapted protocols will be incorporated as well.
The treatment will be divided into three phases: Evaluation/Psychoeducation, Basic Intervention, and Relapse Prevention, with a total of 12 sessions.
Prior to beginning the treatment, to make sure the subject qualifies, parent(s) and subject will be asked to come in to complete a baseline assessment component.
Evaluation/Psychoeducation (Sessions 1-2): The first 1-2 sessions will focus on assessing the subject's tics and ADHD symptoms, and assessing the impact of tics and ADHD on the subjects' lives. Psychoeducation about tics/Tourette Syndrome and ADHD, and the CBIT and CBT models will be provided. The therapist will create a hierarchy with the patient regarding which tics are most bothersome and what other symptoms/stressors are most impactful on everyday life. Planning and organizing skills and the idea of function-based interventions will also be introduced. Participants will be encouraged to bring their parent(s) to these initial assessment sessions to familiarize the parent(s) with the treatment methods and allow them to ask questions about tics and ADHD and/or the intervention. If appropriate, parents will be involved in the treatment or homework procedures, but this will vary depending on the comfort level and potential benefit as assessed for each child.
Basic Interventions (Session 3 to Session 10): Beginning in Session 3, basic CBIT, cognitive and behavioral methods will be taught during office sessions and assigned as homework throughout the treatment. In addition to including modules that will specifically target ADHD symptoms (such as those on organization and planning and distractibility), modules in general will be designed to target an ADHD population. Modules will include a combination of activity schedules, positive reinforcements to promote on-task behavior, short "brain breaks" in between activities, repetition of key concepts, and the use of visual aides during the sessions and between sessions at home. Handouts describing the topics covered will also be provided to the parent/patient at the conclusion of each session. Relaxation techniques will be incorporated. Some adapted modules from "Living with Tics" will be included depending on the patients' identified difficulties.
Relapse Prevention (Sessions 11-12): The final sessions, each spaced two weeks after the last session, will focus on relapse prevention. The purpose of the spaced sessions in to allow the patient to get more practice and learn to be their own therapist in between meetings. Residual problems and fears about ending treatment will be addressed, and unrealistically optimistic or pessimistic thoughts about treatment termination will be challenged. Patients will learn to anticipate possible symptom recurrence and its relationship to stress, mood, and other factors; counter negative thoughts about setbacks; and handle lapses and setbacks. Parents will also be encouraged to attend the last session(s) if the child/adolescent or clinician feels it would be appropriate.
- Conditions
- Tourette Syndrome, ADHD
- Being tested
- Modified Comprehensive Behavioral Intervention for Tics, Comprehensive Behavioral Intervention for Tics
- Medical subject headings
- Tourette Syndrome, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Comprehensive Behavioral Intervention for TicsBehavioural
In this arm, participants will receive the modified CBIT protocol. In addition to addressing tics, the treatment in this arm will also directly address ADHD symptoms using CBT for ADHD techniques, and quality of life concerns. The treatment itself will be modified to be more accessible to an ADHD population. The treatment will consist of twelve 50-min sessions: ten weekly and then two every other week for relapse prevention.
Comprehensive Behavioral Intervention for TicsBehavioural
In this arm, participants will receive the standard CBIT intervention (Piacentini et al 2010). The primary components of CBIT are habit reversal training, relaxation training and a functional interventional to assess the environment for situations/factors that exacerbate or sustain tics. The treatment will consist of twelve 50-min sessions: ten weekly and then two every other week for relapse prevention.
