Tic Disorder, ChildhoodNCT04878302
Improving Symptom Trajectories of Tic Disorders and Co-occurring Diagnoses: The Role of Integrative Intensive Intervention
A study testing Combination of Comprehensive Behavioral Intervention for Tics (CBIT) and Evidence-based interventions for co-occurring diagnoses (i.e., Cognitive Behavioral Therapy, Behavioral Parent Training) in people with Tic Disorder, Childhood and Comorbidities and Coexisting Conditions, run by Florida International University at 1 site in United States.
Trial summary
The purpose to the current study was to examine the efficacy of a telehealth, group-based, combined and intensive intervention for youth with tic disorders (TDs) and common co-occurring diagnoses. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Tic Disorder, Childhood, Comorbidities and Coexisting Conditions
- What is being tested?
- Combination of Comprehensive Behavioral Intervention for Tics (CBIT) and Evidence-based interventions for co-occurring diagnoses (i.e., Cognitive Behavioral Therapy, Behavioral Parent Training)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2021to 31 Oct 2021
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Youth participants are between seven and 17 years old
- Meet diagnostic criteria for a primary or co-primary diagnosis of a Tic Disorder
- Are available to participate in all sessions
- Are comfortable in English
- Youth participants have at least borderline clinician symptoms of ADHD, oppositional defiant disorder (ODD), obsessive compulsive disorder (OCD) and/or an anxiety disorder.
Who cannot join
- Are identified as having a psychiatric condition that is more impairing and requiring treatment prior to a tic intervention.
- Meet criteria for Autism Spectrum Disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
The purpose to the current study was to examine the efficacy of a telehealth, group-based, combined and intensive intervention for youth with tic disorders (TDs) and common co-occurring diagnoses. Families seeking treatment for TDs and common co-occurring diagnoses will be randomly assigned to receive treatment immediate (enrollment in the next group) or remain on a 1-month waitlist, and then receive treatment. Outcomes will be assessed across the treatment phase, immediately following treatment (post), as well as 1-month following the end of treatment.
Read the detailed description
Over 1,000,000 children in the U.S. have a tic disorder (TD). TDs can substantially impact daily child functioning across numerous domains leading to a significant public health impact of TDs. Additionally, an overwhelming majority of children with a TD have at least one co-occurring disorder. Over 60% also meet criteria for attention deficit/hyperactivity disorder (ADHD), half struggle with anxiety and at least a third have clinically elevated Obsessive Compulsive-spectrum symptoms.
Comprehensive Behavioral Intervention for Tics (CBIT) is a first-line treatment for youth with TDs. It has been shown to be effective in reducing the frequency, duration, and severity of tics in children and adolescents. Nonetheless, access to trained CBIT providers remains limited, and common comorbid conditions are not addressed in standard CBIT. Thus, there is a desperate need for interventions that can simultaneously increase CBIT access and incorporate treatment strategies for comorbidities.
Intensive, group-based interventions are well-established for the treatment of comorbid disorders and have been shown to be a cost-efficient modality for delivering multimodal interventions. Intensive formats provide the opportunity for families to gain access to treatment for a limited time without the extended burden often associated with weekly treatment sessions. Further, intensive group-based treatments can simultaneously treat comorbidities.
To address the critical need for increasing access to CBIT and simultaneously treating common comorbidities, a week-long group-based intensive intervention for children with TDs and common co-occurring diagnoses (Taming Tics Together) has been developed and will be evaluated. Participants will be randomly assigned to immediate treatment or a 1-month waitlist control. Assessments will take place pre-treatment, daily throughout the intervention, as well as at 1-month post treatment.
The primary aims of the current study are to evaluate symptom reduction in tic severity and co-occurring condition symptom severity. Importantly, the investigators seek to learn more about the effectiveness of an intensive-format for tics and co-occurring diagnoses, which may lead to mechanisms to improve access to care for families who often are not able to access effective treatment.
