Modified Comprehensive Behavioral Intervention for Tics for Children with Tic Disorder, Co-occurring Attention Deficit Hyperactivity Disorder, and Psychosocial Impairment

  • STATUS
    Recruiting
Updated on 25 March 2021

Summary

Modified Comprehensive Behavioral Intervention for Tics for Children with Tic Disorder, Co-occurring Attention Deficit Hyperactivity Disorder, and Psychosocial Impairment

Description

We are conducting a treatment study to examine the use of Comprehensive Behavior Intervention for Tics (CBIT). CBIT is the current gold standard first-line behavioral treatment for children and adolescents with tic disorders. The treatment includes three main components: (1) it helps patients become more aware of their tics, (2) it trains patients to do other competing behaviors when they feel the urge to tic, and (3) it helps patients make changes in their day-to-day activities in ways that can be helpful in reducing tics. CBIT has been shown to be very helpful in reducing tics, but it hasn’t been as effective in treating children and adolescents who also have ADHD symptoms, or in helping to improve their quality of life, which tends to be lower in individuals with tics.

The purpose of the current study is to demonstrate the efficacy of modified CBIT protocol that has been designed to specifically target ADHD symptoms and psychosocial improvement, in addition to tic symptoms. To examine the effectiveness of this newly developed treatment, the modified CBIT protocol will be compared with the standard CBIT protocol in a randomized control trial. One of the unique benefits of this study is that every individual who is enrolled in the study will receive a form of immediate, active treatment, rather than one group receiving a placebo or being put on a waitlist.

Participation in the study involves a few different stages. The first stage is the screening stage. If you believe that this study would be a good fit for your child, you would first complete a preliminary screen over the telephone to briefly assess for the eligibility criteria. This telephone screen would take between 20-30 minutes. Next, you and your child would come to our clinic at Massachusetts General Hospital for an initial, more thorough, assessment with a clinical to ensure that your child would be eligible to participate in the study. This visit would take between 2-3 hours.

If your child is deemed eligible for the study, they would progress to the randomization stage. Your child would be randomized, which is like the flip of a coin, into a treatment group to receive either the standard CBIT treatment or the modified treatment that is being tested in the study.

After your child is randomized, they will begin the treatment stage. Your child would receive 12 sessions of behavior therapy over the course of 14 weeks, at no cost. The weekly sessions would take place at our clinic at Massachusetts General Hospital and would last approximately 1 hour. The first ten treatment sessions would be weekly, and then the last two treatment sessions would be every other week. During or right after the 6th session and the last session, there would be another assessment that would take approximately 2 hours.

The final stage would be the follow-up stage, which would occur three months after your child has completed the treatment stage. There would be one last visit at our clinic at Massachusetts General Hospital to assess how your child has been doing since treatment ended. This session would also last about 2 hours.

Please note that if your child participates in this study, they will receive behavioral treatment at no cost—this means that we will not bill you or your insurance company, and there would not be any co-pays for the visits to our clinic at Massachusetts General Hospital. In addition to the no-cost treatment, we would reimburse your parking fees related study sessions at our clinic at Massachusetts General Hospital, and we will compensate $25 dollars at the end of study participation once all assessments are completed.

For more information, please contact Erin Curley at 617-643-8464.

Details
Condition Attention Deficit/Hyperactivity Disorder (ADHD - Pediatric)
Clinical Study IdentifierTX146581
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female between 11-17 years of age
Meets DSM-5 criteria for a diagnosis for Attention Deficit Hyperactivity Disorder
Meets DSM-5 criteria for a diagnosis of Tourette Syndrome or Persistent Motor or Vocal Tics
Tic disorder is the most problematic disorder and the primary reason for seeking psychiatric treatment
Current tic symptoms meet a severity threshold (>13/50 YGTSS total severity score for patients with Tourette Syndrome and >9/50 YGTSS score for patients with Persistent Motor or Vocal Tic Disorder) and causing some impairment (>19/50 YGTSS total impairment score)
Proficiency in English
Able to communicate meaningfully with investigators and be competent to provide written assent and have parents who can provide informed parental consent

Exclusion Criteria

Severity of illness that would warrant immediate psychopharmacological intervention for tic disorder and/or comorbid condition
Comorbid psychopathology not appropriate for treatment, such as
Substance abuse or dependence within the past 3 months
Psychosis
Organic mental disorder
Current mania
Lifetime diagnosis of Pervasive Developmental Disorder
IQ equivalent of<80 on the Wechsler Abbreviated Scale of Intelligence
Those deemed to pose a serious suicidal or homicidal threat
Concurrent psychotherapy and/or failure to benefit from 10+ sessions of previous Cognitive-Behavioral Treatment
Recent adjustment/initiation of psychotropic medication (<8 weeks)
Clear my responses

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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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