| Study group | Role | What they receive |
|---|---|---|
| Modified CBIT Treatment Arm | Experimental | In this arm, participants will receive the modified CBIT protocol. In addition to addressing tics, the treatment in this arm will also directly address ADHD symptoms using CBT for ADHD techniques, and quality of life concerns. The treatment itself will be modified to be more accessible to an ADHD population. The treatment will consist of twelve 50-min sessions: ten weekly and then two every other week for relapse prevention. Receives: Behavioral: Modified Comprehensive Behavioral Intervention for Tics |
| Standard CBIT Treatment Arm | Active comparator | In this arm, participants will receive the standard CBIT intervention (Piacentini et al 2010). The primary components of CBIT are habit reversal training, relaxation training and a functional interventional to assess the environment for situations/factors that exacerbate or sustain tics. The treatment will consist of twelve 50-min sessions: ten weekly and then two every other week for relapse prevention. Receives: Behavioral: Comprehensive Behavioral Intervention for Tics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction Questionnaire
Scale that measures the subject's satisfaction with the treatment
Measured: 26 weeks
Expectancy Therapy Evaluation Form
Rates subject's expectations about effectiveness of the treatment
Measured: Baseline
Satisfaction Scale for Module 1
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Measured: 1 week
Expectancy Therapy Evaluation Form
Rates subject's expectations about effectiveness of the treatment
Measured: 6 weeks
Satisfaction Scale for Module 2
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Measured: 2 weeks
Satisfaction Scale for Module 3
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Measured: 3 weeks
Satisfaction Scale for Module 4
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Measured: 4 weeks
Satisfaction Scale for Module 5
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Measured: 5 weeks
Satisfaction Scale for Module 6
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Measured: 6 weeks
Satisfaction Scale for Module 7
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Measured: 7 weeks
Satisfaction Scale for Module 8
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Measured: 8 weeks
Satisfaction Scale for Module 9
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Measured: 9 weeks
Satisfaction Scale for Module 10
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Measured: 10 weeks
Satisfaction Scale for Module 11
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Measured: 12 weeks
Satisfaction Scale for Module 12
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Measured: 14 weeks
Patient Satisfaction Questionnaire
Scale that measures the patient's satisfaction with the treatment
Measured: 6 weeks
Patient Satisfaction Questionnaire
Scale that measures the patient's satisfaction with the treatment
Measured: 14 weeks
Secondary outcomes (41)
Yale Global Tic Severity Scale
Measures tic symptom severity and impairment
Measured: Change from baseline to mid-point (6 weeks)
Yale Global Tic Severity Scale
Measures tic symptom severity and impairment
Measured: Change from baseline to end-point (14 weeks)
Yale Global Tic Severity Scale
Measures tic symptom severity and impairment
Measured: Change from baseline to 3months following end-point (26 weeks)
Vanderbilt Assessment Scale - ADHD
Measures DSM-IV ADHD and other externalizing behaviors
Measured: Change from baseline to mid-point (6 weeks)
Vanderbilt Assessment Scale - ADHD
Measures DSM-IV ADHD and other externalizing behaviors
Measured: Change from baseline to end-point (14 weeks)
Vanderbilt Assessment Scale - ADHD
Measures DSM-IV ADHD and other externalizing behaviors
Measured: Change from baseline to 3months following end-point (26 weeks)
Clinical Global Impression - Improvement Scale
Measures improvement on a Likert scale
Measured: Change from baseline to one week
Clinical Global Impression - Severity Scale
Measures severity of illness on a Likert scale
Measured: Change from baseline to one week
Clinical Global Impression - Improvement Scale
Measures improvement on a Likert scale
Measured: Change from baseline to two weeks
Clinical Global Impression - Severity Scale
Measures severity of illness on a Likert scale
Measured: Change from baseline to two weeks
Clinical Global Impression - Improvement Scale
Measures improvement on a Likert scale
Measured: Change from baseline to three weeks
Clinical Global Impression - Severity Scale
Measures severity of illness on a Likert scale
Measured: Change from baseline to three weeks
Clinical Global Impression - Improvement Scale
Measures improvement on a Likert scale
Measured: Change from baseline to four weeks
Clinical Global Impression - Severity Scale
Measures severity of illness on a Likert scale
Measured: Change from baseline to four weeks
Clinical Global Impression - Improvement Scale
Measures improvement on a Likert scale
Measured: Change from baseline to five weeks
Clinical Global Impression - Severity Scale
Measures severity of illness on a Likert scale
Measured: Change from baseline to five weeks
Clinical Global Impression - Improvement Scale
Measures improvement on a Likert scale
Measured: Change from baseline to six weeks (mid-point)
Clinical Global Impression - Severity Scale
Measures severity of illness on a Likert scale
Measured: Change from baseline to six weeks (mid-point)