- Being tested
- Combination of Comprehensive Behavioral Intervention for Tics (CBIT) and Evidence-based interventions for co-occurring diagnoses (i.e., Cognitive Behavioral Therapy, Behavioral Parent Training)
- Medical subject headings
- Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Comprehensive Behavioral Intervention for Tics (CBIT) and Evidence-based interventions for co-occurring diagnoses (i.e., Cognitive Behavioral Therapy, Behavioral Parent Training)Behavioural
Families assigned to the immediate treatment group will receive the telehealth-based Taming Tics Together protocol(created using well-established, evidence-based treatment protocols), which includes group (parent/caregiver-only, child/teen-only) and individualized one-to-one sessions to address tics and co-occurring diagnoses.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Taming Tics Together Protocol | Experimental | Families will participate in the 5-day telehealth-based intensive intervention and will receive three treatment formats which will provide CBIT and co-occurring diagnosis treatment:
1. Child/teen-only groups
2. Individual one-to-one sessions
3. Parent/caregiver-only groups Receives: Behavioral: Combination of Comprehensive Behavioral Intervention for Tics (CBIT) and Evidence-based interventions for co-occurring diagnoses (i.e., Cognitive Behavioral Therapy, Behavioral Parent Training) |
| 1-Month Waitlist Control | No intervention | Families in the 1-month waitlist control group will participate in the initial intake assessment, then receive no treatment for a 1-month period. Following the 1-month period, families will participate in an assessment, then will be offered a place in a Taming Tics Together group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Global Tic Severity Scale (YGTSS)
Yale Global Tic Severity Scale (Leckman et al., 1989). The Yale Global Tic Severity Scale is a clinician-administered assessment evaluating tic history, as well as tics present over the past 7-10 days. The Yale Global Tic Severity Scale has been used in several randomized controlled trials and has exhibited excellent internal consistency (i.e., McGuire et al., 2018). Motor and vocal tics are rated based on their number, frequency, intensity, complexity and interference (each rated on a scale from 0-5), and impairment (rated on a scale from 0-50). The Total Tic Severity Score evaluates overall motor and vocal tic severity (range 0-50), and the Total Yale Global Tic Severity Scale Score evaluates the total tic severity score in additional to impairment, with a range of scores from 0 to 100. Higher scores indicate increased severity.
Measured: Change from pre-treatment to post, and 1-month following the end of treatment
Secondary outcomes (2)
Revised Child Anxiety and Depression Scale (RCADS)
Revised Child Anxiety and Depression Scale (RCADS; Chorpita et al., 2000). The RCADS is a 47-item self-report measure to evaluate several internalizing domains. Items are rated on a scale from 0 (never) to 3 (always). The RCADS has demonstrated high internal consistency (Chorpita, Moffit, \& Gray, 2005)).
Measured: Change from pre-treatment to post and 1-month
Disruptive Behavior Disorder Rating Scale (DBD-RS)
Disruptive Behavior Disorder Rating Scale (DBD-RS; Pelham et al.,1992). The DBD-RS is a 45-item parent rating scale to assess for disruptive behaviors, specifically, ADHD, oppositional defiant disorder, and conduct disorder. Informants complete the rating scale using a four-point Likert scale (zero = not at all; one = just a little; two = pretty much; three = very much). The DBD-RS has demonstrated high internal consistency (Pelletier et al., 2006).
Measured: Change from pre-treatment to post and 1-month following the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start26 Mar 2021
- Primary completion29 Sep 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Tic Disorder, ChildhoodStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible families will be randomly assigned to an immediate treatment group or a 1-month waitlist.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878302
- Sponsor's protocol ID
- IRB-20-0562
- Status last verified
- Jul 2022
- First submitted
- 4 May 2021
- Last updated
- 15 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Leckman JF, Riddle MA, Hardin MT, Ort SI, Swartz KL, Stevenson J, Cohen DJ. The Yale Global Tic Severity Scale: initial testing of a clinician-rated scale of tic severity. J Am Acad Child Adolesc Psychiatry. 1989 Jul;28(4):566-73. doi: 10.1097/00004583-198907000-00015.
PubMed 2768151Pelham WE Jr, Gnagy EM, Greenslade KE, Milich R. Teacher ratings of DSM-III-R symptoms for the disruptive behavior disorders. J Am Acad Child Adolesc Psychiatry. 1992 Mar;31(2):210-8. doi: 10.1097/00004583-199203000-00006.
PubMed 1564021Pelletier, J, Collett, B, Gimpel, G, & Crowley S. Assessment of Disruptive Behaviors in Preschoolers: Psychometric Properties of the Disruptive Behavior Disorders Rating Scale and School Situations Questionnaire. Journal of Psychoeducational Assessment. 2006; 24(1): 3-18.
Chorpita BF, Moffitt CE, Gray J. Psychometric properties of the Revised Child Anxiety and Depression Scale in a clinical sample. Behav Res Ther. 2005 Mar;43(3):309-22. doi: 10.1016/j.brat.2004.02.004.
PubMed 15680928Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE. Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child anxiety and depression scale. Behav Res Ther. 2000 Aug;38(8):835-55. doi: 10.1016/s0005-7967(99)00130-8.
PubMed 10937431Woods, D, Piacentini, J, Chang, S, Deckersbach, T, Ginsburg, G, Peterson, A, Scahill, L, Walkup, J, & Wilhelm, S. Managing Tourette Syndrome: A Behavioral Intervention for Children and Adults Therapist Guide. 2008; New York, NY: Oxford University Press.
