Clinical trial NCT02900144: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tourette Syndrome
ADHD
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 17
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Patient Satisfaction Questionnaire
timeFrame: 26 weeks
measure: Expectancy Therapy Evaluation Form
timeFrame: Baseline
measure: Satisfaction Scale for Module 1
timeFrame: 1 week
measure: Expectancy Therapy Evaluation Form
timeFrame: 6 weeks
measure: Satisfaction Scale for Module 2
timeFrame: 2 weeks
measure: Satisfaction Scale for Module 3
timeFrame: 3 weeks
measure: Satisfaction Scale for Module 4
timeFrame: 4 weeks
measure: Satisfaction Scale for Module 5
timeFrame: 5 weeks
measure: Satisfaction Scale for Module 6
timeFrame: 6 weeks
measure: Satisfaction Scale for Module 7
timeFrame: 7 weeks
measure: Satisfaction Scale for Module 8
timeFrame: 8 weeks
measure: Satisfaction Scale for Module 9
timeFrame: 9 weeks
measure: Satisfaction Scale for Module 10
timeFrame: 10 weeks
measure: Satisfaction Scale for Module 11
timeFrame: 12 weeks
measure: Satisfaction Scale for Module 12
timeFrame: 14 weeks
measure: Patient Satisfaction Questionnaire
timeFrame: 6 weeks
measure: Patient Satisfaction Questionnaire
timeFrame: 14 weeks
Secondary outcomes:
measure: Yale Global Tic Severity Scale
timeFrame: Change from baseline to mid-point (6 weeks)
measure: Yale Global Tic Severity Scale
timeFrame: Change from baseline to end-point (14 weeks)
measure: Yale Global Tic Severity Scale
timeFrame: Change from baseline to 3months following end-point (26 weeks)
measure: Vanderbilt Assessment Scale - ADHD
timeFrame: Change from baseline to mid-point (6 weeks)
measure: Vanderbilt Assessment Scale - ADHD
timeFrame: Change from baseline to end-point (14 weeks)
measure: Vanderbilt Assessment Scale - ADHD
timeFrame: Change from baseline to 3months following end-point (26 weeks)
measure: Clinical Global Impression - Improvement Scale
timeFrame: Change from baseline to one week
measure: Clinical Global Impression - Severity Scale
timeFrame: Change from baseline to one week
measure: Clinical Global Impression - Improvement Scale
timeFrame: Change from baseline to two weeks
measure: Clinical Global Impression - Severity Scale
timeFrame: Change from baseline to two weeks
measure: Clinical Global Impression - Improvement Scale
timeFrame: Change from baseline to three weeks
measure: Clinical Global Impression - Severity Scale
timeFrame: Change from baseline to three weeks
measure: Clinical Global Impression - Improvement Scale
timeFrame: Change from baseline to four weeks
measure: Clinical Global Impression - Severity Scale
timeFrame: Change from baseline to four weeks
measure: Clinical Global Impression - Improvement Scale
timeFrame: Change from baseline to five weeks
measure: Clinical Global Impression - Severity Scale
timeFrame: Change from baseline to five weeks
measure: Clinical Global Impression - Improvement Scale
timeFrame: Change from baseline to six weeks (mid-point)
measure: Clinical Global Impression - Severity Scale
timeFrame: Change from baseline to six weeks (mid-point)
measure: Clinical Global Impression - Improvement Scale
timeFrame: Change from baseline to seven weeks
measure: Clinical Global Impression - Severity Scale
timeFrame: Change from baseline to seven weeks
measure: Clinical Global Impression - Improvement Scale
timeFrame: Change from baseline to eight weeks
measure: Clinical Global Impression - Severity Scale
timeFrame: Change from baseline to eight weeks
measure: Clinical Global Impression - Improvement Scale
timeFrame: Change from baseline to nine weeks
measure: Clinical Global Impression - Severity Scale
timeFrame: Change from baseline to nine weeks
measure: Clinical Global Impression - Improvement Scale
timeFrame: Change from baseline to ten weeks
measure: Clinical Global Impression - Severity Scale
timeFrame: Change from baseline to ten weeks
measure: Clinical Global Impression - Improvement Scale
timeFrame: Change from baseline to twelve weeks (session 11)
measure: Clinical Global Impression - Severity Scale