Clinical Global Impression - Improvement Scale
Measures improvement on a Likert scale
Measured: Change from baseline to seven weeks
Clinical Global Impression - Severity Scale
Measures severity of illness on a Likert scale
Measured: Change from baseline to seven weeks
Clinical Global Impression - Improvement Scale
Measures improvement on a Likert scale
Measured: Change from baseline to eight weeks
Clinical Global Impression - Severity Scale
Measures severity of illness on a Likert scale
Measured: Change from baseline to eight weeks
Clinical Global Impression - Improvement Scale
Measures improvement on a Likert scale
Measured: Change from baseline to nine weeks
Clinical Global Impression - Severity Scale
Measures severity of illness on a Likert scale
Measured: Change from baseline to nine weeks
Clinical Global Impression - Improvement Scale
Measures improvement on a Likert scale
Measured: Change from baseline to ten weeks
Clinical Global Impression - Severity Scale
Measures severity of illness on a Likert scale
Measured: Change from baseline to ten weeks
Clinical Global Impression - Improvement Scale
Measures improvement on a Likert scale
Measured: Change from baseline to twelve weeks (session 11)
Clinical Global Impression - Severity Scale
Measures severity of illness on a Likert scale
Measured: Change from baseline to twelve weeks (session 11)
Clinical Global Impression - Improvement Scale
Measures improvement on a Likert scale
Measured: Change from baseline to fourteen weeks (session 12)
Clinical Global Impression - Severity Scale
Measures severity of illness on a Likert scale
Measured: Change from baseline to fourteen weeks (session 12)
Clinical Global Impression - Improvement Scale
Measures improvement on a Likert scale
Measured: Change from baseline to 3months after end-point (26 weeks)
Clinical Global Impression - Severity Scale
Measures severity of illness on a Likert scale
Measured: Change from baseline to 3months after end-point (26 weeks)
Pediatric Quality of Life Inventory (PedsQL)-Child Version
Assesses pediatric population subject's quality of life on a scale of 0-100, with higher scores indicating a better quality of life.
Measured: Change from baseline to mid-point (6 weeks)
Pediatric Quality of Life Inventory (PedsQL)-Child Version
Assesses pediatric population subject's quality of life on a scale of 0-100, with higher scores indicating a better quality of life.
Measured: Change from baseline to end-point (14 weeks)
Pediatric Quality of Life Inventory (PedsQL)-Child Version
Assesses pediatric population subject's quality of life on a scale of 0-100, with higher scores indicating a better quality of life.
Measured: Change from baseline to 3months following end-point (26 weeks)
Parent Tic Questionnaire (PTQ)
Measures severity of specific motor and vocal tics in terms of their frequency and intensity on a scale of 1-4, with higher scores indicating greater frequency and intensity.
Measured: Mid-point (6 weeks)
Parent Tic Questionnaire (PTQ)
Measures severity of specific motor and vocal tics in terms of their frequency and intensity on a scale of 1-4, with higher scores indicating greater frequency and intensity.
Measured: End-point (14 weeks)
Parent Tic Questionnaire (PTQ)
Measures severity of specific motor and vocal tics in terms of their frequency and intensity on a scale of 1-4, with higher scores indicating greater frequency and intensity.
Measured: 3months following end-point (26 weeks)
ADHD - Self-report
Self-report of ADHD symptoms
Measured: Change from baseline to mid-point (6 weeks)
ADHD - Self-report
Self-report of ADHD symptoms
Measured: Change from baseline to end-point (14 weeks)
ADHD - Self-report
Self-report of ADHD symptoms
Measured: Change from baseline to 3months following end-point (26 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion10 Apr 2019
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)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 Massachusetts General HospitalThe 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
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erica Greenberg, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900144
- Sponsor's protocol ID
- 2016P001396
- Acronym
- M_CBIT
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2016
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Achenbach, T. M. (1991). Manual for the child behavior checklist/4-18 and 1991 Profile. Burlington: University of Vermont, Department of Psychiatry.
Antshel KM, Faraone SV, Gordon M. Cognitive behavioral treatment outcomes in adolescent ADHD. J Atten Disord. 2014 Aug;18(6):483-95. doi: 10.1177/1087054712443155. Epub 2012 May 24.
PubMed 22628140"Attention Deficit Hyperactivity Disorder (ADHD)." Centers for Disease Control and Prevention - National Center for Health Statistics. 2015
Barkley, R.A. (1990). Attention-deficit hyperactivity disorder: A handbook for diagnosis and treatment. New York, NY: Guilford Press.
Borkovec TD, Nau SD: Credibility for analogue therapy rationales. J Behav Ther Exp Psychiatry 1972; 3:257-260
Brannan AM, Heflinger CA, Bickman L. The Caregiver Strain Questionnaire: measuring the impact on the family of living with a child with serious emotional disturbance. J Emot Behav Disord. 1997;5(4):212-222
Chang S, Himle M, Tucker B, Woods D, Piacentini J. Initial psychometric properties of a brief parent- report instrument for assessing tic severity in children with chronic tic disorders. Child Fam Behav Ther. 2009; 31(3):181-191.
