Modified Comprehensive Behavioral Intervention for Tics (M_CBIT)

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Brief Title

Modified Comprehensive Behavioral Intervention for Tics (M_CBIT)

Official Title

Modified Comprehensive Behavioral Intervention for Tics: Treating Children With Tic Disorders, Co-occurring ADHD and Psychosocial Impairment

Brief 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. 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 Type

Interventional


Primary Outcome

Patient Satisfaction Questionnaire

Secondary Outcome

 Yale Global Tic Severity Scale

Condition

Tourette Syndrome

Intervention

Modified Comprehensive Behavioral Intervention for Tics

Study Arms / Comparison Groups

 Modified CBIT Treatment Arm
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

17

Start Date

September 2016

Completion Date

April 10, 2019

Primary Completion Date

April 10, 2019

Eligibility Criteria

        Inclusion Criteria:

          1. Have a DSM-5-based diagnosis of Tourette Syndrome or Persistent Motor or Vocal Tic
             Disorder

          2. 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.

          3. Tic disorder is the most problematic psychiatric disorder and the primary reason for
             seeking treatment

          4. 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

          5. Be male or female and between 10-17 years of age at the start of the treatment,
             inclusive

          6. 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

          7. Be English speaking

        Exclusion Criteria:

          1. 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

          2. 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)).

          3. Current illness (tics or otherwise) so severe that an immediate psychopharmacological
             evaluation is warranted

          4. Any clinical features requiring a higher level of care than outpatient (as determined
             by evaluator).

          5. 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.

          6. 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).

          7. Four or more sessions of previous CBT treatment similar to the current treatment (CBIT
             and/or CBT for ADHD) within the last five years

          8. 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.
      

Gender

All

Ages

10 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02900144

Organization ID

2016P001396


Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital


Study Sponsor

, , 


Verification Date

September 2021