McGuire JF, Piacentini J, Storch EA, Murphy TK, Ricketts EJ, Woods DW, Walkup JW, Peterson AL, Wilhelm S, Lewin AB, McCracken JT, Leckman JF, Scahill L. A multicenter examination and strategic revisions of the Yale Global Tic Severity Scale. Neurology. 2018 May 8;90(19):e1711-e1719. doi: 10.1212/WNL.0000000000005474. Epub 2018 Apr 13.
PubMed 29653992
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Symptom Trajectories of Tic Disorders and Co-occurring Diagnoses: The Role of Integrative Intensive Intervention
- ClinicalTrials.gov ID
- NCT04878302
- Acronym / sponsor ID
- IRB-20-0562
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 7 May 2021 (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.
The purpose to the current study was to examine the efficacy of a telehealth, group-based, combined and intensive intervention for youth with tic disorders (TDs) and common co-occurring diagnoses. Families seeking treatment for TDs and common co-occurring diagnoses will be randomly assigned to receive treatment immediate (enrollment in the next group) or remain on a 1-month waitlist, and then receive treatment. Outcomes will be assessed across the treatment phase, immediately following treatment (post), as well as 1-month following the end of treatment.
Detailed description
Over 1,000,000 children in the U.S. have a tic disorder (TD). TDs can substantially impact daily child functioning across numerous domains leading to a significant public health impact of TDs. Additionally, an overwhelming majority of children with a TD have at least one co-occurring disorder. Over 60% also meet criteria for attention deficit/hyperactivity disorder (ADHD), half struggle with anxiety and at least a third have clinically elevated Obsessive Compulsive-spectrum symptoms.
Comprehensive Behavioral Intervention for Tics (CBIT) is a first-line treatment for youth with TDs. It has been shown to be effective in reducing the frequency, duration, and severity of tics in children and adolescents. Nonetheless, access to trained CBIT providers remains limited, and common comorbid conditions are not addressed in standard CBIT. Thus, there is a desperate need for interventions that can simultaneously increase CBIT access and incorporate treatment strategies for comorbidities.
Intensive, group-based interventions are well-established for the treatment of comorbid disorders and have been shown to be a cost-efficient modality for delivering multimodal interventions. Intensive formats provide the opportunity for families to gain access to treatment for a limited time without the extended burden often associated with weekly treatment sessions. Further, intensive group-based treatments can simultaneously treat comorbidities.
To address the critical need for increasing access to CBIT and simultaneously treating common comorbidities, a week-long group-based intensive intervention for children with TDs and common co-occurring diagnoses (Taming Tics Together) has been developed and will be evaluated. Participants will be randomly assigned to immediate treatment or a 1-month waitlist control. Assessments will take place pre-treatment, daily throughout the intervention, as well as at 1-month post treatment.
The primary aims of the current study are to evaluate symptom reduction in tic severity and co-occurring condition symptom severity. Importantly, the investigators seek to learn more about the effectiveness of an intensive-format for tics and co-occurring diagnoses, which may lead to mechanisms to improve access to care for families who often are not able to access effective treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible families will be randomly assigned to an immediate treatment group or a 1-month waitlist.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Taming Tics Together Protocol | Experimental | Behavioral: Combination of Comprehensive Behavioral Intervention for Tics (CBIT) and Evidence-based interventions for co-occurring diagnoses (i.e., Cognitive Behavioral Therapy, Behavioral Parent Training)Families will participate in the 5-day telehealth-based intensive intervention and will receive three treatment formats which will provide CBIT and co-occurring diagnosis treatment: 1. Child/teen-only groups 2. Individual one-to-one sessions 3. Parent/caregiver-only groups |
| 1-Month Waitlist Control | No intervention | –Families in the 1-month waitlist control group will participate in the initial intake assessment, then receive no treatment for a 1-month period. Following the 1-month period, families will participate in an assessment, then will be offered a place in a Taming Tics Together group |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Youth participants are between seven and 17 years old
- Meet diagnostic criteria for a primary or co-primary diagnosis of a Tic Disorder
- Are available to participate in all sessions
- Are comfortable in English
- Youth participants have at least borderline clinician symptoms of ADHD, oppositional defiant disorder (ODD), obsessive compulsive disorder (OCD) and/or an anxiety disorder.
Key exclusion criteria (2 listed)
- Are identified as having a psychiatric condition that is more impairing and requiring treatment prior to a tic intervention.
- Meet criteria for Autism Spectrum Disorder.