DuPaul, G.J., Power, T.J., Anastopoulos, A.D., & Reid, R. (1998). ADHD rating scale-IV: Checklists, norms, and clinical interpretations. New York, NY: Guilford Press
Eddy CM, Cavanna AE, Gulisano M, Agodi A, Barchitta M, Cali P, Robertson MM, Rizzo R. Clinical correlates of quality of life in Tourette syndrome. Mov Disord. 2011 Mar;26(4):735-8. doi: 10.1002/mds.23434. Epub 2010 Nov 10.
PubMed 21506153El Malhany N, Gulisano M, Rizzo R, Curatolo P. Tourette syndrome and comorbid ADHD: causes and consequences. Eur J Pediatr. 2015 Mar;174(3):279-88. doi: 10.1007/s00431-014-2417-0. Epub 2014 Sep 17.
PubMed 25224657Fabiano GA, Pelham WE Jr, Coles EK, Gnagy EM, Chronis-Tuscano A, O'Connor BC. A meta-analysis of behavioral treatments for attention-deficit/hyperactivity disorder. Clin Psychol Rev. 2009 Mar;29(2):129-40. doi: 10.1016/j.cpr.2008.11.001. Epub 2008 Nov 11.
PubMed 19131150Guy W. ECDEU Assessment Manual for Psychopharmacology. Washington, DC, US Department of HEW Publications, 1976
Halldorsdottir T, Ollendick TH, Ginsburg G, Sherrill J, Kendall PC, Walkup J, Sakolsky DJ, Piacentini J. Treatment Outcomes in Anxious Youth with and without Comorbid ADHD in the CAMS. J Clin Child Adolesc Psychol. 2015;44(6):985-91. doi: 10.1080/15374416.2014.952008. Epub 2014 Oct 13.
PubMed 25310142Hirschtritt ME, Lee PC, Pauls DL, Dion Y, Grados MA, Illmann C, King RA, Sandor P, McMahon WM, Lyon GJ, Cath DC, Kurlan R, Robertson MM, Osiecki L, Scharf JM, Mathews CA; Tourette Syndrome Association International Consortium for Genetics. Lifetime prevalence, age of risk, and genetic relationships of comorbid psychiatric disorders in Tourette syndrome. JAMA Psychiatry. 2015 Apr;72(4):325-33. doi: 10.1001/jamapsychiatry.2014.2650.
PubMed 25671412Jarrett MA, Ollendick TH. Treatment of comorbid attention-deficit/hyperactivity disorder and anxiety in children: a multiple baseline design analysis. J Consult Clin Psychol. 2012 Apr;80(2):239-44. doi: 10.1037/a0027123. Epub 2012 Feb 6.
PubMed 22309474
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Comprehensive Behavioral Intervention for Tics: Treating Children With Tic Disorders, Co-occurring ADHD and Psychosocial Impairment
- ClinicalTrials.gov ID
- NCT02900144
- Acronym / sponsor ID
- M_CBIT / 2016P001396
- Conditions
- Tourette Syndrome, ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 14 Sep 2016 (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 main purpose of this trial is to develop and investigate the effects of a modified comprehensive behavioral intervention for tics (CBIT) protocol for children and adolescents with chronic tic disorders and ADHD.
CBIT is a first-line behavioral treatment for individuals with tic disorders. However, the benefit of CBIT is mitigated in those with co-occurring ADHD, as ADHD is negatively associated with effect size in behavioral treatments for tics. Additionally, while tic disorders are associated with reduced quality of life measures, CBIT is 'tic-specific.' Despite improving tics, measures do not show associated improved quality of life. Currently, there are no standardized behavioral treatments for tics that account for ADHD symptoms and/or addresses the impact that tics and ADHD symptoms have on quality of life.
The first aim is to develop a treatment protocol that combines elements from CBIT, Cognitive Behavioral Therapy (CBT) for ADHD and factors targeting psychosocial impairment.
The second aim is to determine the treatment feasibility and acceptability (e.g. retention, reasons for treatment refusal and dropout, and motivation) of this modified CBIT treatment. The investigators will evaluate and assess the randomization process, the treatment modules, and the expectations and satisfaction of the participants and their parents.
The final aim is to use a pilot randomized control trial (RCT) design to evaluate improvement using measures including tic, ADHD and quality of life scales as rated by a blinded clinician. Though the investigators will evaluate efficacy of the modified protocol, the primary purpose will remain feasibility. The hope is to use this study to develop larger trials in the future.