timeFrame: Change from baseline to twelve weeks (session 11)
measure: Clinical Global Impression - Improvement Scale
timeFrame: Change from baseline to fourteen weeks (session 12)
measure: Clinical Global Impression - Severity Scale
timeFrame: Change from baseline to fourteen weeks (session 12)
measure: Clinical Global Impression - Improvement Scale
timeFrame: Change from baseline to 3months after end-point (26 weeks)
measure: Clinical Global Impression - Severity Scale
timeFrame: Change from baseline to 3months after end-point (26 weeks)
measure: Pediatric Quality of Life Inventory (PedsQL)-Child Version
timeFrame: Change from baseline to mid-point (6 weeks)
measure: Pediatric Quality of Life Inventory (PedsQL)-Child Version
timeFrame: Change from baseline to end-point (14 weeks)
measure: Pediatric Quality of Life Inventory (PedsQL)-Child Version
timeFrame: Change from baseline to 3months following end-point (26 weeks)
measure: Parent Tic Questionnaire (PTQ)
timeFrame: Mid-point (6 weeks)
measure: Parent Tic Questionnaire (PTQ)
timeFrame: End-point (14 weeks)
measure: Parent Tic Questionnaire (PTQ)
timeFrame: 3months following end-point (26 weeks)
measure: ADHD - Self-report
timeFrame: Change from baseline to mid-point (6 weeks)
measure: ADHD - Self-report
timeFrame: Change from baseline to end-point (14 weeks)
measure: ADHD - Self-report
timeFrame: Change from baseline to 3months following end-point (26 weeks)
Other outcomes:
measure: Children's Yale-Brown Obsessive Compulsive Scale
timeFrame: Change from baseline to mid-point (6 weeks)
measure: Children's Yale-Brown Obsessive Compulsive Scale
timeFrame: Change from baseline to end-point (14 weeks)
measure: Children's Yale-Brown Obsessive Compulsive Scale
timeFrame: Change from baseline to 3months following end-point (26 weeks)
measure: Children's Depression Inventory
timeFrame: Change from baseline to mid-point (6 weeks)
measure: Children's Depression Inventory
timeFrame: Change from baseline to end-point (14 weeks)
measure: Children's Depression Inventory
timeFrame: Change from baseline to 3months following end-point (26 weeks)
measure: Emotion Regulation Questionnaire
timeFrame: Change from baseline to mid-point (6 weeks)
measure: Emotion Regulation Questionnaire
timeFrame: Change from baseline to end-point (14 weeks)
measure: Emotion Regulation Questionnaire
timeFrame: Change from baseline to 3months following end-point (26 weeks)
measure: Concomitant Medication and Therapy Questionnaire
timeFrame: 1 week
measure: Concomitant Medication and Therapy Questionnaire
timeFrame: 2 weeks
measure: Concomitant Medication and Therapy Questionnaire
timeFrame: 3 weeks
measure: Concomitant Medication and Therapy Questionnaire
timeFrame: 4 weeks
measure: Concomitant Medication and Therapy Questionnaire
timeFrame: 5 weeks
measure: Concomitant Medication and Therapy Questionnaire
timeFrame: 6 weeks
measure: Concomitant Medication and Therapy Questionnaire
timeFrame: 7 weeks
measure: Concomitant Medication and Therapy Questionnaire
timeFrame: 8 weeks
measure: Concomitant Medication and Therapy Questionnaire
timeFrame: 9 weeks
measure: Concomitant Medication and Therapy Questionnaire
timeFrame: 10 weeks
measure: Concomitant Medication and Therapy Questionnaire
timeFrame: 12 weeks
measure: Concomitant Medication and Therapy Questionnaire
timeFrame: 14 weeks
measure: The Caregiver Strain Questionnaire
timeFrame: Change from baseline to mid-point (6 weeks)
measure: The Caregiver Strain Questionnaire
timeFrame: Change from baseline to end-point (14 weeks)
measure: The Caregiver Strain Questionnaire
timeFrame: Change from baseline to 3months following end-point (26 weeks)
measure: Child Tourette's Syndrome Impairment Scale
timeFrame: Change from baseline to mid-point (6 weeks)
measure: Child Tourette's Syndrome Impairment Scale
timeFrame: Change from baseline to end-point (14 weeks)
measure: Child Tourette's Syndrome Impairment Scale
timeFrame: Change from baseline to 3months following end-point (26 weeks)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
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