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 |
|---|---|---|
| Combination of Comprehensive Behavioral Intervention for Tics (CBIT) and Evidence-based interventions for co-occurring diagnoses (i.e., Cognitive Behavioral Therapy, Behavioral Parent Training)Families assigned to the immediate treatment group will receive the telehealth-based Taming Tics Together protocol(created using well-established, evidence-based treatment protocols), which includes group (parent/caregiver-only, child/teen-only) and individualized one-to-one sessions to address tics and co-occurring diagnoses. | Behavioural | Experimental: Taming Tics Together Protocol |
Primary outcome
Yale Global Tic Severity Scale (YGTSS)
Time frame: Change from pre-treatment to post, and 1-month following the end of treatment
Yale Global Tic Severity Scale (Leckman et al., 1989). The Yale Global Tic Severity Scale is a clinician-administered assessment evaluating tic history, as well as tics present over the past 7-10 days. The Yale Global Tic Severity Scale has been used in several randomized controlled trials and has exhibited excellent internal consistency (i.e., McGuire et al., 2018). Motor and vocal tics are rated based on their number, frequency, intensity, complexity and interference (each rated on a scale from 0-5), and impairment (rated on a scale from 0-50). The Total Tic Severity Score evaluates overall motor and vocal tic severity (range 0-50), and the Total Yale Global Tic Severity Scale Score evaluates the total tic severity score in additional to impairment, with a range of scores from 0 to 100. Higher scores indicate increased severity.
2 secondary outcomes
Revised Child Anxiety and Depression Scale (RCADS)
Time frame: Change from pre-treatment to post and 1-month
Disruptive Behavior Disorder Rating Scale (DBD-RS)
Time frame: Change from pre-treatment to post and 1-month following the end of treatment.
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 15 Jul 2022.
- Background: PubMed 2768151Leckman JF, Riddle MA, Hardin MT, Ort SI, Swartz KL, Stevenson J, Cohen DJ. The Yale Global Tic Severity Scale: initial testing of a clinician-rated scale of tic severity. J Am Acad Child Adolesc Psychiatry. 1989 Jul;28(4):566-73. doi: 10.1097/00004583-198907000-00015.
- Background: PubMed 1564021Pelham WE Jr, Gnagy EM, Greenslade KE, Milich R. Teacher ratings of DSM-III-R symptoms for the disruptive behavior disorders. J Am Acad Child Adolesc Psychiatry. 1992 Mar;31(2):210-8. doi: 10.1097/00004583-199203000-00006.
- BackgroundPelletier, J, Collett, B, Gimpel, G, & Crowley S. Assessment of Disruptive Behaviors in Preschoolers: Psychometric Properties of the Disruptive Behavior Disorders Rating Scale and School Situations Questionnaire. Journal of Psychoeducational Assessment. 2006; 24(1): 3-18.
- Background: PubMed 15680928Chorpita BF, Moffitt CE, Gray J. Psychometric properties of the Revised Child Anxiety and Depression Scale in a clinical sample. Behav Res Ther. 2005 Mar;43(3):309-22. doi: 10.1016/j.brat.2004.02.004.
- Background: PubMed 10937431Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE. Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child anxiety and depression scale. Behav Res Ther. 2000 Aug;38(8):835-55. doi: 10.1016/s0005-7967(99)00130-8.
- BackgroundWoods, D, Piacentini, J, Chang, S, Deckersbach, T, Ginsburg, G, Peterson, A, Scahill, L, Walkup, J, & Wilhelm, S. Managing Tourette Syndrome: A Behavioral Intervention for Children and Adults Therapist Guide. 2008; New York, NY: Oxford University Press.
- Background: PubMed 29653992McGuire JF, Piacentini J, Storch EA, Murphy TK, Ricketts EJ, Woods DW, Walkup JW, Peterson AL, Wilhelm S, Lewin AB, McCracken JT, Leckman JF, Scahill L. A multicenter examination and strategic revisions of the Yale Global Tic Severity Scale. Neurology. 2018 May 8;90(19):e1711-e1719. doi: 10.1212/WNL.0000000000005474. Epub 2018 Apr 13.
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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 Combination of Comprehensive Behavioral Intervention for Tics (CBIT) and Evidence-based interventions for co-occurring diagnoses (i.e., Cognitive Behavioral Therapy, Behavioral Parent Training) in people with Tic Disorder, Childhood and Comorbidities and Coexisting Conditions, run by Florida International 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 5 inclusion and 2 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 15 Jul 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?
Yale Global Tic Severity Scale (YGTSS) (time frame: Change from pre-treatment to post, and 1-month following the end of 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 NCT04878302, which also lists 7 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 15 Jul 2022.