Detailed description
Comprehensive behavior intervention for tics (CBIT) is a first-line behavioral treatment for individuals with tic disorders. However, the benefit of CBIT is mitigated in those with co-occurring ADHD, as ADHD is negatively associated with effect size in behavioral treatments for tics. Additionally, while tic disorders are associated with reduced quality of life measures, CBIT is 'tic-specific.' Despite improving tics, measures do not show associated improved quality of life. Currently, there are no standardized behavioral treatments for tics that account for ADHD symptoms and/or address the impact that tics and ADHD symptoms have on quality of life. The main purpose of this trial is to develop and then investigate the effects of a modified comprehensive behavioral intervention for tics (CBIT) protocol for children and adolescents with chronic tic disorders and ADHD.
Aim 1: Development a treatment protocol. The first aim is to develop a treatment protocol that combines elements from CBIT, Cognitive Behavioral Therapy (CBT) for ADHD, and factors targeting psychosocial impairment. A new treatment protocol, called "Living With Tics" was recently developed by Dr. Eric Storch et al to help improve quality of life in those with tic disorders. In addition to incorporating components of modules of the above listed treatments, the modules themselves will be adapted to be more accessible to those with ADHD. As tic disorders often have a significant impact on the family, the investigators will incorporate parent involvement into the treatment as well.
Aim 2: Treatment Feasibility and Acceptability. The investigators' second aim is to determine the treatment feasibility and acceptability of the developed protocol. They will examine the retention rates, reasons for treatment refusal and dropout, and subject/parents motivation for this modified CBIT treatment. They plan to evaluate and assess the randomization process, the treatment modules, and the expectations and satisfaction of the participants and their parents. They will use measures including expectancy and satisfaction scales, and Likert scales will be provided at the end of each session to help determine which components of the modules were most and/or least helpful. From those results, the investigators can continue to adapt the treatment protocol for future, larger studies.
Aim 3: Pilot test the treatment's effectiveness. The final aim is to conduct a pilot randomized control trial (RCT) to test the developed protocol in youth with tic disorders and co-morbid ADHD. Half the subjects will undergo treatment with the modified protocol, and half of the subjects will receive standard CBIT treatment. A broad range of outcome measures will be used to evaluate tic symptoms, ADHD symptoms, and quality of life, and predictors of treatment response will be explored. The following scales will be used: Yale Global Tic Severity Scale (YGTSS), NICHQ Vanderbilt Assessment Scales, and Pediatric Quality of Life Inventory-Child Version (PedsQL) scale, as rated by a blinded clinician. Additionally, the investigators will compare which components were most/least helpful to subjects. Though the investigators will evaluate efficacy of the modified protocol, the primary purpose will remain feasibility. The investigators hope to use this study to develop larger randomized controlled trials in the future.
The modified CBIT treatment will be based on the original CBIT protocol developed by Dr. John Piacentini et al in 2010, a CBT for ADHD in adolescents protocol recently developed by Dr. Susan Sprich et al, and Dr. Eric Storch's "Living with Tics" protocol. Techniques from other studies, which combined and adapted protocols will be incorporated as well.
The treatment will be divided into three phases: Evaluation/Psychoeducation, Basic Intervention, and Relapse Prevention, with a total of 12 sessions.
Prior to beginning the treatment, to make sure the subject qualifies, parent(s) and subject will be asked to come in to complete a baseline assessment component.
Evaluation/Psychoeducation (Sessions 1-2): The first 1-2 sessions will focus on assessing the subject's tics and ADHD symptoms, and assessing the impact of tics and ADHD on the subjects' lives. Psychoeducation about tics/Tourette Syndrome and ADHD, and the CBIT and CBT models will be provided. The therapist will create a hierarchy with the patient regarding which tics are most bothersome and what other symptoms/stressors are most impactful on everyday life. Planning and organizing skills and the idea of function-based interventions will also be introduced. Participants will be encouraged to bring their parent(s) to these initial assessment sessions to familiarize the parent(s) with the treatment methods and allow them to ask questions about tics and ADHD and/or the intervention. If appropriate, parents will be involved in the treatment or homework procedures, but this will vary depending on the comfort level and potential benefit as assessed for each child.
Basic Interventions (Session 3 to Session 10): Beginning in Session 3, basic CBIT, cognitive and behavioral methods will be taught during office sessions and assigned as homework throughout the treatment. In addition to including modules that will specifically target ADHD symptoms (such as those on organization and planning and distractibility), modules in general will be designed to target an ADHD population. Modules will include a combination of activity schedules, positive reinforcements to promote on-task behavior, short "brain breaks" in between activities, repetition of key concepts, and the use of visual aides during the sessions and between sessions at home. Handouts describing the topics covered will also be provided to the parent/patient at the conclusion of each session. Relaxation techniques will be incorporated. Some adapted modules from "Living with Tics" will be included depending on the patients' identified difficulties.
Relapse Prevention (Sessions 11-12): The final sessions, each spaced two weeks after the last session, will focus on relapse prevention. The purpose of the spaced sessions in to allow the patient to get more practice and learn to be their own therapist in between meetings. Residual problems and fears about ending treatment will be addressed, and unrealistically optimistic or pessimistic thoughts about treatment termination will be challenged. Patients will learn to anticipate possible symptom recurrence and its relationship to stress, mood, and other factors; counter negative thoughts about setbacks; and handle lapses and setbacks. Parents will also be encouraged to attend the last session(s) if the child/adolescent or clinician feels it would be appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified CBIT Treatment Arm | Experimental | Behavioral: Modified Comprehensive Behavioral Intervention for TicsIn this arm, participants will receive the modified CBIT protocol. In addition to addressing tics, the treatment in this arm will also directly address ADHD symptoms using CBT for ADHD techniques, and quality of life concerns. The treatment itself will be modified to be more accessible to an ADHD population. The treatment will consist of twelve 50-min sessions: ten weekly and then two every other week for relapse prevention. |
| Standard CBIT Treatment Arm | Active comparator | Behavioral: Comprehensive Behavioral Intervention for TicsIn this arm, participants will receive the standard CBIT intervention (Piacentini et al 2010). The primary components of CBIT are habit reversal training, relaxation training and a functional interventional to assess the environment for situations/factors that exacerbate or sustain tics. The treatment will consist of twelve 50-min sessions: ten weekly and then two every other week for relapse prevention. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Have a DSM-5-based diagnosis of Tourette Syndrome or Persistent Motor or Vocal Tic Disorder
- Have a diagnosis of ADHD by DSM-5 standards, or a previous diagnosis of ADHD where there are some residual symptoms (at least 7/18) but does not currently meet diagnostic criteria due to current medications.
- Tic disorder is the most problematic psychiatric disorder and the primary reason for seeking treatment
- Have a current total tic severity score of >13 (or >9 if CTD) on the Yale Global Tic Severity Score (YGTSS), and a current total impairment score of >19 on the YGTSS
- Be male or female and between 10-17 years of age at the start of the treatment, inclusive
Key exclusion criteria (8 listed)
- Comorbid psychiatric diagnoses including: alcohol or substance abuse or dependence within the past 3 months, psychosis, organic mental disorder, current mania, developmental delay, estimated IQ <80 on the Wechsler Abbreviated Scale of Intelligence (WASI), other cognitive impairment that would interfere with ability to engage in CBT, or other developmental/cognitive impairment that precludes the participant from being able to communicate meaningfully with the treater
- Those deemed to pose a serious suicidal or homicidal threat (e.g., suicide attempt within past 6 months and/or endorsement of "I want to kill myself" on the Children's Depression Inventory (CDI)).
- Current illness (tics or otherwise) so severe that an immediate psychopharmacological evaluation is warranted
- Any clinical features requiring a higher level of care than outpatient (as determined by evaluator).
- Intent to travel for a period longer than two weeks (such that three sessions would be missed) during the proposed time-frame of the study. However, this criterion may be waived as per the discretion of the Principal investigator.
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 |
|---|---|---|
| Modified Comprehensive Behavioral Intervention for TicsIn this arm, participants will receive the modified CBIT protocol. In addition to addressing tics, the treatment in this arm will also directly address ADHD symptoms using CBT for ADHD techniques, and quality of life concerns. The treatment itself will be modified to be more accessible to an ADHD population. The treatment will consist of twelve 50-min sessions: ten weekly and then two every other week for relapse prevention. | Behavioural | Modified CBIT Treatment Arm |
| Comprehensive Behavioral Intervention for TicsIn this arm, participants will receive the standard CBIT intervention (Piacentini et al 2010). The primary components of CBIT are habit reversal training, relaxation training and a functional interventional to assess the environment for situations/factors that exacerbate or sustain tics. The treatment will consist of twelve 50-min sessions: ten weekly and then two every other week for relapse prevention. | Behavioural | Standard CBIT Treatment Arm |
Primary outcome
Patient Satisfaction Questionnaire
Time frame: 26 weeks
Scale that measures the subject's satisfaction with the treatment
Expectancy Therapy Evaluation Form
Time frame: Baseline
Rates subject's expectations about effectiveness of the treatment
Satisfaction Scale for Module 1
Time frame: 1 week
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Expectancy Therapy Evaluation Form
Time frame: 6 weeks
Rates subject's expectations about effectiveness of the treatment
Satisfaction Scale for Module 2
Time frame: 2 weeks
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Satisfaction Scale for Module 3
Time frame: 3 weeks
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Satisfaction Scale for Module 4
Time frame: 4 weeks
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Satisfaction Scale for Module 5
Time frame: 5 weeks
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Satisfaction Scale for Module 6
Time frame: 6 weeks
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Satisfaction Scale for Module 7
Time frame: 7 weeks
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Satisfaction Scale for Module 8
Time frame: 8 weeks
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Satisfaction Scale for Module 9
Time frame: 9 weeks
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Satisfaction Scale for Module 10
Time frame: 10 weeks
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Satisfaction Scale for Module 11
Time frame: 12 weeks
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Satisfaction Scale for Module 12
Time frame: 14 weeks
Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.
Patient Satisfaction Questionnaire
Time frame: 6 weeks
Scale that measures the patient's satisfaction with the treatment
Patient Satisfaction Questionnaire
Time frame: 14 weeks
Scale that measures the patient's satisfaction with the treatment
41 secondary outcomes
Yale Global Tic Severity Scale
Time frame: Change from baseline to mid-point (6 weeks)
Yale Global Tic Severity Scale
Time frame: Change from baseline to end-point (14 weeks)
Yale Global Tic Severity Scale
Time frame: Change from baseline to 3months following end-point (26 weeks)
Vanderbilt Assessment Scale - ADHD
Time frame: Change from baseline to mid-point (6 weeks)
Vanderbilt Assessment Scale - ADHD
Time frame: Change from baseline to end-point (14 weeks)
Vanderbilt Assessment Scale - ADHD
Time frame: Change from baseline to 3months following end-point (26 weeks)
Clinical Global Impression - Improvement Scale
Time frame: Change from baseline to one week
Clinical Global Impression - Severity Scale
Time frame: Change from baseline to one week
Clinical Global Impression - Improvement Scale
Time frame: Change from baseline to two weeks
Clinical Global Impression - Severity Scale
Time frame: Change from baseline to two weeks
Clinical Global Impression - Improvement Scale
Time frame: Change from baseline to three weeks
Clinical Global Impression - Severity Scale
Time frame: Change from baseline to three weeks
Clinical Global Impression - Improvement Scale
Time frame: Change from baseline to four weeks
Clinical Global Impression - Severity Scale
Time frame: Change from baseline to four weeks
Clinical Global Impression - Improvement Scale
Time frame: Change from baseline to five weeks
Clinical Global Impression - Severity Scale
Time frame: Change from baseline to five weeks
Clinical Global Impression - Improvement Scale
Time frame: Change from baseline to six weeks (mid-point)
Clinical Global Impression - Severity Scale
Time frame: Change from baseline to six weeks (mid-point)
Clinical Global Impression - Improvement Scale
Time frame: Change from baseline to seven weeks
Clinical Global Impression - Severity Scale
Time frame: Change from baseline to seven weeks
Clinical Global Impression - Improvement Scale
Time frame: Change from baseline to eight weeks
Clinical Global Impression - Severity Scale
Time frame: Change from baseline to eight weeks
Clinical Global Impression - Improvement Scale
Time frame: Change from baseline to nine weeks
Clinical Global Impression - Severity Scale
Time frame: Change from baseline to nine weeks
Clinical Global Impression - Improvement Scale
Time frame: Change from baseline to ten weeks
Clinical Global Impression - Severity Scale
Time frame: Change from baseline to ten weeks
Clinical Global Impression - Improvement Scale
Time frame: Change from baseline to twelve weeks (session 11)
Clinical Global Impression - Severity Scale
Time frame: Change from baseline to twelve weeks (session 11)
Clinical Global Impression - Improvement Scale
Time frame: Change from baseline to fourteen weeks (session 12)
Clinical Global Impression - Severity Scale
Time frame: Change from baseline to fourteen weeks (session 12)
Clinical Global Impression - Improvement Scale
Time frame: Change from baseline to 3months after end-point (26 weeks)
Clinical Global Impression - Severity Scale
Time frame: Change from baseline to 3months after end-point (26 weeks)
Pediatric Quality of Life Inventory (PedsQL)-Child Version
Time frame: Change from baseline to mid-point (6 weeks)
Pediatric Quality of Life Inventory (PedsQL)-Child Version
Time frame: Change from baseline to end-point (14 weeks)
Pediatric Quality of Life Inventory (PedsQL)-Child Version
Time frame: Change from baseline to 3months following end-point (26 weeks)
Parent Tic Questionnaire (PTQ)
Time frame: Mid-point (6 weeks)
Parent Tic Questionnaire (PTQ)
Time frame: End-point (14 weeks)
Parent Tic Questionnaire (PTQ)
Time frame: 3months following end-point (26 weeks)
ADHD - Self-report
Time frame: Change from baseline to mid-point (6 weeks)
ADHD - Self-report
Time frame: Change from baseline to end-point (14 weeks)
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 16 Sep 2021.
- BackgroundAchenbach, T. M. (1991). Manual for the child behavior checklist/4-18 and 1991 Profile. Burlington: University of Vermont, Department of Psychiatry.
- Background: PubMed 22628140Antshel KM, Faraone SV, Gordon M. Cognitive behavioral treatment outcomes in adolescent ADHD. J Atten Disord. 2014 Aug;18(6):483-95. doi: 10.1177/1087054712443155. Epub 2012 May 24.
- Background"Attention Deficit Hyperactivity Disorder (ADHD)." Centers for Disease Control and Prevention - National Center for Health Statistics. 2015
- BackgroundBarkley, R.A. (1990). Attention-deficit hyperactivity disorder: A handbook for diagnosis and treatment. New York, NY: Guilford Press.
- BackgroundBorkovec TD, Nau SD: Credibility for analogue therapy rationales. J Behav Ther Exp Psychiatry 1972; 3:257-260
- BackgroundBrannan AM, Heflinger CA, Bickman L. The Caregiver Strain Questionnaire: measuring the impact on the family of living with a child with serious emotional disturbance. J Emot Behav Disord. 1997;5(4):212-222
- BackgroundChang S, Himle M, Tucker B, Woods D, Piacentini J. Initial psychometric properties of a brief parent- report instrument for assessing tic severity in children with chronic tic disorders. Child Fam Behav Ther. 2009; 31(3):181-191.
- BackgroundDuPaul, G.J., Power, T.J., Anastopoulos, A.D., & Reid, R. (1998). ADHD rating scale-IV: Checklists, norms, and clinical interpretations. New York, NY: Guilford Press
- Background: PubMed 21506153Eddy CM, Cavanna AE, Gulisano M, Agodi A, Barchitta M, Cali P, Robertson MM, Rizzo R. Clinical correlates of quality of life in Tourette syndrome. Mov Disord. 2011 Mar;26(4):735-8. doi: 10.1002/mds.23434. Epub 2010 Nov 10.
- Background: PubMed 25224657El Malhany N, Gulisano M, Rizzo R, Curatolo P. Tourette syndrome and comorbid ADHD: causes and consequences. Eur J Pediatr. 2015 Mar;174(3):279-88. doi: 10.1007/s00431-014-2417-0. Epub 2014 Sep 17.
- Background: PubMed 19131150Fabiano GA, Pelham WE Jr, Coles EK, Gnagy EM, Chronis-Tuscano A, O'Connor BC. A meta-analysis of behavioral treatments for attention-deficit/hyperactivity disorder. Clin Psychol Rev. 2009 Mar;29(2):129-40. doi: 10.1016/j.cpr.2008.11.001. Epub 2008 Nov 11.
- BackgroundGuy W. ECDEU Assessment Manual for Psychopharmacology. Washington, DC, US Department of HEW Publications, 1976
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Comprehensive Behavioral Intervention for Tics and Comprehensive Behavioral Intervention for Tics in people with Tourette Syndrome and ADHD, run by Massachusetts General Hospital 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 7 inclusion and 8 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 16 Sep 2021. 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?
Patient Satisfaction Questionnaire (time frame: 26 weeks). The study lists 17 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 NCT02900144, which also lists 52 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 16 Sep 2021; AzTrials last refreshed its copy on 28 Oct 2026.